Developing World Health Partnerships Directory (2010 Edition)

Transcription

The International Federation of Pharmaceutical Manufacturers & Associations is the
global non-profit NGO representing the research-based pharmaceutical industry,
including the biotech and vaccine sectors. Its members comprise 25 leading
international companies and 45 national and regional industry associations covering
developed and developing countries. The industry’s R&D pipeline contains hundreds
of new medicines and vaccines being developed to address global disease threats,
including cancer, heart disease, HIV/AIDS and malaria. The IFPMA Clinical Trials
Portal (www.ifpma.org/ClinicalTrials), the IFPMA’s Ethical Promotion online resource
(www.ifpma.org/EthicalPromotion/) and its Developing World Health Partnerships
Directory (www.ifpma.org/HealthPartnerships) help make the industry’s activities
more transparent. The IFPMA supports a wide range of WHO technical activities,
notably those relating to medicine efficacy, quality and safety, and coordinates
industry participation in the WHO IMPACT initiative to combat counterfeit medicines.
It also provides the secretariat for the International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
The program information in this book is also available in searchable form in the
IFPMA website, at www.ifpma.org/healthpartnerships, and on the Global Health
Progress website www.globalhealthprogress.org.
Developing World
Health Partnerships Directory
Chemin Louis-Dunant 15
Tel: +41 22 338 32 00
P.O. Box 195
Fax: +41 22 338 32 99
1211 Geneva 20
E-mail: [email protected]
Switzerland
Web: www.ifpma.org
© 2010 IFPMA P-0024-1 (EN)
2010
Developing World
2010
Cover photo: A few Children are waiting for medicine and hold a cup in their hands, Madagascar, Merck Praziquantel Donation Program.
Table of Contents
7
Introduction
HIV/AIDS
8
HIV/AIDS – ARV Access
10
AAI - Accelerating Access Initiative
Abbott Program for Expanding Access to Treatment
Boehringer Ingelheim Access
Bristol-Myers Squibb Global Access Program
Gilead Access Program
Merck & Co., Inc. Access to ARVs
Roche - Access to ARVs
Single Tablet per Day: Atripla® Fixed-Dose Combination
Technology Transfer & ARV Licensing in Developing Countries
ViiV Healthcare Access to ARVs
10
10
11
11
12
12
13
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14
15
HIV/AIDS – Mother & Child Programs
16
Abbott Fund Program for Supporting Children Affected by AIDS
Bristol-Myers Squibb’s Secure The Future® Children’s Clinics & Pediatric AIDS Corps
Elizabeth Glaser Pediatric AIDS Foundation
Empowering Africa’s Young People Initiative
End Violence against Women and Prevent HIV and AIDS Program
Life Skills: Community Support for Children Affected by HIV/AIDS
Mothers 2 Mothers Mentoring Program
Nyumbani Children’s Home
PMTCT: Abbott Rapid HIV Test Donation Program
Regional Psychosocial Support Initiative
Roche Children’s Walk
Women and Families Initiative
16
16
17
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18
18
19
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20
20
21
21
HIV/AIDS – Capacity Building
22
Abbott Fund Program to Strengthen Tanzania’s Health Care System
African Comprehensive HIV/AIDS Partnerships (ACHAP)
Associação Saude Da Familia HIV/AIDS Awareness
AstraZeneca & AMREF: An Integrated Approach to Managing HIV/AIDS, Malaria & TB in Uganda
Bristol-Myers Squibb’s Secure The Future®
Collaboration for Health in Papua New Guinea (CHPNG)
GlaxoSmithKline- Other HIV/AIDS Capacity-Building Initiatives
Health at Home/Kenya
HIV South Africa
Humana: Total Control of the Epidemic
IMIFAP: HIV/AIDS Education
J&J Health Care Training Fund
J&J - UCLA Management Development Institute
JPMA’s HIV/AIDS Training Program
Medical Mission Sisters
Merck & Co., Inc. HIV/AIDS Programs - Africa
Merck & Co., Inc. HIV/AIDS Programs - Caribbean
Merck & Co., Inc. HIV/AIDS Programs - China
Merck & Co., Inc. HIV/AIDS Programs - Latin America
Nawa Sport Program
Pfizer Diflucan® Partnership
Pfizer Global Health Fellows
Pfizer - Infectious Diseases Institute
Pfizer - PDA Positive Partnership
Saber para Reagir
Sikiliza Leo Project, Uganda
Takeda Initiative with Global Fund
Tibotec Cost Recovery Distribution Program
ViiV Healthcare’s Positive Action on HIV/AIDS
‘Youth Speak-Up!’ HIV Peer Education
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Developing World Health Partnerships Directory © IFPMA 2010 – www.ifpma.org/healthpartnerships
HIV/AIDS – R&D
37
Gilead Clinical Development Partnerships
HIVACAT public-private partnership for HIV vaccine development
International AIDS Vaccine Initiative (IAVI)
International Partnership for Microbicides (IPM)
Merck & Co., Inc. HIV Vaccine R&D
Pediatric Formulations for ARVs
PEPFAR Partnership for Pediatric AIDS Treatment
ViiV Healthcare Collaborative Research Program for Resource-Poor Settings
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41
TUBERCULOSIS
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TUBERCULOSIS – Access & Capacity Building
44
AstraZeneca & Red Cross: Fight against TB in Africa
AstraZeneca & Red Cross: Fight against TB in Central Asia
Lilly MDR-TB Partnership
Novartis TB DOTS Donation
Sanofi-aventis: TB Free & Other Initiatives
Stop TB Partnership
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45
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46
TUBERCULOSIS – R&D
47
Aeras Global TB Vaccine Foundation
AstraZeneca Bangalore Research Institute
GlaxoSmithKline - TB Alliance Drug Discovery Program
Global Alliance for TB Drug Development (TB Alliance)
Lilly TB Drug Discovery Initiative
Moxifloxacin TB Clinical Trials (Bayer HealthCare)
Novartis Institute for Tropical Diseases (NITD)
Otsuka Pharmaceutical: MDR-Tuberculosis R&D
Ranbaxy R&D for TB
Sanofi-aventis: R&D for TB
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47
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51
MALARIA
52
MALARIA – Access & Capacity Building
54
ACCESS II - Improving Access to Effective Malaria Treatment
GlaxoSmithKline & Access to Malaria Care
Millennium Villages Project
Novartis Coartem®
Pfizer - Mobilize Against Malaria
Roll Back Malaria Partnership
Sanofi-aventis: Impact Malaria
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MALARIA – R& D
58
Crucell’s Malaria Vaccine R&D
Medicines for Malaria Venture (MMV)
Eisai Exploratory Research for the Treatment of Malaria
Eurartesim™ International Development Program
GlaxoSmithKline & Malaria R&D
Novartis R&D for Malaria
PATH Malaria Vaccine Initiative (MVI)
Pfizer - Azithromycin/chloroquine for Malaria
Ranbaxy R&D for Malaria
Sanofi-aventis - DNDi Malaria Medicine
Sanofi-aventis - Semisynthetic Artemisinin Project
TLR9 Inhibitor for Cerebral Malaria
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3
TROPICAL DISEASES
62
TROPICAL DISEASES – Access & Capacity Building
64
Bayer HealthCare & African Sleeping Sickness
Bayer HealthCare: Fight Against Chagas Disease
Children Without Worms
Gilead - AmBisome for Leishmaniasis
Global Alliance to Eliminate Lymphatic Filariasis (GAELF)
Guinea Worm Eradication Program (GWEP)
International Trachoma Initiative (ITI)
Leprosy Elimination
Merck Mectizan® Donation Program
Merck Praziquantel Donation Program
Sanofi-aventis Sleeping Sickness Program
Sanofi-aventis ‘Most Neglected Diseases’ Program
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TROPICAL DISEASES – R&D
72
Eisai - DNDi Chagas R&D Collaboration
GlaxoSmithKline - DNDi Collaboration
GlaxoSmithKline Proprietary Knowledge Pool
GlaxoSmithKline’s Sitamaquine for Leishmaniasis
GlaxoSmithKline’s Tres Cantos Open Lab for DDW R&D
Merck & Co., Inc. – DNDi Master Agreement
Merck Serono Collaboration with TDR
Next-Generation Onchocerciasis Treatment R&D
Nifurtimox-Eflornithine for Sleeping Sickness with TDR
Pfizer Collaborative Programs for Parasitic & Worm Diseases
Ranbaxy R&D for Dengue
Singapore Dengue Consortium
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PREVENTABLE DISEASES
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PREVENTABLE DISEASES – Access & Capacity Building
80
Bristol-Myers Squibb Foundation: Delivering Hope
GAVI Alliance
Global Polio Eradication Initiative
HPV Vaccine & Cervical Cancer
Merck Vaccine Network - Africa (MVN-A)
Pandemic Influenza & Developing Countries
Pneumococcal Conjugate Vaccine Programs
Rotavirus Vaccine Program
Sanofi-aventis & EPIVAC
Sigma-Tau & AMREF: ‘Uganda Project’
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PREVENTABLE DISEASES – R& D
86
Crucell Vaccine Research
Infectious Disease Research Institute (IDRI)
MSD-Wellcome Trust Hilleman Laboratories
Novartis Vaccines Institute for Global Health (NVGH)
Pediatric Dengue Vaccine Initiative (PDVI)
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4
CHILD & MATERNAL HEALTH
CHILD & MATERNAL HEALTH – Access & Capacity Building
Abbott Fund Program to Fight Malnutrition in Vietnam
Abbott Fund Program to Improve Children’s Health in Cambodia
Abbott Fund Program to Improve Children’s Health in the Democratic Republic of Congo
Abbott Fund Program to Improve Maternal & Child Health in Afghanistan
Arpana Research and Charitable Trust
Bayer Schering Pharma & Family Planning
Bidan Delima Midwife Training Program
Computerized Training for Management of Childhood Diseases
Freedom of Breath, Fountain of Life
Fuyang AIDS Orphan Salvation
Ghazipur Children’s Hospital
GlaxoSmithKline & Integrated Management of Childhood Illness
GlaxoSmithKline: Namibia Sanitation & Hygiene Program
GlaxoSmithKline’s Midwife Training in Vietnam
GlaxoSmithKline’s PHASE Program
Global Campaign to End Fistula
Global Fund for Women
Home-Based Newborn Care (HBNC) Initiative
Integrated Midwives Association of the Philippines
International Rescue Committee
It’s Worth Dreaming Project
Pankararu Health & Culture Project
Ranbaxy Community Health Care Society
Renascer: Helping Poor Mothers in Brazil
Safe Motherhood Initiative
Sanofi-aventis Children’s Programs
Save the Children
Unamos al Mundo por la Vida
CHRONIC DISEASES
90
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CHRONIC DISEASES – Access & Capacity Building
108
Abbott Fund Program to Improve Cardiac Care in Rwanda
Abbott Program to Advance Diabetes Care in Bolivia
AstraZeneca Breast Cancer Program in Ethiopia
Bayer HealthCare Nexavar® Access Program
Cancer Awareness Leadership Initiative (CALI)
Changing Diabetes in Children
China Diabetes Education Program
Circle of Care: Mental Health in Malaysia
Glivec® International Patient Assistance Program (GIPAP™)
Hypertension Program in China
IDF BRIDGES Program
India Diabetes Educator Project
Novo Nordisk: Differential Pricing on Insulin
Novo Nordisk: Haemophilia Foundation
Novo Nordisk: World Partner Project
Piramal: HelpyourbodyTM Chronic Disease Campaign
Pfizer Global Health Partnerships
Sanofi-aventis: Diabetes Prevention
Sanofi-aventis: Impact Epilepsy Program for Developing Countries
Sanofi-aventis: Mental Health Disorders (Schizophrenia)
Sanofi-aventis: My Child Matters
Staying Away from Tobacco for a Healthy Life
The World Diabetes Foundation
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5
ADDITIONAL HEALTH INITIATIVES
120
ADDITIONAL HEALTH INITIATIVES – Access & Capacity Building
122
Arogya Parivar Program - A Rural Health Initiative
AstraZeneca Product Donations
Boehringer Ingelheim Cares Foundation
Boehringer Ingelheim: Strengthening Healthcare Capacity
Bristol-Myers Squibb Medical Product Donations
Ghana Surgical Skills Training Center
GlaxoSmithKline & Leonard Cheshire Disability in Sri Lanka
GlaxoSmithKline: Nurse Training in Tamil Nadu
GlaxoSmithKline: Reinvestment in LDC Communities
GlaxoSmithKline: Saloum Islands Health Project, Senegal
Global Pharma Health Fund
Health Training at Egypt’s National Training Institute
Healthy Communities, Healthy Ecosystems
Initiative Accès: Access to Primary Health Care in Mali
Johnson & Johnson Burn Treatment Center (JJBTC) in Soweto
JPMA: Anti-Counterfeiting Program in Cambodia
JPMA: Strengthening Quality Control in Asia
LEEM Quality Control Program
Medical Product Donations Fellowship Program
Merck Medical Outreach Program
Nurse Training in East Africa
Nurse Training in Somalia
Red Cross Children’s Hospital, Cape Town
Regional Hospital Management Program
Otsuka Welfare Clinic
Phelophepa Healthcare Train
Roche Employee Secondment
Tanzanian Training Center for International Health
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135
DDITIONAL HEALTH INITIATIVES
EMERGENCY RELIEF EFFORTS
96
136
COMPLETED PROGRAMS
141
Note: “Merck & Co., Inc.” has its headquarters in Whitehouse Station, NJ, USA and operates in most countries outside the USA as Merck Sharp & Dohme. “Merck KGaA” has its
headquarters in Darmstadt, Germany. “Bayer Schering Pharma AG”, with its headquarters in Berlin, Germany, is a division of “Bayer HealthCare AG”, which has its headquarters in
Leverkusen, Germany. Merck & Co. Inc., Merck KGaA and Bayer HealthCare are all members of the IFPMA.
Merck & Co., Inc. and Schering-Plough merged in 2009, while Pfizer acquired Wyeth. Merck & Co., Inc. and Pfizer remain members of the IFPMA.
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline and Pfizer to deliver advances in treatment and care for people living with HIV.
6
INTRODUCTION
The research-based pharmaceutical industry implements a wide and growing range of access and capacity building
programs to help improve health in developing countries. It is also the third largest funder of R&D for diseases of the
developing world. These programs are documented in this directory, which exists as an electronic book and as a
searchable online database at www.ifpma.org/healthpartnerships.
Many industry programs are focused on one or more of the health-related UN Millennium Development Goals: MDG 4)
reduce child mortality, MDG 5) improve maternal health, MDG 6) combat HIV/AIDS, malaria and other diseases and MDG
8E) provide access to affordable, essential drugs in developing countries. However, there are also industry programs helping to address other developing world health issues, such as the growing burden of chronic diseases, or strengthening
primary care.
In the 2010 edition, we document a total of 213 programs, up from 202 last year. In fact, the total number of industry
programs has continued to grow year on year since we started recording them in 2003. In that year, we listed 36 programs, in HIV/AIDS, tuberculosis, malaria and tropical diseases. Today, the number of programs for those 4 disease areas
alone has grown to 119, but we have had to expand the directory to capture the growing number of programs to address
other health needs, including preventable diseases, child and maternal health, chronic diseases and additional health initiatives. The latter do not address a single disease or disease area, but rather aim at strengthening overall health care.
Japanese companies have contributed to this growth. Eisai has notified two new R&D partnerships for malaria and one
for Chagas disease, while Takeda started a capacity building program with the Global Fund to fight AIDS, Tuberculosis
and Malaria.
Also contributing to the increased tropical disease R&D effort was Merck & Co., Inc. through a new master agreement
with DNDi covering Chagas disease, leishmaniasis and other diseases. GlaxoSmithKline also played a part, through its
new Proprietary Knowledge Pool and Tres Cantos Open Lab initiatives.
Listed in the Directory for the first time this year is a Quality Control program run by the IFPMA’s member association in
France, LEEM, which offers expert analytical resources to help poorly resourced African countries to fight counterfeit and
substandard medicines.
The contribution of the research-based pharmaceutical industry to R&D for diseases of the developing (DDW) world is
substantial. The end of 2009 saw the publication of the second G-FINDER report on funding for DDW R&D, covering the
year 2008. Once again, our industry was the third largest source of funding for R&D for these diseases, after the US
Government and the Bill and Melinda Gates Foundation. Complementary IFPMA data shows that the number of DDW
medicine R&D projects undertaken by our companies continues to increase, from 32 in 2005 to 75 in 2009.
Our industry’s strong and sustained commitment to help improve health in developing countries is underlined by the
further increase in the number of industry programs in 2009. In particular, our industry is playing an important and growing
role in the development of new medicines and vaccines for diseases of the developing world, including ones focused
primarily on addressing children’s health problems. Our companies are willing to enter into new partnerships to help
improve global health and the IFPMA is pleased to help bring together potential partners in this area.
Eduardo Pisani
Director General
IFPMA
7
HIV/AIDS
Western and
Central Europe
13,000
North America
25,000
Caribbean
12,000
Latin America
77,000
Estimated adult and child deaths from AIDS during 2008
(Source: UNAIDS/WHO AIDS Epidemic Update, 2009
8
An estimated 33.4 million people were living with HIV in 2008. There
were 2.7 million new HIV infections and 2 million AIDS-related
deaths.
AIDS continues to be the leading cause of death in Africa which is
home to 67% of all people living with HIV. In Africa, 60% of people
living with HIV in the region are women and three out of four young
people living with HIV are female. Nearly 2 million children live with
HIV worldwide, two-thirds in sub-Saharan Africa. In addition, 12
million children in sub-Saharan Africa have lost one or two parents
due to HIV/AIDS. Many more live with a parent or carer with HIV.
As of December 2008, approximately 4 million people in low- and
middle-income countries were receiving antiretroviral therapy - a
10-fold increase over five years. Antiretroviral therapy coverage
rose from 7% in 2003 to 42% in 2008, with especially high
coverage achieved in eastern and southern Africa (48%) While the
rapid expansion of access to antiretroviral therapy is helping to
lower AIDS-related death rates in multiple countries and regions, it
is also contributing to increases in HIV prevalence.
the drop in new HIV infections among children in 2008 suggests
that these efforts are saving lives. Although current estimates of
coverage of antiretroviral therapy for children are close to those
of adults, the provision of antiretroviral therapy to children has
specific challenges, including the faster progression to AIDS
and death, the difficulty of diagnosing HIV in children and the
challenges in developing affordable and appropriate antiretroviral
regimens for children. Despite substantial progress in 2008, most
low- and middle-income countries are still far from achieving
universal access goals. Obstacles include weak health care
systems, a critical shortage of human resources and a lack of
sustainable, long-term funding.
Pharmaceutical research and biotechnology companies are
continuing their efforts to develop more effective new therapies
and vaccines to contain the disease and improve and lengthen
the lives of patients. In 2009, they were testing 97 medicines and
vaccines to treat and prevent HIV/AIDS and related conditions. A
total of 31 medicines to treat HIV/AIDS have been approved since
the virus was first identified in 1983.
Globally, coverage for services to prevent mother-to-child HIV
transmission (PMTCT) rose from 10% in 2004 to 45% in 2008, and
(Sources: UNAIDS/WHO AIDS Epidemic Update 2009; PhRMA 2009 Report: Medicines in Development for HIV/AIDS)
East Asia
59,000
Middle East
and North Africa
20,000
Eastern Europe
and Central Asia
87,000
South and
South-East Asia
270,000
Sub-Saharan
Africa
1.4 million
Oceania
2,000
Total AIDS deaths in 2008: 2 million
9
AAI - Accelerating Access Initiative
Abbott Program for Expanding Access to Treatment
HIV/AIDS
Abbott, Boehringer Ingelheim, Bristol-Myers Squibb,
Merck & Co. Inc., Roche, Tibotec, ViiV Healthcare
UNAIDS, UNFPA, UNICEF, WHO, World Bank
Since 2000
Access - Pricing & Tech Transfer
Developing countries
www.who.int/hiv/AAI_fs_4Q2005.pdf
HIV/AIDS
Abbott
Various partners
Since 2001
Access - Pricing
Africa, LDCs, low & lower-middle income countries
www.abbottglobalcare.org
The Accelerating Access Initiative (AAI), begun in 2000, is a partnership between UNAIDS, the World Health Organization (WHO), the
UN Children’s Fund (UNICEF), the UN Population Fund (UNFPA), the
World Bank and seven research-based pharmaceutical companies
(Abbott, Boehringer Ingelheim, Bristol-Myers Squibb, Merck & Co.,
Inc., Roche, Tibotec (an affiliate of Johnson & Johnson) and ViiV
Healthcare, which combines the HIV medicine operations of
GlaxoSmithKline, Pfizer. Participants in AAI are committed to working with governments, international organizations and other stakeholders to find ways to broaden access, whilst ensuring rational, safe
and effective use of medicines for HIV/AIDS.
Abbott has a longstanding commitment to the fight against HIV/AIDS
and has implemented five practical measures to ensure the company’s medicines are as broadly available as possible:
The strong commitment of the AAI companies to improve access to
treatment has manifested itself in many innovative ways. All AAI companies have individual programs through which they provide their
own antiretroviral medicines at more affordable prices in developing
countries. Some AAI companies have also expanded manufacturing
capacity to meet product demand in the developing world. Individual
AAI companies are also taking other actions to increase the overall
availability of ARVs, including the granting of voluntary licenses or
non-assert declarations, contract manufacturing with generic manufacturers and technology transfer agreements. These efforts are
delivering results. As of 30 September 2008, some 773,803 patients
in developing countries were estimated to be taking one or more
medicines supplied at preferential prices by an AAI company. In addition, the number of patients in developing countries treated with
generic ARVs - including those through cooperative efforts with AAI
companies - has increased significantly.
AAI companies also recognize that expanded access to medications
requires a collaborative approach with governments, NGOs, multilateral organizations, and other public and private bodies. Many AAI
companies are involved in initiatives to strengthen healthcare systems, streamline product registrations, and conduct clinical studies
in developing countries. AAI companies also continue to invest significantly in research and development of new medications - including pediatric formulations - and diagnostics, to help combat the
global HIV/AIDS pandemic.
• Innovation with the Needs of the Developing World in Mind: Abbott
developed the lopinavir/ritonavir tablet, the only co-formulated protease inhibitor tablet that does not require refrigeration and can be
taken with or without food – two important advances in delivering
HIV medicine, especially in developing countries.
• Broad Registration: The heat-stable tablet formulation of
lopinavir/ritonavir has been filed, is available or has been approved
in 170 countries. The new, lower-strength tablet formulation of
lopinavir/ritonavir, which is suitable for pediatric use, has been
filed, is available or has been approved in 124 countries. Abbott
intends to make the lower-strength tablet available or approved in
every country where the adult tablet is available.
• In January 2010, Abbott received approval for a new, heat-stable
tablet formulation of its protease inhibitor ritonavir, and the company intends to register the new ritonavir tablet as broadly worldwide as the lopinavir/ritonavir tablet.
• Commitment to the Treatment of Children with HIV: Abbott has a
longstanding commitment to the treatment of children with HIV.
The company has made the liquid formulation of lopinavir/ritonavir
available in the developing world since 2001. The new, lowerstrength lopinavir/ritonavir tablet complements the liquid formulation and was first launched in Africa in 2007, even before it was
available in developed countries.
• Investment in Consistent Quality Manufacturing: Abbott has
invested hundreds of millions of dollars in the development of the
heat-stable tablet formulations and sufficient manufacturing
capacity to ensure they can be supplied to all who need them at
universally high quality standards.
• Affordable Pricing: Since 2002, our HIV medicines have been available in all 69 African and least developed countries at prices that
are among the lowest for branded or generic protease inhibitors.
• Philanthropic Measures: As part of the company's broad efforts to
expand access to health care, Abbott and the company's philanthropic foundation, the Abbott Fund, have invested more than
USD 175 million to improve the lives of more than 1 million people
affected by HIV/AIDS in Africa and elsewhere in the developing
world.
10
Boehringer Ingelheim Access
Bristol-Myers Squibb Global Access Program
HIV/AIDS
Boehringer Ingelheim
Governments in most recipient countries
Since 2000
Access - Donation & Pricing
59 developing countries
www.boehringer-ingelheim.com
HIV/AIDS
Bristol-Myers Squibb
Various partners, including Health Ministries
Since 2001
Access - Pricing
Africa & least developed countries
www.bms.com
As part of its policy to extend access to Viramune®, since 2000
Boehringer Ingelheim offers its antiretroviral product Viramune®
(nevirapine) for single-dose use in the prevention of mother-to-child
transmission (PMTCT) for free through the Viramune® Donation
Program. So far, around 1.9 million mother/child doses have been
made available to 170 programs in 60 countries.
The goal of the Bristol-Myers Squibb Global Access program is to
enable broad access to the company’s HIV medicines at no-profit
prices in the regions most impacted by HIV and with limited ability to
pay, notably sub-Saharan Africa. The Global Access program is
based on three essential pillars of activity and policy: 1) no-profit pricing policy; 2) patent policy; and 3) efforts to enable generic manufacturing. Information on the latter two activities can be found below
under the heading “ARV Licensing in Developing Countries”.
Viramune® should be administered with additional anti-retroviral
medicine as recommended by actual WHO guidelines. Recent studies suggest that in women and infants previously treated with singledose nevirapine for prevention of mother-to-child-transmission of
HIV-1, the efficacy of subsequent Viramune® combination therapy
may be reduced.
For chronic treatment, Boehringer Ingelheim charges a substantially
reduced price for all countries classified by the World Bank as low
income, all Least Developed Countries according to UN definition
and for all countries in sub-Saharan Africa - a total of 74 countries.
In addition, all middle income countries qualify for a lowered price (67
countries).
For more information on the company’s other HIV/AIDS activities,
see the HIV/AIDS - Mother & Child Programs section, ARV Licensing
in Developing Countries (non-assert declarations) and Additional
Health Initiatives.
In 2001, BMS announced that it would provide all of its HIV medicines at no-profit prices in sub-Saharan Africa, because of the
extreme burden of disease there, combined with the region’s limited
ability to pay for HIV medicines. In July 2005, the company
announced a further reduction in the price of pediatric formulations
from no-profit to significantly below cost in an attempt to reduce all
barriers hampering accelerated, broad access to treatment for the
millions of children in sub-Saharan Africa who need these medicines
most. BMS has also implemented a differential pricing policy globally, to enable collaboration with and support for government activities
in regions with high incidence and low ability to pay for HIV
medicines.
Lamvelase Clinic in Swaziland is supported by EGPAF
and provides various services for its community.
(Keri Oberg, Boehringer Ingelheim)
11
Gilead Access Program
Merck & Co., Inc. Access to ARVs
HIV/AIDS
Gilead
Various partners
Since 2003
Access - Pricing
Least-developed countries
www.gilead.com
HIV/AIDS
Merck & Co. Inc.
Various governments & NGOs
Since 2001
Access - Pricing
www.merck.com
Gilead Sciences, Inc. is committed to providing access to its HIV
medicines to all patients who need them worldwide, regardless of
income or geography. Gilead has developed a tiered pricing system
for its HIV medicines, including Viread® (tenofovir disoproxil
fumarate) and Truvada® (emtricitabine and tenofovir disoproxil
fumarate), based on a country’s economic status and HIV prevalence. It offers substantial price reductions through its Access
Program in 130 countries, representing two-thirds of the countries in
the world, and the regions hardest hit by the AIDS epidemic.
Since 2001, Merck & Co., Inc. has had a tiered pricing policy whereby it provides its antiretroviral medicines (ARVs) at access prices in
least developed countries and those hardest hit by the AIDS pandemic. The offer extends to the governments of these countries, as
well as to international donor agencies, non-governmental organizations (NGOs), charitable organizations and private-sector employers.
Gilead has established an international network of distributors,
whose local knowledge helps to accelerate country-level regulatory
approval of its medicines. These distributors also provide local outreach and on-the-ground logistics, and help ensure secure distribution of Gilead’s HIV medicines in the developing world.
Merck’s ARV pricing policy applies to all of the company’s ARVs:
Crixivan™, Stocrin™, Atripla™ and Isentress™. For each product,
Merck offers its lowest price - a price at which Merck does not
profit - to the world’s least developed countries and those countries
hardest hit by the HIV/AIDS pandemic, as measured by adult HIV
prevalence. Countries with a higher degree of economic development and/or lower prevalence rate receive a significantly discounted
price, within a price band. The price at which patients and countries
can obtain their ARVs are based on their relative level of economic
development, relative burden of disease, the degree to which the
governments are committed to treating its HIV-infected population
and the value that the Merck ARV plays in the local marketplace and
treatment regimen. For the most economically-developed countries,
Merck applies competitive, market-based principles in pricing its
ARV products.
Merck believes that the most relevant measure of the success of its
ARV access strategy is the number of patients treated, and where
they are treated (developing versus developed countries). As of
December 31, 2008, 653,867 patients in 131 countries and territories were being treated with regimens containing at least one of
Merck’s ARVs. Three out of four (76 percent) – or an estimated
498,845 patients – obtained these ARVs in the more than 80 countries in which Merck sells them at a price at which the company does
not profit. An additional 9% received Merck ARVs in countries where
they are offered at significantly discounted prices. Nine out of 10
patients using Merck ARVs live in developing countries in Africa,
Asia, Latin America and the Caribbean, where the pandemic is having its most devastating impact. Of those being treated with Merck
ARVs, there are an estimated 111, 471 children using pediatric formulas, representing 17% of all patients on Merck ARVs.
12
Roche - Access to ARVs
Single Tablet per Day: Atripla® Fixed-Dose
Combination
HIV/AIDS
Roche
Various partners
Since 2002
Access - Pricing
All low & lower-middle income countries
www.roche.com
HIV/AIDS
Bristol-Myers Squibb, Gilead, Merck & Co. Inc.
Ministries of Health
Since 2003
Access - Pricing
www.bms.com, www.gilead.com, www.merck.com
In 2002, Roche recognized that, as efforts to scale up the number of
people on first-line therapy in resource-limited countries became
successful and greater numbers of people received treatment, the
need for second-line treatment options would also become increasingly important. In response, Roche committed to innovative, transparent policies to remove barriers to its second-line HIV protease
inhibitor medicines in countries where resources are fewest and the
need for treatment is greatest.
Combinations of different ARVs are used to treat people living with
HIV/AIDS to reduce the risk of them developing resistance. Atripla®
- the first once-daily single tablet regimen for the treatment of HIV
infection in adults - is a fixed-dose combination of the non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz, and the nucleoside reverse transcriptase inhibitors (NRTIs) emtricitabine and tenofovir disoproxil fumarate. Efavirenz is marketed by Bristol-Myers
Squibb as Sustiva® and by Merck & Co., Inc. as Stocrin®.
Emtricitabine and tenofovir disoproxil fumarate are commercialized
by Gilead Sciences under the tradenames Emtriva® and Viread®.
Roche supplies its HIV protease inhibitors, Invirase® and Viracept®
(including pediatric powder), at no profit prices for people living in
Least Developed Countries (as defined by the United Nations) and in
sub-Saharan Africa. These prices are the lowest at which these medicines can be provided in a sustained, long-term manner, and have
been shown to be similar or less than that of generic versions of the
medicine.
In addition, Roche established significantly reduced pricing for
Invirase® and Viracept® for low and lower middle income countries
(as defined by the World Bank), where there is need for access to
HIV/AIDS treatments, and where local governments are able to play
a greater role and make a more significant contribution towards the
provision of public healthcare.
The reduced prices apply to 86% of all people living with HIV/AIDS
worldwide.
Atripla® was developed by Bristol-Myers Squibb and Gilead and
approved by the US FDA in July 2006, Health Canada in October
2007 and the European Commission in December 2007. On January
15, 2008, the WHO granted Atripla® prequalification status.
In August 2006, Gilead and Merck announced an agreement for the
distribution of Atripla® in 106 developing countries around the world
where convenient treatment options are critical to patient compliance
and adherence to therapy. Gilead is manufacturing Atripla® using
efavirenz supplied by Merck, and Merck is distributing Atripla® in
these markets. In all of these countries, Atripla® is being sold at significantly discounted prices. As of 1 April 2008, 55 countries - including most in sub-Saharan Africa - had either granted regulatory
approval for Atripla® or allowed the product to be imported. Tens of
thousands of patients are already benefitting from this first-of-its-kind
fixed dose combination ARV.
13
Technology Transfer & ARV Licensing
in Developing Countries
HIV/AIDS
Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, GlaxoSmithKline,
Merck & Co. Inc., Roche
Various generic pharmaceutical manufacturers
Since 2001
Access – Tech Transfer
Kenya, India, South Africa
www.boehringer-ingelheim.com, www.bms.com, www.gilead.com,
www.gsk.com, www.merck.com, www.roche.com
Pharmaceutical companies’ preferential pricing of antiretrovirals
make effective, safe, high quality HIV/AIDS treatments available to
developing countries. In some cases, companies also issue voluntary
licenses (VLs) which allow local manufacturers in developing countries to produce and sell generic versions of their products. VLs are
not a universal solution to HIV/AIDS but a response to specific circumstances. Local factors encouraging VL use include a severe
HIV/AIDS epidemic, adequate health care infrastructure, suitable
economic conditions and sufficient manufacturing expertise. Local
manufacturers must ensure a long-term supply of good-quality medicines and implement safeguards to prevent diversion of medicines
to wealthier markets.
Along with its policy to expand access to nevirapine in Least
Developed Countries, low income countries and all countries in
Africa, Boehringer Ingelheim offers a non-assert declaration to all
WHO pre-qualified manufacturers, stating that it will not enforce its
nevirapine patent rights in these countries, in order to ensure supply
at lowest possible cost. To date, eleven generic producers benefit
from the non-assert declaration. The policy reinforces the need to
allow only high-quality products to be distributed in developing countries.
Since 2001, Bristol-Myers Squibb has had a policy of not enforcing
its patents for HIV products in sub-Saharan Africa and has immunity
from suit agreements with eleven African generic companies for
stavudine and didanosine and three for atazanavir. In February 2006,
it concluded technology transfer agreements with generic companies Aspen PharmaCare (South Africa) and Emcure Pharmaceuticals
(India), for its newest antiretroviral, atazanavir (sold as Reyataz® in
the US). Bristol-Myers Squibb has transferred intellectual property
and technical know-how related to the manufacturing, testing, packaging, storage and handling of the active pharmaceutical ingredient
and finished dosage form.
Gilead has partnered with Aspen Pharmacare, South Africa to manufacture and distribute branded and generic versions of Viread® and
Truvada® in Africa. Gilead has entered into non-exclusive licensing
agreements with 13 Indian generic companies, allowing them to distribute generic versions of tenofovir and tenofovir-based regimens in
95 developing countries, including India, South Africa and Thailand.
The agreements include technology transfer to ensure high-quality
products. The generic companies are free to establish their own pricing for their products, as Gilead believes this will ensure competitive
pricing and the broadest access possible for patients. Gilead
receives a five percent royalty on finished product sales. These Indian
generic manufacturers have received a combined 10 tentative
approvals through the U.S. Food and Drug Administration and two
prequalifications by the World Health Organization. Most importantly, more than 700,000 patients are now receiving Gilead’s medicines
and more than half of these patients are receiving high-quality, lowcost generic versions of Gilead’s medicines.
14
GlaxoSmithKline granted its first voluntary license in 2001. Now
under the auspices of ViiV Healthcare, the number of licenses has
been extended to eight royalty free licensing agreements for ViiV
Healthcare’s ARVs to all of sub-Saharan Africa. Since August 2007
ViiV Healthcare has allowed Apotex, a Canadian company, to manufacture a generic fixed-dose combination ARV, containing two molecules over which ViiV Healthcare has patent rights, for the treatment
of HIV/AIDS in Rwanda. This consent was granted under Canada’s
Access to Medicines Regime which reflects the WTO ‘31f’ agreement. This enables governments to authorize the production of certain patented medicines for export. ViiV Healthcare agreed to waive
royalties on the basis that Apotex’s triple combination generic ARV
will be supplied on a not-for-profit basis. ViiV Healthcare’s licensees
supplied 439 million tablets of their versions of Epivir® and
Combivir® to Africa in 2009. This represents more than 60% growth
over 2008. This trend is welcome as it gives customers in subSaharan Africa greater choice and contributes to better security of
supply.
Merck & Co., Inc. is committed to seeking additional ways to reduce
the cost of its ARVs and increase access for people living in the
world’s poorest countries and those hardest hit by the pandemic,
including through working with external manufacturers and suppliers
to achieve incremental efficiencies. In addition, to date Merck has
granted royalty-free licenses of its ARV efavirenz to five generic manufacturers, of which four are currently on the market. All but one
licensee donates a percentage of efavirenz net sales to Msizi (Cares)
Trust, a charitable trust established to further the fight against
HIV/AIDS in South Africa through the provision of preventative and
educational programs.
Roche has committed not to file any new patents or enforce existing
patents for any of its medicines in the UN-defined Least Developed
Countries. Nor will it enforce existing patents for its antiretrovirals in
sub-Saharan Africa. As a result, generic versions of ARVs can be
produced in these countries, encompassing 88% of all people living
with HIV.
In 2006, Roche committed to an ‘AIDS Technology Transfer
Initiative’, to help local firms in Least Developed Countries and subSaharan Africa to manufacture second-line HIV medicines. Thirteen
agreements have now been signed with entities from eligible countries and expressions of interest have been received from 41 more in
17 eligible countries. Roche has conducted assessment visits with
39 companies to determine timing and delivery of technical expertise. Roche expanded its program in 2008 to include training seminars for local manufacturers across sub-Saharan Africa, focused on
the development of good manufacturing practices to improve locally-produced essential medicines - not just ARVs. The first two training seminars were attended by 56 delegates from 21 organizations.
ViiV Healthcare Access to ARVs
HIV/AIDS
ViiV Healthcare
Various partners
Since 1997
Access - Pricing
www.viivhealthcare.com
In the Least Developed Countries and sub-Saharan Africa
GlaxoSmithKline has offered its HIV/AIDS medicines at not-for-profit
(nfp) prices since 2001. ViiV Healthcare will maintain this commitment, and will include the additional products in its portfolio. All of
ViiV Healthcare’s ARVs are now available at not-for-profit prices to
public sector customers and not-for-profit organizations in all Least
Developed Countries and all of sub-Saharan Africa - 64 countries in
total. In addition, all private employers in sub-Saharan Africa who
provide care and treatment to their uninsured staff can purchase its
ARVs at not-for-profit prices. All CCM projects fully funded by the
Global Fund to Fight AIDS, TB and Malaria and projects funded by
the US President’s Emergency Plan for AIDS Relief (PEPFAR) are also
eligible bringing the number of countries accessing ViiV Healthcare
nfp price to over 80.
ViiV Healthcare’s prices are sustainable - it does not make a profit on
them, but it does cover its costs. This means that it can sustain supply of these high-quality products for as long as they are needed. ViiV
Healthcare’s not-for profit prices are applicable to orders of any size
and are not dependent on large order quantities. They also include
insurance and freight costs. Combivir, ViiV Healthcare’s leading ARV,
now sells at USD 197 per patient per year in the Least Developed
Countries compared to USD 730 in 2001.
During 2009, ViiV Healthcare supplied ARVs at not-for-profit prices to
21 countries, compared to 37 in 2008. ViiV Healthcare shipped 11.7
million tablets of not-for-profit Combivir® and 21.0 million tablets of
not-for-profit Epivir® to the developing world in 2009 compared with
11.4 million and 58.6 million tablets respectively in 2008. This
decrease was expected and is primarily due to more customers purchasing ARVs from generic manufacturers, including those licensed
by ViiV Healthcare. In 2009, ViiV Healthcare licensees supplied more
than 439 million tablets of their versions of Epivir® and Combivir® to
Africa. These figures do not include syrup and capsule formulations.
They are therefore conservative in giving an estimate of the ARV
treatments shipped at preferential prices by ViiV Healthcare and ViiV
Healthcare licensees. This a positive indication that ViiV Healthcare’s
licensing policy is working (see section on ARV Licensing in
Developing Countries).
Technology transfer involves an R&D-based company which
has developed a particular medicine helping a generic
manufacturer, usually in a low or middle income country, to
make an identical copy of that medicine, with the same quality
level as the original. This approach is not a “soft option”, as
it requires significant investment in time and money by both
parties to achieve the required standards. (Merck & Co., Inc.)
15
Abbott Fund Program for Supporting Children
Affected by AIDS
Children’s Clinics & Pediatric AIDS Corps
HIV/AIDS
Abbott
Baylor College of Medicine, EGPAF & other partners
Since 2000
Capacity Building - Support & Training
Burkina Faso, India, Kenya, Malawi, Romania, Tanzania, Uganda
HIV/AIDS
Baylor College of Medicine in USA
Since 1999
8 developing countries in Africa
www.securethefuture.com
The Abbott Fund is partnering with several organizations to expand
access to health care for mothers and children affected by HIV/AIDS
in developing countries. Since 2001, more than 1 million children and
adults have received services in Burkina Faso, India, Kenya, Malawi,
Romania, Tanzania and Uganda.
Bristol-Myers Squibb’s Secure The Future® initiative (see HIV/AIDS
Capacity Building), in partnership with Baylor College of Medicine,
Houston, Texas, USA, funded the first clinical center in Africa for children and families with HIV/AIDS, located in Botswana. This center
now has more than 1,500 children under treatment. Additional children’s clinical centers have now been opened in Lesotho, Swaziland
and Uganda, and two more are being built in Tanzania and Kenya.
These centers add capacity to fight HIV/AIDS by providing modern
facilities for testing, treating and monitoring children and their families, as well as training of local health care professionals.
The Abbott Fund supported the Baylor College of Medicine in establishing a pediatric HIV/AIDS treatment program in Romania that
reduced the death rate for children with HIV in the program by more
than 90%. The Abbott Fund is now supporting Baylor’s efforts to
replicate this model across Africa, including opening the first pediatric treatment center in Malawi and building Tanzania’s first pediatric
treatment center. Baylor and the Abbott Fund also partnered to
establish the Baylor Children’s Clinical Centers of Excellence
Network to train health professionals who together treat 30,000 children - the largest number of children with HIV in any treatment program worldwide.
The Abbott Fund is working with Catholic Medical Mission Board
(CMMB) to help prevent mother-to-child HIV transmission in 100
health facilities in Kenya. Through the partnership, testing, care and
treatment will be provided to pregnant women and exposed infants.
To increase the number of trained pediatric specialists, Secure The
Future® and Baylor College of Medicine created the Pediatric AIDS
Corps, which will send 50 doctors a year over five years to Africa to
treat some 100,000 children and train local health care professionals.
The first class of 50 doctors arrived in Africa in August 2006.
Additional Secure The Future® projects provide education, psychosocial care and support for orphans and vulnerable children,
training, food security and income-generating projects for caregivers;
and works to reduce stigma and encourage testing.
The Abbott Fund-Elizabeth Glaser Pediatric AIDS Foundation
(EGPAF) partnership in Tanzania and Uganda is working to accelerate enrollment of HIV-infected children into care and treatment programs, and to train and support health care workers.
The Abbott Fund and Family Health International (FHI) partnered in
Tanzania and Malawi to reduce mother-to-child HIV transmission and
expand access to HIV care and treatment for children.
In Kenya, the Abbott Fund works with the Academic Model for
Providing Access To Healthcare, or AMPATH (also known as the
Indiana University-Moi University, Kenya Partnership) to prevent HIV
infections through testing and counseling (primarily home-based),
education and treatment.
Abbott Fund is working with Partners In Health in Malawi to scale up
and improve pediatric HIV services and support construction of a
new 40-bed hospital.
The Abbott Fund is supporting efforts to provide testing, care
and treatment to pregnant women and infants exposed to HIV
in 100 health facilities in Kenya. (Craig Bender, Abbott Fund)
16
Elizabeth Glaser Pediatric AIDS Foundation
Empowering Africa’s Young People Initiative
HIV/AIDS
Abbott, Boehringer Ingelheim, Johnson & Johnson
EGPAF
Since 1988
Access - Donation, Capacity Building - Training, Education
www.pedaids.org
HIV/AIDS
Johnson & Johnson
International Youth Foundation
Since 2006
Capacity Building – Support, Education
Zambia
www.jnj.com
The Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) is an international leader in the fight to eliminate pediatric HIV/AIDS, working in
17 countries around the world to halt the pandemic and help those
already infected with HIV to lead healthier lives. Since its inception in
1988, EGPAF has remained deeply committed to preventing motherto-child transmission (PMTCT) of HIV, ensuring better overall medical
treatments, and creating a healthier future for children and families
worldwide. The Abbott Fund, Boehringer Ingelheim and Johnson &
Johnson are major supporters of EGPAF and its work.
Johnson & Johnson partners with the International Youth Foundation
on the HIV/AIDS prevention program Empowering Africa’s Young
People Initiative in Zambia. Support from Johnson & Johnson
enables the International Youth Foundation to expand its services
and training, including increasing the number of peer educators who
teach other youth in their communities about preventing the spread
of HIV/AIDS. Since the partnership began in 2006, more than 1,900
peer educators have been trained.
EGPAF collaborates with host governments, international health care
facilities, non-governmental organizations and community-based
organizations to plan, implement and/or expand pediatric HIV/AIDS
programs. It also provides technical assistance and support for community mobilization and training of health care workers, HIV counseling and testing, prevention of mother-to-child transmission regimes
and infant feeding education.
As of September 2009, EGPAF had provided more than 8.6 million
women with services to prevent transmission of HIV from mothers to
their babies, and tested more than 7.4 million women for HIV. More
than 850,000 individuals have been enrolled into EGPAF care and
support programs, including nearly 69,000 children under the age of
15. Of those ever enrolled, more than 442,000 individuals have
begun antiretroviral treatment (ART), including more than 35,000 children.
EGPAF’s comprehensive approach includes prevention, diagnosis,
and treatment of opportunistic infections such as pneumonia, malaria and tuberculosis. EGPAF is working to increase identification and
care and treatment of young HIV-positive or HIV-exposed children
and their mothers, through reproductive and child health (RCH) clinics, general clinics, and inpatient wards. EGPAF is also implementing
routine testing of children and/or mothers of unknown HIV status in
well-child clinics and inpatient pediatric wards.
The Abbott Fund-EGPAF partnership in Tanzania and Uganda is
working to accelerate enrolment of HIV-infected children into care
and treatment and develop the capacity of health care workers.
J&J has supported EGPAF’s international programs since 2003, with
support to six countries during 2009. As of June 2009, the EGPAFJ&J PMTCT Partnership has contributed to reaching more than 1.6
million women with counseling, providing over 1.4 million women
with HIV testing, and administering ARV prophylaxis to over 124,000
HIV-positive mothers in over 1,300 sites.
Two-thirds of all people living with HIV/AIDS are in
sub-Saharan Africa. (GlaxoSmithKline)
17
End Violence against Women and Prevent
HIV and AIDS Program
Life Skills: Community Support for Children
Affected by HIV/AIDS
HIV/AIDS
Johnson & Johnson
UNIFEM, UNAIDS
Since 2006
Botswana, Dominican Republic, India, Nigeria, Vietnam
www.unifem.org, www.jnj.com
HIV/AIDS
Johnson & Johnson
Life Skills Development Foundation
Since 2005
Capacity Building - Training, Education
Thailand
www.lifeskills-stl.org
Globally, violence against women is both a cause and a consequence of HIV/AIDS: women facing violence within intimate relationships often cannot negotiate safer sex practices, such as condom
use. Rape and harmful practices such as female genital mutilation
also spread the virus. In addition to untenable levels of stigma and
discrimination from the community, women who test positive for HIV
are often subjected to physical abuse from partners and can face
eviction from their homes. Further, as a result of such stigma associated with HIV/AIDS, they are prevented from obtaining life-saving
medical care and treatment.
There are some 150,000 AIDS orphans in the Upper Northern region
of Thailand. From economic struggle and emotional hardship to
social stigma and isolation, they face many problems. The Life Skills
Development Foundation, a NGO that provides life skills education
and training for children, youth, women and families, works in many
districts to reach children affected by HIV/AIDS. With the help of
Johnson & Johnson, the foundation provides assistance to these
children and their caregivers through HIV/AIDS education, psychological and financial support, and community education. Using a
holistic approach, the foundation extends its support to the people it
serves, and to the communities and schools that have a stake in the
well-being of their children.
Johnson & Johnson partners with the United Nations Development
Fund for Women (UNIFEM) to award grants to community-based
organizations. These organizations implement prevention programs
addressing the link between gender-based violence and HIV/AIDS.
They pursue innovative strategies to raise awareness, uphold laws,
provide medical assistance, train service providers and reduce stigma and discrimination to empower women.
18
Mothers 2 Mothers Mentoring Program
HIV/AIDS
Johnson & Johnson
Mothers 2 Mothers
Since 2005
Kenya, Lesotho, Malawi, Rwanda, South Africa, Swaziland, Zambia
www.m2m.org
HIV/AIDS
Johnson & Johnson
Since ?
Kenya
www.jnj.com
Mothers 2 Mothers (M2M) provides education for South African HIVpositive pregnant women about how to prevent mother-to-child
transmission of the disease and later mentor other HIV-positive pregnant women. Program participants learn about medications, nutrition, formula feeding, and how to combat stigma and societal pressures. After their infants are born, the women become mentors to
new women entering the program. Mentors are paid, helping them
to gain financial independence.
Johnson & Johnson supports the Nyumbani Children’s Home which
covers communities throughout Nairobi. The Children’s Home serves
as a home to nearly 100 abandoned or orphaned children with
HIV/AIDS. The children receive holistic care antiretroviral therapy,
psychological, academic and spiritual support.
Johnson & Johnson began its partnership with M2M in 2005 in East
London, focusing on hospitals with high numbers of HIV-positive
patients who needed better health care. Since the Company’s association with M2M, 50% more women in the area are now getting tested for HIV. J&J helped establish two M2M sites in 2005 and the company currently supports 15 sites across East London, Port Elizabeth
and the Cape Town area. M2M has established itself in six provinces
in South Africa, and other African countries such as Kenya, Lesotho,
Malawi, Rwanda, Swaziland and Zambia. By 2008, the M2M program had grown to 400 program sites, reaching 130,000 women
each month. More than 1,000 mothers have been trained as mentors. M2M served more than 6,000 HIV-positive mothers-to-be at
these locations in 2008.
19
PMTCT: Abbott Rapid HIV Test Donation Program
Regional Psychosocial Support Initiative
HIV/AIDS
Abbott
Various partners
Since 2002
Access - Donation
39 countries, including all of Africa
HIV/AIDS
Novartis
REPSSI, Swiss & Swedish Development Agencies
Since 2002
Capacity Building - Support
13 developing countries in Africa
www.novartisfoundation.org, www.repssi.org
Each year, approximately 430,000 babies around the world become
infected with HIV during their mothers’ pregnancy, during birth or
through breastfeeding. Enabling pregnant women to know their HIV
status before they give birth is the first step in preventing mother-tochild transmission (PMTCT) of HIV. However, for many pregnant
women living in the developing world, testing is limited because of
cost, time required to receive results, and lack of trained health care
staff and testing facilities.
UNAIDS estimated that by the end of 2007 there were approximately 6.5 million children orphaned by AIDS in Southern Africa. Millions
more children in the region feel the triple effects and impact of
HIV/AIDS, poverty and conflict. While there is no doubt that all these
children have to be provided with basic services like food, shelter,
education and healthcare, they also need care and support to cope
with the emotional side of these difficult life situations.
Rapid on-site testing can have a significant impact in the fight against
HIV/AIDS. Using a small amount of whole blood, serum or plasma,
any program in a remote setting can obtain results regardless of
access to laboratory equipment or electricity. To facilitate access to
rapid HIV testing, Abbott has made a commitment to donate a rapid
(15 minute) HIV test to PMTCT programs in 69 countries, including
all of Africa and the Least Developed Countries, as defined by the
United Nations. Abbott also has extended its PMTCT donations to
include testing of spouses and children of pregnant women who are
found to be HIV positive through the program.
To date, Abbott has donated 15 million rapid HIV tests in 40 countries: Angola, Benin, Botswana, Burkina Faso, Burundi, Cambodia,
Cameroon, Central African Republic, Chad, Côte d’Ivoire, Djibouti,
Democratic Republic of Congo, Ethiopia, Gabon, Ghana, Guinea
Bissau, Guinea, Haiti, Kenya, Laos, Lesotho, Liberia, Madagascar,
Malawi, Mali, Mozambique, Namibia, Nepal, Niger, Nigeria, Rwanda,
Senegal, Sierra Leone, South Africa, Swaziland, Tanzania, Togo,
Uganda, Zambia and Zimbabwe.
The Regional Psychosocial Support Initiative for Children affected by
AIDS, Poverty and Conflict
(REPSSI) was founded with the support of the Novartis Foundation
for Sustainable Development and the official development aid agencies of Switzerland (SDC and Sweden (SIDA), with the aim of laying
down benchmarks in psychosocial support (PSS) in Eastern and
Southern Africa.
REPSSI works with over 140 local NGOs to train course leaders and
develop courses and manuals, and cooperates with the governments of the 13 countries in which it operates with the objective of
securing recognition of PSS as a basic right and a fundamental element of social policy. REPSSI, along with its partners, has developed
a range of tools and approaches in order to maximize both the quality of psychosocial care and support, as well as the numbers of children who are able to access various levels of PSS.
The organization had reached over 3 million children orphaned by
AIDS by the end of 2009.
The Abbott Fund is supporting efforts in Western Kenya to
prevent HIV infections through Home-based Counseling and
Testing (HCT), education and treatment services.
(Craig Bender, Abbott Fund)
20
Roche Children’s Walk
Women and Families Initiative
HIV/AIDS
Roche
UNICEF & European Coalition of Positive People
Since 2003
Capacity Building - Support, Education
Malawi
www.roche.com
HIV/AIDS
Johnson & Johnson
HIV Collaborative Fund
Since ?
Uganda
www.jnj.com, www.hivcollaborativefund.org
The Roche Children’s Walk (formerly the Global Roche Employee
AIDS Walk) extended its scope to all vulnerable children in 2008. In
2008, 14,000 employees from 100 sites walked around five kilometers each to raise an estimated CHF 1.2 million, including the amount
contributed by the company. While 35% was contributed via company affiliates to local children’s charities, the balance was donated
through Re&Act to Roche’s long-term partners, the European
Coalition of Positive People and UNICEF Switzerland, for their work
in Malawi.
The HIV Collaborative Fund, a community organization that raises
funds to support treatment for people living with HIV/AIDS, and
Johnson & Johnson are partnering in a Women and Families initiative, which focuses on HIV/AIDS treatment preparation services for
women. These services include advocacy, treatment and adherence
education, counseling on stigma and discrimination, skills-building
workshops, and direct service delivery in each of the communities
served. Thousands of women in communities throughout SubSaharan Africa have been reached over the past few years. In
Uganda, the partnership supports The Mama’s Club and the
Together Against AIDS Positive Association, two grassroots groups
focused on treatment preparedness education of women.
In 2003, a pilot Roche Employee AIDS Walk was initiated across
three sites in Switzerland and the USA to support children orphaned
as a result of AIDS in Malawi, Africa. The event is now conducted
each year, across Roche sites worldwide. To date, over 60,000
Roche employees from 100 sites worldwide have raised a total of
over CHF 6 million.
Funds raised via the Employee Walk supports 7 orphan day care
centers in the Mulanje district of Southern Malawi where the children
are given food, clothing, vocational training and the chance of a secondary school education. The centers are supported by the
European Coalition of Positive People, a UK-Malawi NGO, led by and
for people living with HIV and AIDS. The centers currently look after
some 3,000 children. Local community leaders and villagers are
being trained to manage the centers.
A further partnership was announced in 2006 with the United
Nations Children’s Fund (UNICEF), to strengthen the local primary
schools these children attend. Seventy five percent of children are
unable to access secondary school education in Malawi. Money
raised by the Employee Walk has paid for the construction, repair
and equipment of the orphan centers and school classrooms, the
drilling of bore holes for water, as well as school fees and educational equipment. All efforts are designed to make a visible, long term
and sustainable difference in the lives of these orphaned children.
Boehringer Ingelheim offers the antiretroviral medicine
Viramune® free-of-charge to developing countries.
(Keri Oberg, Boehringer Ingelheim)
21
Abbott Fund Program to Strengthen
Tanzania’s Health Care System
African Comprehensive HIV/AIDS Partnerships
(ACHAP)
HIV/AIDS
Abbott
Tanzania Ministry of Health
Since 2003
Access - Donation, Capacity Building - Support & Training
Tanzania
HIV/AIDS
Merck & Co. Inc.
Bill and Melinda Gates Foundation & other partners
Since 2000
Access - Donation, Capacity Building - Support & Training, Education
Botswana
www.achap.org
The Abbott Fund and the Government of Tanzania have formed a
unique public-private partnership to modernize the country’s health
care system. The Abbott Fund has invested more than USD 60 million aimed at enhancing access to health care on a national scale.
Today, one in three Tanzanians with HIV taking antiretroviral therapy
receive services at a facility that has benefited from Abbott Fund support.
The African Comprehensive HIV/AIDS Partnerships (ACHAP) was
established in 2000 by the Government of Botswana, The Merck
Company Foundation/Merck & Co., Inc. and the Bill & Melinda Gates
Foundation, to support and enhance Botswana’s response to the
HIV/AIDS epidemic through a comprehensive approach to prevention, care, treatment and support and impact mitigation. The two
foundations have committed USD 106.5 million to the partnership
and Merck is donating its antiretroviral (ARV) medicines to
Botswana’s national ARV treatment program, Masa (new dawn), for
the partnership’s duration.
Work is being conducted across the country, including significant
work at Muhimbili National Hospital, the country’s leading teaching
and referral hospital. Key results include a new three-story outpatient
center that serves hundreds of patients a day, and a renovated laboratory that provides accurate, automated diagnostic testing crucial
for lifelong monitoring of HIV and other chronic diseases. Donated
laboratory equipment is maintained by engineers supported by the
Abbott Fund.
In 2007, ACHAP expanded its support to target co-infection of HIV
and tuberculosis, as it is estimated that 65-85% of TB patients in
Botswana are HIV positive, and HIV-related TB is the leading cause
of death among adult AIDS patients.
In 2009, a new Emergency Medical Department was opened and
training programs in emergency medicine were initiated at Muhimbili.
Through Abbott Fund support, emergency room services meeting
international standards are now available for the first time at
Muhimbili.
The partnership’s strength lies in its full integration with government
strategy and with private-sector expertise. ACHAP has made a significant contribution to key aspects of Botswana’s response to the
HIV and AIDS epidemic and has served as a catalyst for the provision of urgently needed infrastructure, equipment, human resources,
training and program support for the Botswana ARV program.
More than 15,000 health care worker trainings have been conducted to date in Tanzania. At Muhimbili, 200 physicians now serve as
trainers for other health staff. More than 250 staff have been trained
in lab equipment operation, while 600 senior doctors and hospital
directors have received management training.
Today, Masa is one of the largest national HIV treatment programs on
the African continent, with 35 infectious disease care clinics and
satellite facilities in operation across the country. As of October 2009,
more than 141,000 people were receiving ARV treatment with ART
compliance rates of 90 percent – among the highest in the world.
One of the most extensive hospital IT systems in East Africa has
been installed at Muhimbili to track health history, referrals, test
results and drug prescriptions. Volunteer Abbott employees provide
technical support in construction, engineering, infection control, IT,
waste management, security and lab management.
The partnership has worked with Harvard Medical School and the
Botswana Ministry of Health to provide training for more than 6,300
of Botswana’s health care workers, while more than 3,200 physicians, nurses and other health care professionals have received
hands-on, clinic-based training through the partnership’s preceptorship program between 2002 and 2006. The preceptorship program
has now been incorporated into the ongoing national clinical training
program managed by the Government of Botswana.
Facilities, systems and training have been upgraded at 90 sites
throughout the country to improve VCT services. Due to these
improvements, more than 300,000 people have received VCT services. The Abbott Fund also donated 1 million HIV tests to President
Kikwete’s National Testing campaign. In addition, the Abbott Fund is
modernizing all 23 of the country’s regional-level hospital laboratories.
The Abbott Fund is working with the Touch Foundation to support
105 lab technology students pursuing university degrees, and also is
providing funds to upgrade the laboratory at Bugando Medical
Centre, a referral hospital for a population of 13 million in the Lake
Zone.
22
ACHAP has also made significant contributions in the area of
HIV prevention, including the development of a national plan for scaling up prevention, improving condom availability and safe blood
transfusion.
Associação Saude Da Familia HIV/AIDS Awareness
AstraZeneca & AMREF: An Integrated Approach
to Managing HIV/AIDS, Malaria & TB in Uganda
HIV/AIDS
Johnson & Johnson
Associação Saude da Familia
Since 2004
Brazil
www.saudedafamilia.org
HIV/AIDS, malaria, tuberculosis
AstraZeneca
AMREF
Since 2004
Uganda
www.astrazeneca.com
The Associação Saude da Familia (ASF) mobilizes community support in poor favelas in Sao Paulo, Brazil, to protect young people
from unwanted pregnancies and sexually transmitted diseases. This
includes raising awareness and spreading information about
HIV/AIDS. In these teeming slums, where drugs and violent crime are
a constant reminder of the fragility of civil societies, ASF works with
local community leaders, and municipal and state governments, to
implement its programs to encourage safer and healthier behavior.
AstraZeneca and the African Medical and Research Foundation
(AMREF) have been working together since 2004. The partnership
initially focused on TB in the Eastern Cape province of South Africa.
In 2006, AstraZeneca extended its commitment to support AMREF
in strengthening healthcare systems and integrating management of
TB, HIV and malaria programs in Uganda, where there is a high burden of all three diseases. AstraZeneca is one of a few organizations
involved in this integrated approach.
In its program ‘Expanding Prevention and Assistance to
HIV/AIDS/STD’, ASF trains lay persons in poor communities to
become outreach workers. They make door-to-door visits providing
HIV prevention education and offer voluntary testing and counseling
services. With a grant from Johnson & Johnson, ASF was able to
expand the scope of this program, and to help local health care units
to provide diagnosis, prevention, treatment and care for people living
with HIV/AIDS.
The program is focused on women of child-bearing age, people living with HIV/AIDS and children under the age of seven in the poor,
remote Luwero and Kiboga districts of central Uganda, which have
high disease incidence rates, influenced by lack of healthcare funding in and destruction of local healthcare infrastructure by conflict.
AMREF works with district health teams in Luwero and Kiboga to
encourage ownership and continued implementation. Training and
support for health workers, coupled with public campaigns, is essential for effective implementation.
The program is focused on:
• Enhancing the capacity of health centers to prevent, diagnose and
treat malaria, HIV/AIDS and TB, particularly through improved
laboratory diagnostic capacity;
• Improving community-based prevention, treatment and care;
• Strengthening links between the formal health system and informal
community-based capabilities;
• Gathering data to support an integrated and community based
strategy.
• The program is aligned to Ugandan Ministry of Health targets and
also to MDGs 4 and 5, which focus on the reduction of child and
maternal mortality.
Progress to date includes:
• Three laboratories have been completed to Ministry of Health standards, management of which has been handed over to district
management teams;
• 144 Village Health Teams with 776 members have been established, trained in health promotion;
• 161 health awareness outreach activities and 91 educational films
screenings s at HIV Counselling and Testing clinics;
• 183 local peer educators trained in reproductive health, life skills,
counseling and MAT (Malaria HIV/AIDS TB) testing;
The Ministry of Health has implemented a policy of integrated MAT
testing and is working with AMREF on this program.
In Tanzania, the Abbott Fund is training health care workers
and modernizing or building 23 regional-level laboratories
nationwide, including this newly opened laboratory in Tanga.
(Craig Bender, Abbott Fund)
23
Collaboration for Health in Papua New Guinea
(CHPNG)
HIV/AIDS
Various partners, including African NGOs
Since 1999
www.securethefuture.com
HIV/AIDS
Boehringer Ingelheim, Gilead, GlaxoSmithKline, Merck & Co., Inc.,
Pfizer, Tibotec
Papua New Guinea Ministry of Health & others
Since 2003
Papua New Guinea
www.apbca.com/files/_media/CHPNG_Case_Study.pdf
Secure The Future® is a comprehensive initiative to fight HIV/AIDS in
sub-Saharan Africa, sponsored by Bristol-Myers Squibb and the
Bristol-Myers Squibb Foundation. It combines medical treatment
and care, access to antiretroviral medicines, with research, social
support with community education, and training for health care professionals with new facilities and infrastructure investments in remote
areas of sub-Saharan Africa where resources are extremely limited.
The initiative now is reaching women, children, their families and
communities in 20 nations: Benin, Botswana, Burkina Faso, Burundi,
Democratic Republic of Congo, Côte d’Ivoire, Kenya, Lesotho,
Liberia, Malawi, Mali, Mozambique, Namibia, Niger, Senegal, South
Africa, Swaziland, Tanzania, Uganda and Zambia.
Papua New Guinea has the highest incidence of HIV in the Pacific
region. An estimated 2 per cent of the adult population is now HIV
positive. Recent research predicts that unless interventions to
address the spread and impact are stepped up, by 2025 adult prevalence will have escalated to 11 per cent. Left unchecked, Papua New
Guinea will be in a similar position to that of parts of Africa, where
the impact of HIV has been felt in every aspect of society and the
economy.
Secure The Future® has evolved and remained agile over the years
in order to play as relavant a role as possible in the global response
to HIV/AIDS. From 1999 to 2002, the program was focused on
broad-based grant-making to support medical research and community outreach and education. From 2003 to 2007, focused investments were made in community based HIV/AIDS care and treatment
support, NGO training, and pediatric AIDS.
In 2008 Secure The Future® entered its third phase as a Technical
Assistance and skills transfer program. This phase will capitalize on
Secure The Future’s funding, program management experience and
expertise, and track record as a committed private-public partnership program. The aim is to replicate Secure the Future’s lessons,
experiences and successful models, and address a strategic challenge of operational multi-sectoral collaborations in HIV by harnessing community resources and capacity. Program support is executed by an experienced and expert pool of faculty members who have
played a critical role in supporting NGO’s and CBO’s to provide
essential services in the Community Based Treatment Support and
NGO Training Institute Programs. The aim of the faculty is to develop and strengthen organizational and technical capacity and leverage and harness the potential of civil society in improve health outcomes of health programs.
24
The quality and availability of HIV diagnosis, care and treatment in
PNG is limited by severe resource shortages in the health system.
Many health centers lack medical supplies and essential drugs to
deliver basic health services. Misinformation and poor understanding
about HIV has contributed to discriminatory attitudes toward people
living with the virus, creating a hurdle to access health services. The
shortage of skilled health workers mirrors the greater human
resource challenge impacting on all service sectors in PNG.
Boehringer Ingelheim, Gilead, GlaxoSmithKline, Merck & Co., Inc.,
Pfizer and Tibotec have helped to set up the Collaboration for Health
in Papua New Guinea (CHPNG), which works with various departments of the Government of PNG, Government departments in
PNG, the National Catholic AIDS Office (PNG), the Australasian
Society for HIV Medicine (ASHM) and the National Association for
People Living with HIV/AIDS (NAPWA) in projects to build the local
capacity of PNG to fight the HIV epidemic.
CHPNG activities include the provision of day care centres to provide
a safe space for people living with HIV/AIDS and where their carers
can meet and share experiences. It also undertakes the training of
multidisciplinary teams of nearly 300 healthcare workers to manage
HIV and provides an ongoing education and mentoring programme
to maintain and improve the skills of those providing care.
GlaxoSmithKline - Other HIV/AIDS Capacity-Building
Initiatives
Health at Home/Kenya
HIV/AIDS
GlaxoSmithKline
AMREF & other partners
Since 1998
Capacity Building - Support & Training, Education
17 African countries
www.gsk.com, www.childrensaidsfund.org
HIV/AIDS, tuberculosis, malaria
Abbott, Bristol-Myers Squibb, Pfizer
Kenya MoH, USAID, PEPFAR & other partners
Since 2009
Kenya
www.pfizer.com
The GlaxoSmithKline Foundation supports a range of HIV/AIDSrelated programs around the world. Since 1998, the GSK France
Foundation has supported 86 programs to improve healthcare
through prevention, education and training in 14 developing countries. The GSK Foundation Canada also supports community programs in Africa, including AIDS Orphans Uganda, working with the
African Medical Research Foundation (AMREF).
Health at Home/Kenya is an initiative coordinated by Global Business
Coalition on HIV/AIDS, Tuberculosis & Malaria (GBC) that is providing
home-based HIV/AIDS testing, TB screening and malaria bed nets,
and de-worming for children into the homes of millions of Kenyans
in a remote region with difficult access to health care. This innovative
door-to-door model includes community preparation by local volunteers.
GSK supports community programs in Botswana, Cote d’Ivoire,
Democratic Republic of Congo, Ethiopia, Ghana, Kenya, Malawi,
Mozambique, Namibia, Nigeria, Senegal, South Africa, Swaziland,
Tanzania, Uganda, Zambia and Zimbabwe. These provide treatment
for HIV/AIDS patients, counseling and testing, home-based care,
training for health care professionals and community volunteers, life
skills training for orphans, hospice care, day care centers, feeding
schemes, as well as support for basic primary healthcare and
HIV/AIDS clinics.
To date, 97% of households in communities reached by the Health
at Home/Kenya Impact Initiative have welcomed HIV counselors
inside their homes. More than 3,000 people have been found to be
HIV positive and directly connected to treatment programs.
For example, GSK has supported the AIDS Care Treatment and
Support (ACTS) initiative in Masoyi, South Africa, since 1999. GSK’s
initial support included building a dedicated HIV/AIDS primary health
care clinic and training center, and supporting running costs for the
first three years. Since the opening of the ACTS clinic in May 2001
more than 28,000 patients have been tested and/or treated. ACTS
offer a comprehensive service caring for people at all stages of
HIV/AIDS. Facilities and services include a specialist HIV outpatient
clinic, complemented by a home-based care team (average of 120
visits per month) an eight-bed community hospice, on-site laboratory, cervical cancer prevention program and a newly established
Mother & Child Clinic. There are currently 1,737 patients on ARVs,
152 of which are children under the age of 12 years. Nearly 2,000
patients are seen each month.
On-the-ground implementation of Health at Home/Kenya is being
managed by the Academic Model Providing Access to Healthcare
(AMPATH), based in Eldoret, Kenya, working closely with the Kenyan
government and PEPFAR.
This two-year initiative is supported by PEPFAR and GBC member
companies. The initiative is being brought to scale by industry competitors working side-by-side in common cause – serving as a model
to be replicated in other AIDS endemic regions of the world.
Participants in the initiative include the Abbott Fund, Accenture,
Bristol-Myers Squibb Foundation, Standard Bank Group, CocaCola, Deutsche Post DHL, Pfizer, Premier Medical Corporation, SAB
Miller, Standard Chartered Bank.
In 2004, GSK’s US Business launched a project called ‘Hope after
HIV: Africa’. Through the Children’s AIDS Fund, GSK has helped
open 6 clinics in Uganda, Malawi, Zambia, and South Africa that
have treated more than 9,000 HIV/AIDS patients. The sponsored
clinics offer testing, medicines, education, mother-to-child transmission care, counseling and follow-up. Patients are also supported by
more than 1,500 volunteers who provide adherence counseling, disease education and palliative care.
GSK has also established the ‘Hope after HIV 501(c)(3) Fund’ that
allows employees and others to donate funds to support life-enhancing, non-medical needs. The fund has been used to improve nutrition
and generate income for patients and their families; provide bicycles,
pumps and refrigerators; and education for promising young HIVpositive people.
Medical services are provided by the African Medical and
Research Foundation (AMREF) in the Kiberia slum district in
Nairobi, Kenya. (GlaxoSmithKline)
25
HIV South Africa
Humana: Total Control of the Epidemic
HIV/AIDS
Johnson & Johnson
HIV South Africa
Since 2003
South Africa
www.hivsa.com
HIV/AIDS
Johnson & Johnson
International Humana People to People Movement, Irish Aid
Since 2000
Education
Developing countries in Africa, China, India,
www.humana.org
With the support of Johnson & Johnson, HIV South Africa (a program
of the Baragwanath Hospital Perinatal HIV Research Unit) has provided a wide variety of Johnson & Johnson healthcare products to
community-based organizations that provide care and support to
HIV patients in their homes.
‘Only people can liberate themselves from the AIDS epidemic’.
These are the motivating words behind the Total Control of the
Epidemic (TCE) program, which was created by the International
Humana People to People Movement. Driven by a grassroots doorto-door approach, TCE has been completed in 24 areas with
2,340,000 inhabitants and at present is operating in 62 areas with
6,170,000 inhabitants in Africa, 2 areas with 200,000 inhabitants in
India and 3 areas with 300,000 inhabitants in China. Created by
Humana People to People, TCE provides communities with HIV risk
assessments and prevention education.
The project has both an urban and a rural component, which together serve approximately 3,500 households at any given time. The project involves 39 home-based care partner organizations in Soweto
and distributes approximately 2,500 healthcare product packs
monthly. The product donation is complemented by distribution support, caregiver training and program monitoring. Supplemental support also is provided to selected hospice organizations.
Johnson & Johnson currently supports the TCE areas of Main Reef
and Sekhukhune in South Africa, reaching up to 400,000 people. In
partnership with Irish Aid, it also supports the TCE in Narela, Baddi
in India, covering an additional 200,000 people. The projects supported by the company provide one-on-one counseling sessions,
briefings for pregnant women about preventing transmission of disease to their newborns and large-scale distribution of condoms.
A lab worker at Nyumbani Diagnostic Laboratory, Nairobi, Kenya, which provides specialized HIV tests and other general diagnostic lab
services for abandoned and orphaned children. (Willie Davis, Johnson & Johnson)
26
IMIFAP: HIV/AIDS Education
J&J Health Care Training Fund
HIV/AIDS
Johnson & Johnson
Instituto Mexicano de Investigación de Familia y Población
Since 2005
Education
Mexico
www.imifap.org.mx
HIV/AIDS
Johnson & Johnson
AMREF, i+solutions
Since 2004
Capacity Building - Training
Kenya, South Africa
www.jnj.com, www.iplussolutions.org/platform
“I Want to, I Can prevent HIV/AIDS’, is the slogan behind the Instituto
Mexicano de Investigación de Familia y Población (IMIFAP) HIV prevention programs, which mobilize citizens to raise neighborhood
HIV/AIDS awareness in Mexico.
The Johnson & Johnson Health Care Training fund was started in
2004. It is a collaboration between J&J and i+solutions in the
Netherlands which specializes in pharmaceutical supply chain management training in developing countries.
Johnson & Johnson supports an educational program for youth that
utilizes the existing national network of middle schools to teach students about HIV prevention before they become sexually active,
increasing the likelihood that these adolescents will practice safe sex
in the future. IMIFAP engages all levels of the community from the
Ministries of Health and Education, to the school administrators and
local politicians, to the teachers and students.
Activities include:
The program includes teacher training, a software program, and Web
site support. The 10,400 schools in Mexico with Internet access
bring this program to more than 300,000 students. For those
schools without Internet access, IMIFAP trains teachers and students to run the program, and has partnered with UNETE, a member of The Resource Fund, to raise educational levels using technology to distribute the program in more rural and remote areas.
• Training in ‘Supply Chain Management of HIV/AIDS Medicines &
Supplies’. A two-week pilot course for 12 managers was organized in 2005, and the course is now run several times a year in
Pretoria, South Africa;
• Development of a web-based Supply Chain Management
Discussion Platform in 2006, which is open to all health professionals involved in supply chain management of healthcare commodities;
• Translation of the ‘Supply Chain Management of HIV/AIDS
Medicines & Supplies’ training curriculum in 2007 to reach
Francophone African health professionals. A 2-week course in
French is run once a year in the Netherlands;
• Training in ‘Monitoring & Evaluation of Antiretroviral Treatment
Procurement & Supply Management’. Monitoring and evaluation is
essential for donor reporting purposes and to identify and improve
weaknesses in the supply chain. The curriculum was developed in
2007 and the first course took place in 2008 in the Netherlands,
and is now run once a year. Since 2008, this course is also run in
French once a year in the Netherlands;
• CD-ROM-based training course on ‘Supply & Warehouse
Management for the First level Health Facility’, for staff who are
unable to attend off-site training courses. This course was developed in Nairobi with the African Medical and Research Foundation
(AMREF);
• Training of trainers (TOT) course for the CD-DROM-based training
on ‘Supply & Warehouse Management for the First level Health
Facility’ in English and French. The first English version of this
course was run in Sudan in 2009 and the first French version in the
Democratic Republic of Congo in 2009. Roll out of this course in
four countries will be undertaken in 2010.
HIV prevention program. (GlaxoSmithKline)
27
J&J - UCLA Management Development Institute
JPMA’s HIV/AIDS Training Program
HIV/AIDS
Johnson & Johnson
AMREF, GIMPA, UCLA Management Development Institute
Since 2006
Education
Ghana, Kenya
www.anderson.ucla.edu/x13888.xml
HIV/AIDS
JPMA
ASEAN Institute for Health Development AIHD
Since 2004
10 developing countries in Asia
www.jpma.or.jp/english
The Johnson & Johnson - UCLA Management Development Institute
(MDI) was created in 2006 as an intensive one-week program
designed to enhance the management skills of health care leaders of
East and West African organizations devoted to the care, treatment
and support of people and their families living with HIV/AIDS.
The Japan Pharmaceutical Manufacturers Association (JPMA) has,
at its own expense, commissioned the ASEAN Institute for Health
Development (AIHD) to train medical professionals in ASEAN member countries in the ‘Management of Community-based Prevention
of HIV/AIDS and Care’. This two-week course is intended to contribute to the promotion of the physical and mental health care of
patients and residents through the professional development of
health workers in the AIDS-related divisions of public institutions.
Based upon accumulated observations, findings, insights and personal experiences, the participants will design their own ‘action
plans’ that can be used when they return to their home country.
Dr. Ernest O. Nyamato, director of services at Liverpool Voluntary
Counseling & Testing (LVCT) care & treatment centers in Kenya,
attended the program in 2006. ‘MDI changed the way I oversee
operations at 15 voluntary counseling and testing sites across
Kenya’, he said. ‘My involvement in the program has helped me to
more effectively get our patients treated’.
‘Attending the MDI training pointed me in the right direction’, noted
Dr. Nyamato. With a new mental picture of how his LVCT sites should
operate, he began building better communication channels between
the staff, creating new human resources and compensation policies,
and focusing more on patients´ perspectives, expectations and feedback.
To date, 141 health professionals have been trained, distributed as
follows: Bhutan (6), Cambodia (26), China (2), Indonesia (4), Laos
(30), Myanmar (16), Nepal (2), Pakistan (2), Sri Lanka (2), Thailand
(21), Vietnam (30).
Assessing community needs, aligning operations with a mission and
strategy, budgeting and human resources management were just a
few areas discussed in the 2007 MDI training sessions, held in April
and September. Participants in such sessions are encouraged to
pass along the management and leadership skills they learn to all levels of their organization. By doing so, the knowledge to prevent and
treat HIV/AIDS is spread throughout Africa´s sub-Saharan region.
More than 200 AIDS-service organizations leaders from 12 countries
have graduated since 2006.
JPMA trains health workers in the AIDS-related divisions
of public health institutions in ASEAN countries. (JPMA)
28
Merck & Co., Inc. HIV/AIDS Programs - Africa
HIV/AIDS
Johnson & Johnson
Since 2005
Kenya
www.medicalmissionsisters.org
HIV/AIDS
Merck & Co. Inc.
Various partners, including universities & NGOs
Since 1998
www.merck.com
In 1989, Sister Gill Horsfield of Medical Mission Sisters (MMS) began
training health workers in Nairobi, Kenya, to provide home-based
care to individuals suffering from HIV/AIDS-related illnesses. Her program offered medical and pastoral counseling, and social services in
the Korogocho slums, one of Nairobi’s poorest areas.
In 2009, with support from The Merck Company Foundation, the
Earth Institute at Columbia University launched a community health
worker training program to strengthen community health services for
over 400,000 people in 10 African countries as part of the Millennium
Villages project. The initiative aims to develop a professional cadre of
800 community health workers to fill a critical gap in primary healthcare provision for rural communities throughout Africa.
Johnson & Johnson supports Sister Gill’s continued involvement in
caring for people with HIV/AIDS. Today, MMS has joined with the
Comboni Missionary Sisters to provide more extensive holistic care
for those affected by HIV/AIDS. The partnership includes programs
in home-based care and tuberculosis treatment, programs for deaf
and handicapped youth, and a voluntary HIV/AIDS counseling and
testing program. It also includes distribution of antiretroviral therapy,
other medicines, and prepared meals and dry goods to families with
sick parents.
More than 1,800 people affected by HIV/AIDS are benefiting from
this work. School dropout rates among children receiving nutrition
and social support have decreased significantly.
In 2008, Merck began supporting Mothers2Mothers (m2m), an
organization that addresses prevention of mother-to-child transmission by employing mothers living with HIV (“Mentor Mothers”) as peer
educators and professional members of the healthcare team, in public health facilities in Kenya, Lesotho, Malawi, Rwanda, South Africa,
Swaziland and Zambia. By the end of 2008, m2m had almost 500
sites across Africa, employing 1,400 mentors and reaching more
than one million people.
Since 2006, Merck & Co., Inc. has supported the Health Economics
and HIV/AIDS Research Division (HEARD) of the University of
KwaZulu-Natal, South Africa in a study of factors influencing participation rates, voluntary counseling and testing services. The research
will estimate the economic costs of low uptake on the voluntary
counseling and testing services offered by one multinational corporation.
Since 2002, Merck has supported the Regional AIDS Initiative of
Southern Africa (RAISA), a Voluntary Services Overseas project, to
strengthen partners’ capacity to develop coordinated programs to
respond to the HIV and AIDS pandemic. In 2008, Merck helped
RAISA launch the “Glove Campaign” raising awareness of the need
for clean gloves to reduce the spread of HIV infection as well as other
infections.
Since 2005, Merck has supported the African Medical & Research
Foundation (AMREF) in its efforts to improve health of young people
living with HIV and AIDS in the Nakasangola District of Northern
Uganda. In 2008, Merck provided support to AMREF to scale up the
HIV and AIDS intervention in Uganda where HIV prevalence among
young women in Kawempe Division is at 24%.
Since 2004, Merck has supported UNCHR’s Strategic Plan for HIV,
AIDS and Refugees, strengthening HIV/AIDS interventions in refugee
operations in Angola, Botswana, Lesotho, Malawi, Mozambique,
Namibia, South Africa, Swaziland, Zambia and Zimbabwe. In 2008,
UNHCR and the Red Cross scaled up HIV prevention programs,
developing an HIV plan for refugees within the established HIV program in Malawi.
Merck and DHL announced an agreement in 2004 to team up to
expand access to critically needed HIV/AIDS medicines in countries
throughout sub-Saharan Africa. Under this agreement, DHL is currently delivering Merck’s HIV and AIDS medicines at cost by air
express to designated treatment centers in 35 countries.
Mothers2Mothers is an organization that addresses prevention
of mother-to-child transmission by employing mothers living
with HIV as peer educators and professional members of the
healthcare team in public health facilities. (Merck & Co., Inc.)
29
Merck & Co., Inc. HIV/AIDS Programs - Caribbean
Merck & Co., Inc. HIV/AIDS Programs - China
HIV/AIDS
Merck & Co. Inc.
USAID & other partners
Since 2003
Jamaica, Mexico, Venezuela
www.merck.com
HIV/AIDS
Merck & Co. Inc.
China Ministry of Health & other partners
Since 2005
China
www.merck.com
Merck has been working in the Caribbean to spur a broader private
sector response to HIV and AIDS. Merck recently awarded a grant to
the AIDS Responsibility Project, which, in conjunction with the
Constella Futures Group, supports the creation of a national business council on HIV and AIDS in Jamaica. The project aims to reduce
stigma and discrimination in the workplace and to mobilize companies to formulate specific workplace policies on HIV and AIDS, with
the goal of increasing disease awareness and prevention efforts,
care, counseling, testing and, if needed, treatment. The establishment of the business coalition builds upon similar efforts that Merck
has supported with partners in Mexico and Venezuela. This initiative,
which also receives funding from USAID, is already serving as a
model for regional Caribbean efforts to mobilize the private sector to
take a more active role in fighting HIV and AIDS.
In 2005, Merck & Co., Inc. and the Government of China established
the first large-scale comprehensive public/private partnership known
as the China-MSD HIV/AIDS Partnership (C-MAP), to address HIV
and AIDS prevention, patient care, treatment and support, in support
of “China’s Action Plan for Reducing & Preventing the spread of
HIV/AIDS 2006-2010.” The partners introduced the program in
Liangshan Prefecture, Sichuan Province, with the aim of developing
a model that could be replicated in other provinces. The Merck
Company Foundation has committed USD 30 million to support this
partnership over five years. The Government of China, through the
leadership of the Ministry of Health, is providing staff, facilities and
equipment. C-MAP is led by two co-national directors and has project offices in Beijing, Sichuan Province and Liangshan Prefecture.
In 2007, Merck and The Merck Company Foundation granted USD
36,500 to the Caribbean Coalition of National AIDS Programme
Coordinators (CCNAPC), a peer-based organization working to
improve national AIDS Programs in 35 Caribbean countries, committed to and Commissions. The grant is to support efforts to increase
prevention and awareness. Also in 2007, Merck sponsored an
exchange between Caribbean and Botswana business leaders to
promote understanding of the private sector role in fighting
HIV/AIDS.
From 2007 through 2008, C-MAP launched 82 initiatives in support
of the following six core strategies:
• Raising awareness and reducing discrimination among target populations through training and education;
• Deploying comprehensive, integrated risk-education approaches
to reduce HIV transmission in high-risk populations;
• Establishing a service network to provide consecutive treatment,
care and support to HIV and AIDS patients;
• Providing support to orphans and families affected by HIV to alleviate negative social and economic impact;
• Building capacity of health care workers and organizations and
developing new anti-HIV strategies and techniques;
• Strengthening monitoring and evaluation systems, data usage and
follow-up outcomes to put intervention strategies into practice and
apply best practices in a timely manner.
When the partnership launched in 2005, C-MAP covered three countries in Liangshan Prefecture of Sichuan Province. In 2008, C-MAP
expanded to cover 62 countries/districts targeting 21 million out of
87.5 million total population in Sichuan Province.
As C-MAP continues to reach its goals, an important task will be to
disseminate lessons learned to other health officials in China and
other countries combating the pandemic.
An ACHAP training program for doctors in Botswana.
(Merck & Co., Inc.)
30
Merck & Co., Inc. HIV/AIDS Programs - Latin America
Nawa Sport Program
HIV/AIDS
Merck & Co. Inc.
PAHO & other partners
Since 2003
Argentina, Brazil, Chile, Colombia, Mexico, Venezuela
www.merck.com
HIV/AIDS
Johnson & Johnson
Academy for Educational Development AED, NawaLife Trust
Since 2008
Education
Namibia
www.jnj.com
With some 720,000 people infected with the HIV virus, Brazil is estimated to have approximately one third of Latin America’s HIV-positive population. In response to the epidemic and in support of the
Brazilian government’s well-recognized commitment to address HIV
and AIDS, Merck’s Office of Contributions and MSD Brazil provided
financial support to HIV programs developed by local nongovernmental organizations, focusing primarily on prevention, education
and awareness. These organizations have included Grupo de
Amparo ao Doente de AIDS, which supported the creation of a
mobile unit for STD/AIDS prevention and assistance to offer pre- and
post-test counseling for HIV and AIDS in São Jose do Rio Preto
The Nawa Sport Program is a collaboration between the Academy
for Educational Development (AED) and Johnson & Johnson, in partnership with NawaLife Trust. The program uses the large-scale
appeal of soccer to inspire young men ages 14 to 25 to get involved
in a community activity, which could provide a way to teach them
about HIV/AIDS prevention.
A number of projects also have focused on adolescents and young
adults — an especially vulnerable group. In Brazil, Centro Corsini’s
‘Prevention Just in Time’ project is aimed at increasing screening,
diagnosis and early treatment of HIV and AIDS and other sexually
transmitted diseases among low-income teenagers and adults in the
city of Campinas. Another project, ‘Prevention: The Sooner The
Better’ with INMED Partnership for Children, supports sexual health
education and information and HIV/STD prevention programs for
young people in the town of Francisco Morato, São Paulo.
But the program does more than just teach about HIV/AIDS prevention. It gives all involved a greater sense of accomplishment and
involvement within the community. The program operates in 20 sites
across two regions in the north of Namibia, Ohangwnea and
Omusati. In its first year, the Nawa Sport Program enrolled more than
3,000 young men in its soccer and HIV/AIDS prevention education
program. In its second year, the program has expanded to include
female players and coaches as well.
31
Pfizer Diflucan® Partnership
Pfizer Global Health Fellows
HIV/AIDS
Pfizer
Axios International, IMA World Health, International Dispensary
Association
Since 2000
Access - Donation, Capacity Building - Training
www.diflucanpartnership.org, www.pfizerglobalhealth.com
HIV/AIDS, malaria
Pfizer
Multiple partner organizations
Since 2003
www.pfizer.com
Pfizer created the Diflucan® Partnership in 2000 to provide treatment for two AIDS-related fungal infections in developing countries.
Since the program’s inception, Pfizer has over provided USD 1.1 billion of products and its program partners distribute millions of
Diflucan® (fluconazole) treatments free of charge to governments
and NGOs in 63 developing countries in Africa, Asia, the Caribbean
and Latin America. Pfizer has also provided training and education
materials to 20,000 healthcare professionals.
The Pfizer Global Health Fellows program utilizes the professional
expertise of Pfizer employees through specialized volunteer assignments with nonprofit organizations to improve health care services
for underserved communities around the world. Since 2003, more
than 230 employees with a range of technical skills have served in 39
nations for 3-6 month assignments investing nearly 200,000 hours of
skills-based service to help increase the capacity of nonprofits
organizations providing health care to the underserved (in the reporting period, 54 Global Health Fellows were deployed). The program
has been recognized by the U.S. Corporation for National and
Community Service as a pro bono “best-in-class” model of international corporate volunteerism. Global Health Fellows has been replicated in different forms by leading corporations such as: IBM,
Becton Dickinson, Ernst and Young, and most recently, GlaxoSmithKline.
Pfizer’s partners provide technical assistance, support program management and distribute Diflucan to participating governments and
organizations. These partners include Axois International, IMA World
Health and International Dispensary Association.
The Diflucan® Partnership involves the following activities:
• Donating Diflucan® to governments and organizations to treat
patients;
• Distributing materials to train healthcare workers in the diagnosis
and treatment of AIDS-related infections;
• Providing inventory management training tools for pharmacists to
improve medicine handling and distribution;
• Sharing best practices for effective medicine distribution and
supporting industry collaboration on access to medicines.
Since inception, Pfizer has worked with Boston University’s Center
for Global Health and Development to evaluate the efficacy of the
program and guide its development to drive impact on the ground.
The following data reflects findings from the 2009 Global Health
Fellows Evaluation Study:
• 85% of Fellows and 83% of partner organizations reported the
contributions of the Fellowship resulted in greater efficiency. Many
accomplishments related to efficiency included introducing standard operating procedures (SOPs), technological support including databases, and supply and financial tracking sheets, communications, and overall general systems strengthening;
contributions of the Fellowship improved the quality of services.
Accomplishments related to improved quality of services included
the introduction of stronger data collection, monitoring, and evaluation tools and skills, the introduction of best practices in areas
from laboratories to customer relations, a variety of trainings, and
the introduction of SOPs;
contributions of the Fellowship resulted in service expansion. One
partner reflects that its medical program had discussed conducting clinical research for over four years, but had made no progress.
“When the Fellow came, he helped us develop the clinical research
division of our team and established policies and procedures and
the mechanisms for making the division operational.”
At the Mulago Hospital in Uganda, Pfizer Global Health Fellow
Ponni Subbiah discusses her findings with medical students.
Fellowship assignments are designed by Pfizer’s partners
according to their needs. Many involve teaching.
(Richard Lord, Pfizer)
32
Pfizer - Infectious Diseases Institute
Pfizer - PDA Positive Partnership
HIV/AIDS
Pfizer
Various partners, including universities
Since 2002
Uganda
www.academicalliancefoundation.org, www.pfizerglobalhealth.com
HIV/AIDS
Pfizer
Population and Community Development Association
Since 2004
Thailand
www.pfizerfoundation.or.th
The Infectious Diseases Institute (IDI) in Kampala, Uganda was
established in 2004 as a Center of Excellence in Infectious Disease,
combining a research program, innovative training program, and
locally relevant strategies for prevention, treatment & care, to build
regional capacity to address HIV/AIDS, malaria and tuberculosis.
Partners in the IDI include Accordia Global Health Foundation,
Makerere University and Mulago Hospital, the Ugandan Ministry of
Health, and the Infectious Diseases Society of America.
Since 2004, Pfizer Foundation New York, Pfizer Thailand Foundation
and the Population and Community Development Association (PDA)
have collaborated to improve the quality of life of people living with
HIV/AIDS. This micro-credit loan scheme provides economic security for people living with AIDS while reducing stigmatization and discrimination in their communities. Since 2007, the Pfizer Thailand
Foundation has provided financial support for the program and has
worked together with PDA to equip project members with technical
skills. The effort results in improved overall quality of life and health of
people living with HIV/AIDS and strengthened bonds within their
communities. To date, the project has provided new opportunities to
1,278 project members nationwide and has recently been recognized by UNAIDS as ‘Best Practice’ subject for duplication on international stage.
IDI is internationally recognized for building the capacity of health
systems in Africa to deliver sustainable, high quality care and prevention of HIV/AIDS and related infectious diseases through training,
research and advanced clinical services:
By enhancing the stature and recognition of the Faculty of Medicine
at Makerere University, Pfizer’s support of the IDI is helping to reverse
the trend of African healthcare professionals pursuing career opportunities abroad. African doctors, medical scientists, and other healthcare professionals can now pursue their clinical interests in a worldclass academic medical setting and serve their home countries and
people. The IDI model, combining training, clinical care and prevention, and research in an African-based and African-led academic
medical institution, has proven extraordinarily productive.
Since 2004, more than 5,100 health care workers from 27 African
countries have received training in various aspects of the prevention
and care of HIV/AIDS and related infectious diseases, and indicate
they train on average 20 additional health care workers per month.
Also, IDI provides ongoing care and treatment to over 14,000
HIV/AIDS patients in Uganda, and conducts regular outreach to
strengthen other providers in the region. More than forty projects are
currently underway in IDI’s research department, which works closely with Uganda’s Ministry of Health to improve national policy and
practice.
33
Saber para Reagir
Sikiliza Leo Project, Uganda
HIV/AIDS
Johnson & Johnson
ALIA
Since 2005
Education
Brazil
www.jnj.com, www.alia.org.br
HIV/AIDS
Johnson & Johnson
Sikiliza Leo
Since 2003
Access - Donation, Capacity Building - Support
Uganda
www.tibotec.com
According to a survey of 600 adolescents from the impoverished
São Jorge community in the Brazilian city of Londrina, 60% do not
use contraceptives and 30 percent have used illegal drugs. To protect these vulnerable teens from infectious diseases, ALIA began the
Saber para Reagir (To Know Is to React) program.
Johnson & Johnson, its Tibotec subsidiary and the African Medical
Research Foundation help the Ugandan NGO Sikiliza Leo to provide
HIV testing, counseling, treatment and care in rural Uganda. Since
March 2003, HIV testing and counseling have been offered to 3,586
community members, of whom 559 have tested positive for HIV. A
total of 272 persons receive Home Based Care and a first group of
20 are now receiving ARV therapy. Basic drug kits containing a variety of essential medicines, including miconazole MAT and co-trimoxazole prophylaxis, are among the tools used by home care volunteers.
The program’s workshops educate 80 participants at a time about
sexually transmitted diseases (including HIV/AIDS), early pregnancy,
correct use of male and female contraceptives, and citizen rights. In
addition, monthly meetings with families in the community spark dialogue and empower their involvement in the education process. “
Saber para Reagir is just one of 18 projects run by ALIA, which was
established in 1989 by HIV-positive professionals working in several
fields. Now the largest HIV/AIDS-related organization in Brazil, its
mission is to protect the civil rights of people living with HIV/AIDS and
to prevent the spread of HIV/AIDS through the creation and implementation of scientific and social programs. ALIA is considered an
authority in combating HIV/AIDS and actively participates in formulating policies related to public health, social assistance and education.
The program has also established two day-care facilities that support
some 250 orphans and vulnerable children in Mulanda and Lwala
parishes. Psychosocial development, education, nutrition and care
are offered to children from 3 to 8 years of age. The program has
been recognized by the American Embassy, and a grant has been
provided to improve facilities and food.
Since the partnership with Johnson & Johnson began in 2005, ALIA’s
Saber para Reagir program has reached more than 240 teens at high
risk for HIV/AIDS infection.
Rapid on-site testing can have a significant impact in the fight
against HIV/AIDS. (GlaxoSmithKline)
34
Takeda Initiative with Global Fund
Tibotec Cost Recovery Distribution Program
HIV/AIDS, Tuberculosis, Malaria
Takeda Pharmaceutical
Global Fund to Fight AIDS, Tuberculosis & Malaria
Since 2010
Nigeria, Senegal, Tanzania
www.takeda.com
HIV/AIDS
Johnson & Johnson
CCBRT in Tanzania
Since 2003
Access - Pricing, Capacity Building - Support
Sub-Saharan Africa
www.tibotec.com
The Takeda Initiative is an endowment made by Takeda
Pharmaceutical, with an annual value of JPY 100,000,000 (approximately USD 1 million). It is designed to support the Global Fund to
Fight AIDS, Tuberculosis and Malaria over the period 2010-2019, primarily for the training of health care workers and strengthening of
health care systems in Africa.
Johnson & Johnson’s Tibotec subsidiary makes TibozoleTM
Miconazole MAT, a muco-adhesive buccal tablet that can treat oral
thrush in AIDS patients. To date, Tibotec has sold at cost or donated over two million patient treatments of Miconazole nitrate 10 mg
MAT for use in sub-Saharan Africa. Of these, more than 1,300,000
treatment units have been sold to international procurement agencies for distribution in resource poor settings, through Tibotec’s Cost
recovery distribution program. Tibotec collaborates with major notfor-profit suppliers to the developing world, such as IDA and MSF, to
maximize access and ensure sustainable product supply. Pilot collaborations with voluntary organizations have led to an increase in
donations of patient treatments in a number of sub-Saharan African
countries.
Controlling the spread of the three major infectious diseases is one
of the eight targets set by the United Nations Millennium
Development Goals (MDGs). The lack of trained health care workers
is particularly severe in Africa, and poses a major obstacle to providing the health care services required to combat infectious diseases.
The Takeda Initiative is contributing to Global Fund-supported programs in Africa, to enhance health care systems mainly through training and strengthening the competence of individuals involved in providing health care.
During the first phase, the initiative will focus on:
• Nigeria (target disease: HIV/AIDS): Scale-up of comprehensive
HIV/AIDS treatment, care and support, training staff members of
not-for-profit and grass-roots organizations engaged in providing
community-based care for HIV/AIDS patients and orphans, and
advocacy and awareness increasing activities;
• Senegal (target disease: tuberculosis): Reinforce tuberculosis control by training health workers engaged in tuberculosis diagnosis
and treatment;
One community-based program benefiting from at-cost miconazole
is the Comprehensive Community Based Rehabilitation center in Dar
es Salaam, Tanzania (CCBRT). Dr. Geert Vanneste, Medical Director
of the holistic HIV program at CCBRT, said ‘the product has really
provided us with a convenient, fast acting topical product, which can
be used at the lowest level of care, and represents a real advance in
the armamentarium for our home based care workers’. The home
based care providers working in the program have also spoken out
regarding the product benefits: its efficacy, minimal side effects and
good compliance.
• Tanzania (target disease: malaria): Support the National Insecticide
Treated Nets Implementation Plan (NATNETS) by strengthening
the system to distribute insecticide treated nets and by developing
the human resources engaged in promoting the use of nets.
35
ViiV Healthcare’s Positive Action on HIV/AIDS
‘Youth Speak-Up!’ HIV Peer Education
HIV/AIDS
GlaxoSmithKline
AMREF, CRS, EGPAF, IHAA, NEPHAK
Since 1992
www.positiveaction.com
HIV/AIDS
Johnson & Johnson
Indonesian Youth Partnership
Since 2006
Education
Indonesia
www.jnj.com
Set up in 1992, Positive Action is ViiV Healthcare’s international
HIV/AIDS education, care and community support program. It works
with community organizations to build capacity to counter the ignorance and stigma surrounding HIV and AIDS through outreach, education and advocacy. In 2009, ViiV Healthcare provided more than
GBP 1 million, funding projects in 46 countries across Africa, Asia,
Latin America and Eastern Europe. Positive Action has pioneered
support for vulnerable communities, including men who have sex
with men, intravenous drug users, sex workers, migrants, young
people, orphans and vulnerable children and marginalized poor rural
women. In July 2009, ViiV Healthcare launched a new Positive Action
for Children Fund which will make GBP 50 million (USD 80 million)
available over ten years to help prevent mother-to-child transmission
of HIV and to support orphans and vulnerable children. During 2009,
ViiV Healthcare supported 17 Positive Action programs in 46 countries, examples of which are given below.
Young people in Indonesia account for 46% of all HIV/AIDS infections. ‘Youth Speak-Up!’ was initiated by the Indonesian Youth
Partnership (IYP), a nationwide network of youth leaders fighting for
Adolescent Reproductive Health and Rights. ‘Youth Speak-Up!’ uses
a network of peer educators to raise awareness about HIV/AIDS
transmission and prevention.
Johnson & Johnson supports ‘Youth Speak-Up!’ programs in which
adolescents from 12 provinces are trained to educate others in their
communities, reaching more than 3,000 young people. In 2007, 240
peer educators were recruited and an additional 21 peer education
trainers were trained in the program. With the support of the IYP, the
program is growing into a sustainable network of peer educators
with the capacity to ensure education in the provinces. The IYP collaborates with the national media to spread the importance of their
message.
Reach India aims to make HIV/AIDS prevention, financial and business education available to millions of poor women in rural India. ViiV
is giving USD 595,000 over four years to develop the capacity of
community organizations and self-help groups to reach 500,000
women and 2.5 million family members in rural areas. Reach India is
supported by Catholic Relief Services (CRS).
In Kenya, ViiV is giving USD 2.2 million over four years to integrate
HIV/AIDS treatment and support services into 38 general healthcare
clinics, to enable people to avoid the stigma of visiting an HIV clinic.
Positive Action also helps to train healthcare professionals and create patient self-help groups. Other partners include the African
Medical and Research Foundation (AMREF), Elizabeth Glaser
Pediatric AIDS Foundation (EGPAF) and the National Empowerment
Network of People Living with HIV and AIDS in Kenya (NEPHAK).
In Mexico, ViiV is working on a four-year project with the International
HIV/AIDS Alliance (IHAA) and its Mexican partner, Colectivo Sol, to
improve quality of life for people with HIV/AIDS, reduce stigma and
discrimination, and educate people about HIV/AIDS.
The TREAT Asia program is run by the Foundation for AIDS Research
(amfAR) with support from Positive Action and seeks to teach proper, safe and effective use of HIV therapies, working with clinicians and
other health care workers in 25 clinics across a number of Asian
countries, including Cambodia, China, Thailand and Vietnam.
In 2009 ViiV Healthcare announced support for the Staying Alive
Foundation in its efforts to raise awareness about HIV/AIDS and its
prevention among young people worldwide.
Many programs supported by industry involve training
to strengthen local health care capacity. (GlaxoSmithKline)
36
HIV/AIDS – R &D
Gilead Clinical Development Partnerships
HIVACAT public-private partnership for HIV vaccine
development
HIV/AIDS
Gilead
US CDC, US NIH
Since ?
R&D
Uganda, Zimbabwe
www.gilead.com
HIV/AIDS
Esteve
IrsiCaixa, Obra Social La Caixa, Hospital Clínic de Barcelona, Catalan
Government
Since 2008
R&D
R&D work in Spain
www.esteve.com, www.irsicaixa.org
Gilead is investing in clinical research to develop new medical interventions that address the health needs of developing countries. At
the end of 2008, Gilead was involved in 36 ongoing studies that had
enrolled more than 13,500 patients in Asia, Africa and Latin America.
The largest of these studies is the Development of Antiretroviral
Therapy (DART) study with two sites in Uganda and one site in
Zimbabwe
The development of an effective vaccine is the only affordable and
sustainable way to halt the HIV pandemic. In response to this challenge, the “HIVACAT” program was launched in 1995to design,
develop and test potential HIV vaccine candidates in clinical trials for
further development and regulatory approval. HIVACAT is a joint
effort by two leading European HIV research institutions - the
Hospital Clinic de Barcelona and Irsicaixa - and brings together the
expertise and projects of more than 60 investigators from both centers.
Clinical studies supported by the US Centers for Disease Control and
Prevention, the National Institutes of Health and other public health
leaders also are underway to evaluate the potential of Viread® and
Truvada® to prevent HIV infection in high-risk individuals. For these
studies, Gilead provides Viread®, Truvada® and/or placebo at no
cost. Preliminary results from these studies may be available in 2010.
Esteve’s involvement started in 2008 and consists of financing part
of the research phase and helping with regulatory and intellectual
property issues. Once proof-of-concept in humans is reached,
Esteve will take care of submission for regulatory approval and commercialization.
The program tackles some of the current roadblocks in HIV vaccine
design, including the incomplete knowledge of host immune control
of HIV, viral sequence diversity and adequate vaccine vector design.
Through extensive national and international collaboration and the
stature of its members, the program is well integrated in the global
effort to develop an HIV vaccine. The program is structured in 8 highly interactive lines of investigation that address cellular and humoral
immunity to HIV and their relationship with viral control, assess the
impact of viral sequence diversity and host genetics on vaccine
immunogen design and study the function of dendritic cells as vaccine carriers. It contains a straightforward path to design preventive
vaccine approaches and select the most promising candidates for
clinical trials. The work is strongly supported by a unique access to
patients and the proven ability of the two centers to conduct extensive clinical trials and cohort-based studies.
The project is advancing at good pace. In the last months several
important papers on the research have published, the latest in
“Nature Medicine” (Feb 2010) about how innate immune mechanisms can control disease progression in HIV-positive patients.
37
HIV/AIDS – R &D
International AIDS Vaccine Initiative (IAVI)
HIV/AIDS
Bristol-Myers Squibb, Crucell, GlaxoSmithKline, Merck & Co. Inc.,
Pfizer
IAVI, BD, Gates, Rockefeller, USAID, World Bank
Since 1996
R&D
Worldwide
www.iavi.org
The International AIDS Vaccine Initiative (IAVI) was created in 1996
out of the recognition that the best long-term solution to the growing
AIDS epidemic is a vaccine. As a global organization operating
across borders to meet the challenges posed by the epidemic, IAVI
is working to ensure the development of safe, effective, accessible
and preventive HIV vaccines for use throughout the world. IAVI’s
work focuses on four areas:
• Support through advocacy and education (by identifying and filling
other scientific gaps);
• Scientific progress (by supporting promising vaccine development
partnerships);
• Industrial participation in AIDS vaccine development (by expanding
public-private collaboration and creating incentives for private sector investment and participation in HIV vaccine development); and
• Global access (by creating the policies necessary for getting the
vaccines to all those who need it).
IAVI collaborates with developing countries, governments and international agencies that are dedicated to accelerating the development
of a vaccine to halt the AIDS epidemic. IAVI is working on HIV/AIDS
vaccine projects with Crucell and GlaxoSmithKline, while BristolMyers Squibb, Merck & Co., Inc. and Pfizer are IAVI funding partners,
as are the Rockefeller Foundation, World Bank, USAID, the Bill and
Melinda Gates Foundation and other donors.
In 2005, GlaxoSmithKline launched the first formal public-private
partnership with IAVI to research vaccines against HIV strains that circulate predominantly in Africa. IAVI contributes technical expertise
and funding, and GSK and IAVI researchers form a joint research
team. The partnership is doing preclinical research for a vaccine
using a vector derived from an adenovirus common in non-human
primates carrying pieces of the HIV genome. Disabled adenoviruses
are innocuous and produce a very strong immune response.
Previous exposure to naturally occurring adenoviruses may limit the
potency of such vaccines, which is why GSK and IAVI are concentrating on adenoviruses that do not occur in humans.
IAVI entered into an agreement with Crucell to develop an HIV vaccine based on Crucell’s AdVac adenovirus vector technology and
obtained the rights from Crucell to use a cell line for these vectors. A
Phase I clinical trial evaluating safety and immunogenicity of a candidate vaccine based on this technology started in 2009.
The virus that causes AIDS can become resistant to current
treatments, so it is important to continue R&D to develop new
medicines and vaccines. (Merck & Co., Inc.)
38
HIV/AIDS – R &D
International Partnership for Microbicides (IPM)
Merck & Co., Inc. HIV Vaccine R&D
HIV/AIDS
Bristol-Myers Squibb, Gilead, Johnson & Johnson, Merck & Co. Inc.,
ViiV Healthcare
International Partnership for Microbicides
Since 2004
R&D
Rwanda, South Africa, Tanzania
www.ipm-microbicides.org
HIV/AIDS
Merck & Co. Inc.
HIV Vaccine Trials Network & other partners
Since 2003
R&D
R&D around the world
www.merck.com
Johnson & Johnson’s Tibotec affiliate established a first-of-its-kind
public-private partnership with the non-profit International
Partnership for Microbicides (IPM) in 2004, providing a royalty-free
license and technology transfer to develop, manufacture and distribute TMC120 as a topical vaginal microbicide to reduce sexual transmission of HIV in developing countries. IPM is conducting safety trials of TMC120 as a vaginal gel in Belgium, South Africa, Rwanda and
Tanzania. Following two successful safety studies, IPM is now
researching dapivirine’s use in an innovative vaginal ring delivery system which could offer women extended HIV protection.
Merck & Co., Inc.’s HIV vaccine research program began in 1986
and continues to make progress in bringing forward new innovative
vaccines, working with others in public/private partnership to make
them accessible to those who need them around the world, and
helping to build capacity in developing countries.
In October 2005, Bristol-Myers Squibb announced that it had granted a royalty-free license to IPM to develop, manufacture and distribute their new antiretroviral compound as a microbicide to protect
women from HIV in resource poor countries. The compound was an
‘entry inhibitor’, some of which bind directly to the HIV itself, others
to the CCR5 receptor. The compound is designed to prevent HIV
from entering host cells efficiently, thus preventing infection.
In December 2006, Gilead granted royalty-free rights to the IPM and
Conrad to develop, manufacture, and distribute tenofovir gel as a
microbicide. The gel is currently being evaluated in Phase II/III clinical
studies conducted by the HIV Prevention Trials Network (HPTN),
Microbicide Trials Network (MTN), and the Centre for the AIDS
Programme of Research in South Africa (CAPRISA).
In 2005, Merck granted a no-cost license to IPM for development,
manufacture and distribution as a microbicide for use in developing
countries. Most recently, in March 2008, Merck granted a non-royalty-bearing, non-exclusive license to IPM to develop, manufacture
and distribute a novel antiretroviral compound for use as a potential
vaginal microbicide. The compound is the fourth Merck has granted
to IPM since 2005.
In January 2008, Pfizer agreed to give IPM a royalty-free license to
maraviroc, its newly-approved HIV treatment, as a microbicide for
the prevention of HIV infection. Maraviroc is one of a new class of
antiretroviral drugs known as CCR5 blockers. Under this agreement,
IPM will work to develop maraviroc as a vaginal microbicide with the
right to develop, manufacture and distribute it in developing countries. Pfizer granted these rights to IPM without a royalty. Pfizer’s contribution now falls under ViiV Healthcare.
Given the high-risk nature of pharmaceutical research and development, setbacks are common. Phase II ‘test of concept’ clinical trial
of Merck’s lead HIV vaccine candidate, a trivalent adenovirus based
vaccine, was conducted in partnership with the HIV Vaccine Trials
Network (HVTN) and the National Institutes of Health (NIH). The study
began in 2004 in Australia, the Caribbean, and North and South
America. Another Phase II study of this vaccine candidate - called
Phambili - was initiated in South Africa by the HVTN and NIH in
February 2007.
In 2007, Merck, the HVTN and NIH announced that vaccination and
enrollment were discontinued in both STEP and Phambili trials
because in interim analyses of STEP the vaccine was found to be
ineffective. In scientific meetings, results from STEP were presented
which showed that the vaccine neither prevented infection in uninfected volunteers nor reduced viral loads in those who became
infected with HIV during the course of the study. In certain STEP subgroups, there were more infections in volunteers who received the
vaccine than in those who received placebo. Merck, HVTN and NIH
are conducting extensive analyses to better understand the STEP
data and the reason for this result.
While the STEP study results were disappointing to Merck and the
external HIV community, the partners are committed to gaining scientific insights from STEP to inform the ongoing search for an HIV
vaccine. The partnership between Merck, HVTN and NIH in this
endeavor has been hailed by many as a model for collaboration
between industry, government and academia in the advancement of
science. Merck is also collaborating with NIH and HVTN to implement a fair and rigorous scientific evaluation of STEP results and to
enable external investigators to gain access to specimens and data
from this study in an effort to advance the search for an effective HIV
vaccine.
The HIV Vaccine Trials Network is an international collaboration of
scientists and institutions whose goal is to accelerate the search for
an HIV vaccine by sharing trial results and facilitating parallel, concurrent testing. The HVTN is funded and supported by the US
National Institute of Allergy and Infectious Disease (NIAID) at the
National Institutes of Health (NIH).
39
HIV/AIDS – R &D
Pediatric Formulations for ARVs
HIV/AIDS
Abbott, Bristol-Myers Squibb, Gilead, Ranbaxy, ViiV Healthcare
Various partners
Since ?
R&D - Pediatric R&D
Clinical programs include developing countries
www.abbott.com, www.bms.com, www.gilead.com, www.gsk.com
Of the 2.5 million HIV-positive children in the world in 2007, nearly
90% were in sub-Saharan Africa, according to UNAIDS.
Antiretrovirals (ARVs) are developed for adults, most clinical trials are
in adults, with doses and dosage forms designed for adults. But children cannot be dosed like small adults, as their metabolic capacity
to absorb ARVs is not simply proportional to their weight. Safety, efficacy and dosage need to be determined via specific pediatric trials.
Most ARVs were developed in tablet form, yet these are impractical
for children under five, who require special liquid formulations. While
older children can take tablets, those intended for adults often contain too large a dose.
Abbott has had a longstanding commitment to the treatment of children with HIV. In 2007, as an industry first, Abbott launched the
lower-strength tablet formulation of lopinavir/ritonavir in the developing world (Uganda) before the product was available in the developed
world. The lopinavir/ritonavir tablet is the only co-formulated protease inhibitor tablet that can be used in children, the tablets do not
require refrigeration and can be taken with or without a meal – important advances in delivering HIV medicine in developing countries. The
tablet is easier for children to take than its liquid formulation, which
has been used in Africa since 2001. The lower-strength tablet is sold
at half the price of the original formulation in 69 countries, including
all of Africa.
Ranbaxy, which is majority owned by Daiichi Sankyo, is active in
pediatric HIV R&D, with 2 fixed dose combinations and 9 single
ingredient products in development, in line with WHO pediatric
guidelines. Ranbaxy has developed a triple fixed dose combination
of Lamivudine, Stavudine and Nevirapine but, as WHO subsequently changed its dosing recommendations for this combination, the
company is now seeking a partner to help fund a new bio-equivalence study.
In 2007, ViiV gained European Commission and FDA approval for
new scored tablets for Epivir, Combivir and Ziagen. This will enable
children above 14kg of weight to benefit from a solid dosage form.
Scored tablets enable ARVs to be broken into two smaller doses
which simplifies treatment for children. Tablets are often easier to
store and distribute, and also less complicated to administer than the
liquid formulations currently available - particularly when two or three
medicines are combined in one pill. For example, a child weighing
20kg can now take half a tablet of Combivir in the morning and the
second half in the evening in combination with another ARV, instead
of requiring 8ml of Epivir solution twice a day plus 12ml of Retrovir
solution three times daily.
Bristol-Myers Squibb currently produces pediatric formulations of
Videx® (didanosine), Zerit® (stavudine) and Sustiva® (efavirenz), and
is working with the Pediatric AIDS Clinical Trials Group to develop
Reyataz® (atazanavir) for infants from 3 months old to 18 years. It is
also developing Sustiva® oral solution for children from 3 months to
16 years. Sustiva capsules are currently approved for use in children
3 years and older.
Gilead Sciences is working to advance development of a pediatric
formulation of tenofovir. To address issues with the initial formulation,
Gilead has developed a new heat-stable encapsulated sprinkle formulation for future studies. Two Phase III studies in pediatrics are fully
enrolled and ongoing.
GlaxoSmithKline’s ARV interests are now managed by ViiV
Healthcare. It has developed a number of ARV liquid formulations for
children, all available at not-for-profit prices in the world’s poorest
countries. ViiV has also committed to support five pediatric clinical
trials in resource-poor countries to determine the best ways to
expand access to HIV/AIDS treatment. The development of oral
solutions for its combination therapies, Combivir® and Trizivir®, is
complicated because two key components (zidovudine and lamivudine) require different pH ranges to maintain stability, and daily dosing issues associated with abacavir have hampered a Kivexa® pediatric formulation.
An estimated 2.5 million children were living with HIV/AIDS
in 2007. (Abbott)
40
HIV/AIDS – R &D
PEPFAR Partnership for Pediatric AIDS Treatment
ViiV Healthcare Collaborative Research Program
for Resource-Poor Settings
HIV/AIDS
Abbott, Bristol-Myers Squibb, Gilead, Merck & Co. Inc., ViiV
Healthcare
PEPFAR, UNAIDS, UNICEF, WHO
Since 2006
Access - Pricing, R&D - Pediatric R&D
www.pepfar.gov
HIV/AIDS
ViiV Healthcare
WHO & other partners
Since 2000
R&D - Pediatric R&D
www.gsk.com
The US President’s Emergency Plan for AIDS Relief (PEPFAR)
Partnership for Pediatric AIDS Treatment was launched in 2006. This
public-private partnership includes innovator and generic pharmaceutical companies and multilateral organizations such as UNAIDS,
WHO and UNICEF. The initiative will identify scientific obstacles to
treatment for children, take practical steps to address key barriers,
share best practices and develop systems for clinical and technical
support.
ViiV Healthcare is committed to the development of new molecules
that target unmet medical needs in HIV. The treatment of children
with HIV/AIDS remains a significant unmet medical need and there is
a pressing need for new medicines to tackle problems such as drug
resistance, complex treatment regimens, and side effects associated
with current treatments. Through its HIV-collaborative research program for resource-poor settings, ViiV Healthcare is supporting clinical trials that are sponsored by external organizations - such as the
World Health Organization (WHO), the UK Medical Research Council
and the US National Institutes of Health (NIH).
In addition to making medicines available at preferential prices to
PEPFAR, Abbott is also working with PEPFAR to advance treatment
for children with HIV in developing countries by actively participating
in the PEPFAR Partnership for Pediatric AIDS Treatment.
Bristol-Myers Squibb is an active partner in the PEPFAR Partnership
for Pediatric AIDS Treatment, working to find solutions to issues concerning pediatric HIV treatment, formulations and access. In 2004,
Bristol-Myers Squibb agreed to allow the FDA to make right of reference to its confidential dossiers and product registration files to facilitate approval of generic combination products under the PEPFAR
program.
Gilead is an active member of the PEPFAR Partnership for Pediatric
AIDS Treatment.
Merck & Co., Inc. is working in partnership with the PEPFAR
Partnership for Pediatric AIDS Treatment, working to identify scientific and technical solutions to improving access to antiretroviral treatment for children living with HIV/AIDS in resource-limited settings.
At the end of 2009, 22 trials, involving approximately 23,300,
patients, were either underway or committed to, with 19 of these trials being in Africa. These CRTs focus predominantly on public
health-related issues such as prevention of mother-to-child HIV
transmission, pediatric treatments strategies and HIV-TB co-infection. Five of these are pediatric studies, one of which will provide the
first significant clinical data in the resource-poor setting on the efficacy, safety and pharmacokinetics of ViiV Healthcare’s NRTI scored
tablets. ViiV Healthcare donates study antiretrovirals and/or financial
support, and also provides scientific input.
Countries in which HIV clinical trials are being conducted under the
aegis of this program include: Botswana, Brazil, Cambodia, Haiti,
India, Kenya, Malawi, Peru, South Africa, Tanzania, Thailand,
Uganda, Zambia and Zimbabwe.
ViiV Healthcare is a major supplier of ARVs to PEPFAR at access
prices and has also participated in the State Department’s program
to expand the number of pediatric formulations for HIV medicines
that are appropriate for PEPFAR and other child access programs in
the developing world.
The treatment of children with HIV/AIDS remains a significant
unmet medical need. (GlaxoSmithKline)
41
TUBERCULOSIS
Estimated TB incidence rates, 2008
>
_ 300
100 – 299
50 – 99
25 – 49
0 – 24
No estimate
(Source: WHO Global Tuberculosis Control 2009, A short update to the 2009 report)
42
About one third of the world’s population is infected with
Mycobacterium tuberculosis. While only 1 in 10 infected people
with healthy immune systems will develop tuberculosis (TB)
symptoms, those with weakened immune systems, such as
those with HIV, are much more likely to contract TB. More than
90 % of TB cases and deaths occur in the developing world,
primarily among young adults.
In 2008, there were an estimated 9.4 million cases of TB globally,
up from 9.3 million in 2007, as slow reductions in incidence
continue to be outweighed by increases in population. Most of
the cases in 2008 were in Asia (55 %) and Africa (30 %). In 2008,
some 1.4 million (15 %) of all TB cases were HIV-positive, most of
them in Africa and South-East Asia.
Directly Observed Treatment Short-Course (DOTS) is the WHOrecommended TB therapy and uses a combination of antibiotics
over a 6-8 month period. Patients are observed taking their
medication, to ensure the continued compliance needed for
complete eradication of the bacteria. Nearly 32 million TB
patients have been treated under DOTS since 1995. Although a
vaccine exists to prevent childhood tuberculous meningitis, a
100% effective, affordable and practical vaccine has yet to be
developed against adult pulmonary TB.
Multidrug-resistant TB (MDR TB) affected some 440,000 people
worldwide in 2008 and a third of them died. It does not respond
to the standard first-line treatment and it can take up to two years
or more to treat with medicines that are less potent, more toxic
and more expensive. Extensively drug-resistant TB (XDR TB)
occurs when resistance develops to the second-line drugs used
to treat MDR-TB. It is virtually untreatable and cases have been
confirmed in more than 57 countries, notably China and India.
The pharmaceutical industry is developing new TB medicine and
vaccine candidates and supports a range of programs to
increase access to TB medicines and to strengthen healthcare
capacity in affected countries.
(Source: WHO Global Tuberculosis Control 2009, Epidemiology, Strategy, Financing; WHO Global Tuberculosis Control, A short update to the 2009 report; WHO
Multidrug and extensively drug-resistant TB (M/XDR TB), 2010 Global Report on Surveillance and Response)
43
AstraZeneca & Red Cross: Fight against TB in Africa
AstraZeneca & Red Cross: Fight against TB
in Central Asia
Tuberculosis
AstraZeneca
Red Cross
Since 2006
Lesotho, Liberia, South Africa
www.astrazeneca.com
Tuberculosis, HIV/AIDS
AstraZeneca
British Red Cross
Since 2002
Kazakhstan, Kyrgyzstan, Turkmenistan
www.astrazeneca.com
Since 2006, AstraZeneca has supported the Red Cross in its community-based work to help reduce TB incidence and improve the
quality of life of people affected by TB and TB/HIV in sub-Saharan
Africa.
AstraZeneca’s long-standing partnership with the British Red Cross
Society is focused on helping the international Red Cross and Red
Crescent movement to deliver community-based programs in
Central Asia which encourage people to seek early diagnosis,
Improve patient compliance, provide care in the home, promote TB
and TB/HIV awareness/education and address the stigma associated with the diseases.
With AstraZeneca’s support, the South African Red Cross is delivering improved care and support to people living with TB or TB/HIV in
10 provinces, including the KwaZulu Natal, Western Cape, Eastern
Cape, Limpopo, Gauteng and Free State. To date, some 2,500 people affected by TB or TB/HIV have successfully completed their treatment and over 6,000 suspected cases of TB identified and sent for
screening. This has been achieved mainly through patient follow-up
by trained volunteers. Volunteers also distribute TB prevention information and have reached over 60,000 people.
In Lesotho, the company’s support has enabled the Lesotho Red
Cross to deliver improved TB and TB/HIV care to people living in the
isolated, rural communities of Mapholaneng, Leribe, Mafeteng, Kena
and Maseru, who have little access to formal health facilities. More
than 160 Red Cross volunteers have been trained in TB management and prevention, including how to recognize TB symptoms, how
it is transmitted, infection control and care, and referral of people suffering from the disease. These trained volunteers then work within
the local communities to share their knowledge with local volunteers
and village committees.
During 2008, AstraZeneca expanded its support to include a new
project in Liberia, where treatment completion rates are estimated to
be below 75%. Working with the Liberian Ministry of Health, the
Liberian Red Cross has developed a new program to increase TB
awareness through community based education and provide support to people living with TB. Implementation began in December
2008 in the Montserrado region, building on the existing communitybased health work of the Liberian Red Cross. To date, the Liberian
Red Cross trained 27 community volunteers in TB care and prevention and 9 ‘focal’ volunteers, who coordinate activity within their
communities. A further 67 volunteers are currently receiving training.
AstraZeneca’s support has helped the Red Cross to expand its coverage and form strong relationships with ministries of health and
partner organizations and is playing a significant role in helping
national TB programs in Kyrgyzstan, Turkmenistan and Kazakhstan
to stabilize and reduce TB incidence in these countries.
In 2002, AstraZeneca started helping the Red Cross to address TB
in Kyrgyzstan and Turkmenistan, poor countries with a high incidence of TB. Since 2006, the company has also supported a program in Kazakhstan, aimed at mitigating the consequences of
TB/HIV co-infection. All programs are managed by the national Red
Crescent Societies.
The Kyrgyz and Turkmen programs focus on improving patient compliance, raising awareness of TB and fighting the stigma associated
with the disease. Progress to date includes:
• Over 10,000 people living with TB or TB/HIV successfully completed their TB treatment;
• TB treatment completion rates up to 89% and 92% in
Turkmenistan and Kyrgyzstan, respectively;
• Increased awareness following media campaigns and health education sessions in schools and public places that reached more
than 2 million people.
The Kazakh program is providing community-based social support
for people living with TB and HIV, and their families, bringing together social workers, psychologists and employment lawyers, with volunteers – many of them former patients - to support those on treatment and those who have recently completed treatment.
Consultations encourage treatment compliance and help patients
deal with social and emotional difficulties. Between January and
September 2009, over 800 consultations, 68 group discussion and
73 home visits took place and some 1,800 food parcels were distributed. Treatment completion rates increased from 54% to 73% in
2008.
Kyrgyz Red Crescent nurses and volunteers hand out leaflets
in Bishkek’s Ortsai market. The leaflets explain the symptoms
of TB and how to prevent infection. (Claudia Janke, British
Red Cross)
44
Lilly MDR-TB Partnership
Novartis TB DOTS Donation
Tuberculosis
Lilly
Since 2003
Access - Pricing & Tech Transfer, Capacity Building - Support &
Training, Education
Partnership activities in over 80 countries
www.lillymdr-tb.com
Tuberculosis
Novartis
WHO
Since 2003
Access - Donation
Tanzania
www.novartisfoundation.org
The Lilly MDR-TB Partnership was launched by Eli Lilly and Company
in response to the growing threat of multidrug-resistant tuberculosis.
Operating in over 80 countries, and with a specific focus on those
countries hardest hit by MDR-TB (China, India, Russia and South
Africa), the partnership is based on a multi-pronged approach that
includes the following components: technology transfer to increase
the MDR-TB drug supply; training to improve disease management
and surveillance; and support for communities, including patient
advocacy and workplace awareness and prevention programs.
The WHO’s TB control strategy consists of Directly Observed
Therapy Short-Course (DOTS) and combines political commitment
to sustained TB control activities: early detection, a standardized
treatment regimen, effective drug supply, as well as monitoring and
evaluation.
In close collaboration with the WHO Green Light Committee, Lilly
works to increase access to second-line TB medicines. Initially, it
provided medicines at discounted prices; however, as demand
began to exceed supply, Lilly began transferring the product and
manufacturing know-how to produce its two second-line medicines
to companies in China, India, Russia and South Africa. Lilly also partnered with Purdue University to provide assistance in safety, quality
and business management to its manufacturing partners.
The Lilly MDR-TB Partnership also supports a variety of activities
aimed at increasing health-care provider knowledge and disease surveillance. Partner projects include:
• The International Council of Nurses’ online “Global TB/MDR-TB
Resource Center” for 13 million nurses worldwide. Launched in
South Africa and the Philippines in 2005, this “train the trainers”
has expanded to more than 20 countries;
• Harvard Medical School and Partners in Health run an MDR-TB
training Center of Excellence in Tomsk, Russia. PIH works with 5
Russian TB research centers to standardize MDR-TB training
nationwide;
• The International Hospital Federation has developed comprehensive TB and MDR-TB-control training manuals and distributed
them to 65,000 hospitals and clinics in some 100 countries;
• The World Medical Association has edited clinical MDR-TB guidelines targeted on physicians and has been training physicians
worldwide.
From 2005 to 2008, Novartis donated nearly 250,000 rifampicinbased fixed-dose combination tablets for the treatment of TB in
Tanzania. Another 250,000 treatments will be delivered from 2009 to
2012 which ensures a country-wide coverage. The medicines are
given to the Global Drug Facility (GDF) of the Stop TB Partnership
which is part of the WHO.
Novartis also provides the necessary funds for logistics and independent quality control, to be carried out in addition to the quality
control performed by the Novartis Group.
The fixed-dose combination therapy reduces the treatment duration
from 8 to 6 months. The medicines are provided in blister packs
which facilitate the intake of several different pills, reduce the risk of
resistance, simplify logistics and minimize prescription errors.
In collaboration with the Tanzanian National Tuberculosis and
Leprosy Control Program (NTLP), the Novartis Foundation for
Sustainable Development developed the Patient-Centered Treatment
(PCT) approach allowing people to choose where they wish to be
treated and supervised – in a health center or at home with support
of a family or community member. PCT also adheres to the DOTS
strategy but avoids daily traveling for physically weak patients and
those living far from the health facility. Moreover, PCT promotes
patients’ empowerment and responsibility for their treatment.
The Novartis Foundation and the NTLP complemented the PCT
approach with a social marketing campaign to inform people about
TB, its causes, symptoms and new therapies. The aim was to destigmatize the illness, since many patients are co-infected with
HIV/AIDS. Results show that 88% of TB patients opt for home-based
treatment and that the rate of treatment compliance (completed
treatments) could be increased from 72% to 77.5%.
The partnership also supports various community, advocacy and
workplace initiatives. These include:
• A World Economic Forum toolkit to increase TB and MDR-TB
workplace awareness in India, China and South Africa;
• The International Federation of Red Cross and Red Crescent
Societies is implementing patient-support programs in over 15
countries, including public-awareness, psychological support, and
food supplements for vulnerable populations;
• The Advocacy Partnership and Global Health Advocates have
been raising awareness on TB and advocating on behalf of
patients.
These women are performing street theatre to educate
the population on TB prevention and treatment
in New Delhi, India. (Lilly)
45
Sanofi-aventis: TB Free & Other Initiatives
Stop TB Partnership
Tuberculosis
sanofi-aventis
Nelson Mandela Foundation & other partners
Since 2002
India, Kenya, South Africa
www.sanofi-aventis.com
Tuberculosis
AstraZeneca, GlaxoSmithKline, Lilly, Novartis
Stop TB, MSF, Red Cross & other partners
Since 2000
Access - Donation & Pricing, R&D
Endemic countries & vulnerable populations
www.stoptb.org
In March 2002, sanofi-aventis and the Nelson Mandela Foundation
established the TB Free program, a EUR 15 million effort to increase
detection and treatment rates for tuberculosis in South Africa. Initially
planned to finish in 2007, it has now been extended to 2010. The
partnership trains volunteers to encourage patient compliance during
the 6-month treatment, using the WHO-recommended DOTS
(Directly Observed Therapy Short-Course) strategy.
The Stop TB Partnership was established in 2000 to realize the goal
of eliminating tuberculosis (TB) as a public health problem. It comprises a network of more than 500 international, governmental, nongovernmental and private sector organizations and individuals with
an interest in working together to achieve this goal. The Partnership
is a global movement to accelerate social and political action to stop
the spread of TB around the world. A number of IFPMA members,
including AstraZeneca, GlaxoSmithKline, Lilly, Novartis, Pfizer and
IFPMA are currently partners of the Stop TB Partnership, and actively contribute to its aims and programs.
The agreement mandated TB Free to provide infrastructure for training and conduct training and also develop and implement education
and awareness programs. The actions would help to increase the TB
cure rate by as much as 80% through improved compliance to TB
treatment. In each of the country’s nine provinces, a TB Free Center
has been established, which works closely with the Ministry of
Health. By 2009, nine training centers had been opened, in which
33 000 ‘DOTS supporters’ have been trained.
TB Free provides a fully accredited training program which equips
the DOT supporters with skills to provide care and support to TB
patients and their families. The training program is integrated with the
South Africa Community Workers Program, designed to qualify
Community Workers in the fields of health, social welfare and other
disciplines.
A comprehensive TB advocacy, communication and social mobilization program is being implemented, to increase testing, compliance
and cure rates. The program harnesses television and radio adverts
and information programs, billboard campaigns, print media, taxis
advertisements and door-to-door information visits by DOTS supporters. Such activities are helping to change community attitudes to
TB and put it high on decision makers’ agendas.
In Kenya, sanofi-aventis works with the Kenya Association for the
Prevention of Tuberculosis and Lung Diseases to train health-care
workers in 200 targeted treatment centers. Sanofi-aventis also supports the Kenya’s World TB day awareness activities.
In India, sanofi-aventis formed a partnership with the Association
Père Ceyrac in 2007 to fight tuberculosis and support TB-affected
families living in the slums of Mumbai, Navi-Mumbai and Pune.
Sanofi-aventis supports the Inter-Aide NGO through local partners by
means of 51 DOTS (Directly Observed Treatment short-course) centers, 11 centers for collecting samples, and 4 testing laboratories
located in the heart of the slums, which manage to treat almost
4,000 patients a year.
46
The targets set by the Stop Partnership are:
• By 2005: 70% of people with infectious TB will be diagnosed and
85% of them cured;
• By 2015: the global burden of TB disease will be reduced by 50%
relative to 1990 levels (Millennium Development Goal);
• By 2050: The global incidence of TB disease will be less than 1 per
million population (Elimination of TB as a global public health problem).
The partnership develops advocacy and resource mobilization
strategies in support of these priorities, and coordinates and ‘brokers’ resource flows. In addition, there are six Working Groups that
contribute significantly to the achievement of partnership aims:
DOTS Expansion Working Group; TB-HIV Working Group; Stop TB
Working Group on MDR-TB; Working Group on New TB Drugs,
Working Group on New TB Diagnostics and Working Group on New
TB Vaccines.
The Stop TB Partnership Private Sector Constituency is the community of businesses with a recognized role or interest in TB control. The
Private Sector has been represented on the Coordinating Board of
the Global Stop TB Partnership since 2004, following a proposal by
the World Economic Forum. The current Board Members are
AstraZeneca and Mérieux Alliance.
The Global Drug Facility, run by the Stop TB Partnership, is expanding access to medicines for DOTS scale up; in just 5 years it has
committed over 7 million TB treatments. Projects managing MDR-TB
can apply through the Green Light Committee (GLC) for access to
quality MDR-TB medicines at reduced prices - in some cases by as
much as 99%. The Committee is operated by WHO and the Stop TB
Partnership. Lilly has a program to make two critical medicines for
treatment of drug-resistant strains available in developing countries
and will supply 1.4 million vials of capreomycin at concessionary
prices to the GLC in 2009. Novartis is donating 500,000 fixed dose
combinations to the Global Drug Facility during 2005-2012.
TUBERCULOSIS – R & D
Aeras Global TB Vaccine Foundation
AstraZeneca Bangalore Research Institute
Tuberculosis
Crucell, GlaxoSmithKline
Aeras & other partners
Since 2004
R&D
Kenya, Philippines, South Africa
www.aeras.org, www.crucell.com, www.gsk.com
Tuberculosis
AstraZeneca
European Union Framework Program VI
Since 2003
R&D
India
www.astrazeneca.com
The Aeras Global TB Vaccine Foundation was founded in 1997 to
develop new concepts and tools to control the global TB epidemic.
It is the goal of Aeras to develop, test, characterize, license, manufacture and distribute at least one new TB vaccine within 10 years.
Backed by its skills and experience in infection research,
AstraZeneca joined the global effort to find new TB therapies in 2003,
with the opening of a USD 20 million dedicated TB research centre
in Bangalore, India.
In partnership with the Aeras Global TB Vaccine Foundation, Crucell
is developing a recombinant vaccine against tuberculosis. The
Crucell-Aeras TB vaccine program focuses on improvement of the
only currently available TB vaccine, the Bacillus Calmette-Guérin
(BCG) vaccine. Aeras and Crucell began jointly developing this vaccine candidate, called AERAS-402, in 2004. Data from completed
AERAS-402/Crucell Ad35 trials support the immunogenicity
and acceptable safety profile of this candidate at all dose levels
evaluated.
More than 80 scientists work there, with full access to all
AstraZeneca’s platform technologies, such as high throughput
screening and compound libraries. They also work closely with the
company’s infection research centre in Boston, USA, as well as with
external academic leaders, to capture and share best practice. The
company continues to invest more than USD 5 million each year in
this research effort, which is focused on finding new therapies that
will act on drug-resistant strains, shorten the duration of treatment,
eradicate disease (including the latent form) to reduce the chances of
relapse, and be compatible with HIV/AIDS therapies (TB and
HIV/AIDS form a lethal combination, each speeding the other’s
progress).
Completed Phase I trials:
• USA: safety;
• South Africa: high CD8-cell immune response;
• St. Louis, USA: immunogenic response for boost doses;
• Kenya: no safety issues for AERAS-402 in BCG-vaccinated adults.
Ongoing Phase I trials:
• South Africa: vaccine safety in infants previously vaccinated with
BCG vaccine.
Ongoing Phase II trials:
• South Africa: safety in adults who have had active TB.
GSK Biologicals is developing a prophylactic vaccine to prevent
mycobacterium tuberculosis disease in infants, adolescents and
adults. The company’s candidate vaccine is composed of the M72
antigen and GSK’s proprietary AS01 adjuvant system. In a BCG
prime-boost regimen, the candidate vaccine has been shown to
improve the protection conferred by BCG and confer a long-term
protection in monkeys primed with BCG and challenged with a high
dose of virulent mycobacterium tuberculosis.
Completed Phase I/II clinical trials:
• Belgium and South Africa: PPD-negative adults;
• South Africa and the Philippines: PPD-positive adults;
• Switzerland: HIV positive individuals under HAART.
Clinical trials are ongoing to evaluate the safety and immunogenicity
of the candidate vaccine in adolescents, infants and HIV treatment
naive adults, som in partnership with Aeras global TB foundation and
TBVAC. The ultimate aim of these partnerships is to accelerate the
vaccine development to ensure rapid access to the populations who
need it most.
2009 was a year of considerable progress:
• In December 2009, AstraZeneca’s first candidate TB drug,
AZD5847, started phase I clinical trials, having showed potential in
pre-clinical studies to treat MDR-TB. If phase I testing is successful, the company will conduct further clinical development with
external partners;
• In collaboration with the European Framework 6 consortium,
AstraZeneca researchers in Bangalore have identified a new class
of compounds with potential as novel TB treatments. The findings
were published in Science, a leading academic journal, and the
company continues to explore their potential;
• Researchers at the National Institute of Health (NIH) in the USA
discovered that meropenem, AstraZeneca’s marketed antibiotic
for hospital-acquired infection, is also active against MDR-TB. The
company donated supplies of meropenem for an NIH-sponsored
research project in South Korea, combining meropenem and
clavulanic acid (a component of another marketed antibiotic) to
assess the combination’s potential as a treatment for MDR-TB.
AstraZeneca is also part of the European Union Framework Program
VI collaboration (NM4TB - New Medicines for Tuberculosis) that will
enable it to work with academic leaders in TB research. AstraZeneca
is the only major pharmaceutical company involved in this project,
which began in 2006. Funded by a grant from the EU Framework VI
program and consisting of around fifteen groups of prominent EU
researchers, this consortium seeks to combine academic and pharmaceutical skills to further the discovery of new therapies for TB.
47
TUBERCULOSIS – R& D
GlaxoSmithKline - TB Alliance Drug Discovery Program
Global Alliance for TB Drug Development (TB Alliance)
Tuberculosis
GlaxoSmithKline
Global Alliance for TB Drug Development
Since 2005
R&D
R&D in Spain
www.gsk.com
Tuberculosis
Bayer HealthCare, Cumbre, GlaxoSmithKline, KRICT, Novartis
DFID, NIAD, USAID & other partners
Since 2000
R&D
China, India, South Africa, Zambia
www.tballiance.org
In March 2005, GlaxoSmithKline and the Global Alliance for TB Drug
Development (TB Alliance) announced a joint discovery partnership
to improve the treatment of tuberculosis (TB).
The Global Alliance for TB Drug Development (TB Alliance), established in 2000, brings together industry, NGOs, governments and
foundations to work together with more than 30 partners around the
world to accelerate the discovery and development of cost-effective
new medicines. The TB Alliance draws on the best practices and
resources of the public and private sectors. Its mission is to accelerate the discovery and development of cost-effective new anti-TB
medicines, which should shorten or simplify treatment, provide a
more effective treatment of multidrug-resistant TB and improve treatment of latent TB infection.
All compounds will be screened to ensure they can be taken with HIV
treatments, since people living with AIDS are often susceptible to TB
infection. The TB Alliance supports 25 full-time scientists working
exclusively on the TB drug program at the GSK R&D facility in Tres
Cantos, Spain. GSK will contribute a matching number of staff and
all remaining overhead costs. Around 1.5 million compounds have
been tested for anti-TB activity and any medicines discovered will be
made as affordable and accessible as possible to those most in
need.
The program broadens the worldwide TB medicine pipeline by
adding several novel classes of compounds that use new mechanisms of action. The joint research program consists of four projects
intended to yield new compounds that attack Mycobacterium tuberculosis (M.tb) on multiple levels. Drug candidates arising from these
projects could shorten the standard duration of treatment and treat
patients who are resistant to conventional therapies.
The program includes a novel class of antibiotics targeting a
Mycobacterium gyrase and two target-based projects, malate synthase (MS) and InhA. The fourth project screened GSK’s antimicrobial libraries for novel compounds that could kill M.tb. A shorter TB
regimen is expected to improve patient compliance, increase cure
rates and lower toxic side effects, thereby limiting the rise of new
resistant strains. A novel TB regimen that is compatible with HIV
treatments would improve TB control and help in the fight against
AIDS.
In January 2008, GSK announced a 3-year extension of its program
with the TB Alliance. Dr. Mel Spigelman, Director of R&D, TB Alliance,
said ‘We are encouraged by the success of our pioneering work with
GSK, which has nearly doubled the number of TB drug discovery
projects in our pipeline. This collaboration is advancing the TB
Alliance’s mission to develop revolutionary, faster and better TB treatment regimens by exploring new ways to attack the disease.
Company partners include: Bayer HealthCare, Cumbre,
GlaxoSmithKline, the Korea Research Institute of Chemical
Technology (KRICT) and Novartis. Other partners include the Beijing
Institute of Materia Medica, the Beijing Tuberculosis and Thoracic
Tumor Research Institute, the US National Institute of Allergy and
Infectious Disease (NIAID), University of Auckland, University of
Illinois, Yonsei University. Funders include the Bill and Melinda Gates
Foundation, the Rockefeller Foundation, the US Agency for
International Development (USAID), Irish Aid, the Netherlands’
Ministry of Foreign Affairs and the UK Department of International
Development (DFID).
The partnership functions as a virtual R&D organization. By outsourcing medicine research and development projects, medicine
compounds are moved along the development line to achieve regulatory approval and bring them to market at affordable prices for
those countries experiencing the highest burden from TB.
The TB Alliance activities in developing countries include clinical trials in Kenya, South Africa and Zambia and non-clinical or preclinical
work in China and India.
GSK’s lead TB project on Mycobacterium Gyrase Inhibitors expects
to select a candidate for development in the first half of 2010.
GlaxoSmithKline and TB Alliance are working together to
improve the treatment of tuberculosis. (GlaxoSmithKline)
48
TUBERCULOSIS – R & D
Lilly TB Drug Discovery Initiative
Moxifloxacin TB Clinical Trials (Bayer HealthCare)
Tuberculosis
Lilly, Academia Sinica, Jubilant Biosystems, Summit plc
IDRI, NIH NIAID & other partners
Since 2007
R&D
India
www.TBDrugDiscovery.org, www.lillymdr-tb.com
Tuberculosis
Bayer HealthCare
Global Alliance for TB Drug Development
Since 2005
R&D
South Africa, Zambia
www.bayerscheringpharma.de
Although a large percentage of tuberculosis cases worldwide remain
susceptible to current TB antibiotics, drug-resistant TB is a major
and growing threat. Created in June 2007, the Lilly TB Drug
Discovery Initiative’s major goal is to fill the early stage pipeline. The
primary members are Eli Lilly and Company, the Infectious Disease
Research Institute (IDRI), and the National Institute of Allergy and
Infectious Diseases (NIAID), which is part of the U.S. National
Institutes of Health (NIH).
In 2005, Bayer HealthCare announced a partnership with the Global
Alliance for TB Drug Development (TB Alliance) for a global clinical trial
program to study the potential of an existing antibiotic, moxifloxacin,
to shorten the standard 6-month treatment of pulmonary tuberculosis. If the trials are successful, the partnership is committed to register moxifloxacin for a pulmonary tuberculosis indication and to making it accessible in developing countries where patients need it most.
Lilly has given USD 15 million to establish the Initiative, including USD
9 million in-kind, including fully equipped high throughput screening
and chemistry laboratories, research tools, databases, and scientific
and technical expertise, plus USD 6 million in cash over five years to
seed the organization. Lilly is also providing access to its library of
500,000 compounds and is making available its expertise in drug
discovery and chemistry. IDRI, a Seattle-based not-for-profit organization committed to research and development of products for infectious diseases of poverty, is providing expertise in TB and chemistry,
as well as managing the Initiative’s laboratories, and serving as its
principal coordinator.
Organizations co-developing compounds with the Initiative or contributing research tools can request access to NIH-sponsored
resources and receive valuable data to assist in compound development. Others collaborating with the Initiative include Jubilant
Biosystems (India), the Seattle Biomedical Research Institute,
Summit plc (UK), the University of Washington’s Department of
Global Health and YourEncore. The Microbial Chemistry Research
Foundation in Japan brings strong expertise in natural product
chemistry, as well as CPZEN-45, a compound with a novel mechanism of action which has shown promising in vitro and in vivo activity against multidrug resistant TB strains. Most recently, Academia
Sinica joined the Lilly TB Drug Discovery Initiative as a Contributing
member. Academia Sinica’s proprietary library of more than two million compounds adds critical chemical diversity, and their provision of
some of the world’s most advanced technologies in high-throughput
screening and genomic sequencing greatly enhances chances for
success.
Moxifloxacin is being studied in a large, pivotal Phase III clinical trial
(REMoxTB), which will enroll over 2,400 pulmonary tuberculosis
patients. The REMoXTB study is currently being conducted in South
Africa, Tanzania and Zambia. It is anticipated that the trial will also be
performed in other countries, including China, India and some Latin
American countries, if clinical trial approvals can be obtained in these
countries.
Two drug regimens are being tested. The first substitutes moxifloxacin
for ethambutol, and the second substitutes moxifloxacin for isoniazid.
Both moxifloxacin treatment arms comprise a shortened treatment
duration of 4 months, while the control arm is current standard treament of 6 months duration. The aim is to prove that one or both shortened moxifloxacin treatment regimens are as good as the current
6-month treatment. If successful, the REMoxTB study results will be
submitted to regulatory agencies to support approval of a shortened
TB treatment indication with moxifloxacin. Bayer donates moxifloxacin
for each trial site, provides ongoing operational support, and will cover
the costs of regulatory filings.
Current standard TB therapy is based on four medicines discovered
forty or more years ago that must be administered for six to eight
months, often under the direct observation of a healthcare professional
(DOTS). A shorter TB treatment regimen should help to increase
patient compliance, reduce failure rates and lower TB-related healthcare expenditure in endemic countries. Preclinical studies showed
moxifloxacin could reduce treatment time by two months when substituted for isoniazid, a cornerstone of current TB treatment. The
results of Phase II clinical studies support the treatment-shortening
potential of moxifloxacin. Currently, moxifloxacin is approved in 104
countries to treat bacterial respiratory and skin infections.
Collectively, the Initiative mobilizes extensive resources to address
the challenge of TB drug discovery. However, the magnitude of the
task is so large and so urgent that the help of all qualified players is
needed. Success will come about as the result of the combined
efforts of all sectors.
The Lilly MDR-TB Partnership is about transfer of
technology, know-how – and hope. (Lilly)
49
TUBERCULOSIS – R& D
Novartis Institute for Tropical Diseases (NITD)
Otsuka Pharmaceutical: MDR-Tuberculosis R&D
Tuberculosis
Novartis
Global Alliance for TB Drug Development & other partners
Since 2003
R&D
Indonesia
www.nitd.novartis.com
Tuberculosis
Otsuka Pharmaceutical
Various partners
Since 2004
R&D
China, Egypt, Peru, Philippines
www.otsuka-global.com
The Novartis Institute for Tropical Diseases (NITD) research center in
Singapore is a public-private partnership between Novartis and the
Singapore Economic Development Board (SEDB) and focuses exclusively on the discovery of innovative medicines for the treatment of
diseases that are endemic to developing countries. With more than
110 scientists from 25 countries employed and activities that range
from target discovery, screen development and compound optimization to preparation for clinical testing, NITD also offers teaching and
training opportunities in the field of tropical diseases.
At a preclinical level, Otsuka Pharmaceutical’s OPC-67683 has
shown particularly strong bactericidal activity on Mycobacterium
tuberculosis. The compound has also been confirmed to have no
cross resistance with any of the currently used anti-tuberculosis
agents and its strong bactericidal effect is seen even on clinically isolated strains of multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB).
The goal of NITD’s Tuberculosis Unit is to apply new genomic and
bioinformatic technologies to develop novel treatments for multidrugresistant TB. NITD researchers are using the tuberculosis mycobacterium genome sequence to identify vulnerable parts that could be
targeted by small molecules. Those molecules can then be further
refined to produce resulting medicines that will be made available at
no profit in developing countries where the disease is endemic.
Phase II-a studies to evaluate the early bactericidal effects in TB
patients have been completed and a Phase II-b study for MDR-TB is
currently underway in China, Egypt, Peru and the Philippines, as well
as five developed countries (Estonia, Japan, Korea, Latvia, and the
USA).
In 2006, NITD and ten other collaborators led by the Imperial College
received a grant from the Grand Challenges for Global Health
Initiative to discover new targets for latent tuberculosis.
A recent Collaboration and License Option Agreement between NITD
and the Global Alliance for TB Drug Development aims at accelerating development of potential cost-effective new drugs towards
clinical use.
To secure direct access to hospitals and patients in a real-life context, in 2007 NITD also teamed up with the Hasanuddin University
and Eijkman Institute for Molecular Biology in Indonesia to form
NEHCRI - a clinical research initiative that aims to strengthen translational research in tuberculosis, but also malaria and dengue fever,
two other diseases NITD is working on.
The Novartis Institute for Tropical Diseases research center
in Singapore focuses exclusively on the discovery of
innovative medicines for the treatment of diseases that are
endemic to developing countries. (Novartis)
50
TUBERCULOSIS – R &D
Ranbaxy R&D for TB
Sanofi-aventis: R&D for TB
Tuberculosis
Ranbaxy
Indian Ministry of Science and Technology
Since 2008
R&D
India
www.ranbaxy.com
Tuberculosis
sanofi-aventis
Global Alliance for TB Drug Development & other partners
Since 2007
R&D
International R&D
In collaboration with the Department of Biotechnology of the Indian
Ministry of Science and Technology, Ranbaxy has dedicated
resources to explore its compound library to find molecules that may
show activity against tuberculosis. Studies are also being conducted
to determine the mode of action for identified compounds. Once a
hit is identified, it can be optimized to develop a clinical candidate. All
studies are conducted in a BSL3 facility funded by the Indian
Government.
Sanofi-aventis helps various international organizations such as the
US Centers for Disease Control and Prevention (CDC) and US
National Institutes of Health (US NIH), the US CDC Foundation, the
Global Alliance for TB Drug Development (TB Alliance), the
Consortium to Respond Effectively to the TB/AIDS epidemic (CREATE) and the International Consortium for trials of chemotherapeutic
agents in tuberculosis (INTER-TB) at St. George’s Medical School, in
their clinical research into new therapeutic regimens for both latent
and active tuberculosis, using Rifapentine and other TB drugs. The
aim is to reduce treatment duration and the number of tablets, without compromising efficacy.
Daiichi Sankyo Co. Ltd. of Japan took a majority stake in Ranbaxy in
2008.
Sanofi-aventis is also researching new treatment mechanisms, using
two parallel approaches:
• Systematic screening of sanofi-aventis’ product portfolio to identify new drugs which are active against M. tuberculosis, especially
drug-resistant strains;
• Evaluation of new compounds proposed by external partners.
The objectives of this new sanofi-aventis research and development
program coincide with those of the global Stop TB program backed
by the WHO and the United Nations’ Millennium Summit, namely to
arrest the spread of tuberculosis and begin reducing its incidence by
2015.
In addition, Sanofi Pasteur, the vaccines division of sanofi-aventis, is
actively engaged in TB vaccine development through a collaboration
with the Statens Serum Institut of Denmark. The lead candidate of
this collaboration is currently being evaluated in Phase I clinical studies being conducted in collaboration with the Aeras Global TB
Foundation at sites in Europe and Africa. The outcome of these
studies will guide the further development and continued clinical
evaluation of Sanofi Pasteur’s candidate vaccine.
GSK is working on various new candidate therapies for TB.
(GlaxoSmithKline)
51
MALARIA
Estimated incidence of malaria
per 1000 population, 2006
>200
50-200
5-49
0-4
(Source: WHO World Malaria Report 2008)
52
Malaria is now recognized as a major disease of poverty,
alongside HIV/AIDS and tuberculosis, but it has become harder
to combat, as drug-resistant forms have developed and health
infrastructures in malaria-endemic areas have deteriorated.
Malaria is caused by a unicellular parasite transmitted to humans
through the bites of infected female anopheles mosquitoes. In the
absence of immunity or medicines, the most virulent species of
the parasite, plasmodium falciparum, can cause death within 24
hours of the appearance of noticeable symptoms. Malaria
symptoms include anemia, chills, coma, exhaustion, fevers,
partial paralysis, seizures and speech disorders.
There were an estimated 243 million episodes of malaria in 2008,
resulting in 863,000 malaria deaths in 2008, of which 89% were
in Africa and 85% were of children under 5 years of age. Pregnant
women are also particularly vulnerable, being three times more
likely to develop serious malaria than other adults during a
malaria epidemic.
very much underutilized, primarily due to inadequate funding and
poor health infrastructure in endemic countries. The WHO also
recommends sleeping under insecticide treated mosquito nets,
spraying the interior of dwellings with approved insecticides,
preventive antimalarial treatment for pregnant woman, diagnostic
testing of anyone suspected of having malaria, followed by
treatment with appropriate antimalarials for confirmed cases.
The pharmaceutical industry is at the forefront of the growing
number of R&D projects, looking for new medicines, vaccines,
diagnostics and other health products to fight malaria. They are
important actors in access programs to make current malaria
treatments more widely available to those worst affected by the
disease. In Cambodia and Thailand, artemisinin may be losing its
potency, which underlines the need for continued R&D to find
new malaria medicines.
Because of resistance, WHO recommends artemisinin combination
therapies as the first line treatment for malaria, but these remain
(Sources : Roll Back Malaria, What Exactly Is Malaria ? ; WHO, World Malaria Report 2005 ; WHO World Malaria Report 2009)
53
ACCESS II – Improving Access
to Effective Malaria Treatment
GlaxoSmithKline & Access to Malaria Care
Malaria
Novartis
Swiss Tropical and Public Health Institute & other partners
Since 2003
Access - Pricing, Capacity Building - Support, Education
Tanzania
Malaria
GlaxoSmithKline
Various partners
Since 2003
Access - Pricing, Capacity Building - Support, Education
www.gsk.com/malaria
Since 2003, the ACCESS Project has been devoted to analyzing and
improving access to effective malaria treatment in Tanzania. Main
interventions have included social marketing campaigns to inform
the population on causes, symptoms and appropriate treatment of
malaria, training and supportive supervision of health personnel and
the establishment of licensed private drug stores.
GlaxoSmithKline offers its antimalarials at not-for-profit prices to
publGlaxoSmithKline offers its antimalarials at not-for-profit prices to
public sector customers and not-for-profit organizations in 64 countries - all the Least Developed Countries and all of sub-Saharan
Africa. All CCM projects fully funded by the Global Fund to Fight
AIDS TB and Malaria are also eligible. GSK does not make a profit at
these prices, but it does cover its costs, so it can sustain supply of
these high-quality products for as long as they are needed. These
prices apply to orders of any size and include insurance and freight
costs.
One of the initiative’s achievements has been the development of a
general analytical and planning framework on the issue of access,
which can also be applied to other diseases and contexts. The second phase of the project – ACCESS II – began in 2008 by building
on this model as well as on the results and experiences gathered so
far. The purpose of the project is to increase the demand for adequate malaria services to induce more people with the relevant
symptoms to come for treatment in a health center or a licensed
drug store.
Despite the initial success, ACCESS II faces further challenges. An
increasing number of people with fever go to health centers and drug
stores, but may fail to receive adequate treatment in all of them. In
addition, the results from the first phase show that beyond information on malaria and its treatment, the financial resources available to
potential patients must be increased. People who are affected by
malaria ultimately need enough money to be able to finance insurance coverage and treatment. Thus, access to insurance coverage
through community health funds is being promoted. In addition,
ACCESS II supports micro-credits and new measures to generate
income, particularly for women. More participatory information campaigns on malaria and healthcare services with community involvement are also pursued. By simultaneously strengthening healthcare
services and patient resources, access should sustainably improve.
GSK’s African Malaria Partnership was set up in 2003 to support
education programs in eight African countries, through partnerships
with Freedom from Hunger, AMREF and Plan International. These
focused on prevention and prompt treatment, particularly among
children and pregnant women. GSK funding for these initiatives has
now ended, but the investment will have a long-term positive impact.
The scale of the malaria problem requires a significantly bigger
response, so in 2005, GSK gave a USD 1.5 million three-year grant
to a new partner, the Malaria Consortium, to launch the Mobilizing for
Malaria initiative. In 2009, GSK extended its support for the initiative
for an additional year. The aim is to increase awareness, generate
political commitment and sustained funding to combat the disease.
It will increase the number of NGOs engaged in tackling malaria, and
give more African communities the knowledge and tools they need
to prevent transmission of malaria. National Coalitions Against
Malaria were launched in Belgium, Cameroon, Mozambique,
Ethiopia, France and the UK, bringing together advocates from the
public sector, NGOs, the media, the private sector and the political,
academic and scientific communities.
Over the last two years Innovation Grants were awarded to NGOs in
Africa to boost advocacy efforts. Grants were awarded to civil organizations in Nigeria, Tanzania, Ghana, Mozambique, Democratic
Republic of Congo and Burkina Faso. The GSK African Malaria
Partnership awarded four new grants in 2009, with a total commitment of GBP1.5 million over three years, to Kenya, (via Save the
Children UK), Ghana (via Family Health International), Tanzania (via
AMREF) and Nigeria (via the Planned Parenthood Foundation of
Nigeria).
Girl receiving malaria treatment at a health facility near
Ifakara, Tanzania. (Novartis)
54
Millennium Villages Project
Novartis Coartem®
Malaria
Novartis
Millenium Village Project
Since 2007
Tanzania
Malaria
Novartis
WHO, MMV
Since 2001
Access - Pricing, Capacity Building - Training, Education
www.novartis.com
As three out of eight Millennium Development Goals (MDGs) are
health-related, the Novartis Foundation for Sustainable Development
agreed in 2007 to support the Millennium Villages Project (MVP) in
health-related research interventions. The MVP was founded with the
goal of helping impoverished communities in rural Africa achieve the
MDGs formulated and agreed to by all member countries of the
United Nations. The MVP is active at 12 sites in ten African countries.
Coartem® is the first World Health Organization-prequalified fixeddose, artemisinin-based combination therapy (ACT) antimalarial,
approved by stringent regulatory authorities and on the WHO Model
List of Essential Medicines. Coartem® is fast-acting and cures over
97% of patients after a 3-day treatment course. Coartem® combines artemether, a derivative of artemisinin (from the Chinese medicinal plant Artemisia annua), with a synthetic substance, lumefantrine,
which has not been used as a monotherapy.
In 2007, the Novartis Foundation started financing one of the six
Millennium Villages in Tanzania, the Ilolangulu Village. For a five-yearperiod, the Novartis Foundation invests in the village´s transition from
mainly subsistence farming to more self-sustaining commercial activity. Challenges facing Ilolangulu Village included inadequate water supply, extreme hunger, failed crops and a high prevalence of malaria.
The Novartis Foundation also donated the artemisinin-based combination therapy of Novartis (Coartem®) for the treatment of malaria in
MVP sites all over sub-Saharan Africa where Coartem is registered
on the national essential drugs list.
After two years, positive results have been seen. Crop diversification
and the use of fertilizers and hybrid seeds have increased the yields
for maize from 1.5 tons/hectare in 2007 to close to 5 tons/hectare in
2009. A new clinic constructed by MVP in the Mbola cluster
improved the overall health of the population with better health services and the distribution of more than 20,000 treated bed nets.
Education and nutrition have improved for more than 7,000 children
in the cluster with training of teachers, supply of new textbooks as
well as meals in school. Finally, new infrastructures were developed
– such as water and sanitation systems, as well as mobile phone
towers.
Since 2001, Novartis has provided more than 300 million treatment
courses of Coartem® - without profit - for public sector use in Africa.
These treatments have helped save an estimated 750,000 lives in
more than 60 malaria-endemic countries.
In early 2009, Novartis and Medicines for Malaria Venture introduced
Coartem® Dispersible, the first artemisinin-based combination therapy (ACT) developed especially for children with malaria, to address
specific treatment needs of millions of children with malaria.
Coartem® Dispersible contains the same amounts of artemether
and lumefantrine as Coartem® tablets (20mg/120mg) and delivers
the same high cure rates.
Prior to this innovative pediatric medicine, health workers and parents had to crush bitter-tasting antimalarial tablets for children to
swallow. New, sweet-tasting Coartem® Dispersible tablets dissolve
quickly in small amounts of water, easing administration and ensuring effective dosing for children. Six million treatments of Coartem®
Dispersible were delivered in 2009. To date, Coartem® Dispersible
has been approved in 26 African countries as well as Brazil and
Switzerland.
Coartem® Dispersible received the Medicines for Malaria Venture
(MMV) Project of the Year Award in 2008. Further, the Coartem®
Dispersible packaging won the 2009 Healthcare Compliance
Packaging Council Award. The pack was recognized for aiding
patient compliance, thanks to clear separation per body weight, the
availability of one full treatment course on the same blister and clear
pictorial instructions.
Education being a key factor in malaria control, the Coartem® program includes training materials and courses for healthcare workers
and mothers/caregivers – translated into several African languages
and distributed free of charge. Twice a year, Novartis also brings
together the managers of national malaria control program across
Africa to share best practice in community awareness, healthcare
worker training, stock management and distribution, and health
impact measurement.
Family in Millennium Village, Ilolangulu, Mbola, Tanzania.
(Novartis)
55
Pfizer – Mobilize Against Malaria
Roll Back Malaria Partnership
Malaria
Pfizer
London School of Hygiene & Tropical Medicine & other partners
Since 2006
Ghana, Kenya, Senegal
www.pfizerglobalhealth.com
Malaria
GlaxoSmithKline, Novartis, sanofi-aventis
Roll Back Malaria & other partners
Since 1998
www.rollbackmalaria.org
Unveiled at the Clinton Global Initiative in 2006, Mobilize Against
Malaria is Pfizer’s signature social investment in malaria, supporting
programs to reduce the malaria burden in three hard-hit African
countries, Ghana, Kenya and Senegal, over a five year period (20072011). Under this USD 15 million program, Pfizer helps four leading
NGOs to close critical gaps in malaria treatment, training, and public
demand for quality services.
To provide a coordinated global approach to fighting malaria, the Roll
Back Malaria (RBM) Partnership was launched in 1998 by the World
Health Organization (WHO), the United Nations Children´s Fund
(UNICEF), the United Nations Development Program (UNDP) and the
World Bank.
In Ghana, Pfizer is helping to bring the public and private sectors
together to find new solutions to the malaria challenge. The program
specifically supports Family Health International and Ghana Social
Marketing Foundation which have demonstrated that investments in
Ghana’s licensed chemical sellers, small retail outlets which act as a
major source of basic medicines, can dramatically improve malaria
treatment, diagnosis and prevention. Through Pfizer’s partners, thousands of LCSs are receiving training and job support and are developing closer ties to the communities they serve.
In Kenya, Pfizer is helping Population Services International to reduce
malaria in pregnant women and children under five, two groups most
at-risk for malaria-related mortality and morbidity. While Kenya is one
of the most progressive African countries in terms of malaria programming, resources are still needed to reach women and healthcare providers, especially in hard-to-reach rural communities.
Recognizing that more than 70% of women attend antenatal clinics
at least once during their pregnancy, Pfizer’s partners are providing a
boost to healthcare providers and patients at these clinics by supplying improved training, health education and new information
packets designed especially for new mothers.
In Senegal, Pfizer is working with IntraHealth International to
strengthen the country’s system of health huts, rudimentary clinics
which are often the only healthcare facility accessible to rural communities. During the rainy season, when populations become even
more isolated, these clinics frequently function without running water,
electricity, adequate supplies or medicines. Recognizing the critically
important role these health huts play in the country’s healthcare system, Pfizer and its partners are investing in improving their infrastructure, malaria training, supply chain, provider skills, and community demand for services.
The RBM Partnership has expanded exponentially since its launch
and is now made up of a wide range of partners, including malaria
endemic countries, their bilateral and multilateral development partners, the private sector, nongovernmental and community-based
organizations, foundations, and research and academic institutions.
These bring a formidable array of expertise, infrastructure and funds
to the fight against the disease. The partners are working together to
scale up malaria-control efforts at country level, coordinating their
activities to avoid duplication and fragmentation and to ensure optimal use of resources.
A key role of the RBM Partnership is to lead continuing advocacy
campaigns to raise awareness of malaria at the global, regional,
national and community levels, thus keeping malaria high on the
development agenda, mobilizing resources for malaria control and
for research into new and more effective tools, including a vaccine,
and ensuring that vulnerable individuals are key participants in rolling
back malaria.
In 2009, sanofi-aventis represented the private sector on the
Partnership Board; GlaxoSmithKline is an alternate member. IFPMA
member companies also take part in the private sector delegation to
the Board and in various working groups.
In 2009, Novartis initiated the SMS for Life pilot, a new public-private
partnership involving RBM, IBM, Vodafone and the Ministry of Health
in Tanzania. The program uses mobile phones, SMS messages and
electronic mapping technology to monitor stock levels of artemisininbased combination therapies (ACTs) and quinine injectables at health
facilities on a weekly basis. This helps eliminate stockouts, even in
the most remote areas. In a five-month pilot covering 226 villages
and over one million people in Tanzania, SMS for Life showed dramatic results. For example, during the first eight weeks, in one district alone, the number of health facilities with stock-outs was
reduced by over 75%.
Pfizer is working with the London School of Hygiene and Tropical
Medicine, along with KEMRI-Wellcome Trust and Health Partners
Ghana, to evaluate the impact of this program.
56
Sanofi-aventis: Impact Malaria
Malaria
sanofi-aventis
Various national & international partners, including universities
Since 2001
Access - Pricing, Capacity Building - Training, Education,
R&D - Pediatric R&D
Benin, Burkina Faso, Côte d’Ivoire, Ghana, Republic of Congo
www.impact-malaria.com
The Impact Malaria program embodies sanofi-aventis´ longstanding
commitment to fight malaria.
Sanofi-aventis is researching new treatments that are affordable,
adapted to patients´ needs, especially children, and can help circumvent growing resistance to existing medicines. The most
advanced projects are ferroquine for uncomplicated malaria, developed with Lille University and ‘bicationic compounds’ for severe
malaria with Montpellier University, both in Phase II clinical trials.
Upstream projects include development of ‘trioxaquins’ with
Palumed in Toulouse.
Sanofi-aventis seeks to improve access to its antimalarials, by making them available at a ‘no profit, no loss’ prices to needy populations. Sanofi-aventis and Drugs for Neglected Diseases intitiative
(DNDi) launched a new artesunate-amodiaquine combination treatment in early 2007. The company has relinquished its patents and
committed to supply it at prices scaled to income. In the poorest
countries, this is less than USD 1 for an adult treatment and a less
than USD 0.5 for a pediatric one. Tablets are soluble, facilitating their
use with children. This combination was pre-qualified by the WHO in
October 2008 and, in 2009, 23 million treatments were sold at preferential prices to over 20 malaria-endemic countries.
Sanofi-aventis, Medicines for Malaria Venture, DNDi, and Medicines
for Malaria Venture have set up an innovative ‘ASAQ field monitoring
program’ with clinical trials in sub-Saharan Africa to generate good
efficacy and safety data on the new artemisinin-amodiaquine antimalarial in ‘real life’ conditions, and help build clinical trial and pharmacovigilance expertise. This program that aims at including over
20,000 patients was formalized as a “Risk Management Plan”, the
first to be submitted to the World Health Organization.
In 2009, sanofi-aventis provided over 20 African health professionals
with high-level malaria training. In addition, information, education
and communication tools and training sessions have been developed with national malaria control programs and NGOs. In 2009,
over 40,000 children were informed about malaria in Côte d’Ivoire,
Ghana and Burkina Faso, through an initiative entitled
“Schoolchildren against malaria”. The www.impact-malaria.com
website provides disease, prevention and treatment information, plus
educational tools and an online library.
In 2009, sanofi-aventis continued to support malaria prevention and
treatment by Actions de Solidarité Internationales in Makoua,
Republic of Congo and new initiatives were launched with the NGOs
Jeremi in Burkina Faso and Caritas in several African countries. In
Benin, the company works with PlanetFinance to help local NGOs to
train health workers to educate communities about malaria.
Malaria is the leading cause of death in children under
the age of five in Ghana. Mobilize Against Malaria works
on local, national, and global levels to raise awareness
and fight th disease. (Mark Tuschman, Pfizer)
57
MALARIA – R &D
Crucell’s Malaria Vaccine R&D
Medicines for Malaria Venture (MMV)
Malaria
Crucell, GlaxoSmithKline
NIAID & other partners
Since 2003
R&D
R&D in USA (Phase I)
www.crucell.com
Malaria
Bayer HealthCare, Chong Qing Holley, Genzyme, GlaxoSmithKline,
Merck & Co. Inc., Novartis, Pfizer, sanofi-aventis, Shin Poong, Sigma-Tau
MMV & other partners
Since 1999
R&D - Pediatric R&D
www.mmv.org
Many of the vaccines Crucell develops combat diseases severely
affecting developing countries, including vaccines against tuberculosis and malaria. Crucell is currently developing a malaria vaccine in
collaboration with the US National Institute of Allergy and Infectious
Diseases (NIAID), part of the US National Institutes of Health (NIH).
The vaccine candidate is based on Crucell´s AdVac adenovirus technology.
Medicines for Malaria Venture (MMV), was established as a not-forprofit public-private partnership in Switzerland in 1999, after talks
between the World Health Organization (WHO) and the IFPMA. MMV
brings public, private and philanthropic partners together to fund and
manage the discovery, development and delivery of new medicines
for the treatment and prevention of malaria.
The vaccine specifically targets Plasmodium falciparum, the most
deadly of the malaria parasites and is being developed under a cooperative research and development agreement with the Walter Reed
Army Institute of Research (WRAIR) and GlaxoSmithKline Biologicals
(GSK). Under the CRADA, Crucell´s malaria vaccine candidate was
tested in preclinical studies as a stand-alone vaccine and in combination with GSK´s RTS,S malaria vaccine candidate. Pre-clinical data
generated from the CRADA indicated significantly enhanced immune
responses against the malaria parasite (circumsporozoite stage of
the Plasmodium falciparum) when Crucell’s AdVac® technology and
GSK’s RTS,S technology are used in combination, versus either
component alone.
A Phase I study of a Crucell´s AdVac stand-alone vaccine candidate
is currently underway in the USA. Initial findings of the Phase I trial
are expected to be available in 2009.
MMV is funded by foundations, governments and corporations.
Regarded by WHO and the Roll Back Malaria partnership as an
important partner, it now manages the largest portfolio of malaria
medicine research in history, with nearly 40 projects underway at the
end of 2008. MMV has mini-portfolio agreements with Genzyme,
GlaxoSmithKline, Novartis and sanofi-aventis. Other partners include
Bayer HealthCare, Chong Qing Holley, Merck & Co., Inc., Pifzer, Shin
Poong and Sigma-Tau.
MMV subsidizes 30 scientists at GSK´s dedicated DDW research
facility in Tres Cantos. As compounds move into clinical development, GSK provides clinical, regulatory and manufacturing expertise
and resources via its global R&D and supply network. In 2008, GSK
announced a new collaboration with MMV to identify novel drugs for
the treatment of malaria. Research will focus on macrolide antibiotics, which may help treat drug-resistant malaria. GSK and MMV
are currently developing tafenoquine, a potential new treatment for
the radical cure of P vivax malaria).
The Novartis Institute for Tropical Diseases is working with MMV to
develop a one-dose cure for P. falciparum, and a curative modality
for P. vivax. In 2009, Novartis and MMV introduced Coartem®
Dispersible, the first artemisinin-based combination (ACT) developed
for children with malaria. It delivers the same 97%+ cure rate as
Coartem® and the sweet-tasting tablets dissolve quickly in water,
easing administration and dosing for children.
In 2008, MMV signed an MoU with sanofi-aventis for discovery work,
including early-stage molecule testing, and screening, plus clinical
development of ferroquine, SAR97276 and trioxaquine. In 2009,
MMV contributed to the DNDi and sanofi-aventis ‘ASAQ field monitoring program’ in Côte d’Ivoire. With approximately 15,000 patients,
this is the largest study ever done on an antimalarial and should help
African experts and government bodies to develop innovative pharmacovigilance methods in ‘real life’ conditions.
In 2009, Merck & Co., Inc. granted MMV an exclusive, royalty-free
license to pursue development of an investigational drug candidate
for the treatment of malaria in the developing world. The antimalarial
candidate is an orally available compound, which could potentially
provide a daily or twice-daily curative dosing regimen. In preclinical
studies, it has shown to be effective against P. falciparum, the organism that causes acute malaria, including multi-drug resistant strains.
Many of the vaccines Crucell develops combat diseases
severly affecting developing countries, including vaccines
against tuberculosis and malaria. (Crucell)
58
In 2009, Pfizer and MMV signed an agreement which will allow
Griffith University in Brisbane, Australia to screen approximately
200,000 compounds in the Pfizer compound library against P. falciparum malaria.
Sigma-Tau is developing a new artemisinin combination with MMV.
MALARIA – R & D
Eisai Exploratory Research for the Treatment of Malaria
Eurartesim™ International Development Program
Malaria
Eisai
University of Osaka in Japan
Since 2006
R&D
R&D in Japan
www.eisai.co.jp
Malaria
Sigma-Tau
MMV
Since 2004
R&D
www.mmv.org, www.sigma-tau.it
A potential new malaria target, GWT1, has been identified and a
patent entitled “Methods of screening for compounds that inhibit the
biosynthesis of GPI in malaria” was filed in 2003, based on the
results from the collaborative research undertaken by Eisai & Co.,
Ltd. and the University of Osaka. Exploratory research targeting
GWT1 is now underway, with a view to identifying suitable lead compounds.
Sigma-Tau S.p.A. and Medicines for Malaria Venture (MMV) have
completed development of Eurartesim™ a fixed-dose Artemisininbased Combination Therapy (ACT) which contains dihydroartemisinin (a derivative of artemisinin) and piperaquine.
Eurartesim™ is indicated for the treatment of uncomplicated
Plasmodium falciparum malaria. The registration dossier has been
submitted to EMA on July 2009. The registration is expected during
Q4 2010. After that, dossiers will be submitted to the endemic countries.
The new Sigma-Tau ACT corresponds to WHO´s recommended firstline treatment for malaria, as it combines in a single tablet a shortlived but potent artemisinin-based active ingredient (dihydroartemisinin) with a second antimalarial (piperaquine) which
remains longer in the body. The ACT strategy is based on the concept that the combination reduces the chances of resistance developing and improves its efficacy.
The second edition of the WHO Guidelines for the treatment of
malaria (March 2010) report. “DHA/PPQ is an option for the first line
treatment of uncomplicated p. falciparum malaria worldwide. Strong recommendation, high quality evidence”
During the last four years, several published trials, not sponsored by
the company, showed that the cure rate of Eurartesim™ is not inferior to other ACTs (artemether-lumefantrine, artesunate-amodiaquine, artesunate-mefloquine). In addition, it has been documented
that with Eurartesim™ in comparison with the other ACTs, there was
a significantly lower percentage of new infections during the followup period which lasted up to two months. The treatment schedule is
very simple: one daily administration for a total of 3 days. The new
medicine is very well tolerated with no significant side effects.
The Sigma-Tau / MMV clinical development included two large
Phase III comparative clinical trials carried out in Africa and Asia, with
a total of about 2,700 patients treated, all with uncomplicated P. falciparum malaria. The trial in Africa included about 1,600 children
aged six months to 5 years, and the comparator was artemetherlumefantrine. The second Phase III trial was carried out in Asia in
about 1,200 patients (aged six months to 63 years), and the comparator was artesunate-mefloquine. Eurartesim™ tablets used in the
clinical development program were produced under Good
Manufacturing Practice in Sigma-Tau´s industrial facilities in Italy. The
Phase III trial results confirmed the efficacy and safety of
Eurartesim™ as well as the prophylactic effect in lowering, in comparison with the other ACTs utilized, the incidence of new infections.
The development of a water-dispersible Eurartesim™ tablet formulation is ongoing and clinical tests are expected to start between Q4
2010 and Q1 2011.
Investigational site in Uganda (Hospital of Mbrara).
(Sigma-Tau)
59
MALARIA – R &D
GlaxoSmithKline & Malaria R&D
Novartis R&D for Malaria
Malaria
GlaxoSmithKline
MMV, WRAIR
Since 2001
R&D
R&D in UK and Spain (Pre-clinical)
www.gsk.com/malaria
Malaria
Novartis
TDR & other partners
Since 2006
R&D - Pediatric R&D
www.novartis.com
GlaxoSmithKline has created a dedicated R&D group to focus on
diseases of the developing world (DDW), specifically malaria and TB,
with a DDW drug discovery centre at its Tres Cantos R&D site in
Spain and clinical development experts in the UK and US. DDW projects are prioritized by their social and public health benefits rather
than commercial return. GSK works closely with the Medicines for
Malaria Venture (MMV), which subsidizes 30 scientists at Tres
Cantos. GSK provides the clinical, regulatory and manufacturing
expertise to advance compounds in clinical development.
Novartis is working with the UNICEF-UNDP-World Bank-WHO
Special Programme for Research and Training in Tropical Diseases
(TDR) and the Government of Zambia to study the use of Artemisinin
Combination Therapy to treat uncomplicated P. falciparum malaria in
pregnant women, for which there is currently little reliable data available.
GSK´s malaria treatment projects include:
• Tafenoquine, which is a potential new treatment for the radical cure
of P. vivax malaria being developed in partnership with MMV and
the US Walter Reed Army Institute of Research (WRAIR). An initial
clinical study is focusing on further understanding the safety of
tafenoquine in subjects with G6PD deficiency. The study began in
2009 and interim results are expected in 2010;
Novartis has worked with the Medicines for Malaria Venture (MMV) to
develop a pediatric formulation for Coartem®; an important need,
given the disproportionate vulnerability of children under 5 year to
malaria. Clinical development took place in several African countries
and the new product, Coartem® Dispersible, was formally launched
in January 2009.
Since 2007, the Novartis Institute for Tropical Diseases (NITD) in
Singapore has been working with MMV, the Singapore Economic
Development Board and the Wellcome Trust to discover new malaria medicines.
• Pyridone GSK932121 is being developed in partnership with MMV.
It entered ‘first time in human’ clinical trials early in 2009. In addition, a back-up effort is ongoing to identify a alternative pyridone
compound in case issues with the lead GSK932121 prevent further development. These are a new class of compounds with the
potential to be highly effective against drug-sensitive and drugresistant strains of both P. falciparum and P. vivax malaria.
The partnership is focusing on the development of a once daily-dose
cure for P. falciparum, the most dangerous form of malaria, and a
curative modality for P. vivax, the most frequently-occurring and
widely distributed type of malaria. NITD will manage the program and
conduct research jointly with several institutes including the
Genomics Institute of the Novartis Research Foundation, the Swiss
Tropical and Public Health Institute and the Biomedical Primate
Research Center.
GlaxoSmithKline has an R&D center focused on diseases of
the developing world in Tres Cantos, Spain. (GlaxoSmithKline)
Novartis is working on medicines to treat malaria in pregnant
women and on pediatric formulations. (Novartis)
60
MALARIA – R &D
PATH Malaria Vaccine Initiative (MVI)
Pfizer - Azithromycin/chloroquine for Malaria
Malaria
GlaxoSmithKline
MVI & other partners
Since 1999
Capacity Building - Support & Training, R&D - Pediatric R&D
Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, Tanzania
www.malariavaccine.org
Malaria
Pfizer
London School of Hygiene & Tropical, MMV
Since 2006
R&D - Pediatric R&D
www.pfizer.com/responsibility
The PATH Malaria Vaccine Initiative (MVI) was launched in 1999 to
accelerate development of malaria vaccines and ensure their availability and accessibility in the developing world. MVI was funded by
a USD 50 million grant from the Bill & Melinda Gates Foundation and
the Initiative is administered by the US not-for-profit Program for
Appropriate Technology in Health (PATH). MVI is guided by Technical
Advisory Groups, a Strategic Advisory Council and PATH´s board.
Partners include malaria experts around the world, government
agencies, academia, public and private research institutions, and
vaccine producers.
Pfizer, in partnership with Medicines for Malaria Venture (MMV) and
London School of Hygiene and Tropical Medicine, is developing a
fixed dose combination of azithromycin and chloroquine (AZCQ) for
intermittent treatment of malaria in pregnant women (IPTp) in subSaharan Africa. IPTp is aimed at lowering the incidence of adverse
pregnancy outcomes associated with malaria in pregnancy.
Sulfadoxine/pyrimethamine (SP) is the current standard of care for
IPTp in high transmission areas in Africa. However, recent emergence of resistance to SP, especially in East and Southern Africa has
made the search for SP replacement IPTp regimens an urgent
priority.
GSK´s candidate RTS,S/AS is the most clinically advanced malaria
vaccine in the world. In 2008, two separate Phase II trials confirmed
of earlier studies´ findings that the vaccine provides infants and
young children, the most vulnerable groups, with significant protection against malaria. In children aged five to 17 months, the
RTS,S/ASO1 vaccine reduced the risk of clinical episodes of malaria by 53% over an eight-month period. In the other trial, amongst
infants under 12 months who received three doses of a modified
RTS,S/AS02 vaccine, the risk of first infection from malaria was
reduced by 65% over a six month period. Importantly, trials also
showed that the RTS,S/AS02 vaccine does not interfere with the efficacy of vaccines for other diseases, such as diphtheria, tetanus and
polio, administered to infants through existing African national immunization programs. This means that in malaria-prevalent countries,
the vaccine could be delivered through the current immunization
schedule for infants, called the WHO Expanded Program on
Immunization (EPI).
The AZCQ development program is in Phase III of clinical development. In two multi-country clinical trials in sub-Saharan Africa, AZCQ
recently demonstrated 98% and 100% efficacy in treatment of symptomatic, uncomplicated falciparum malaria in non-pregnant adults.
The trials were conducted in Burkina Faso, Ghana, Mali, Kenya,
Senegal and Uganda. A phase III multi-country pediatric treatment
trial is currently ongoing in Burkina Faso, Ghana, Mali, Cote d’Ivoire
and Kenya. The pivotal IPTp trial is planned to start in the third quarter of 2010 in Kenya, Uganda, Tanzania and Malawi.
In 2009, GSK and its partners launched a large-scale phase III efficacy trial of RTS,S in seven countries in Africa. The trial, which is
expected to involve up to 16,000 children, is on schedule, with
almost 7,500 children enrolled by the end of January 2010. Christian
Loucq, MVI Director, commented on the significance of the trial
results by saying, “we are closer than ever before to developing a
malaria vaccine for children in Africa”.
Under current plans, the RTS.S vaccine candidate would be submitted to regulatory authorities in 2012 based on efficacy in children 517 months of age. Depending on the final clinical profile of the vaccine and timetable of the regulatory process, the first vaccine introduction could take place over the next three to five years.
Maintaining treatment records can be a challenge in
developing countries. (GllaxoSmithKline)
61
MALARIA – R &D
Ranbaxy R&D for Malaria
Sanofi-aventis - DNDi Malaria Medicine
Malaria
Ranbaxy
Clinical trial partners
Since 2003
R&D
India, Thailand
www.ranbaxy.com
Malaria
sanofi-aventis
DNDi & other partners
Since 2005
Access - Pricing, Capacity Building - Support & Training,
R&D - Pediatric R&D
www.sanofi-aventis.com, www.dndi.org
Arterolane maleate, or RBx-11160, is a synthetic version of
artemisinin discovered by the University of Nebraska Medical Center,
Omaha, under a Medicines for Malaria Venture (MMV) program.
Being synthetic, arterolane is not dependent on the artemisia annua
plant-based supply chain which has presented some challenges to
increasing the availability of artemisinin combination treatments
(ACTs), and may also offer cost advantages.
In April 2005, sanofi-aventis signed an agreement with Drugs for
Neglected Diseases initiative (DNDi) to develop a new medicine
against malaria, in response to a call from the World Health
Organization (WHO) for malaria be treated by drug combinations to
combat resistance.
A partnership between Ranbaxy and MMV was initiated in May 2003
to develop the compound into a new anti-malarial medicine. A Phase
IIa trial evaluating single doses of arterolane maleate demonstrated
that the drug has parasiticidal properties similar to the short-acting
artemisinin derivatives. In early 2007, MMV discontinued support for
the program. However, Ranbaxy´s desire to develop a product for
India and other malaria-endemic developing countries has encouraged it to continue development work.
A Phase IIb clinical trial in India and Thailand has evaluated 3 daily
doses of arterolane maleate with piperaquine phosphate, an established antimalarial drug in China and South East Asia. It has proven
antimalarial activity against both P. vivax and P. falciparum, including
strains of chloroquine-resistant P. falciparum. The arterolane
maleate-piperaquine phosphate combination was found to be as
effective and safe as the standard artemether-lumefantrine ACT.
Ranbaxy has obtained approval from the Drug Controller General of
India to initiate Phase III human clinical trials for this drug in India.
2008.
DNDi and sanofi-aventis have developed a fixed-dose combination
(FDC) of two antimalarial compounds, artesunate and amodiaquine
(ASAQ) that is easier to use and more affordable than any other combination currently available. DNDi developed the formulation combining the two active ingredients in a single tablet and carried out the initial pharmaceutical and clinical development, before choosing sanofiaventis as its industrial partner for further development.
Sanofi-aventis developed the product at industrial level, carried out
additional clinical studies, prepared the dossier for regulatory authorities and applied for WHO prequalification. Sanofi-aventis has
launched this new FDC in malaria endemic countries and embarking
on a large follow-up clinical trial program (‘ASAQ field monitoring program’) with DNDi and Medicines for Malaria Venture to collect good
efficacy and safety data on this new medicine in ‘real life’ conditions,
in several countries including Côte d’Ivoire, Liberia, Uganda and
Senegal. This program is being set up in close coordination with the
WHO.
The medicine, now registered in 24 African countries was prequalified by the WHO in October 2008. The new formulation simplifies
adult treatment to 2 tablets once a day for three days. The pediatric
dose is also simplified: one tablet a day for three days. Tablets are
soluble in water or in semi-liquid food, making them suited to the
needs of children, the population most at risk of complications from
malaria.
Sanofi-aventis committed to sell the product ‘at no profit-no loss’ to
health ministries in affected countries, intergovernmental institutions,
NGOs and programs promoting access to drugs in pharmacies. A
full treatment costs less than USD 0.50 for children less than 5 years
old and less than USD 1 for older children and adults. In 2009, the
first full year after WHO prequalification, 23 million treatments were
sold at preferential prices to over 20 malaria-endemic countries.
62
Sanofi-aventis - Semisynthetic Artemisinin Project
TLR9 Inhibitor for Cerebral Malaria
Malaria
sanofi-aventis
Amyris Biotechnologies, iOWH
Since 2008
R&D
R&D in USA
www.sanofi-aventis.com, www.oneworldhealth.org
Malaria
Eisai
FioCruz, University of Massachusetts in USA
Since 2006
R&D
Brazil
www.eisai.co.jp
In March 2008, sanofi-aventis entered into a partnership with the
Institute for OneWorld Health (iOWH) and Amirys Biotechnologies, a
US synthetic biology company, to develop semisynthetic artemisinin
for use in the Artemisinin-Combination Therapies (ACTs) now recommended by WHO as first-line treatment for malaria.
Eisai Co., Ltd.’s ER-820446 is a selective inhibitor of Toll Like
Receptor 9 (TLR9) signaling. TLRs are mediators of innate immunity.
In vitro, ER-820446 inhibits CpG oligonucleotide (TLR9 agonist)mediated induction of transcription factors in TLR9 transfected cells
and the production of proinflammatory cytokines in dendritic cells. In
a short term in vivo model in mice, administration of ER-820446 prevented a systemic cytokine response to a s.c. challenge with CpG
oligonucleotide. In a Plasmodium chabaudi malaria murine infection
model, ER-820446 did not reduce parasitemia, but prevented spontaneous release of proinflammatory cytokines triggered in response
to infection in vivo. In a Plasmodium berghei cerebral malaria murine
model, prophylactic treatment with ER-820446 significantly reduced
mortality due to cerebral malaria. Pre-clinical development activities
have been initiated for ER-820446, in conjunction with researchers
at the Oswaldo Cruz Foundation in Brazil and the University of
Massachusetts in the USA.
This collaboration aims to create a complementary source of nonseasonal, high-quality and affordable artemisinin to supplement the
current botanical supply, thereby enabling millions of people infected
with malaria to gain consistent access to lower-cost, life-saving
ACTs. Under the terms of the agreement, sanofi-aventis, iOWH and
Amirys will jointly develop pilot and commercial scale manufacturing
processes, with the goal of introducing low-cost, semisynthetic
artemisinin into the supply chain in 2011.
The project will be based on initial research conducted by the
University of California, Berkeley and funded by the Bill & Melinda
Gates Foundation. The specific input from sanofi-aventis will be to
provide fermentation and chemistry process development expertise.
If successful, this project will secure enough artemisinin to treat up to
200 million individuals each year with ACTs.
63
TROPICAL DISEASES
Neglected tropical diseases (non-exhaustive list)
Buruli ulcer is a severe skin disease caused by a bacterium. When left untreated, the disease leads to extensive destruction of
the skin and, in some cases, bone, eyes and other tissues. Buruli ulcer has been reported in over 30 countries; mainly in Africa.
Chagas disease (American trypanosomiasis) is a parasitic disease resulting from the bite of a protozoan parasite or transfusion
of infected blood. Patients with severe chronic disease become progressively ill and ultimately die. Chagas disease afflicts
people in Latin America with 12-14 million infections and 100 million people at risk.
Dengue is a mosquito-borne viral infection and an estimated 50 million cases occur worldwide every year. Dengue
haemorrhagic fever is a complication characterized by high fever, haemorrhagic phenomena and circulatory failures. It is a
leading cause of hospitalization and death among children in Asia.
Dracunculiasis (guinea-worm disease) is an excruciatingly painful and disabling parasitic disease. It causes an intensely
painful swelling, a blister, and then an ulcer accompanied by fever, nausea, and vomiting. Rural communities in Africa, with
access only to unprotected water sources for drinking, are invariably affected.
Human African trypanosomiasis (sleeping sickness) is spread by the bite of the tsetse fly. Untreated, the disease invariably
progresses to body wasting, somnolence, coma and death. The disease affects some 70 000 people in Africa.
Leishmaniasis is a parasitic infection transmitted by the bite of the sandfly. The disease has four forms ranging in severity from
self-healing cutaneous ulcers to severe life-threatening infection. An estimated 12 million people are infected and around 1.5 to
2 million new infections occur each year.
Leprosy has a notorious history as a cause of deformity, disability, loathing and fear. However, the disease is not highly
infectious and is curable. If untreated, it can cause permanent damage to the skin, nerves, limbs and eyes. Today 116 out of
122 endemic countries have eliminated leprosy as a public health problem.
Lymphatic filariasis is caused by thread-like parasitic worms and is transmitted by mosquitoes. The worst symptoms
generally appear in adults: damage to the lymphatic system, kidneys, arms, legs or genitals. Over 120 million people are
currently infected.
Onchocerciasis (river blindness) is a parasitic disease caused by the filarial worm that is transmitted to humans through the
bites of black flies. It causes visual impairment, including permanent blindness. Other devastating effects are intolerable itching
and disfigurement of the skin. Some 37 million are estimated to be infected and over 99% of those affected live in Africa.
Schistosomiasis (bilharzia) is a parasitic disease that leads to chronic ill health. An estimated 70 million people with urinary
schistosomiasis in Africa alone suffer from blood in the urine, indicating damage of the bladder and urinary tract.
Soil-transmitted helminthiasis (intestinal worms) is caused by ingestion of eggs from contaminated soil or by active
penetration of the skin by larvae in the soil. Worm infections aggravate malnutrition and amplify rates of anaemia. More than
1 billion people - one sixth of the world’s population - are at risk of infection.
Trachoma is an eye infection, which spreads from person to person and often begins during infancy or childhood and can
become chronic. If left untreated, the infection eventually causes the eyelid to turn inwards. This ultimately leads to irreversible
blindness, typically between 30 and 40 years of age. Trachoma affects about 84 million people of whom about 8 million are
visually impaired.
Yaws is a contagious infection, which is usually transmitted through direct skin contact and mainly affects children under
15 years of age. Without treatment, multiple lesions appear all over the body. Yaws is a significant public health problem in some
countries in South-East Asia, Africa and the Western Pacific region.
(Source: WHO Neglected Tropical Diseases Fact Sheet)
64
At least 1 billion people – 1 person in 6 – suffer from tropical
diseases such as Buruli ulcer, cholera, dengue, dracunculiasis
(Guinea worm disease), leishmaniasis, lymphatic filariasis,
onchocerciasis, schistosomiasis, soil-transmitted helminthiasis,
trachoma and trypanosomiasis. These diseases, many of which
are vector-borne, primarily affect poor people in tropical and
subtropical areas. Some affect individuals for life, causing
disability and disfigurement, often leading to stigmatization.
Others are acute infections, with transient, severe and
sometimes fatal outcomes.
With the end of the colonial era, developed countries lost
interest in these diseases, research waned and they came to be
known as “neglected diseases”. Thanks in part at least to
committed public-private partnerships, these diseases are now
receiving greater attention, both with regard to improved access
to treatment and increased R&D activity. The pharmaceutical
industry is the third largest global investor in neglected disease
R&D, behind the United States’ National Institutes of Health and
the Bill & Melinda Gates Foundation.
More than 14 million people have been cured of leprosy; the
number of people infected with Guinea worm has dropped from
3 million to just 25,000 cases; blinding diseases such as
onchocerciasis and trachoma are being brought under control;
millions of people are now protected from disfiguring lymphatic
filariasis. Schistosomiasis has been effectively controlled in
Brazil, China and Egypt, and eliminated from Iran, Mauritius and
Morocco. Intestinal helminths have been eliminated in South
Korea and are under control in many endemic countries. These
successes demonstrate that interventions against neglected
tropical diseases are technically feasible, immediate, visibly
powerful and highly cost effective.
(Sources: WHO Control of Neglected Tropical Diseases (NTD); WHO/CDS/NTD/2006.2, Neglected Tropical Diseases: Hidden Successes, Emerging Opportunities;
G-Finder Neglected Disease Research and Development: How much are we really spending? 2009)
Weight of specific tropical diseases by death and by annual DALY1 losses, 2004
DALYs
Deaths per year
4.1 million
110’000
72.3 million
2 million
Dengue
663’000
18’000
Helminth Infections
12 million
47’000
(however some estimates
suggest 49 million)
(however some estimates
suggest 415’000)
Bacterial Pneumonia & Meningitis
93.3 million
3.9 million
Typhoid & Paratyphoid Fever
No reliable figures
No reliable figures
Leprosy
194’000
5’000
Buruli Ulcer
No reliable figures
No reliable figures
Trachoma
1.3 million
Rheumatic Fever
5.1 million
280’000
Total
188’957’000
6’360’000
Kinetoplastid Diseases
Leishmaniasis
Sleeping sickness
Chagas disease
Diarrhoeal Diseases
Rotavirus
Cholera
Shigella
Enerotoxinegic E. coli
Cryptosospridium
Enteroaggregative E. coli
Giardi
Schistosomiasis
Hookworm
Lymphatic filariasis
Onchocerciasis
Roundworm
Tapeworm
Strongyloidiasis
Whipworms
1Disability
Adjusted Life Years (DALY) combines in one measure the time lived with disability and the time lost due to premature mortality. One
DALY can be thought of as one lost year of ‘healthy’ life and the burden of disease as a measurement of the gap between current health
status and an ideal situation where everyone lives into old age free of disease and disability.
(Source: G-Finder Neglected Disease Research and Development: How Much Are We Really Spending? 2009)
65
Bayer HealthCare & African Sleeping Sickness
Bayer HealthCare: Fight Against Chagas Disease
Sleeping sickness
Bayer HealthCare
WHO
Since 2002
Access - Donation
Chagas disease
Bayer HealthCare
WHO
Since 2004
Access - Donation
Endemic countries in Latin America
In 2002, Bayer HealthCare agreed to supply - at no cost and for an
initial five-year period - as much of the sleeping sickness medicine
Germanin® (suramin) as the World Health Organization (WHO) determines is needed to eliminate the disease. The initial donation comprised 50,000 ampoules. Bayer is also in favor of supporting an
‘Integrated Sleeping Sickness Initiative’ fostered by a broad base of
institutions and covering all aspects of the disease from infection,
diagnosis and therapy to prevention.
In April 2007, Bayer signed a new agreement to provide the World
Health Organization (WHO) with 2.5 million Lampit® tablets and
additional funding for the distribution of the drug. The latest agreement assures the supply of Lampit® until 2012.
The agreement was renewed in 2008, whereby Bayer will provide,
free-of-charge, 50,000 ampoules of Germanin® to the WHO, over a
five-year period.
To widen access of patients to affordable medicines, Bayer
HealthCare signed agreements with the World Health Organization
(WHO) in 2004 and 2005 for donations of its medicine Lampit®
(nifurtimox) to combat Chagas disease, the form of sleeping sickness
found in Latin America. A total of 500,000 tablets was given to the
WHO, which informs the governments of disease endemic countries
of the availability of the free supplies, including the procedure to
be followed for obtaining such supplies, and decides about its
distribution.
The goal of the WHO is to distribute Lampit® in all 21 endemic countries in Latin America. Currently, the medicine is approved in
Argentina, El Salvador, Honduras, Nicaragua, Chile, Guatemala and
Uruguay. Lampit® will also be provided in small quantities, as needed, in some non-endemic countries, like Canada, France, Japan,
Spain, UK and the USA.
Dr. Luis Alberto Benios, doctor in the Hospital of San Marcos de Sierra, explains the taking of Lampit® tablets to Yadira and her mother
Catalina Nuñez. The 14 year old Yakira is affected with the Chagas disease. (Bayer HealthCare)
66
Children Without Worms
Gilead - AmBisome for Leishmaniasis
Soil-transmitted helminthiasis
Johnson & Johnson
Task Force for Child Survival and Development
Since 2007
Access - Donation
www.ChildrenWithoutWorms.org
Leishmaniasis
Gilead
WHO
Since ?
Access - Pricing, R&D
Endemic countries
www.gilead.com/access_developing_world
Globally, up to 400 million children suffer from Soil-Transmitted
Helminthiasis (STH), an infection of intestinal worms, but fewer than
20% of at-risk children were reached with de-worming treatment in
2005, falling far short of the World Health Assembly´s target to treat
75% of at-risk children by 2010. STH is especially dire for children
because it causes malnutrition, increases susceptibility to other serious infections, and stunts growth during a critical development
period.
Gilead´s therapeutic AmBisome (amphotericin B) liposome for injection has shown potent anti-parasitic and fungicidal activity against
multiple pathogens, including mucosal and visceral leishmaniasis in
clinical studies.
STH has been identified by the WHO and the US Centers for Disease
Control and Prevention as a ‘target of opportunity’, meaning that
with existing diagnostic tools and treatments and greater support, it
can be prevented, treated and controlled.
Gilead´s goal is to expand access to AmBisome for the treatment of
leishmaniasis in settings where the disease has the largest impact.
Gilead works closely with the World Health Organization and NGOs
to provide AmBisome at a preferential price for the treatment of leishmaniasis in resource-limited settings. Gilead also actively supports
multiple clinical research studies aimed at elucidating the best treatment course for visceral leishmaniasis.
In 2007, Johnson & Johnson partnered with the Task Force for Child
Survival and Development to develop and launch a program to
donate up to 50 million doses of mebendazole in 2007 to treat children with or at high risk for STH. Approximately 30 million doses
were donated to strategic recipients in 2007. Mebendazole is one of
a class of medicines known as antihelmintics that are used to treat
numerous kinds of worm infections.
Leishmaniasis is caused by protozoan parasites which are
transmitted by the bite of certain species of sand fly.
(Infectious Disease Research Institute)
67
Global Alliance to Eliminate Lymphatic Filariasis
(GAELF)
Guinea Worm Eradication Program (GWEP)
Lymphatic filariasis
GlaxoSmithKline, Merck & Co. Inc.
GAELF, WHO & other partners
Since 1998
47 out of 80 endemic countries
www.filariasis.org
Dracunculiasis (Guinea worm)
Johnson & Johnson
Carter Center, WHO & other partners
Since 1986
Access - Donation, Capacity Building - Support, Education
Ethiopia, Ghana, Mali, Sudan
www.cartercenter.org/health/guinea_worm/index.html
The Global Alliance to Eliminate Lymphatic Filariasis (GAELF) was
created to eliminate one of the world’s leading causes of disability
and disfigurement as a public health problem by the year 2020. An
estimated 120 million people in at least 80 countries of the world suffer from the disease, and one billion (20% of the world’s population)
are at risk of infection.
Established in 1986 and operating under the auspices of the Carter
Center´s Global 2000 Program, the Guinea Worm Eradication
Program (GWEP) aimed to rid future generations of Guinea worm by
the year 2005. This multilateral partnership brings together organizations like the WHO, UNICEF, the CDC and the World Bank, as well
as national governments and the pharmaceutical industry in a program combining eradication efforts, training and research. To accelerate the eradication of Guinea worm disease, the partners:
Initiated by the World Health Organization (WHO) and
GlaxoSmithKline in 1998, the Global Alliance has evolved into a global partnership between international organizations in the public and
private sectors, academia and non-governmental organizations
working in partnership with ministries of health in tropical countries
where lymphatic filariasis (LF) is endemic. Merck & Co., Inc. joined
the elimination effort in 1998, when it widened the scope of its
Mectizan® Donation Program to include LF in African countries
where river blindness and LF co-exist.
The WHO recommends that lymphatic filariasis be prevented with a
combination of albendazole (donated by GSK) with either DEC or
Mectizan® (donated by Merck). Drug administration for people living
in endemic areas is recommended by WHO once a year for at least
five years to break the cycle of transmission.
In 2009, GSK donated 425 million treatments of albendazole to prevent transmission in 28 countries. To date, GSK has donated over
1.4 billion treatments to 50 countries. Over the 20 year life of the program, GSK expects to donate up to 6 billion preventative albendazole treatments across the LF endemic countries working to fight LF.
Merck approved 110 million treatments of Mectizan® to LF elimination programs in 19 African countries and Yemen in 2009, bringing
the cumulative total to more than 414 million. Merck and GSK have
also provided financial grants to support partners in research programs, coalition building, workshops and communications.
In the ten years since its initiation, the GAELF has become the most
rapidly scaled-up medicine administration program in public health
history. The WHO reported that during 2008, over 496 million people
were treated worldwide. In a study published in October 2008 in
PLoS Neglected Tropical Diseases, researchers found that the LF
elimination effort has prevented 6.6 million children from acquiring
the disease.
• Maintain a community-based surveillance system with monthly
reporting of cases, supervision, and integration of surveillance for
other major preventable diseases (where appropriate and feasible);
• Target specific interventions (provision of safe water, health education, community mobilization, filter distribution, and treatment of
selected water sources);
• Maintain global and national dracunculiasis databases;
• Monitor the epidemiological situation and map all endemic villages;
• Conduct advocacy for eradication of the disease;
• Certify dracunculiasis eradication country-by-country worldwide.
Today, through the joint efforts of many partners, the incidence of this
disease has been reduced worldwide by 99%, from an estimated 3.5
million cases in 1986 in 20 countries to 3,190 reported cases in 2009
(provisional numbers) in 4 countries (Sudan, Ghana, Mali, Ethiopia).
Today, the last 1% of the disease is being fought.
Johnson & Johnson has donated enough medical supplies, such as
Tylenol®, forceps and gauze, to treat more than 3,000 villages in the
endemic countries. In 2007, J&J donated medical supplies to the
GWEP, for use in Sudan, the country most affected by Guinea worm.
The donation included Tylenol® painkiller, to make the excruciating
process of removing the worms from victims more bearable;
Neosporin® and Savlon® antiseptics for disinfecting the wounds;
and scissors, gloves, tape, gauze and sterile bandages for wrapping
the wounds.
The International Trachoma Initiative is working to eliminate
blinding trachoma in Vietnam by 2010. (Mark Tuschman, Pfizer)
68
International Trachoma Initiative (ITI)
Leprosy Elimination
Trachoma
Pfizer
Edna McConnell Clark Foundation & other partners
Since 1998
Access - Donation, Capacity Building - Support & Training, Education
www.trachoma.org
Leprosy
Novartis
WHO
Since 2000
The International Trachoma Initiative (ITI) was founded in 1998 by
Pfizer and the Edna McConnell Clark Foundation to treat and prevent
blinding trachoma, the world’s leading cause of preventable blindness. In March 2009, ITI and the Task Force for Child Survival and
Development announced that they will join forces to scale up efforts
to eliminate trachoma. ITI supports the implementation of the World
Health Organization’s (WHO) recommended SAFE strategy, a comprehensive public health approach that combines treatment and prevention, including sight-saving Surgery, mass treatment with the
Pfizer-donated Antibiotic Zithromax®, Facial cleanliness education,
and Environmental improvements to increase access to clean water
and improved sanitation. ITI’s goal is to eliminate blinding trachoma,
resulting in improved health and livelihood in some of the world’s
poorest countries. ITI supports the WHO’s Alliance for Global
Elimination of Trachoma by 2020 (GET 2020) as well as Vision 2020:
The Right to Sight. Other ITI partners include: AmeriCares, the Carter
Center, Helen Keller International, Lions Club, the United Nations
Children’s Fund (UNICEF), WaterAid, and World Vision.
Recommended by the World Health Organization (WHO), multidrug
therapy (MDT) cures patients, interrupts the transmission of leprosy
and prevents disabilities. Novartis developed two of the three medicines in MDT and has provided MDT, free of charge, for all patients
in the world through the WHO since 2000. This is a core element in
the WHO Elimination Strategy of creating awareness of the early
signs, improving patients´ access to free diagnosis and treatment,
and close monitoring.
The International Trachoma Initiative involves the following activities:
• Provide patients in developing countries with antibiotics and providing surgery to treat advanced cases of trachoma;
• Educating communities about trachoma prevention and training
health care workers to conduct surgeries for advanced trachoma
cases;
• Providing training and technical assistance to support national trachoma programs;
• Advocating for increased funding for trachoma programs and catalyzing partnerships to work towards trachoma elimination.
Since 1998, Pfizer has provided over 145 million treatments of
Zithromax® for treatment and prevention of the disease in 18 countries. With Pfizer’s support, ITI has trained thousands of healthcare
workers who have performed more than 416,000 surgeries to treat
advanced cases of trachoma. With the support of the ITI, Morocco
became the first country to complete the campaign for trachoma
control in 2006, and is now working toward WHO certification to signify that blinding trachoma has been eliminated as a public health
problem.
More than 14 million people have been cured of leprosy since 1985,
over 4.5 million of them with drugs provided free of charge by
Novartis. Two decades ago, leprosy was a public health problem in
122 countries. Today the disease has been eliminated as a public
health problem (i.e. reaching a prevalence rate of less than one case
per 10,000 inhabitants) from all but 3 countries (Brazil, Nepal and
Timor Leste).
Since 2000, the Novartis Group (Novartis Pharma, Novartis
Foundation for Sustainable Development and Sandoz) has been providing high-quality multi-drug therapy (MDT) free of charge to all leprosy patients in the world through the World Health Organization
(WHO). The MDT donation is administered under the terms of a
Memorandum of Understanding that continues until the end of 2010.
Novartis has expressed its willingness to help anyone affected by this
disease until leprosy is eradicated.
Novartis and the foundation also provide the funds for managing the
donation, transport, insurance and independent quality control of
MDT. The value of the Novartis MDT donation from 2000 to 2009
was USD 60 million.
The Novartis Foundation has supported national health ministries,
the WHO and NGOs in field programs since the mid-1980s. It pioneered the use of social marketing to combat the stigma of the disease. The concept of generating and meeting demand for leprosy
treatment is now an integral part of the WHO leprosy elimination
strategy. The Novartis Foundation has also helped simplify the provision of disability prevention services in communities. Many of the
approaches devised by the Novartis Comprehensive Leprosy Care
Association in India have now been incorporated in the government
and NGO disability care packages.
The small remaining number of patients has changed the challenge
of fighting leprosy. New approaches have to be developed to move
towards a world free of leprosy. The Novartis Foundation started a
world-wide study to shed light on what is needed to further improve
the control of leprosy, with special emphasis on improving early
detection.
69
Merck Mectizan® Donation Program
Merck Praziquantel Donation Program
Lymphatic filariasis, onchocerciasis
Merck & Co. Inc.
WHO, World Bank & other partners
Since 1987
33 endemic countries in Africa, Latin America, the Middle East
www.mectizan.com
Schistosomiasis
Merck KGaA
WHO
Since 2007
Access - Donation
8 African priority control countries
www.merck.de
Onchocerciasis, or river blindness, is a leading cause of infectious
blindness in the developing world. The Merck Mectizan® Donation
Program (MDP) was launched in 1987, when Merck & Co., Inc.
announced that it would donate Mectizan® (ivermectin), for the treatment of onchocerciasis to all who needed it for as long as needed.
A multi-sectoral partnership was established with governments in
countries where onchocerciasis is endemic, their ministries of health
and other national and international stakeholders, including the
World Health Organization, to ensure appropriate infrastructure, distribution and support. The Mectizan® Donation Program is the
longest-running, disease-specific drug donation program and public/private partnership of its kind in history, and is widely regarded as
one of the most successful public/private health collaboration in the
world.
According to the World Health Organization (WHO), up to 300 million
people suffer from schistosomiasis, a worm disease caused by
schistosomes, parasitic worms that multiply as swimming eggs in
certain fresh water snails. Human infection occurs when the skin
comes into contact with schistosome parasites released into the
water by infected snails. The parasites migrate to the liver, mature
into adult worms and reproduce, with their eggs being ejected from
the body in the feces. Schistosomiasis causes anemia, stunted
growth and learning disabilities. It is the second-most common tropical disease in Africa after malaria and is also prevalent in Asia, the
Caribbean, the Middle East and South America. Some 600 million
people are at risk and around 200,000 people die of this disease
every year.
Since the inception of the program in 1987, Merck has donated more
than 2.9 billion tablets of Mectizan® for river blindness, with 800 million treatments approved since 1987. The program currently
approves 100 million treatments annually through river blindness programs in Africa, Latin America and Yemen.
In 2007, Merck re-affirmed its pledge to donate as much Mectizan®
as necessary for the elimination of river blindness globally. With this
renewed pledge, Merck’s donation of Mectizan® for river blindness
is estimated to reach 100 million treatments annually by 2010. Also
in 2007, Merck announced a donation of USD 25 million over eight
years as part of an initiative with the World Bank to raise approximately USD 50 million in support of river blindness elimination in
Africa.
In 2007, public health officials announced that transmission of river
blindness had been halted in Colombia: the first time that the disease
has been eliminated as a public health problem on a country-wide
basis anywhere in the world.
Health officials also announced that river blindness transmission has
been halted in certain endemic areas in Ecuador and Guatemala,
and new cases of eye disease caused by river blindness have been
eliminated in nine of the 13 foci in the Americas.
In April 2007, Merck KGaA signed a partnership agreement with the
WHO to supply 200 million tablets of Cesol® 600 (praziquantel) for
the treatment and prevention of schistosomiasis over a 10 year period. Some 27 million African school children will benefit from the
Merck donation, with an estimated value of approximately USD 80
million, which is focused on Sub-Saharan African countries. Angola,
Benin, Cameroon, Central African Republic, Madagascar, Senegal,
Nigeria, Malawi, Mauritania, Tanzania, Mozambique and Zambia
have been designated by WHO/AFRO for priority control of neglected tropical diseases (NTDs).
Praziquantel is the most effective therapy to date for schistosomiasis
infections - often even after just one dose - and it is well tolerated. It
is therefore on the WHO list of essential drugs. The donation will
address the issue of the affordability of praziquantel, which has been
a barrier to access in poor communities and the main obstacle to
implementing preventive anthelminthic chemotherapy in many
African countries. Anthelminthic chemotherapy refers to drug treatment for worm infections, such as schistosomiasis, that disrupt the
metabolism of these worms, which are known generally as
helminths.
In 2008, it was announced that 31 percent of the formerly at-risk
population in the Americas is no longer at risk of contracting the disease. Also in 2008, the Pan American Health Organization passed a
resolution to interrupt transmission of the disease in the Americas by
2012.
The success of the program in Latin America means that 74,476
people in 190 communities are now free of the threat of river blindness.
While much progress has been made in the treatment and progress
toward elimination, a number of additional challenges remain that
Merck and its partners are actively addressing.
A young girl taking her medicine in Madagascar.
(Merck KGaA)
70
Sanofi-aventis Sleeping Sickness Program
Sanofi-aventis ‘Most Neglected Diseases’ Program
Sleeping sickness
sanofi-aventis
Since 2001
Access - Donation, Capacity Building - Support, R&D
Sub-Saharan African countries
Buruli ulcer, Chagas disease, leishmaniasis
sanofi-aventis
Since 2006
Brazil, Chad, Ethiopia, Panama, Sudan, Togo, Middle-East countries
Sleeping sickness has reemerged in Africa as a major health threat.
In 2001, sanofi-aventis committed USD 25 million over the years
2001-2006 to help the World Health Organization (WHO) to implement a strategy of adequate medicine supplies, disease surveillance
and management, plus R&D for new treatments.
As part of its 5-year agreement with the World Health Organization
(WHO) in 2006 to extend its partnership in sleeping sickness (see
separate entry), sanofi-aventis also undertook to support a collaborative program with WHO to improve treatment for some ‘most neglected diseases’, namely leishmaniasis, Chagas disease and Buruli
ulcer.
After five years, WHO and sanofi-aventis´ efforts were estimated to
have saved 110,000 lives. In 2006, the company renewed its contract with the WHO and expanded it to address several additional
‘most neglected diseases’ (see separate entry). It has committed to
provide a further USD 14 million over the years 2006-2011, with continued medicines donation for sleeping sickness, and funding for
training, control & diagnostic programs. It is also working to make
eflornithine a more ‘ready to use’ and safer treatment.
By the end of 2008, more than 1,250,000 vials of eflornithine, pentamidine and melarsoprol had been distributed . Since the peak of
37,000 patients in 1998, 3 years before the signing of the WHOsanofi-aventis partnership, the number of patients diagnosed and
treated each year has been declining, down to less than 11,000 in
2008.
Sanofi-aventis delivered donated medicines to Médecins sans
Frontières logistics and funds their storage and distribution, on behalf
of the WHO, to national control programs and to NGOs. Since 2006,
donated drugs have been distributed by the WHO to 37 countries 20 endemic and17 non-endemic countries, in Europe, Asia, and the
Americas;
Sanofi-aventis funds disease management and control programs,
including screening of populations in endemic areas, medical staff
training, and surveillance of resistance to treatments. Thanks to this
program, screening and treatment teams were back in the field in
more than 25 sub-Saharan countries, including Angola, Cameroon,
Chad, Central African Republic, the Democratic Republic of Congo,
Uganda and the Republic of Congo.
Sanofi-aventis is providing USD 6.4 million to WHO over 5 years for
development of training, diagnostics and optimization of treatment
for leishmaniasis. It will transfer the worldwide production of its leishmaniasis medicine Glucantime® to its Brazilian subsidiary, to optimize the product price. Sanofi-aventis provides Glucantime® at a
price of USD 1.20 plus transport and duties per ampoule to all developing countries. In 2008, sanofi-aventis also helped the WHO with
import licenses in some critical endemic countries.
Sanofi-aventis’ Humanitarian Partnership Department is developing a
joint leishmaniasis control program with the Aggeu Magalhaes
Research Center and the Oswaldo Cruz Foundation to set up a
screening, care and follow-up program for 4,000 poor families in
Pernambuco, to fight leishmaniasis and other endemic diseases in
the region, such as tuberculosis and dengue. Other programs on
leishmaniasis are also being developed with the governments of
Panama and Bolivia.
Sanofi-aventis is also giving WHO USD 2 million for new programs to
intensify disease management of Buruli ulcer and Chagas disease
and USD 4 million to support field activities of its Innovative and
Intensified Disease Management program.
In addition to the above-mentioned agreement with WHO, sanofiaventis has partnered in 2007 with Handicap International to set up
a five-year national campaign in Togo to reduce the death rate and
the serious post-disease effects caused by Buruli ulcer. In 2008, 98
health professional were trained, and 194 patients treated under this
program.
Sanofi-aventis also helped fund development of new therapies
through the UNDP-World Bank-WHO Special Program for Research
and Training in Tropical Diseases (TDR). These included an oral form
of eflornithine (stopped in 2007) and a combination of eflornithine
from sanofi-aventis and nifurtimox from Bayer HealthCare (‘NECT’).
With successful results in clinical trials, the development of this combination treatment has been completed and it is now being used to
treat sleeping sickness- see Nifurtimox-Eflornithine below.
Using a blood sample to diagnose sleeping sickness
in a mother and her baby. (Sanofi-aventis)
71
Eisai - DNDi Chagas R&D Collaboration
GlaxoSmithKline - DNDi Collaboration
Chagas disease
Eisai
DNDi
Since 2009
R&D
Latin American countries
www.dndi.org
Chagas disease, leishmaniasis, sleeping sickness
GlaxoSmithKline
DNDi & other partners
Since 2008
R&D
R&D in Spain & UK (Pre-clinical)
www.dndi.org
In September 2009, Eisai Co., Ltd. and DNDi, a non-profit independent foundation based in Geneva, Switzerland, signed a collaboration and license agreement for the clinical development of
Ravuconazole for the treatment of Chagas disease. Ravuconazole,
an anti-fungal drug discovered and developed by Eisai, has been
shown in in vitro and in vivo to have activity against the pathogen
responsible for Chagas disease.
In March 2008, GlaxoSmithKline (GSK) and the Drugs for Neglected
Diseases initiative (DNDi) announced a collaborative research effort
targeting visceral leishmaniasis (kala azar), human African trypanosomiasis (sleeping sickness), and Chagas disease.
Under the terms of the agreement, Eisai will provide E1224, the pro
drug of ravuconazole, as well as its scientific expertise to DNDi for
their clinical development to assess the safety and efficacy of this
drug. Eisai will also have the option to become the industrial partner
with DNDi to manufacture, register and make available E1224 at an
affordable price to the public sector in endemic countries.
The collaboration, which has been established for an initial period of
two years, will focus on identifying and developing compounds from
existing GSK programs and will leverage the expertise of researchers
at GSK´s Tres Cantos facility and leading academic centers like the
London School of Hygiene & Tropical Medicine (LSHTM).
The collaboration has been formed to address unmet patient needs,
as current treatments for these diseases have significant drawbacks,
such as difficulty of administration, severe side effects, length of
treatment, cost and emerging parasitic resistance.
Phase I studies have already been completed in the USA, demonstrating a well-tolerated safety profile and long half life. Phase II studies will be initiated during 2010 by DNDi in Latin American countries.
Eisai will support DNDi by supplying E1224.
Transmitted by the bite of the kissing bug or vinchuca, Chagas disease is a public health problem particularly in the poor areas of Latin
America and the Caribbean. About eight million people are believed
to carry it, and about a third of these will develop serious heart or
intestinal damage that could lead to death if left untreated. Two
drugs, discovered decades ago with limited efficacy at the chronic
phase of the disease and poor tolerability profile in adults, are currently available. The development of a new treatment which could be
effective for the chronic phase of the disease, particularly in adults,
would therefore represent an important advance.
Chagas disease is a public health problem particularly in the
poor areas of Latin America and the Caribbean.
(Greg Goss, Eisai)
72
TROPICAL DISEASES – R & D
GlaxoSmithKline Proprietary Knowledge Pool
GlaxoSmithKline´s Sitamaquine for Leishmaniasis
Tropical Diseases
GlaxoSmithKline
Bio Ventures for Global Health & other partners
Since 2009
R&D
South Africa
www.gsk.com
Leishmaniasis
GlaxoSmithKline
Various partners
Since 1995
R&D
India, Kenya
www.gsk.com
Being more flexible with intellectual property could stimulate research
and help to speed up development of medicines for neglected tropical diseases (NTDs).
Sitamaquine is GlaxoSmithKline´s potential new once-a-day oral
treatment for visceral leishmaniasis. This disease affects half a
million people a year in the developing world and is usually fatal if
untreated.
In March 2009, GlaxoSmithKline created a neglected tropical disease
(NTD) pool to stimulate research into medicines for the16 NTDs
defined by the US Food and Drug Administration (FDA).
To initiate the pool, GSK published details of over 800 of its patents
and patent applications for small molecule pharmaceuticals which it
identified as being potentially useful for the treatment of the target
NTDs.
Since then, GSK has had ongoing discussions with other companies, the scientific and research community to expand the pool and
Bio Ventures for Global Health (BVGH), who have taken over administration of the pool from January 2010, to give it greater independence.
The impact of the pool is dependent on the contribution of pharmaceutical and biotechnology companies, universities and other stakeholders.
Data from two Phase II proof-of-concept studies in Kenya and India
are encouraging overall. After a 28-day course, 85% of patients
remained cured at six months. Sitamaquine was generally well tolerated by patients in these studies. However, there were some concerns regarding renal adverse events seen in a few subjects, some
of which appear to be treatment-related.
Interpretation of these data is complicated, in particular because VL
itself is associated with renal impairment. Before proceeding to
Phase III trials, GSK set up a Phase IIb study to compare the safety
and tolerability of a 21 day course of sitamaquine with that of intravenous amphotericin B. Early results showed comparable efficacy to
previous studies, despite the shorter course, and sitamaquine was
very much better tolerated than amphotericin. A small number of
patients had mild, reversible renal side effects.
GSK is currently in discussions with potential partners with a view to
progressing development. The company is also targeting VL through
their partnership with the Drugs for Neglected Diseases Initiative. A
new treatment for visceral leishmaniasis is urgently needed, since
current medicines are either impractical or becoming ineffective due
to drug resistance, or are simply unaffordable.
73
GlaxoSmithKline’s Tres Cantos Open Lab for DDW R&D
Merck & Co., Inc. – DNDi Master Agreement
Tropical Diseases
GlaxoSmithKline
MMV & TB Alliance
Since 2009
R&D
R&D in Spain
www.gsk.com
Chagas disease, leishmaniasis
Merck & Co. Inc.
Drugs for Neglected Diseases initiative DNDi
Since 2008
R&D
R&D in various places
www.dndi.org.
GlaxoSmithKline has an R&D facility in Tres Cantos, Spain, which has
been dedicated to developing new treatments to combat diseases of
the developing world (DDW) since it was established in 2001. Since
that time, GSK has worked in a number of Public Private
Partnerships (PPPs) with more than 100 scientists at the site partly
funded by GSK’s partners. In 2009, GSK announced its intention to
open up the Tres Cantos facility further, to become a global centre of
excellence that brings new partners to the facility and stimulates
research and collaboration on neglected diseases where research is
still too fragmented.
In June 2009, Merck & Co., Inc. and the not-for-profit product development partnership Drugs for Neglected Diseases initiative (DNDi)
announced a master agreement to support discovery and development of improved treatments for a wide range of neglected tropical
diseases (NTDs).
GSK has launched an open lab at Tres Cantos, to create up to 60
spaces for scientists from around the globe. GSK will not initiate the
projects but will encourage universities, not-for-profit partnerships
and other research institutes to bring forward proposals for new collaborative projects, between the scientists’ home laboratory and
GSK at Tres Cantos. Visiting researchers will have access to facilities,
scientists and know-how. All projects will have clear objectives and
the shared aim of discovering new medicines for neglected diseases.
To meet the needs of the new researchers, GSK is expanding facilities at Tres Cantos and establishing a not-for-profit foundation with
an initial investment of £5 million.
The agreement covers a wide range of NTDs including visceral leishmaniasis and Chagas disease that infect millions of people. As with
many other NTDs, adequate treatments suitable for poor populations
are lacking. Current therapies may be toxic, prohibitively expensive,
or difficult to administer, particularly in resource-poor settings.
Under the terms of the agreement, Merck will contribute small molecule assets and related intellectual property via a non-exclusive, royalty-free license to DNDi to conduct early development programs for
drug candidates for treatment of NTDs, with the primary goal of manufacture and distribution of drugs at low cost to the public sector in
resource-poor countries. Merck and DNDi will share joint intellectual
property on drug candidates generated through early development,
and Merck will retain the option to undertake late clinical development and registration of candidate medicines.
GlaxoSmithKline has an R&D facility in Tres Cantos, Spain,
which has been dedicated to developing new treatments to
combat diseases of the developing world (DDW). (GSK)
74
TROPICAL DISEASES – R &D
Merck Serono Collaboration with TDR
Next-Generation Onchocerciasis Treatment R&D
Malaria, schistosomiasis, sleeping sickness
Merck KGaA
TDR & other partners
Since 2004
R&D
www.merck.de
Onchocerciasis
Pfizer
TDR
Since 1998
R&D
Democratic Republic of Congo, Ghana, Liberia
www.pfizer.com
There is a great need for new medicines for treating tropical disease.
Even today, tropical parasitic diseases such as malaria, leishmaniasis, African sleeping sickness (HAT) or Chagas disease still represent
a major health threat for much of the world’s population. They lead
to millions of deaths per year and massive socio-economic effects in
many countries. New medicines should be focused on the needs of
target patients, and be suitable for use in the field. They need to be
cost-effective, orally bio-available and stable under extreme conditions of heat and humidity.
Pfizer is collaborating with the UNICEF-UNDP-World Bank-WHO
Special Programme for Research and Training in Tropical Diseases
(TDR) to evaluate moxidectin for the potential to be a macrofilaricidal
agent for onchocerciasis (river blindness). This collaboration was initiated by Wyeth, which was acquired by Pfizer in October 2009.
The Merck Serono division of Merck KGaA is headquartered in
Geneva - the ideal place to run international projects with the World
Health Organization (WHO) and the UNICEF-UNDP-World BankWHO Special Program for Research and Training in Tropical
Diseases (TDR). In 2004, Merck started a project in collaboration with
World Health Organization (WHO) to train two visiting scientists in
drug discovery, screening compounds from the library against tropical diseases. Since 2006, TDR, a Special Program for Research and
Training in Tropical Diseases, has sponsored a “Medicinal Chemistry
Workstation” at Merck Serono, a team now composed of three postdoctoral researchers in medicinal chemistry and in drug metabolism
and pharmacokinetics, to find new lead molecules against tropical
diseases. The team is supervised by experienced Merck Serono scientists and has access to the company’s entire drug discovery infrastructure and expertise to help to advance their projects.
Data from the Phase II Proof-of-Concept study in Ghana, although
still blinded, suggests microfilaricidal activity among all study groups,
and a favorable safety profile. In consultation with independent
experts, it was agreed that these data warrant evaluation of moxidectin in a Phase III study. This study is currently enrolling.
With funds provided by Wyeth, TDR has completed clinical trial
capacity building for the Phase III study, including building/renovation
and equipping of one clinical research center in Liberia and two clinical research centers in the Democratic Republic of Congo, and
extensive training of study staff.
Pfizer is providing substantial funding support to TDR to ensure successful implementation and completion of the Phase III studies.
In 2009, the WHO sponsored team discovered a new lead against
malaria which demonstrated good in vivo activity in the disease
model of malaria with curative action, while significantly increasing
the survival of an infected animal. The compound is oral available, relatively inexpensive to produce and has several favourable in vitro/in
vivo parameters, making this compound a promising candidate for
further development.
In parallel with its work on the malaria project, the project team also
extended its activities to identify in vivo active, orally available molecules for further development against African sleeping sickness disease and schistosomiasis. So far, more than 250,000 compounds
have been tested against molecular targets for tropical diseases at
Merck Serono. Chemists have synthesized around 2,000 new compounds for testing in in vitro or in vivo assays for their anti-parasitic
activities at TDR partner sites.
A new clinical trial research centre stands, ready to start
operations. (Kuesel, WHO/TDR)
75
Nifurtimox-Eflornithine for Sleeping Sickness with TDR
Pfizer Collaborative Programs for Parasitic & Worm
Diseases
Sleeping sickness
Bayer HealthCare, sanofi-aventis
TDR, DNDi & other partners
Since 2003
R&D
Democratic Republic of Congo, Uganda
www.bayerscheringpharma.de, www.sanofi-aventis.com
Chagas disease, leishmaniasis, malaria, onchocerciasis,
schistosomiasis, sleeping sickness
Pfizer
TDR, MMV, DNDi & other partners
Since 2006
R&D
R&D in Australia, Korea, UK (Preclinical)
www.pfizer.com/responsibility
Bayer HealthCare and sanofi-aventis provided financial support for
development of new therapies for sleeping sickness (Human African
Trypanosomiasis or HAT) through the UNDP-World Bank-WHO
Special Program for Research and Training in Tropical Diseases
(TDR). R&D projects supported include an oral form of eflornithine,
manufactured by sanofi-aventis, and a combination of eflornithine
and nifurtimox - the active ingredient of Lampit®, originally used to
treat Chagas disease.
Pfizer is working to advance tropical disease research by providing
access to research tools for developing country researchers and
large chemical libraries for screening to identify quality lead compounds as starting points for the development of new, improved
medicines to fight neglected diseases.
Bayer HealthCare provides nifurtimox free in the quantities required
for the clinical trials and sanofi-aventis is providing eflornithine
ampoules, also free of charge thanks to its partnership with WHO.
Other partners involved include the Drugs for Neglected Diseases initiative (DNDi), Epicentre, Médecins sans Frontières (MSF) and the
Swiss Tropical Institute.
The Nifurtimox-Eflornithine Combination Trial (NECT) enrolled 280
HAT patients and was completed in 2008 after a total duration of five
years. It compared the safety and efficacy of co-administration of the
oral drug nifurtimox and the intravenous drug eflornithine, with eflornithine monotherapy, the current first-line treatment for the Stage 2
T. b. gambiense form of sleeping sickness. The trial conclusively
demonstrated that NECT is as well-tolerated and efficacious as eflornithine monotherapy. NECT is a far more practical treatment than
eflornithine monotherapy (which requires 56 injections over 14 days)
because the number of injections is reduced to 14, the frequency of
injections is halved, and the treatment duration is reduced to 10
days. In November 2008, DNDi submitted that nifurtimox, already
classified as an essential drug to treat Chagas disease, be added to
the WHO Model List of Essential Medicines (EML) for treatment of
HAT, as a prelude to inclusion of the combination treatment.
In May 2009, following a successful submission by DNDi, the NECT
combination was added to the WHO Essential medicine list for the
treatment of sleeping sickness, and the regimen is now being introduced into the endemic countries.
76
In October 2006, Pfizer initiated a collaborative program with the
UNICEF-UNDP-World Bank-WHO Special Programme for Research
and Training in Tropical Diseases (TDR) to speed the search for new
medicines to combat some of the world´s most deadly parasitic diseases, including malaria, visceral leishmaniasis (VL), African trypanosomiasis (sleeping sickness, HAT), Chagas diseas, onchocerciasis and schistosomiasis.
Under this arrangement, scientists in institutes affiliated with the
TDR-sponsored Compound Evaluation Network have screened
thousands of compounds from the Pfizer library for ‘hits’: signs of
activity against a range of tropical parasites. Developing country
researchers, supported by various TDR-sponsored groups, are
working with scientists at Pfizer´s laboratories in Sandwich, UK and
Kalamazoo, Michigan, to evaluate the ‘hits’ and from those select
‘lead’ compounds with the greatest potential to be developed into
new medicines for parasitic disease treatment and prevention. They
are also being trained by Pfizer in the latest drug discovery research
methods, before returning home to use their new knowledge and
skills.
In 2009, Pfizer expanded its collaborative research by signing agreements with the Medicines for Malaria Venture (MMV)and Drugs for
Neglected Diseases initiative (DNDi), that provide these organizations
with access to the Pfizer library to screen for compounds that have
potential to be developed into new treatments for malaria, HAT,
Chagas disease and VL. These additional screens will complement
and extend the efforts already underway with TDR.
Under these agreements, scientists in institutes affiliated with MMV
and DNDi will test approximately 200,000 compounds for activity
against specific parasites. Screening will be undertaken at the Eskitis
Institute at Griffith University in Brisbane, Australia for malaria and
HAT and the Institut Pasteur Korea, for VL and Chagas disease.
Pfizer scientists will share their knowledge and expertise to select the
most promising compounds from these screens for further testing
and optimization.
Ranbaxy R&D for Dengue
Singapore Dengue Consortium
Dengue
Ranbaxy
Government of India, ICGEB
Since 2007
R&D
India
www.ranbaxy.com
Dengue
Novartis
Genome Institute of Singapore & other partners
Since 2003
R&D
R&D in Singapore
www.nitd.novartis.com
In 2007, Ranbaxy announced a 3-year collaborative research with
the International Centre for Genetic Engineering and Biotechnology
(ICGEB), to develop an effective therapy for treatment of dengue
infection. Project funding is provided by the Government of India.
The Singapore Dengue Consortium (SDC) was established in 2003
and has grown in the mean time to include 11 organizations together with NITD. The aim of the consortium is to explore ways to understand and better manage dengue infection, and ultimately minimize
the incidence of dengue. In recent years, there has been an
increased reporting of dengue incidence from various parts of the
world; 50-100 million people get infected per year, of which 250500,000 with the potentially fatal hemorrhagic form of the disease. At
present, there is no cure or vaccine for this disease.
Ranbaxy has adopted a two-pronged approach:
Exploring the available indigenous herbal repertoire for anti-dengue
activity. Twenty plants were selected based on traditional knowledge
and literature search. Two plant extracts with promising anti-dengue
activity against all four serotypes were identified. These are being
developed for advanced pre-clinical studies.
Screening of Ranbaxy´s compound library has generated a few early
hits. These hits are being optimized using a rational drug design
approach to create a lead compound which could be developed in
to an effective antiviral medicine.
2008.
The SDC provides a platform for different parties to participate and
share current work on dengue. The other consortium members
include the DSO National Laboratories, national University of
Singapore acting through its Duke-NUS Graduate Medical School,
Experimental Therapeutics Centre, Genome Institute of Singapore,
Institute of Molecular and Cell Biology, Nanyang Technological
University, National Environment Agency, National Healthcare Group,
National University of Singapore, Singapore Health Services and the
Institute for Infocomm Research.
The NITD is contributing its drug discovery know-how to find new
therapies for dengue, complementing the contributions of other
members of the consortium. The first task is the dengue virussequencing project, which will provide information on the entire virus
genome together with annotation of clinical data and patient history.
This information will be valuable for surveillance, as well as understanding the genetic variations of different serotypes.
Long-term goals of those studies are to characterize virus- and hostspecific factors responsible for the onset of the disease, as well as to
correlate viral genetic markers with the clinical severity of the disease.
77
PREVENTABLE DISEASES
Milestones in saving and improving lives through immunization
Smallpox
Smallpox was eradicated in 1977 after a 10-year WHO campaign. When the program began, smallpox threatened 60%
of the world’s population and killed every fourth person infected.
Polio
Launched in 1988 by the WHO and partners, the Global Polio Eradication Initiative has reduced infections by more than
99% and some 5 million people have escaped paralysis.
Measles
Measles is virtually eliminated in the Americas. Measles deaths worldwide dropped by more than almost 40% 1999-2003,
thanks to the WHO and partner organizations.
Neonatal tetanus
Neonatal tetanus mortality has been reduced by about three quarters. The estimated number of deaths has decreased from
800,000 in the 1980s to under 200,000 in recent years.
Hepatitis B
An estimated future 600,000 hepatitis B-related deaths (from liver cirrhosis and cancer) are now being prevented on an
annual basis through infant vaccination.
(Source: WHO immunization work: 2005 highlights, WHO/IVB/06.02)
Distribution of the estimated deaths from diseases that are preventable by vaccination in 2002 (WHO)
death <5 years of age (000)
Diseases
deaths total (000)
Diseases for which vaccination is part of most national immunization schedules
Measles
Hib
Pertussis
Tetanus
Yellow fever
540
386
294
198
15
610
386
294
213
30
Diphteria
4
5
Polio
<1
Hepatitis B
<1
Diseases for which a licenced vaccine is available
<1
600
Japanese encephalitis
Meningococcal
Rotavirus
Pneumococcal
TOTAL DEATHS FROM ALL CAUSES
14
26
449
1,612
57,029
78
5
10
402
716
10,468
Immunization reaches over 80 per cent of children worldwide and
is one of the most successful and cost-effective public health
interventions ever, eradicating smallpox, lowering the global
incidence of polio by 99% since 1988, and achieving dramatic
reductions in illness and death from diphtheria, tetanus and
whooping cough. Largely as a result of vaccination, mortality due
to measles decreased by 78 per cent globally between 2000 and
2008.
and cervical cancer (caused by human papillomavirus), which
together kill more than a million people each year, most of them in
developing countries.
Between 2 and 3 million deaths from diphtheria, tetanus, pertussis
(whooping cough), and measles are estimated to be prevented
annually as a result of immunization. Hepatitis B vaccination
prevents an additional 600,000 future deaths (from liver cirrhosis
and liver cancer) annually. However, an estimated 26.3 million of
children under one year of age remained in need of immunization in
2006. The cost of not immunizing is higher because people who are
not vaccinated as infants remain vulnerable for the rest of their lives.
In September 2005, the United Kingdom, France, Italy, Spain, and
Sweden committed nearly USD 4 billion to immunization in
developing countries over the next decade, using an innovative
new mechanism called the International Finance Facility for
Immunization (IFFIm). In March 2010, GlaxoSmithKline and Pfizer
committed to a pilot Advance Market Commitment (AMC), another
innovative finance mechanism set up by GAVI Alliance and the
World Bank to make pneumococcal conjugate vaccine available to
the poorest countries. Such instruments reflect a growing
willingness on the part of developed countries to make significant
financial resources available to meet important health needs in
resource-poor countries.
New vaccines are being developed against major infectious
diseases and several have just been licensed recently. Among the
illnesses targeted are rotavirus diarrhea, pneumococcal disease,
Moreover, continuing efforts are under way to develop vaccines for
AIDS, malaria, tuberculosis, dengue, leishmaniasis, and intestinal
diseases, among others and to adapt new technologies to improve
formulation and delivery.
(Sources: WHO/UNICEF GIVS Global Immunization Vision and Strategy, 2006-2015; Development of new vaccines (WHO fact sheet n°289); WHO Immunization Work:
2006-07 Highlights)
The status of vaccines innovation
Presently Available Vaccines
R&D Pipeline Vaccines
Bacterial
Anthrax
Cholera
Diphteria
Hib 1
Meningococcus 2
Pertussis
Pneumococcus 3
Q Fever
Salmonella typhi (Typhoid)
Tetanus
Tuberculosis (BCG)
Chlamydia
Clostridium difficile
Escherichia coli
Helicobacter pylori
Meningococcus (B)
Pneumococcus 4
Pseudomonas aeruginosa
Salmonella 5
Shigella
Staphylococcus
Streptococcus A&B
Tuberculosis
Yersinia pestis (Plague)
Viral
Cervical Cancer (HPV) 6
Hepatitis A
Hepatitis B
Herpes Zoster (Shingles)
Influenza H1N1
Influenza H5N1
Influenza seasonal
Japanese Encephalitis
Measles
Mumps
Poliomyelitis
Rabies
Rotavirus
Rubella
Smallpox
Tick-Borne Encephalitis
Varicella (Chicken pox)
Yellow Fever
Cervical Cancer (HPV) 7
Cytomegalovirus
Dengue
Ebola
Epstein-Barr Virus
Hepatitis C
Hepatitis E
Herpes simplex
Human Immunodeficiency Virus (HIV)
Human metapneumovirus
Influenza universal
Influenza H7N1
Influenza H9N2
Parainfluenza
Respiratory Syncytial Virus (RSV)
SARS-Associated
Coronavirus 8
West Nile Virus
Parasitic
Hookworm
Leishmania (Leishmaniasis)
Plasmodium falciparum (Malaria)
Therapeutic Bladder Cancer (BCG)
and Other
Vaccines
Acute Myelogenous Leukaemia
Allergic Rhinitis (9)
Alzheimer’s Disease
Breast Cancer
Cervical Cancer
Colorectal Cancer
Glioblastoma Multiforme
Melanoma
Multiple sclerosis
Nicotine Addiction
Non small cell lung cancer
Pediatric Tumors
Source: IFPMA Inquiry – April 2010
1 Haemophilus influenzae Type b 2 A, C, Y, W135 and combinations 3 7, 10 and 13 valent conjugate and 23 valent polysaccharide 4 15 valent conjugate
5 S. typhi, S. paratyphi and S. enteritidis 6 Human Papillomavirus, 2 and 4 valent 7 Human Papillomavirus, 9 valent 8 Severe Acute Respiratory Syndrome 9 Hay Fever
79
Bristol-Myers Squibb Foundation: Delivering Hope
Hepatitis
Various national & local foundations
Since 2002
China, India
http://www.bms.com/foundation/reducing_health_disparities/hepatitis
/Pages/default.aspx
‘Delivering Hope’ is a comprehensive effort to fight Hepatitis B and C
in Asia, sponsored by the Bristol-Myers Squibb Foundation.
Delivering Hope has drawn upon the proven models created by the
Foundation´s work on HIV/AIDS in Africa to address a major health
care challenge in resource-constrained settings.
Support focuses on four areas: creating greater awareness of hepatitis and addressing the stigma associated with the disease; prevention, especially among groups most at risk; disease education and
management training for health care workers; and operational
research to develop data and demonstration projects to generate
lessons that can be shared, adapted and applied in the future.
These efforts are helping to develop a portfolio of projects that aims
to raise the profile of the disease in Asia, inform health policy and
national programs, build institutional and community capacity, and
target prevention in the hardest-hit populations including children,
blood donors and health care professionals.
In many rural communities, lack of hepatitis awareness hinders prevention. The Foundation therefore is seeking to increase awareness
among the general population and lay health care workers. In addition, programs in China and India focus on children as for a way of
building family and community awareness.
Since 2002, Bristol-Myers Squibb and the Bristol-Myers Squibb
Foundation have provided USD 3.1 million in grants in China, already
benefiting more than 700,000 people directly, and USD 1.9 million in
India.
Vaccination is a cost-effective health measure.
(Sanofi Pasteur)
80
GAVI Alliance
Childhood diseases
Crucell, GlaxoSmithKline, Merck & Co. Inc., sanofi-aventis, Pfizer
GAVI Alliance, WHO & other partners
Since 2000
Access - Donation & Pricing, Capacity Building - Support & Training
Low-income countries
www.gavialliance.org
The GAVI Alliance was created to reduce childhood morbidity and
mortality from vaccine preventable diseases by increasing immunization rates and improving vaccine access for children in developing
countries, in response to stagnating global immunization rates and a
widening gap in vaccine access in developing countries. The GAVI
Fund provides financial support to low-income countries, based
upon applications to and recommendations by the GAVI Alliance
Board.
The Alliance’s partners include industrialized countries vaccine manufacturers (Crucell, GlaxoSmithKline, Merck & Co., Inc., Novartis,
Sanofi Pasteur, the vaccines division of sanofi-aventis, and Pfizer),
developing countries vaccine industry, industrialized and developing
country governments, UNICEF, the WHO, the World Bank, charitable
foundations and NGOs. Industry partners invest in the development
of new vaccines and in enhanced global vaccine manufacturing
capacity, including facilities in developing countries. They also help to
educate healthcare providers and develop technologies to facilitate
vaccine distribution.
Crucell support for GAVI includes supplying large quantities of the
first internationally available thiomersal-preservative free, fully liquid
pentavalent (5-in-1) vaccine Quinvaxem™ which protects children
against 5 diseases (DTP-HepB-Hib) in one single shot. Country
applications for Hib-containing combinations grew to their historical
high in 2009 and over half a billion doses of liquid pentavalent vaccine have been requested for 2009-2012.
Of the 1.37 billion vaccine doses GSK supplied in 2009, 50% went
to GAVI countries and 80% went to developing countries. GSK has
actively supported GAVI since its inception and was its main pentavalent and tetravalent vaccine supplier during GAVI Phase I. GSK
has also developed new pneumococcal, rotavirus and cervical cancer vaccines, which will be made available in developing countries
with help from GAVI. GSK was one of the first manufacturers to signon to the Advance Market Commitment for pneumococcal disease,
committing to supply up to 300 doses of its vaccine Synflorix to
developing nations over the next decade. GSK also is developing
new vaccines for diseases which are future GAVI targets, including
dengue and malaria.
As part of its support for the GAVI Alliance, the Merck Company
Foundation funds the Merck Vaccine Network - Africa. Merck also
provided 1 million doses of MMR II vaccine for mumps, measles and
rubella to Honduras over a three-year period and donated hepatitis
B vaccine in support of GAVI. Merck is also providing rotavirus vaccination for all infants in Nicaragua for a three-year period. In 2008,
Merck contributed USD 2 million to the GAVI-supported Measles
Initiative of the UN Foundation, for disease surveillance activities in
Africa. Since 2001, the Measles Initiative has supported the vaccination of more than 600 million children in more than 60 countries.
Sanofi Pasteur supports GAVI’s polio eradication efforts and has
donated 120 million doses of oral polio vaccine (OPV) since 1997. It
also supports the GAVI Yellow fever vaccine initiative for Africa. In
2007, Sanofi Pasteur sponsored the first technical conference on
yellow fever, which drew 150 participants from Benin, Burkina Faso,
Cameroon, Côte d’Ivoire, Guinea, Mali, Senegal and Togo.
In November 2008, GAVI accepted the proposal by Wyeth (subsequently acquired by Pfizer) to donate more than 3 million doses of its
Prevnar® pneumococcal vaccine to protect children in Rwanda and
the Gambia, countries with very high mortality from pneumococcal
disease. Immunization began with “first dose in child” in Rwanda in
April 2009 – the first time a pneumococcal conjugate vaccine was
used in GAVI-eligible countries. Pfizer supports the AMC initiative
and is working with UNICEF, GAVI and other international health partners on next steps in the AMC process relating to Pfizer’s newest
pneumococcal conjugate vaccine, Prevenar 13, including a provisional Supply Agreement.
Vaccination drive against yellow fever in Togo.
(Norbert Domy, Sanofi Pasteur)
81
Global Polio Eradication Initiative
HPV Vaccine & Cervical Cancer
Polio
sanofi-aventis
Since 1988
Afghanistan, Egypt, India, Indonesia, Nigeria, Pakistan
www.polioeradication.org
Cervical cancer
PATH
Since 2005
India, Peru, Uganda, Vietnam
www.gsk.com, www.merck.com
In January 2004, a new plan was unveiled to immunize 250 million
children in the remaining polio-endemic countries to eradicate finally
a disease that once paralyzed hundreds of thousands of children
each year. Working in cooperation, the World Health Organization
(WHO), Rotary International, the US Centers for Disease Control and
Prevention (CDC) and the United Nations Children´s Fund (UNICEF)
agreed to accelerate efforts targeted at eradicating polio.
Cervical cancer is the second most common cancer in women
worldwide, with about 500,000 new cases and 250,000 deaths
occurring each year. Almost 80% of cases occur in low-income
countries, where cervical cancer is the number one cause of cancer
in women. Virtually all cervical cancer cases (99%) are linked to genital infection with human papillomavirus (HPV), a family of virus types
which also causes genital warts and other forms of cancer.
In 2002, Sanofi Pasteur, the vaccines division of sanofi-aventis,
announced that it would donate 30 million doses of the Oral Polio
Vaccine (OPV) to the Global Polio Eradication Initiative through 2005.
Sanofi Pasteur, the longest-standing corporate partner in the
Initiative, has donated 120 million OPV doses since 1997. At the
WHO´s request, Sanofi Pasteur developed and licensed a new vaccine in record time in 2005 – Monovalent Oral Polio Vaccine 1 or
MOPV1 – for use first in Egypt as a critical part of a new WHO strategy to end polio transmission. Sanofi Pasteur also provides bulk
mOPV1 to a manufacturer in India, to fill and package for local use.
In 2007, Sanofi Pasteur donated 270,000 doses of inactivated polio
vaccine (IPV) to Indonesia for a WHO sponsored demonstration project of 5 years on IPV introduction in Yogayarta province.
PATH, the Program for Appropriate Technology in Health, is an international, nonprofit organization that creates sustainable, culturally
relevant health solutions, and works to advance acceptable and
affordable new technologies for low-resource settings. PATH is partnering with GlaxoSmithKline and Merck & Co., Inc., both of which
have developed HPV vaccines, to conduct pilot HPV vaccination
programs in adolescent females, looking at acceptance and accessibility. The countries selected are India, Peru, Uganda and Vietnam.
The PATH project also looks at issues such as adapting vaccination
schedules to fit with the school year, to maximize potential uptake.
PATH has received a grant for this project from the Bill and Melinda
Gates Foundation.
GSK’s HPV vaccine, Cervarix™, received WHO Pre-Qualification in
2009, which allows its purchase by UN agencies on behalf of poorer countries. GSK works with partners to help improve access to its
vaccines and is committed to ensuring pricing is not a barrier to
access in the developing world. For example, it has made Cervarix™
available at substantially reduced prices – with price reductions of up
to 60% – in a diverse array of countries, including several in
Southeast Asia, South Africa and Colombia. GSK has long practiced
tiered pricing for vaccines supplied to government-led programs,
charging lower prices in poorer countries. GSK is also supporting
HPV pilot projects; for example, it has donated more than 133,000
doses of Cervarix™ to PATH-led projects in Uganda and India
(Gujarat).
Merck & Co., Inc. provides its Gardasil® HPV vaccine at no-profit
prices to the public sectors of GAVI-eligible countries. For other
countries, Merck will offer tiered-pricing, largely based on their ability to pay. In 2008, CSL Ltd agreed to waive Merck’s royalties for
sales of Gardasil® in the developing world, which should result in
lower prices there. Gardasil® received WHO pre-qualification in May
2009, which will also help make it more accessible for developing
countries. Through the Gardasil® Access Program, Merck has
pledged to donate at least 3 million doses of Gardasil® to qualifying
organizations in eligible lowest-income countries, where 80% of the
world’s cervical cancer cases occur. The program will help them gain
operational experience in the design and implementation of HPV
vaccination projects. Approval has been given for donation of
496,000 doses of Gardasil® for Bhutan, Bolivia, Cambodia,
Cameroon, Georgia, Ghana, Haiti, India, Kenya, Lesotho, Moldova,
Nepal, Nicaragua, Papua New Guinea, Tanzania, Uganda and
Uzbekistan.
Children at the India Polio Handicap prothesis school.
(Sébirot, Sanofi Pasteur)
82
Merck Vaccine Network – Africa (MVN-A)
Pandemic Influenza & Developing Countries
Vaccine-preventable diseases
Merck & Co. Inc.
Various partners
Since 2003
Kenya, Mali, Uganda, Zambia
www.merck.com/mvna
Pandemic influenza
Biken, GlaxoSmithKline, Roche, sanofi-aventis
Since 2006
Access - Donation & Pricing & Tech Transfer
China, India, South Africa
www.gsk.com, www.roche.com, www.pandemic-influenza
In sub-Saharan Africa, more than 7.8 million children each year do
not receive the most basic vaccines. One major reason for low vaccination rates in developing countries, according to the World Health
Organization, is the lack of skilled health care professionals. As part
of Merck & Co., Inc.´s commitment to the GAVI Alliance, it established the Merck Vaccine Network - Africa (MVN-A) to develop sustainable immunization training centers in Africa. One of Merck’s major
programs in Africa, MVN-A reflects the company´s commitment to
improving access to medicines, vaccines and health care in the
developing world.
Social factors make poor countries particularly vulnerable to an
influenza pandemic and they are less able to afford vaccines and
antiviral medicines.
In 2003, with funding from The Merck Company Foundation and
after a competitive grant application process, MVN-A grantees
established training programs in both Kenya and Mali. Based on their
success, renewed funding was provided to both programs in 2007,
enabling both MVN-A grantees to extend training to additional health
workers in Kenya and Mali and explore innovative training methods
to address emerging immunization management needs. Following a
second competitive grant application process in 2007, The Merck
Company Foundation provided supplemental funding to enable two
new MVN-A grantees to establish immunization training programs in
Uganda and Zambia.
The four MVN-A training programs are led by partners including:
Indiana University School of Medicine and Moi University School of
Medicine (Kenya); University of Maryland School of Medicine’s and
the Center for Vaccine Development and the Centre pour le developpement des vaccines, Centre national d´appui à la lutte contre la
maladie (Mali); The Task Force for Global Health and Makerere
University School of Public Health (Uganda); and Brighton and
Sussex University Hospitals NHS Trust and the University of Zambia
School of Medicine (Zambia).
To date, more than 600 health professionals in Kenya. Mali, Uganda
and Zambia have successfully completed MVN-A training, in vaccine
management and immunization services. Trainees have returned to
their home medical facilities to share their expertise and knowledge
with fellow health care workers. In Kenya, MVN-A trainees in the
Ministry of Health worked to coordinate health services support,
including mass immunization campaigns to prevent outbreaks of
measles and polio for large camps of internally displaced persons. In
Mali, the Ministry of Health leveraged the MVN-A program to help
train immunization managers in preparation for the accelerated introduction of a new Hib pentavalent vaccine (DTP-HepB+Hib), funded
by GAVI. Since its successful expedited introduction in 2005, more
than 675,000 Malian children have received this new combination
vaccine.
GlaxoSmithKline (GSK) has invested over USD 2 billion in research
and expanded production capacity for its antiviral medicine,
Relenza®, and for its pre-pandemic and pandemic influenza vaccines. It has set a preferential price for Relenza® for LeastDeveloped Countries (LDCs) and has granted Simcere, China, a voluntary licence to make zanamivir and sell it in China, Indonesia,
Thailand, Vietnam and all LDCs. In 2009 GSK signed an agreement
to donate 60 million doses of our H1N1 vaccine to developing countries. Shipments are now underway to recipient countries and GSK
has also agreed to donate two million treatment courses of Relenza®
to the WHO for use in developing countries. To further ensure the
vaccine is available to developing countries, GSK has allocated 20
per cent of H1N1 vaccine production capacity at their manufacturing
site in Canada, to developing countries.
Roche has significantly increased its capacity to make Tamiflu®
(oseltamivir) antiviral medicine. It sells Tamiflu® at a reduced price for
pandemic stockpiling and offers further price reductions to low
income countries. Roche holds no patents on Tamiflu® in LDCs,
whose governments are free to make generic versions. Roche has
also granted sublicenses to Shanghai Pharmaceuticals and HEC
Group, China and Hetero Pharmaceuticals, India, to make
oseltamivir, and has given Aspen Pharmaceuticals, South Africa,
information to facilitate local manufacturing of Tamiflu® for pandemic stockpiling by African governments. To date, Roche has donated
10.9 million treatment courses of Tamiflu® to WHO, including
650,000 pediatric treatments.
In June 2009, Sanofi Pasteur, the vaccines division of sanofi-aventis,
announced its commitment to donate 10% of its production (up to
100 million doses) of pandemic influenza vaccine to the WHO’s
stockpile for developing countries. This donation, which is not strain
specific, includes A(H1N1) 2009 influenza. It extends and replaces
the company’s 2008 commitment to donate 60 million doses of
A(H5N1) influenza vaccine over a three year period. Sanofi Pasteur’s
Panenza® non-adjuvanted A(H1N1) monovalent influenza vaccines
were prequalified for global use by the WHO in January 2010 – a key
prerequisite for their distribution to developing countries.
Other manufacturers are also increasing vaccine capacity in developing countries, building new plants or through local partnerships.
These include Biken in Indonesia and GlaxoSmithKline in China.
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Pneumococcal Conjugate Vaccine Programs
Rotavirus Vaccine Program
Pneumonia
GlaxoSmithKline, Pfizer
GAVI Alliance, FioCruz, USAID & other partners
Since 2009
Access - Donation & Pricing & Tech Transfer
Brazil, Rwanda
www.gavialliance.org, www.gsk.com, www.pfizer.com
Rotavirus-induced gastroenteritis
GAVI Alliance, WHO & other partners
Since 2003
Brazil, El Salvador, Mexico, Nicaragua, Panama, Venezuela
www.rotavirusvaccine.org
Pneumococcal disease takes the lives of 1.6 million people each
year, including approximately 800,000 children before their fifth birthday. More than 90% of these deaths occur in developing countries.
Its most common serious form, pneumonia, accounts for one in
every four child deaths.
Rotavirus infection is the leading cause of severe diarrhea and vomiting (gastroenteritis) in children under two and is responsible for
nearly 600,000 deaths among children under five – worldwide – each
year. Eighty percent of rotavirus-related deaths occur in developing
countries. With funding from the GAVI Alliance and the Vaccine Fund,
the Program for Appropriate Technology in Health (PATH) established
the Rotavirus Vaccine Program (RVP) in 2003. With its strategic partners, the World Health Organization (WHO) and the US Centers for
Disease Control and Prevention, RVP is working to accelerate introduction of the two available vaccines. In 2005, WHO moved to recommend rotavirus vaccination as a core childhood immunization. In
late 2006, the GAVI Alliance committed to provide funding for its
introduction in eligible countries around the world.
GlaxoSmithKline and Pfizer have developed pneumococcal conjugate vaccines which protect against this major health threat. On 23
March 2010, these two companies made unprecedented long-term
commitments, via the GAVI Alliance’s Advance Market Commitment
for pneumococcal disease, to supply these new vaccines to developing countries at a fraction of the price charged in industrialized
countries. GAVI estimates that the introduction of suitable and affordable vaccines against this disease could save some 900,000 lives by
2015.
GSK will supply up to 300 million doses of its vaccine Synflorix™, to
GAVI over a ten year period. Synflorix contains 10 serotypes, three of
which – 1, 5, and 14 – were required to be included in the AMC vaccine, due to their high disease burden in the developing world. GSK
has committed to provide an average of up to 30 million doses annually and expects to deliver the first doses to Africa later this year. GSK
has invested more than USD 400 million in a dedicated manufacturing plant in Singapore.
Pfizer’s Prevenar® 13 contains 13 serotypes, which represent the
most prevalent invasive disease-causing strains in young children
worldwide. It has been approved for use in infants and young children in more than 40 countries. Pfizer is increasing its manufacturing
capabilities to help ensure Prevenar® 13 availability through a combination of capital investment, process improvements and efficiency
measures throughout the supply network.
On 17 August 2009, GSK announced a partnership with Brazil’s
Oswaldo Cruz Foundation (Fiocruz), under which GSK will provide
Fiocruz with access to the technology behind its Synflorix™ conjugate pneumococcal vaccine. GSK will supply Synflorix™ to Fiocruz
until the technology transfer is completed, allowing rapid incorporation of the vaccine into Brazil’s national immunization program.
Prevnar® was originally developed by Wyeth, which was acquired by
Pfizer in October 2009. Earlier that year, Wyeth donated 3 million
doses of Prevnar® for use in Rwanda, as part of the first national
pneumococcal immunization campaign undertaken in a GAVI-eligible
country. The program was undertaken with the support of GAVI
Alliance and USAID, and the first dose was administered by
Rwandan Health Minister Dr. Richard Sezibera on 25 April 2009.
84
GlaxoSmithKline´s vaccine, Rotarix™ is a two-dose oral vaccine targeting one rotavirus strain. Early in 2007, GSK obtained WHO
Prequalification for Rotarix™. GSK is helping Brazil to implement a
universal mass vaccination program for rotavirus. The vaccine was
included in the National Programme of Immunizations in 2006 and
the partnership includes a technology transfer agreement with
Brazil’s Oswaldo Cruz Foundation (Fiocruz) signed in 2007. Since
2007, GSK (via Fiocruz) has been the supplier of 50 million doses of
rotavirus vaccine in Brazil. From 2012 Fiocruz will produce Rotarix™
for the Brazilian domestic market and manufacture Rotarix™ for GSK
under contract for export. The deal is helping to ensure that around
17 million babies in Brazil will be protected by Rotarix™ over five
years. The vaccination program has already resulted in an 85%
reduction in rotavirus related hospitalizations, according to the
Brazilian Ministry of Health.
Merck & Co., Inc.´s Rotateq® is a three-dose, ready-to-use oral vaccine that protects against five common rotavirus strains. In 2006,
Merck and the Nicaraguan Ministry of Health announced a new partnership to provide all eligible infants born in Nicaragua in a three-year
period with free doses of Rotateq®. Since the partnership was
launched in 2006, Merck has provided nearly 1 million free doses of
Rotateq® to Nicaragua, with an estimated 27,720 doses administered every month. To date, more than 769,120 doses have been
administered. The Nicaraguan ministry of health reports that 81 percent of eligible infants in Nicaragua were vaccinated in 2008. In addition, Merck is providing assistance in administrative, training and
logistical aspects related to an expansion of Nicaragua´s immunization activities.
Sanofi-aventis & EPIVAC
Sigma-Tau & AMREF: “Uganda Project”
sanofi-aventis
GAVI Alliance, UNICEF, WHO & other partners
Since 2002
www.epivac.org
Vaccine-preventable disease
Sigma-Tau
AMREF
Since 2008
Uganda
www.sigma-tau.com
EPIVAC (from EPIdemiology & VACcinology) is a comprehensive,
one-year, on-the-job professional training program in epidemiology,
applied computing, vaccinology and management of health programs for public health officers in West Africa, culminating in an interuniversity diploma in ‘Organization and Management of Public
Immunization Programs in Developing Countries’ awarded by the
universities of Cocody-Abidjan (Ivory Coast) and Paris-Dauphine
(France).
Sigma-Tau supports the African Medical Research Foundation
(AMREF) in implementing the ‘Uganda Project’, a vaccination and
medical training program in Northern Uganda, in the areas most
affected by the civil war of the 1990s.
The program is a Sanofi Pasteur, the vaccines division of sanofiaventis, contribution to the GAVI Alliance. Implemented by the
Agence de Médecine Préventive, the program was developed in
partnership with national governments of eligible countries and the
participating universities, in collaboration with the WHO, UNICEF, the
French Ministry of Foreign Affairs, and other partners working in
Africa. EPIVAC is coordinated with the GAVI subregional working
group and complements other GAVI support to African countries.
The main aim of the project is to vaccinate more than 3,000 Ugandan
children against the six most common childhood diseases (tuberculosis, diphtheria, tetanus, poliomyelitis, hepatitis B and measles). At
the same time, it also aims to provide medical training for local health
workers, thus furnishing both immediate and long-term support for
health development.
EPIVAC seeks to strengthen the GAVI process within each country in
coordination with the Interagency Coordinating Committee (ICC).
The ICC assists in the selection of EPIVAC enrollees. EPIVAC not only
utilizes classroom, on-the-job training, and distance learning, but
also combines two subject matters that are usually taught separately: applied vaccinology and management sciences. Participants are
trained while continuing to provide vital public health services to their
communities. Studying on-the-job also enables learning to be put
into practice immediately.
The EPIVAC program monitors and evaluates the impact of training
on immunization delivery and management in the district. Between
2002 and 2009, approximately 400 public health officers have been
enrolled in EPIVAC training. Participants have been trained from
Benin, Burkina Faso, Cameroon, Côte d’Ivoire, Central Africa,
Guinea, Mali, Mauritania, Niger, Senegal and Togo.
Sanofi Pasteur is also supporting the EPIVAC Network (REI), which
aims to bring together the graduates of the EPIVAC program for
best-practice sharing and continuous education in vaccination and
logistics.
EPIVAC training program in support of GAVI, Benin, Africa.
(François Mireux, Sanofi Pasteur)
85
Crucell Vaccine Research
Infectious Disease Research Institute (IDRI)
Ebola, HIV/AIDS, malaria, rabies, tuberculosis
Crucell, sanofi-aventis
Various partners
Since 2002
R&D
www.crucell.com
Buruli ulcer, Chagas disease, Chlamydia, Leishmaniasis, leprosy,
malaria, tuberculosis
GlaxoSmithKline, Lilly
IDRI & others partners
Since 1994
R&D
Brazil, India, Sudan, Venezuela
www.idri.org
Crucell is committed to research and develop innovative vaccines
and biologicals, to help developing countries improve their public
health and reach the UN Millennium Development Goals. The company is actively involved in private-public partnership R&D initiatives
aimed at making available vaccines against malaria, tuberculosis,
Ebola and HIV/AIDS to the most needy populations in the world.
Crucell also believes in the benefit of collaboration with other vaccine
manufacturers, and has recently engaged in co-development of antirabies monoclonal antibodies with Sanofi Pasteur, the vaccines division of sanofi-aventis, thus making an important contribution to
address this unmet public health need in developing countries.
The Infectious Disease Research Institute (IDRI) was established in
1994 as a not-for-profit US scientific organization to develop vaccines, therapeutics and diagnostics for a range of diseases of the
developing world. IDRI collaborates with and is partially funded by
GlaxoSmithKline and Eli Lilly and Company.
• Buruli Ulcer: IDRI scientists are interested in leveraging expertise in
mycobacterial diseases (diseases from the same family of bacteria
that cause tuberculosis and leprosy) to assist members of the
Global Buruli Ulcer Initiative (GBUI) and BU research community;
• Chagas: IDRI’s research on Trypanosoma cruzi, the parasite that
causes Chagas disease, has emphasized diagnostic tests, vaccines and therapeutics to treat Chagas disease. In collaboration
with GSK, IDRI scientists have developed an effective blood test
for Chagas disease, which is now being used in South America;
• Chlamydia: IDRI is working with GSK to create and test a vaccine
to help prevent chlamydia. Chlamydia is usually an asymptomatic
disease, so those who are infected do not always seek available
antibiotic treatment;
• Leishmaniasis: In March 2000, IDRI received a USD 15 million
grant from the Bill and Melinda Gates Foundation to fund development of a leishmaniasis vaccine. IDRI, working with GSK, developed the world’s first defined vaccine candidate for leishmaniasis,
which has been tested in the USA, Peru, Brazil and Colombia, and
is currently being tested in India, Sudan, and Venezuela. IDRI has
one diagnostic test for leishmaniasis which has US FDA approval
and is now used extensively in India. It is working on another, for
canine leishmaniasis, with Fiocruz in Brazil;
• Leprosy: In a partnership with the American Leprosy Missions,
IDRI has embarked on an aggressive program to develop an effective vaccine and better diagnostic tests for leprosy;
• Malaria: Using its adjuvant and formulation capabilities, IDRI has
joined forces with the PATH Malaria Vaccine Initiative and others in
the global effort develop a safe and effective malaria vaccine;
• Tuberculosis: IDRI’s research efforts to fight tuberculosis encompass vaccine discovery, drug discovery and diagnostics, including
work with the Aeras Global TB Vaccine Foundation.
Crucell is committed to research and develop innovative
vaccines and biologicals, to help developing countries
improve their public health. (Crucell)
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PREVENTABLE DISEASES – R &D
MSD-Wellcome Trust Hilleman Laboratories
Novartis Vaccines Institute for Global Health (NVGH)
Merck & Co. Inc.
Wellcome Trust
Since 2009
R&D
India
www.hillemanlaboratories.in/
Typhoid fever, paratyphoid fever, shigella, other vaccine-preventable
diseases
Novartis
Associazione Sclavo, Wellcome Trust
Since 2008
R&D – Pediatric R&D
R&D in Italy
www.nvgh.novartis.com
In September 2009, the Wellcome Trust and Merck & Co., Inc.
announced the creation of the MSD Welcome Trust Hilleman
Laboratories, a research and development joint venture with a notfor-profit mission to focus on developing affordable vaccines to prevent diseases that commonly affect low-income countries.
Novartis Vaccines Institute for Global Health (NVGH) is a research
institute with a non-for-profit mission to develop effective and affordable vaccines for neglected infectious diseases of the developing
world.
The joint venture is the first in which a research charity and a pharmaceutical company have jointly created a separate entity with
equally shared funding and decision-making rights. The heart of this
concept is the creation of a sustainable R&D organization that operates like a business, but with a not-for-profit operating model, to
address the vaccine needs of low-income countries. As well as
developing new vaccines in areas of unmet need, the Hilleman
Laboratories will also work on optimizing existing vaccines, an important and powerful way of increasing the impact of vaccination in
resource-limited settings.
The Hilleman Laboratories will be based in India to facilitate engagement and partnership with a broad range of experts in vaccine
research, policy and manufacturing to develop and mature its R&D
pipeline. While an initial portfolio of projects will be selected only after
international consultation and careful technical assessment, examples of the kinds of programs being considered include developing
vaccines that do not require refrigeration and a vaccine against
Group A streptococci, which causes more than 500,000 deaths per
year worldwide.
Inaugurated in February 2008, NVGH is a separate organization with
its own facilities, while being co-located on the campus of the
Novartis Vaccines & Diagnostics’ commercial vaccine organization in
Siena, Italy. NVGH’s focus is to work with collaborators on scientific
aspects, then develop laboratory concepts into a vaccine that can be
manufactured reliably and efficiently to produce a quality, low-cost
vaccine. With funding partners, NVGH substantially reduces development risks and cost of new vaccines for the developing world to
both improve availability of new vaccines and make them affordable
NVGH’s current projects are in the area of diarrheal and enteric diseases. These diseases, responsible for more than 4.5 billion cases of
diarrhea a year globally, have a particularly high burden in infants and
children in developing countries.
The NVGH typhoid vaccine is being funded in part by Associazione
Sclavo, a non-profit organization in Siena who received funding from
Fondazione Monte dei Paschi and Regione Toscana for this project.
The Wellcome Trust is funding part of the NVGH bivalent vaccine,
which will combine the typhoid and paratyphoid fever vaccines into
one product.
Novartis Vaccines Institute for Global Health (NVGH) is
a research institute with a nonprofit mission dedicated to
the transnational R&D of vaccines for diseases of the
developing world. (Novartis)
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Pediatric Dengue Vaccine Initiative (PDVI)
Dengue
GlaxoSmithKline, sanofi-aventis
PDVI
Since 2001
R&D – Pediatric R&D
Thailand
www.pdvi.org
Dengue fever is the second most widespread tropical disease after
malaria. The Pediatric Dengue Vaccine Initiative (PDVI), a Bill and
Melinda Gates funded initiative of the International Vaccine Institute,
in Seoul, Korea, was established in 2001 to accelerate the development of a dengue vaccine that is appropriate, safe and accessible to
poor children in endemic countries. Some of the Initiative’s goals
include: Country surveys to define better the burden of dengue illness; Support R&D and enhance developing country science capacity; A scientific blueprint for a safe, effective and affordable pediatric
dengue vaccine.
No specific treatment is currently available and vector-control strategies have been insufficient. Dengue vaccines offer an impending
solution to control this major global health problem and there are
several robust dengue vaccine candidates, but many challenges
remain. A focused effort should achieve a safe, broadly protective
dengue vaccine for children in a matter of years.
The Initiative is supported by governments of endemic countries,
academic research centers in the USA and South-East Asia and the
pharmaceutical industry, including Sanofi Pasteur, the vaccines division of sanofi-aventis, and GlaxoSmithKline.
In 2006, Sanofi Pasteur and the PDVI announced a collaborative
partnership to prepare for the possible introduction of a Dengue vaccine and to make it widely accessible for prevention of Dengue. At
the forefront of dengue vaccine development with an active R&D program, Sanofi Pasteur´s lead candidate dengue vaccine entered efficacy studies in children in Thailand in 2009, and several other studies are currently underway in Asia and the Americas.
88
The timeframe for developing a new vaccine is usually longer than that for developing a new medicine. (GlaxoSmithKline)
89
CHILD & MATERNAL HEALTH
Neonatal and maternal mortality are related to the absence of a skilled birth attendant
(Source: The World Health Report 2005, Make every mother and child matter)
90
Each year 3 million babies are stillborn, nearly 4 million die within
28 days of coming into the world, and a further 9.2 million children
die before their fifth birthday. Moreover, children suffer from the
same illnesses as adults but they are more seriously affected by
certain conditions such as respiratory tract infections, malaria and
diarrheal diseases. Financial resources are needed to increase
priority interventions for these preventable, manageable and
treatable conditions.
Maternal mortality—the death of women during pregnancy,
childbirth, or in the 42 days after delivery—remains a major
challenge to health systems worldwide. There were 343,000
maternal deaths worldwide in 2008, down from 526,300 in 1980.
More than 50% of all maternal deaths were in only six countries
(India, Nigeria, Pakistan, Afghanistan, Ethiopia, and the
Democratic Republic of the Congo). In the absence of HIV, there
would have been 281,500 maternal deaths worldwide.
Substantial, albeit varied, progress has been made towards MDG
5 (improve maternal health). Although only 23 countries are on
track to achieve a 75% decrease in maternal mortality ratio by
2015, countries such as Egypt, China, Ecuador, and Bolivia have
been achieving accelerated progress.
Interventions that are known to be effective in lowering maternal
and perinatal mortality and morbidity are not universally provided.
Scaling-up the coverage of maternal and newborn health care
provided by skilled personnel is expected to have a considerable
impact in helping to achieve MDG 4 (reduce child mortality) and
MDG 5 (improve maternal health).
The main constraint is the shortage of skilled professionals: it is
necessary to train nurses, midwives and health educators to
provide skilled assistance during labor and delivery, as well as
care for infants and children. Moreover, countries, donors and
multilateral agencies must mobilize resources to strengthen health
infrastructure: to create new hospitals, to upgrade equipment and
facilities, and provide them with essential medicines.
(Sources: WHO The World Health Report 2005, Make every mother and child count; UNICEF The State of the World’s Children 2009, Maternal and Newborn Health;
The Lancet, Maternal mortality for 181 countries, 1980-2008: a systematic analysis of progress towards Millennium Development Goal 5)
Global distribution of cause-specific mortality among children under five
(Source: The State of the World’s Children 2006, Child Survival, UNICEF, December 2007)
91
Abbott Fund Program to Fight Malnutrition in Vietnam
Abbott Fund Program to Improve Children’s Health
in Cambodia
Child & maternal health, malnutrition
Abbott
AmeriCares, Giao-Diem Humanitarian Foundation
Since 2006
Vietnam
www.abbott.com
Child & maternal health
Abbott
Angkor Hospital for Children in Cambodia, Direct Relief International
Since 2006
Cambodia
www.abbott.com
Children in Vietnam are afflicted with some of the most severe forms
of malnutrition, an unacceptable reality caused by limited access to
nourishing food and a lack of nutritional education. According to
UNICEF, more than 25% of Vietnamese children under five are underweight and more than 10% of Vietnamese children suffer from vitamin A deficiency. To help improve the overall nutritional health of children in rural areas of Vietnam, the Abbott Fund is working with
AmeriCares to support the Giao-Diem Humanitarian Foundation.
Malnutrition is a significant contributor of early morbidity and mortality among young children in Cambodia. According to UNICEF, the
mortality rate for children under five increased from 115 per 1,000
live births in 1990 to 143 in 2005; nearly 45% of all children under
five are underweight. Since 2006, Abbott and the Abbott Fund have
partnered with Direct Relief International and Angkor Hospital for
Children in Siem Reap in an effort to reverse these troubling trends.
Together, the Abbott Fund and its partners are improving the nutritional status of school age children in three rural provinces of Vietnam
– Quang Tri, Hue, and Dong Thap – where childhood malnutrition
rates are among the highest in the country. This successful initiative
targets nutritional health early in life. Administered through a network
of local schools, the program focuses on three main components:
nutrition support with multivitamins and nourishing local food products; training and health education for teachers, staff and parents;
and school infrastructure improvements. During the flooding and
raining season, Abbott also donates pediatric nutritional products. In
2009, the Abbott Fund initiative reached 73 classrooms and more
than 2,200 children. During the 2008-2009 school year the program
reduced the prevalence of child malnutrition in three provinces from
an average of 31% to 18%.
In addition to improving the health and nutrition outcomes for
enrolled children, Abbott´s support of the program contributes to
Vietnam´s national efforts to meet the United Nations Millennium
Development Goals. In association with Goal 1 on extreme poverty
and hunger, Vietnam aims to reduce the proportion of people living
under the food poverty line by 75% by 2010. In association with Goal
4 on child mortality, the partnership is helping Vietnam reduce the
proportion of children under five who are malnourished down to 20%
by 2010. This program serves as a sustainable model for improving
pediatric nutrition in rural Vietnam. Abbott is currently supporting
efforts by other organizations to replicate this model program at
seven additional locations.
Abbott and the Abbott Fund have provided more than USD 2.3 million in grants and products to support the work of Angkor Hospital
for Children, a pediatric teaching hospital providing free comprehensive care for children in Siem Reap and neighboring provinces. Direct
Relief, a global humanitarian assistance organization, manages the
distribution of Abbott´s grants and product donations.
The Abbott Fund is focused on improving health professional and
caregiver awareness, knowledge and ability to treat pediatric nutrition through formal training, local and regional educational workshops, cooking demonstrations and donations of essential products.
With the Abbott Fund´s support, in 2009 Angkor Hospital for Children
also sent 117 hospital staff to participate in college-level ‘train the
trainer’ courses to strengthen the overall clinical teaching skills of the
hospital´s nursing staff.
In 2009, the Abbott Fund’s grant made it possible for the Angkor
Hospital for Children to provide services to more than 124,000 children, all of whom were assessed for malnutrition. Of those assessed,
136 were identified and then treated for severe malnutrition.
Additionally, with the Abbott Fund’s support, 1,700 families attended
cooking classes through AHC and 4,000 families attended nutrition
information sessions. In order to sustain what they had learned in the
cooking and nutrition classes, AHC provided more than 3,000 families with locally grown food to put what they had learned into practice.
Since the partnership began, more than 250,000 children have
received nutritional assessments, more than 6,000 families have participated in nutrition information workshops, and more than 400
health professionals have received nutrition training. The program´s
success has helped Angkor Hospital for Children serve as a role
model for hospital nutrition programs in Cambodia.
In Vietnam, the Abbott Fund is helping improve the nutrition
of children in rural schools by providing local foods; teachers,
staff and parents also receive training and health education.
(Abbott)
92
Abbott Fund Program to Improve Children’s Health
in the Democratic Republic of Congo
Abbott Fund Program to Improve Maternal & Child
Health in Afghanistan
Abbott
Église du Christ au Congo, IMA World Health
Since 2007
Democratic Republic of Congo
www.abbott.com
Abbott
Afghan Institute of Learning, Direct Relief International
Since 2005
Afghanistan
www.abbott.com
Years of civil war have had a devastating impact on the health and
lives of women and children in the Democratic Republic of Congo.
The country suffers from one of the highest maternal mortality rates
in the world, at 1,100 deaths per 100,000 live births, the third highest infant mortality rate in Africa at 129 deaths per 1,000 live births,
and 67% of pregnant women are anemic.
According to the World Health Organization, Afghanistan has the
second highest maternal mortality rate in the world, with 1,900
deaths per 100,000 live births. In addition, one in four Afghan children will not live to see their fifth birthday. To improve the lives of
women and children in Afghanistan, Abbott and the Abbott Fund are
partnering with the Afghan Institute of Learning (AIL) and Direct Relief
International to help reverse the country´s high maternal mortality
rate, and increase the survival and overall health of infants and children.
Since 2007, the Abbott Fund is partnering with IMA World Health
and the Église du Christ au Congo to help reverse these statistics.
The partnership supports the training of health care professionals
and water engineers, and provides essential supplies needed to
deliver basic health care services, such as vaccinations, nutrition
counseling, literacy training, screening and counseling on genderbased violence, and prenatal care, to more than 60,000 women and
children in Equator Province. The Abbott Fund also is coordinating
the donation of nutritional products, and rapid HIV/AIDS tests to help
prevent the transmission of HIV from mother to child.
The Abbott Fund has provided more than USD 500,000 in grants
and assisted in coordinating USD 4 million in product donations from
Abbott to support the work of AIL, founded by Nobel Prize nominee
Sakena Yacoobi, a long-time advocate for women´s rights in
Afghanistan. Direct Relief International, a global humanitarian assistance organization, manages the distribution of Abbott´s grants and
product donations to AIL.
Despite ongoing conflict in the targeted areas, which has caused the
internal displacement of thousands of persons and cut off delivery
and access routes, the program continues to deliver life-saving services. More than 100 community health care workers and 133 doctors and nurses have been trained this past year to diagnose and
treat children in a community-care setting. More than 5,000 women
have been educated through on-going gender-based violence campaigns and more than 1,700 women attended literacy classes.
With five clinics serving mostly rural areas in Afghanistan, AIL is
staffed and operated by Afghan women. Abbott Fund support is
focused on empowering Afghan women through the training of
female nurses, midwives and health educators to provide skilled
assistance during labor and delivery, as well as care for infants and
children. The Abbott Fund also is supporting 5-day women´s health
workshops that have provided health education directly to more than
376,000 Afghan women since 2005.
The Abbott Fund´s support is part of its effort to invest in creative programs that advance access to health care around the world, focused
on finding sustainable solutions to make a lasting impact on people´s
lives.
Abbott has donated products to improve maternal and child health,
including rehydration solutions, antibiotics, multivitamins and nutritional supplements.
In the Democratic Republic of Congo, the Abbott Fund is
piloting a comprehensive prenatal health initiative.
(Abbott Fund)
Since the partnership began in November 2005, there has been a
ten-fold increase in the number of healthy babies delivered at AIL’s
clinics. More than 600,000 women and children have received services, and 60 nurses/midwives have been trained, with most now
employed in clinics and hospitals. The Abbott Fund is supporting the
training of 25 additional women in 2010-2011.
The Abbott Fund has helped Afghan women through the
training of female midwives and by strengthening health care
capacity to provide better services for women and children.
(Abbott Fund)
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Bayer Schering Pharma & Family Planning
Pfizer
Since 2002
India
www.pfizer.com
Family planning
Bayer HealthCare
Governments, multilateral organizations & private organizations
Since 1961
Access - Pricing, Capacity Building - Training, Education
Worldwide
One of the biggest obstacles to improving the health of women and
children, the aim of UN Millennium Development Goals 4 and 5, is
inadequate primary care capacity. Pfizer has been working the
Arpana Research and Charitable Trust, an NGO operating in rural
and urban India, since 2002. Pfizer’s funding and in-kind support is
now focused on building technical capacity at Arpana Hospital, a
135-bed facility in rural Haryana, and in the NGO’s operations in two
other Indian States.
For more than 46 years, Bayer Schering Pharma AG (part of Bayer
HealthCare) has been supporting family planning programs in 132
countries with its high quality products in close co-operation with
government organizations (BMZ - German Federal Ministry for
Economic Cooperation and Development, KFW - German
Development Bank, GTZ - German Association for Technical Cooperation, the UK´s DFID and DANIDA), multilateral organizations
(UNFPA, the World Bank, the WHO, and USAID), and private organizations (International Planned Parenthood Federation, Population
Services International, Marie Stopes, IMRES and Missionpharma).
A key focus of Arpana’s work is on expansion of its maternal and
child health work, as well as gender empowerment interventions that
include self help groups and micro-financing. Pfizer has worked with
Arpana to create a self-sustaining business model in which fees from
paying patients help to support low-income patients and community
service programs. Additionally, Pfizer has connected Arpana to other
funding sources, including government programs and multilateral
entities, to promote sustainability and scale up of the NGO’s program
within India.
Key achievements within the rural program in Haryana include:
• Decreasing anemia rates among pregnant women by 32%, and
among adolescent girls by 51%;
• Creating 1,046 home kitchen gardens that have helped reduce
levels of malnutrition, and increasing household nutrition through
the cultivation of local fruits and vegetables;
• Reducing infant and maternal mortality rates, with a 20% reduction
in low-birth-weight infants, a 20% increase in institutional deliveries and a lower prevalence of neural-tube defects; and
• Improved awareness of the health care needs of pregnant women
and children less than five years old, which has led to a 94% coverage rate of antenatal checkups.
In that time, more than 2.6 billion cycle packs of oral contraceptives
have been provided to family planning organizations and users in the
developing world. The product range include a wide choice of contraceptive methods, (mono- and triphasic combined oral contraceptives and progestogen-only products), injectables (one- and threemonthly), implants and intrauterine devices/systems. These products
are of the same quality as those available on the private market but
they are sold at no profit to organizations running family planning
projects in developing countries. In 2009, Bayer contributed about
70 million cycles of oral contraceptives and more than 5.4 million
injectables worldwide, as well as more 900,000 sets of implants.
With its family planning programs, Bayer wants to help people to
make informed and independent decisions concerning their family
size, taking into account the best possible conditions for the future
of their children. Family Planning reduces women´s exposure to
health risks of unwanted childbirth and unsafe abortions.
Bayer is committed to making universal access to fertility control
means a reality by 2015, as recommended by the International
Conference on Population and Development. Through its long-term
commitment to family planning, Bayer is making a substantial contribution to the UN Millennium Development Goals, including empowering women, reducing child mortality and improving maternal health
by 2015.
Training programs for family planning providers are also part of
Bayer´s commitment. Since sexual education is vital to contraception, Bayer supports programs like the CELSAM project (Centro
Latinoamericano Salud y Mujer), providing detailed information on
sexual education in all Latin American countries by radio, educational programs for schools and universities, telephone hotlines and
information booths on the streets. In Asia, Bayer cooperates with
APCOG (Asia Pacific Council on Contraception).
Since 1961, more than 2.5 billion cycle packs of oral contraceptives have been provided to family planning organizations and
users in developing countries. (Kirsi Armanto, Bayer Schering
Pharma)
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Bidan Delima Midwife Training Program
Computerized Training for Management
of Childhood Diseases
Johnson & Johnson
Indonesian Midwives Association
Since 2003
Indonesia
www.jnj.com
Child health
Novartis
WHO
Since 2005
Indonesia, Tanzania, Peru
www.icatt-training.org, www.novartisfoundation.org
In Indonesia, 20,000 women die each year as a result of pregnancy
or delivery, and 165,000 infants die before, during or directly after
birth. Midwives are crucial to improving reproductive health services.
Working with the Johns Hopkins University´s JHPIEGO unit, the
Indonesian Midwives Association is trying to increase the standard of
care among private practice midwives in the country. The Bidan
Delima Program, a component of the Sustaining Technical
Achievements in Reproductive Health/Family Planning project operated by IMA, was implemented in 2003.
Every year, almost 10 million children die before they reach their fifth
birthday. Many of these deaths could be avoided if those children
received timely and appropriate care. It is the goal of the World
Health Organization (WHO) to reduce the infant and child mortality
rate by two-thirds by 2015 (compared with 1990). One of the most
promising instruments for achieving this goal is the Integrated
Management of Childhood Diseases (IMCI), an approach to managing the most common diseases such as pneumonia, diarrhea, malaria, measles, or malnutrition.
Johnson & Johnson has supported this midwife training program
since its inception in 2003. Since then, more than 1,200 midwives
have been trained on the national clinical standards of midwifery.
These standards cover family planning services, infection prevention,
contraceptive technology and safe delivery care. The program also
provides educational material to 28,000 additional midwives
throughout the country. The Association was able to produce an
updated version of its national safe delivery training video, which is
used to train 76,000 practicing midwives in Indonesia.
To train healthcare personnel in IMCI and to respond to different realities in countries, innovative and flexible ways of learning and skills
development have to be established. To that end, the Novartis
Foundation for Sustainable Development has, in collaboration with
the WHO, developed a computer-based learning program: the IMCI
Computerized Adaptation and Training Tool (ICATT).
The 2008 program has trained 200 Bidan Delima facilitators in order
to expand the number of candidates each year. The program spans
12 Indonesian provinces with 177 cities and involves more than
26,000 midwives. By improving the health care services offered to
midwives in private practice, Bidan Delima aims to help reduce the
maternal and neonatal mortality rate of urban births by 30 to 60%
over the next five years.
In 2008, the ICATT software was sent to all IMCI-implementing countries. With the support of the Novartis Foundation, Peru, Tanzania
and Indonesia have started the adaptation process from a generic
version to a country-specific version. In those countries, the first
ICATT training courses were conducted. Close monitoring will document the early findings in order to share them, with stakeholders who
may be interested in the potential use of the tool in the future.
In Cambodia, the Abbott Fund is improving pediatric nutrition
by educating health care workers on how to counsel families on
the nutritional needs of their children and improving their
children's health. (Abbott Fund)
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Freedom of Breath, Fountain of Life
Fuyang AIDS Orphan Salvation
Johnson & Johnson
Chinese Ministry of Health & other partners
Since 2004
China
www.jnj.com
Child health
Johnson & Johnson
Fuyang AIDS Orphan Salvation Association
Since 2006
China
www.jnj.com, www.faaids.com
Each year in China, as many as 125,000 babies may succumb to
neonatal asphyxia, the inability to breathe at or immediately after
birth. Johnson & Johnson Pediatric Institute, LLC, has joined with the
Chinese Ministry of Health, the American Academy of Pediatrics, the
Chinese Society of Perinatal Medicine and the Chinese Nursing
Society to form the ‘Freedom of Breath, Fountain of Life’ national
neonatal resuscitation program.
Founded in December 2003, the Fuyang AIDS Orphan Salvation
Association (AOS) addresses the social stigma and discrimination
associated with HIV/AIDS. With support from Johnson & Johnson,
this NGO serves the needs of more than 500 children affected by
HIV/AIDS in An Hui Province in eastern China. AOS assists more
than 200 families in 20 different villages, providing stipends for basic
health and education needs, clothing, food, vocational education
and emotional support. AOS strives to reduce social stigma by
encouraging meaningful dialogue within Chinese communities to
raise public awareness about HIV/AIDS.
The program aims to reduce infant mortality through education, with
a goal of ensuring that there is at least one trained person is present
at every hospital birth by 2010. In just a few years, the program has
trained health care professionals saving the lives of countless babies
who would have otherwise died. Since 2004, the program has
trained more than 27,000 medical professionals, in more than 6,400
hospitals, in 20 provinces across China, in the techniques of neonatal resuscitation.
Since 2003, AOS has rescued approximately 500 children affected
by HIV/AIDS, most of them orphans. Johnson & Johnson supports
three key AOS initiatives:
• Sponsoring children to attend vocational schools to help prepare
them for better job opportunities and economic independence;
• Providing transportation for infected children to obtain treatment
and nutritional support;
• Operating a summer camp for AOS children ages 5 to 16 who are
infected or affected by HIV/AIDS.
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Ghazipur Children’s Hospital
GlaxoSmithKline & Integrated Management of
Childhood Illness
Child health
Pfizer
Sabera Foundation
Since 2004
India
www.pfizer.com
Maternal, neonatal & child health
GlaxoSmithKline
WHO, UNICEF & other partners
Since 1996
Ethiopia, Ghana, Kenya, Namibia, Nigeria, South Africa
www.gsk.com
Pfizer Spain is supporting the Sabera Foundation, which runs a small
Children´s Hospital in Ghazipur, in the outskirts of Calcutta in India.
The hospital provides specialized residential health care and rehabilitation services for the children of poor families. Pfizer helps fund
maintenance of the building and the hospital´s operating expenses
infrastructures and makes available the company´s expertise in
health care. Therapeutic areas covered include physiotherapy, tuberculosis and ophthalmology. The hospital also provides out-patient
support to the surrounding community.
The World Health Organization (WHO) and UNICEF developed
Integrated Management of Childhood Illness (IMCI) as an improved
delivery strategy for child survival interventions. GlaxoSmithKline has
been involved with IMCI since 1996 when it initiated an unique partnership with the South African Ministry of Health. Since then, GSK
has entered into public-private partnership agreements with WHO,
UNICEF, National Ministries of Health and/or NGOs for the implementation of the IMCI strategy or components thereof in Ethiopia,
Namibia, Nigeria, Ghana and Kenya.
As a part of its corporate social responsibility strategy, Pfizer allows
its employees to work at the Ghazipur Hospital, performing support,
management and medicine distribution activities for two to four
weeks, as well as helping with rehabilitation tasks. To date, 74 Pfizer
volunteers have participated in this program.
IMCI aims to reduce morbidity and mortality due to the major killer
diseases for children under five: malaria, diarrhea, malnutrition,
measles, pneumonia, HIV/AIDS and neonatal causes. The strategy
includes three main components: 1) improving the case management skills of health workers; 2) strengthening the health system; and
3) improving key household and community practicesthat have the
greatest impact on child survival.
The Children’s Hospital in Ghazipur, Calcutta, provides specialized residential health care and rehabilitation services
for the chlidren of poor families. (Pfizer)
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GlaxoSmithKline: Namibia Sanitation & Hygiene
Program
GlaxoSmithKline´s Midwife Training in Vietnam
Child Health
GlaxoSmithKline
Namibia Ministry of Health, UNICEF
Since 2008
Namibia
www.gsk.com
GlaxoSmithKline
Tu Du Hospital in Vietnam
Since 2004
Vietnam
www.gsk.com
Nearly 1.3 million of Namibia’s population of just over 2 million do not
have access to proper toilet facilities, including 84% of all people living in rural areas. Diarrhea is the second highest cause of pediatric
admissions in Namibia and is responsible for more than 30% of
deaths in children under the age of five. In order to achieve the UN
Millennium Development Goals (MDGs), the Namibian government’s
aim for 2015 is to ensure that at least 62% of people will have access
to adequate sanitation.
Since 2004, GlaxoSmithKline has been supporting a unique training
program based in Tu Du Hospital, Ho Chi Minh City, Vietnam. The
project is training birth attendants to provide maternal healthcare
services in rural villages and aims to reduce childbirth complications
and decrease newborn fatalities from the current unacceptably high
level of 6%.
In line with GlaxoSmithKline’s Corporate Social Responsibility commitment to support the MDGs (especially those focused on child survival), a partnership agreement was signed in October 2008 during
the first ever Global Handwashing Day, with UNICEF, Ministry of
Health & Social Services of Namibia and GSK. GSK committed GBP
125,000 to this project of the period 2008-09.
Supported by Tu Du medical and nursing staff, and housed within a
residential training centre built by GSK, the trainees spend four
months gaining practical knowledge of maternal and child healthcare.
Over 500 midwives have now graduated with a government-recognized qualification. Each midwife has been equipped with a medical
pack and some are provided with a motor scooter to facilitate access
to remote areas.
The project goal is to support the development of a National sanitation promotion campaign, and a National policy, strategy and action
plan on Sanitation & Hygiene Promotion in Namibia. The aim of the
campaign is to raise awareness about the benefits of hand washing
and improved sanitation. The campaign has two major components;
firstly, to target the entire population, with a focus on mothers and
other caregivers of children under the age of five, and secondly, to
focus specifically on schools and school-age children, who themselves are often caregivers of their younger siblings.
IMCI aims to reduce morbidity and mortality due to the major
killer diseases for children under five: malaria, diarrhea,
malnutrition, measles, acute respiratory infection and HIV/AIDS.
(GlaxoSmithKline)
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GlaxoSmithKline´s PHASE Program
Global Campaign to End Fistula
Child health
GlaxoSmithKline
AMREF, Earth Institute, Save the Children, national MoHs
Since 1998
Education
www.gsk.com
Maternal health
Johnson & Johnson
UNFPA & other partners
Since 2004
Ethiopia, Tanzania
www.fistulafoundation.org/hospital, www.americansforunfpa.org,
www.ccbrt.or.tz
GlaxoSmithKline´s Personal Hygiene & Sanitation Education (PHASE)
project is helping to reduce diarrhea-related disease by encouraging
school children to wash their hands. GSK established PHASE in
1998 and has so far invested over USD 7 million in the program.
PHASE is run in partnership with AMREF, Save the Children and
Earth Institute at Columbia University, as well as national Ministries of
Health and Education in countries where the program is active.
Fistula is a serious and painful disorder that develops when blood
supply between organs or vessels is cut off during prolonged
obstructed labor. Johnson & Johnson works with organizations in
Africa to prevent and treat fistula.
The program has had impressive results so far. For example, a study
by AMREF in Kenya showed that after four years, 88% of children
from participating schools washed their hands after using the toilet,
compared with 46% from non-participating schools. PHASE was
extended to Millennium Villages in Malawi and Senegal during 2008
and now operates in a total of 13 countries. The aim is for the program to reach over 1 million children by next year.
GSK has a PHASE steering committee with representatives from its
partner organizations to help expand the program into more countries. In 2009, PHASE was extended to the Philippines and Rio de
Janeiro in Brazil.
In Eritrea, it helps the Global Campaign to End Fistula, led by UNFPA
(United Nations Population Fund), which seeks to make this problem
as rare in the developing world as it is in industrialized countries
today. This project focuses on addressing obstetric fistula by increasing the caesarean section rate and the number of fistula repairs,
thereby contributing to the ultimate goal of reducing maternal mortality and morbidity.
Addis Ababa Fistula Hospital is a key partner in the Global Campaign
to End Fistula. It is the only health care facility in Ethiopia dedicated
to victims of fistula, Johnson & Johnson supports outreach efforts to
treat this condition and to educate women in remote areas about the
importance of quality pre-natal and obstetrics care. The hospital
treats more than 1,000 women each year throughout Ethiopia and
serves as a training center for fistula surgery.
Johnson & Johnson also partners with the Comprehensive
Community Based Rehabilitation center in Dar es Salaam, Tanzania
(CCBRT), to provide fistula surgeries to nearly 200 women a year. In
Ethiopia, Johnson & Johnson also supported in 2008 an accredited
degree program at the Hamlin College of Midwifery for 40 rural
women studying to become midwives.
GlaxoSmithKline’s PHASE project is designed to reduce
diarrhea by teaching children to wash their hands and other
sanitation measures. (GlaxoSmithKline)
Johnson & Johnson supports the Addis Ababa Fistula
Hospital in Ethiopia. (Johnson & Johnson)
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Home-Based Newborn Care (HBNC) Initiative
Maternal health, women´s health
Johnson & Johnson
Since 2005
Education
Kenya, Nigeria, Uganda
www.globalfundforwomen.org
Maternal health
Johnson & Johnson
UNICEF
Since 2008
India, Nepal, Pakistan
www.jnj.com
The Global Fund for Women (GFW) advocates for and defends
women´s human rights by making grants to support women´s grassroots organizations around the world. The GFW works to promote
economic security, awareness of the endemic problems of violence
against women, education, health, and leadership.
The Home-Based Newborn Care (HBNC) initiative aims to train a
sufficient number of community midwives in the most underserved
areas to save newborns’ lives. After taking a series of intensive
courses, the community midwives can provide a continuum of quality care from pregnancy through birth and early infancy. The care
includes drying the newborn, keeping the baby warm, initiating
breastfeeding, giving special care to low-birth weight newborns, and
diagnosing and treating common infant infections.
Maternal prenatal care and reproductive health are of especially great
concern. Estimates are that 500,000 women worldwide die each
year in childbirth and another 18 million are left disabled or chronically ill. Johnson & Johnson provides support, through the GFW, to
a dozen community-based groups that address maternal health
issues in multiple African countries, including Kenya, Nigeria, and
Uganda
100
The HBNC initiative has trained the first 32 community midwives in
two pilot areas of Punjab, Pakistan’s most heavily populated
province, where only 33% of births take place in the presence of a
skilled birth attendant. To further improve the health care for newborns and mothers, several midwifery homes have also been built.
With the newly built facilities, each community midwife is now able to
provide clean and safe deliveries to communities with populations of
10,000. By the end of 2009, 190 skilled community midwifes had
been deployed in five districts.
Child & Maternal health
Johnson & Johnson
Since ?
Philippines
www.jnj.com
Child health
Johnson & Johnson
Since 2004
www.theirc.org
Johnson & Johnson supports training of IMAP midwives. More than
170 have been trained in the past few years.
The IRC is a global leader in emergency relief, protection of human
rights, post-conflict development, resettlement services, and advocacy for those affected by conflict and oppression in more than 25
developing countries. Johnson & Johnson provides support to help
the IRC build schools, and train police, peacekeepers, and relief
workers in best practices for assisting victims of trauma.
Johnson & Johnson supports the UNICEF Safe Motherhood Initiative program at the Fabella Memorial Hospital in the Pilippines.
(Janea Wiedmann, Johnson & Johnson)
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It´s Worth Dreaming Project
Pankararu Health & Culture Project
Pfizer
Instituto Kaplan
Since 2004
Education
Brazil
www.pfizer.com
Pfizer
Associação Saúde Sem Limites
Since 2005
Brazil
www.pfizer.com
An initiative of the Instituto Kaplan with the support of Pfizer, the
‘It´s Worth Dreaming Project’ fights unplanned pregnancy among
adolescents in the State of São Paulo. In 2008, approval was given
to implement the initiative in all public schools of the State. By 2010,
37,000 education professionals will have been trained and 1.7 million
students reached, in 645 municipalities.
Pfizer and Associação Saúde Sem Limites (Unlimited Health
Association) have been working together on The Pankararu Health
and Culture Project since 2005. The project provides 5,000
Pankararu Indians in townships located in the Borborema Mountain
Range, in the arid interior of Pernambuco State, with basic health
care information. Pfizer provides both financial and technical support
to the program.
The project was first launched in 2004 in 14 municipalities in the
Ribeira River Valley region, which has the lowest Human
Development Index rating in the state. Since then, the Project has
accomplished a 91% reduction in unwanted pregnancies and assisted more than 11,000 adolescents.
It´s Worth Dreaming Project workshops ask young people to define
their life goals and then encourage them to achieve them. This helps
adolescents to understand better the consequences of unplanned
pregnancy in their lives and become more motivated to learn about
and practice safe sex. The Vale Sonhar game helps teachers and
community agents to explore this theme with youngsters.
102
The Pankararu population also suffers from long droughts, intense
social discrimination, clan conflicts and territorial disputes. To
address these issues, the project has launched initiatives including
diagnosis of the primary illnesses afflicting the population and training Indigenous Health Agents. The young population is also impacted by the project by means of activities focused on sexual education
and family planning.
One of the initiatives is a program to assist traditional midwives and
pregnant women. From 2007 to 2008, the project trained 60 traditional midwives, who provided more than 1,600 prenatal medical
appointments and, on average, assisted more than 400 women. The
project has also trained 40 Pankararu Indians to act as Indigenous
Health Agents. Since the beginning of the project, not a single death
has been registered during pregnancy, upon delivery or following a
birth.
Ranbaxy Community Health Care Society
Renascer: Helping Poor Mothers in Brazil
Ranbaxy
Rural communities throughout India
Since 1994
India
www.abbott.com
Maternal health
Johnson & Johnson
Renascer
Since 2005
Education
Brazil
www.criancarenascer.org.br
Ranbaxy set up the Ranbaxy Community Health Care Society
(RCHS) in 1994 as a professionally managed independent, nonprofit body. RCHS grew out of the work of the Ranbaxy Rural
Development Trust, created by the company in 1979 to deliver primary health care to the underserved and underprivileged in Indian
society and contribute to the national objective ‘Health For All’.
Renascer is a Brazilian NGO which provides medical and educational aid to mothers with chronically ill children living below the poverty
line. The program addresses the specific needs of health, education,
income, housing and citizenship. During 17 years of operation,
Renascer has helped 2,500 families with more than 8,600 children
break the cycle of poverty and illness. The Renascer model has been
so successful that it has inspired the development of 17 similar independent programs throughout Brazil.
RCHS adopts a focused, integrated approach to basic health care
issues its service areas. To help plan needs-based intervention
strategies, RCHS monitors and records events such as live births,
infant deaths, maternal deaths and abortions. It has identified the
main causes of infant and maternal mortality in RCHS areas as low
birth weight, diarrhea, pneumonia, birth asphyxia, hypothermia, anemia in pregnancy, including obstetrical causes like sepsis or hemorrhage. Special attention is given to oral rehydration salts for diarrhea,
and early diagnosis and appropriate treatment of pneumonia. To help
bring down infant and maternal mortality rates in RCHS areas, the
organization works with at-risk groups to prevent low birth weight
and anemia in pregnancy, including referral services for dealing with
obstetrical emergencies.
Johnson & Johnson funds a key component of the Renascer model
- education. Mothers are taught how to create healthy environments
and given the skills to do so. Monthly sessions address issues of
health education, disease prevention, child development, and
domestic abuse. When family goals are met, the women graduate
from the program prepared to provide for their families on their own.
RCHS found that more than 70% of births in its service areas were
conducted at home by untrained or improperly trained dais (traditional midwives). While lack of skills was causing many neo-natal
deaths, the dais were accessible and acceptable to pregnant
women. A two-phase intervention strategy was adopted, where
RCHS Medical officers were trained to train the dais and then went
out to deliver that training to dais in the community. RCHS has also
established various community groups for women, dais, anganwari
(childcare) workers, volunteers, adolescents and breast-feeding to
promote community involvement and self-sustainability.
Daiichi Sankyo Co. Ltd. of Japan took a majority stake in Ranbaxy
in 2008.
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Safe Motherhood Initiative
Sanofi-aventis Children´s Programs
Maternal health
Johnson & Johnson
UNICEF
Since 2004
India
www.unicef.org
Child health
sanofi-aventis
Various partners
Since 1994
One quarter of all women who die from complications of pregnancy
or childbirth around the globe are in India. In two states, Madhya
Pradesh and Rajasthan, the Maternal Mortality Ratio (MMR) is 379
deaths per 100,000 live births and 445 deaths per 100,000, respectively. Both numbers are significantly higher than India’s already high
national average of 305 deaths per 100,000 live births. About half of
all maternal deaths are attributed to hemorrhage and anemia, both
of which can be prevented. Unfortunately, poor maternal health care
and inadequate emergency obstetric care put babies at risk, too.
Sanofi-aventis supports a number of projects in developing countries, the main purpose of which is to help improve children´s health.
These include:
To help address these issues, Johnson & Johnson partners with
UNICEF/Safe Motherhood Initiative to increase access to good
health care, giving mothers better care early and infants a healthy
start in life. The UNICEF/Safe Motherhood Initiative provides extensive technical support, leadership and training programs to midwives, female health workers and staff nurses in Madhya Pradesh
and Rajasthan. The initiative also ensures that skilled caregivers are
available for the community 24 hours a day at nine health care facilities where the staff has received birth attendant training; seven more
centers are to follow. Additionally, UNICEF helped initiate an emergency transport program to take pregnant women to the hospital.
As a result of to the UNICEF/Safe Motherhood Initiative, the percentage of institutional deliveries in the Guna district of Madhya
Pradesh has risen from 35% in 2004-2005 to 76% in 2006-2007,
meaning that many more mothers are being cared for by skilled birth
attendants. The Fatehegarh Health Center, for example, handled 230
deliveries, up from zero in 2006. As part of UNICEF’s overall efforts,
in Madhya Pradesh 22 government agencies are part of a 24-hour
emergency transport initiative, and in Rajasthan more than 100 vehicles are available for this service. More than 300 women have
received emergency obstetric care through this transport service.
Setting up a 4 years pilot program with The Chain of Hope to
improve prevention of childhood rheumatic fever in Cambodia´s rural
Pursat province;
In Vietnam, sanofi-aventis is helping the Sister Elisabeth Association
to build a dispensary in an orphanage for sight-impaired children, to
build a school for street children (to help fight against prostitution)
and to create sculpture and sewing workshops to generate income
for the very poor;
Sanofi-aventis is helping to provide social and medical support to the
homeless, in particular children in Huaycan, Peru, in Bucharest,
Romania and in Moscow, Russia, in partnership with Samusocial
International;
In Haiti, sanofi-aventis has helped set up of a medical and psychosocial program for street children in Port-au-Prince in partnership
with Aide Médicale Internationale;
In Philippines, Chameleon Association protects and rehabilitates girls
aged 5 to 18 who have been mistreated and sexually abused. In
addition to corporate-level help, sanofi-aventis and Sanofi Pasteur
Philippines support Chameleon through local fund-raising and vaccination campaigns among young girls and the center´s staff;
In Senegal, sanofi-aventis has partnered the Kinkeliba association for
its training program of bush doctors: fund of courses for final year
medical students and for post-doctoral students working on such
subjects as parasitology, pharmaceutics and biology;
Sanofi-aventis is partner to the Les Enfants du Noma association
which helps children affected by this terrible disease in Burkina Faso
and Mali. Noma is a disease of poverty, which affects 500,000 children each year worldwide in Africa, Asia and South America. This
bacterial infection disfigures the face, mainly in young children from
birth to the age of six. Those who survive suffer from serious facial
mutilation, leading to speech and eating problems.
Health depends on many factors, including access to clean
water, sanitation, adequate nutrition and basic education.
(GlaxoSmithKline)
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Save the Children
Child health
Johnson & Johnson
Save the Children
Since 1998
Education
Philippines, Thailand, Vietnam
www.jnj.com, www.savethechildren.org
Child health
Johnson & Johnson
Since 2005
Education
Venezuela
www.unamosalmundo.org
Since 1998, Johnson & Johnson has partnered with Save the
Children in efforts to educate children and their families in the
Philippines, Thailand and Vietnam about child development, health
and nutrition.
Johnson & Johnson partners with Unamos al Mundo por la Vida, an
organization dedicated to recruiting and educating children who beg
in the streets of Caracas, Venezuela. Many of these children are
homeless or live in extreme poverty, lacking opportunities to fulfill
their basic needs. Program funding goes to a health clinic and shelter where these children receive basic medical, dental and psychosocial care, as well as meals, education and entertainment.
Unamos al Mundo por la Vida estimates that approximately 3,500
children benefit from this program every year.
The partnership´s first project involved integrating personal, community and environmental hygiene instruction into school curricula in
Thailand. Johnson & Johnson has provided more than USD 1.1 million in grants, contributions, matching gifts and in-kind gifts.
Project Pampalusog works with residents and schools in the community of Masville in the Philippines to improve the health and nutrition of school children. Launched in June 2004, the project has
increased awareness by children and their families living in Masville of
health and diseases, particularly worm infection and some reproductive health risks. Through practical skills in recognizing and preventing the spread of diseases, improving delivery of health and nutrition
services, and forming partnerships for better sanitation practices, the
project has inspired the community in creating a vision for healthy
children living in safe and healthy environments. Since its inception,
worm infections have been reduced from 50% in 2004 to 17% in
2007. In addition, the community has improved drainage and sanitation systems and increased recycling and composting.
In Venezuela, Johnson & Johnson supports Unamos al Mundo por la Vida, which provides safe shelter, health care, education and
food for children who come from poor settings. (Kelly Shimoda, Johnson & Johnson)
105
CHRONIC DISEASES
Global deaths by causes, all ages, 2005
Chronic diseases
(Source: WHO Preventing Chronic Diseases: A Vital Investment, 2005)
106
Some 35 million deaths are attributable to chronic diseases each
year; this is 60% of all deaths worldwide. Principal chronic
diseases include cardiovascular disease (17 million deaths),
cancer (7 million deaths), chronic respiratory disease (4 million
deaths) and diabetes (1 million deaths). About 80% of chronic
disease deaths occur in low and middle income countries and
the number of people, families and communities affected is
increasing. The impact of chronic diseases in these countries will
increase as they progressively control infectious diseases.
A significant proportion of chronic disease morbidity and
mortality can be prevented if medications are made accessible
and affordable, which is a challenge in countries with large
populations of very poor people.
highly cost-effective. Public-private partnerships have a crucial
role to play in accelerating progress with regard to specific
diseases.
Nevertheless, access to medicines is not the only key to
achieving success: inadequate access to good-quality health
services, including diagnostic and clinical prevention services, is
a significant cause of the social and economic inequalities in the
burden of chronic diseases. Investment in chronic disease
prevention programs and the development of services and
infrastructure are essential for many low and middle income
countries.
The chronic disease threat can be largely managed using existing
knowledge and medicines. Many solutions are effective – and
(Sources: WHO Preventing Chronic Diseases: A Vital Investment, 2005)
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Abbott Fund Program to Improve Cardiac Care
in Rwanda
Abbott Program to Advance Diabetes Care in Bolivia
Cardiovascular care
Abbott
Partners In Health
Since 2008
Rwanda
www.abbott.com
Diabetes
Abbott
Centro Vivir Con Diabetes, Direct Relief International
Since 2006
Bolivia
www.abbott.com
Since 2007, Partners In Health coordinated a heart failure treatment
and prevention initiative in two district hospitals in Rwanda
(Rwinkwavu and Kirehe). The heart failure treatment program supports nurse-driven clinics providing routine heart exams and medications, daily patient home visits by community health care workers,
and collaboration with cardiac surgical teams.
Since 2006, Abbott and the Abbott Fund have partnered with Direct
Relief International to support the education and outreach activities
of Centro Vivir Con Diabetes, a non-governmental organization dedicated to low-income adults and children living with both type I and
type II diabetes in Cochabamba, Bolivia.
In 2008, Abbott provided the Cardiac Health Initiative with Abbott’s
i-STAT handheld analyzer, which provides clinic staff with rapid
results for commonly ordered medical tests. Through these donated
diagnostic instruments, Partners In Health was able to identify and
treat 239 patients with heart failure to date, as well as identify and
help manage care for patients with renal failure and other complex
needs in rural parts of Rwanda.
The Abbott Fund has provided grants to support diabetes education,
expand public outreach campaigns, train health care personnel in
diabetes management, and establish and expand the number of
core diabetes educators. Abbott also has donated glucose screening and monitoring equipment, and disease-specific nutritional products.
Since the partnership began, there has been a 260% annual increase
in detections of diabetes. The patients that have been diagnosed
have been counseled on how to manage their disease and encouraged to seek follow-up care through the Centro Vivir Con Diabetes.
In Bolivia, the Abbott Fund is improving the quality of life for
people living with diabetes by providing diabetes education,
expanding public outreach campaigns and training health care
personnel in diabetes management. (Abbott Fund)
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AstraZeneca Breast Cancer Program in Ethiopia
Bayer HealthCare Nexavar® Access Program
Breast cancer
AstraZeneca
Axios, Ethiopian Cancer Association, Ethiopia Ministry of Health
Since 2005
Ethiopia
www.astrazeneca.com
Oncology
Bayer HealthCare
Various partners
Since 2007
Access - Donation
Asia-Pacific region
In Ethiopia, AstraZeneca has been working since 2005 to help build
local capability in managing breast cancer – the second most common cancer among young women in the country. The company´s
partner in this project is Axios, an organization that works with the
private sector to advance healthcare in developing countries.
In 2007, Bayer HealthCare, in partnership with local authorities and
charitable organizations, started the first patient access program for
Nexavar® (sorafenib) in Asia for the treatment of renal cell carcinoma
and is planning further implementation in this region. Bayer
HealthCare donates its medicine Nexavar® to facilitate access for
patients who cannot afford the cost of a full course of therapy.
In the developing world, the incidence of cancer is increasing. It is
predicted that 20 million more people will be diagnosed by 2010, and
70% will live in countries that between them will have less than 5%
of the resources for cancer control.
At the outset of the Ethiopia Breast Cancer Program, the country had
only one cancer specialist for the entire population; there was no
mammography; no easy access to chemotherapy or hormonal
agents; no cancer screening and no national treatment protocols.
The program has focused on strengthening diagnosis and treatment
capabilities at Tikur Anbessa University Hospital in Addis Ababa. In
the last three years, with company help, the hospital has become a
centre of reference for breast cancer treatment across Ethiopia.
Activities have included developing treatment guidelines, strengthening the referral system, setting up an institutional-based cancer registry, raising awareness of the facilities amongst healthcare professionals and providing training for other physicians in Ethiopia.
AstraZeneca´s breast cancer medicines, tamoxifen and anastrazole,
are also being donated.
In 2008, Bayer HealthCare initiated another patient access program
for Nexavar®, for the treatment of hepatocellular carcinoma, after its
approval for this indication.
After a patient is diagnosed with renal cell or hepatocellular carcinoma carcinoma, he or she is referred to a specialist center, which evaluates the patient´s eligibility for participation in the facilitated access
program. If they are eligible for assistance, based on their financial
situation, the patient will receive the medicine free-of-charge, either
immediately or after an initial period of treatment.
The impact of the program has been broader than anticipated for
what was intended as a small, targeted pilot. By collaborating with
the Ministry of Health and other health institutions and by working
with the Ethiopian Cancer Association to help strengthen awareness,
the benefits reach farther than Tikur Anbessa Hospital. This is a sustainable model that could be replicated in other countries and other
disease areas.
Benefits to the patient have included reduced time between diagnosis and surgery, down from 12–18 months in 2006 to 3–6 months in
2009.
A female patient undergoes an ultrasound examination in the
Breast Imaging Department at Tikur Anbessa University
Hospital in Addis Ababa. (Doug Rea, AstraZeneca)
Prof. Ming Li, Chief Physician at Beijing Cancer Hospital in
China, during his round on the oncological ward. Patients here
are treated with the anticancer drug Nexavar, among others.
(Bayer HealthCare)
109
Cancer Awareness Leadership Initiative (CALI)
Changing Diabetes in Children®
Cancer
Novartis
Global Health Council & other partners
Since 2009
Capacity Building
www.globalhealth.org
Diabetes
Novo Nordisk, Roche
WDF, Health Ministries, patient organizations
Since 2008
www.novonordisk.com
The objective of the Cancer Awareness Leadership Initiative (CALI) is
to raise awareness and quantify the burden of cancer in the developing world, to help encourage capacity development by bringing
disparate parties together to explore ways to collaborate on cancer
treatment programs. For example, Novartis and the Global Health
Council (GHC) collaborated with the African Organization for
Research and Treatment in Cancer (AORTIC) to sponsor a medical
education module during an AORTIC conference in Dar-es-Salaam,
Tanzania, in 2009. The education module, which was offered free of
charge, was designed to improve the clinical skills and knowledge
base of participating African oncologists.
The Changing Diabetes® in Children program is part of Novo
Nordisk’s Access to Diabetes Care strategy and aims at improving
availability, accessibility, affordability and quality of diabetes care for
children with type 1 diabetes in least developed countries, via partnerships. It also contributes to the achievement of the UN Millennium
Development Goals, especially Goal 4: Reduce child mortality and
Goal 8: Develop a global partnership for development. In each country, the program works with local partners within the framework of
defined national health policies, while seeking to build on the overall
capacity in the field of diabetes care.
CALI also sponsored a survey of GHC members to determine the
types of cancer they were addressing in developing countries, while
GHC conducted a literature review of articles and papers on the cancer burden in developing countries, to help document the prevalence
of cancer in developing countries.
In 2010, CALI is hosting six workshops and forums on the burden of
cancer. One forum will be dedicated to cervical cancer, the most
common reproductive cancer in the developing world. The workshops will focus on the burden of disease, existing infrastructure, the
stigma associated with cancer, screening and low-cost treatments
such as acetic acid. CALI is the recipient of a grant that will continue
for two more years, with an increased focus on collaboration and
capacity building.
The program, which runs over a 5-year period in each country, has
three overall objectives:
• Improve the health and quality of life of children with type 1
diabetes;
• Strengthen the capacity of the healthcare systems;
• Sensitize national stakeholders to the specificities of type 1
diabetes in children.
Program components include:
• Improvement of existing infrastructure and supply of medical and
laboratory equipment to establish centers for the treatment of children with type 1 diabetes;
• Training of healthcare professionals and diabetes educators to
develop diagnostic abilities and the expertise to treat children with
type 1 diabetes. Development of training material specifically
adapted to a developing country setting, taking into account the
reality in which healthcare professionals operate;
• Provision of insulin free-of-charge, and blood monitoring glucose
equipment and supplies to children and adolescents enrolled in
the program for a period of 5 years;
• Development of diabetes education material for children and their
families adapted to the local context, including education sessions
and children camps to support better self-monitoring;
• Implementation of a patient registry system to enable systematic
data collection and patient follow up;
• Insights gained through the Program will be extracted and shared
to the benefit of the development of health care systems in developing countries in general.
The program is currently implemented in six countries: Bangladesh,
Cameroon, Democratic Republic of Congo, Guinea, Tanzania and
Uganda.
110
China Diabetes Education Program
Circle of Care: Mental Health in Malaysia
Diabetes
Lilly, Roche
Becton Dickinson BD, Project HOPE
Since 1998
China
www.projecthope.org
Mental health
Johnson & Johnson
Circle of Care
Since 2004
Education
Malaysia
www.jnj.com
The China Diabetes Education Program (CDEP) is a Project HOPE
initiative that was launched in 1998. In May 2007, corporate partners
Becton Dickinson (BD), Eli Lilly & Company and Roche Diagnostics
announced a two-year extension in their support for this program.
Since its inception three years ago, Circle of Care has helped more
than 1,000 families in Malaysia cope with mental illness. Individuals
released from mental health institutions are often unable to reintegrate into society because of stigma. Circle of Care provides job
placement support programs in nine cities, while families educated
about mental illness and are connected to local support groups
through the Family Link program. Johnson & Johnson supports
Circle of Care´s efforts to educate and support families through
Family Link, assist patients in finding jobs and re-entering their communities.
The CDEP provides comprehensive diabetes training to local medical
and healthcare providers – known as ‘Trained Trainers’. To date,
Trained Trainers working in 800 local hospitals and community care
centers have successfully trained nearly 37,000 medical professionals and educated about 170,000 diabetes patients. The program has
established diabetes training centers, using modern training methods, and developed diabetes education and training materials that
are supported by the Chinese Ministry of Health.
The two-year extension of the program will allow CDEP to further
increase public awareness of diabetes and the importance of better
diabetes care. It will also provide an opportunity for CDEP to help the
Chinese government in its efforts to provide better community care,
with a special focus on diabetes.
111
Glivec® International Patient Assistance Program
(GIPAP™)
Hypertension Program in China
Leukemia
Novartis
Axios International, Max Foundation
Since 2002
Access - Donation
www.novartis.com, www.maxaid.org
Hypertension
Pfizer
Shanghai Center for Disease Control and Prevention
Since 2006
China
www.pfizer.com
Novartis partners with physicians and international health organizations to facilitate access to its breakthrough cancer therapy Glivec®
via the Glivec® International Patient Assistance Program™
(GIPAP™). This global access program provides Glivec® at no cost
to patients with certain forms of chronic myeloid leukemia (CML) and
gastrointestinal stromal tumors (GIST) who otherwise would not have
access to treatment.
In 2006, Pfizer initiated a pilot Disease Management Program
(DMaP-pilot) with the Shanghai Center for Disease Prevention and
Control (CDC) to help manage and reverse hypertension and related
cardiovascular risk factors, Cardiovascular disease is the leading
cause of death and disease burden in urban centers in China, and
the program is aligned with the Chinese government’s aims to develop the national health care system at the community level and to
cope with the heavy burden of chronic diseases.
GIPAP™ was initiated in 2002, and operates in about 80 developing
countries in Africa, Asia, Eastern Europe, South America and the
Caribbean that have no comprehensive reimbursement system or
available generics. Patients must be properly diagnosed, not covered
by local reimbursement or insurance, and have no other financial
resources. Since the program´s launch, Novartis has provided
Glivec® at no cost through GIPAP™ to more than 35,000 patients in
more than 80 countries. In 2009, Novartis provided USD 912 million
worth of Glivec® to more than 33,000 patients who otherwise would
not have been able to afford treatment.
Unlike many donation programs, GIPAP™ is based on a ‘patientdirect’ model, providing delivery of Glivec® to patients by their treating physicians. GIPAP™ also provides patients with access to support groups, treatment and disease information, education and emotional support. GIPAP™ operates through a global network of almost
1,000 registered physicians and more than 300 qualified treatment
centers, including the leading oncology treatment centers and medical opinion leaders in each country.
The DMaP-pilot phase began in July 2006 in 4 community health
centers in downtown Shanghai, helping them to manage systematically more than 1,400 hypertension patients. Throughout 2007, the
DMaP-pilot achieved good clinical results and cost-effectiveness.
These results were confirmed by a third party evaluation.
Pfizer again partnered with the Shanghai CDC for a one-year DMaP
extension agreed in August 2008. This enabled the DMaP to be
extended to all of Shanghai. This expansion started in September
2008, supported by significantly increased input from the local government. More than 13,000 hypertension patients were enrolled in in
49 community healthcare centers.Data for the 1-year evaluation of
the DMaP-extension was collected at the end of 2009 and a final
evaluation report is expected in March, 2010.
Novartis´ main partners in GIPAP™ are The Max Foundation (TMF)
and Axios International. Novartis is responsible for program development, drug donation and provision of medicine to treatment centers.
TMF, a non-profit organization, is responsible for verifying and
screening patients for eligibility, case management and providing
emotional support and education in about 35 developing countries.
In 45 other countries, many in Africa, Axios implements, coordinates
and supervises the GIPAP™ process by working with institutions on
enrollment of patients and handling logistics of product importation
and delivery. The impact has been especially significant where local
health authorities and civil societies are working together to improve
facilities and educate patients and their families, thereby providing
resources to offer integrated patient care.
112
IDF BRIDGES Program
India Diabetes Educator Project
Diabetes
Lilly
International Diabetes Federation
Since 2007
Education, R&D
Worldwide
www.idf.org
Diabetes
Bayer HealthCare, Lilly
Becton Dickinson BD, Project HOPE
Since 2007
India
www.projecthope.org
Eli Lilly and Company has agreed to support the International
Diabetes Federation´s program ‘Bringing Research In Diabetes to
Global Environments and Systems’ (BRIDGES) with USD 10 million
funding over seven years. The BRIDGES grant research program will
provide the opportunity to ‘translate’ lessons learned from clinical
research to those who can benefit most: people with diabetes.
Lessons learned through the supported research projects provide
the opportunity to steer, for example, the development of treatment
routines and effective behavioral interventions, leading to relevant,
evidence-based health care and improved outcomes for people with
diabetes.
In November 2007, Bayer HealthCare, Becton Dickinson (BD) and Eli
Lilly and Company agreed to support Project HOPE´s ‘India Diabetes
Educator Project’. This four-year, multi-million dollar collaborative
program aims to help health care workers in India reduce morbidity
and mortality related to diabetes and to combat the rapidly growing
threat of diabetes there. With an estimated 40.9 million people currently living with the condition, India leads the world in the prevalence
of diabetes.
Diabetes continues to be a growing pandemic and is the world´s
fourth leading cause of death by disease. Diabetes affects more than
240 million people worldwide and is expected to affect 380 million by
2025. Over the last several decades, a revolution in science has contributed to a greater understanding of the disease and the development of new cutting-edge therapies. Still, diabetes prevalence, morbidity and mortality have continued to grow rapidly. A steering committee appointed by IDF will determine the amounts and types of
grant awards. Projects designed to test pharmaceuticals or disease
mechanisms are not eligible for funding through this program.
The India Diabetes Educator Project offers a comprehensive and
sustainable approach that will provide diabetes training to more than
5,000 health care professionals, including nurses, dieticians and
nutritionists in India. The project includes mentoring support for
newly trained Diabetes Educators and also addresses the role of the
educator in empowering the patient to take responsibility for daily
self-care and to help prevent the onset of diabetes among those at
risk.
The training will be based on the International Curriculum for
Diabetes Health Professional Education developed by the
International Federation Consultative Section on Diabetes Education
(IDF-DECS), adapted for use in India. Implementation of this curriculum will help establish a consistent and standardized protocol for diabetes treatment throughout the country, with the goal of improving
patient quality of life and increasing positive self-care behaviors and
control of diabetes.
113
Novo Nordisk: Differential Pricing on Insulin
Novo Nordisk: Haemophilia Foundation
Diabetes
Novo Nordisk
Health Ministries
Since 2001
Access - Pricing
www.novonordisk.com
Haemophilia
Novo Nordisk
Health Ministries, health care professionals & patient organizations
Since 2005
www.nnhf.org
Among the targets for UN Millennium Development Goal 8 is a call
for partnerships with pharmaceutical companies to provide access
to affordable essential drugs in developing countries. Since 2001,
Novo Nordisk has offered human insulin to the public health systems
in Least Developed Countries (LDCs) at prices which do not to
exceed 20% of the average price in Europe, Japan and North
America. In 2009, Novo Nordisk offered this pricing scheme to all 49
LDCs, of which 36 used it to buy insulin at or below this price, compared to 32 in 2008.
The Novo Nordisk Haemophilia Foundation (NNHF) was created in
2005 to address the significant need to improve haemophilia treatment in developing countries, where it is not a healthcare priority and
many patients go undiagnosed or are inadequately treated.
Consequently, life expectancy for people with haemophilia is low and
treatment with clotting factors is suboptimal. NNHF is an independent trust, located in Zurich, Switzerland, and funds programs to
improve hemophilia care, treatment and awareness in the developing
world.
There are 13 LDC countries in which Novo Nordisk is not selling
insulin at all. In several cases, the government has not responded to
the offer, either because there are no private wholesalers or other
partners with which to work, or because wars or political unrest have
made it impossible to do business.
NNHF programs include awards, fellowships and development projects for patient education, doctor, nurse and laboratory staff training,
as well as setting up diagnostic facilities and creating patient registries. NNHF works in developing or European transition countries
where some haemophilia treatment is already present and can form
the basis for sustainable projects.
Unfortunately, there is no way to guarantee that the price at which
Novo Nordisk sells the insulin will be reflected in the final price on the
pharmacist´s shelf. Pilot projects were launched in 2008 in five countries – Cameroon, the Democratic Republic of Congo, GuineaConakry, Mozambique and Tanzania – to investigate barriers to purchasing insulin at the preferential price. Novo Nordisk is working with
Ministries of Health and business partners in these countries to influence the distribution process so that the preferential price benefits
people with diabetes. Measures include reducing insulin prices on
the private market, initiating discussions with local agents to reduce
mark-ups, and working with governments to centralize insulin procurement. Based on the outcome of the pilots, these measures will
be applied in other LDC countries.
NNHF cooperates with partners in these countries, such as health
ministries and other healthcare authorities or institutions, nongovernmental and patient organisations, healthcare professionals
and other foundations.
Typical examples of NNHF programmes funding are:
• Awareness creation, Awards;
• Capacity building, Fellowships;
• Diagnosis & Registries.
NNHF cooperates with partners in these countries, such as health
ministries and authorities, non-governmental and patient organizations, health care professionals, other foundations and trusts.
A Novo Nordisk employee working as a volunteer in a clinic
in Malaysia. (Novo Nordisk)
114
Novo Nordisk: World Partner Project
Piramal: HelpyourbodyTM Chronic Disease Campaign
Diabetes
Novo Nordisk
Health Ministries & local NGOs
Since 2001
www.novonordisk.com
Arthritis, cardiac disease, diabetes, hypertension
Piramal Healthcare
WHO, Indian Ministry of Health & other partners
Since 2008
India
www.piramalhealthcare.com, www.helpyourbody.com
The diabetes pandemic will undoubtedly affect developing countries’
ability to grow and develop. The World Partner Project (WPP) was
launched in 2001 to establish a foundation on which developing
countries can build their own diabetes healthcare strategies and ultimately improve access to proper care. The WPP works with local
partners, usually health ministries and/or patient organizations, and
is funded by a grant from Novo Nordisk.
India is the chronic disease capital of the world. The number of diabetics in the country is expected to rise from 40 million today to 70
million by 2025. In the same period, hypertensive cases are expected to rise from 118 million to 213.5 million, and cases of osteoarthritis from 15 million to 60 million. Genetic causes, obesity, stress, inappropriate dietary habits and a lack of exercise predispose India to
such chronic ailments in a relatively young population.
HelpyourbodyTM is an Indian nationwide campaign launched by the
Piramal Group to help reduce the projected increases in the incidence of chronic diseases, notably type 2 diabetes, hypertension,
cardiac problems and arthritis, by:
WPP and its partners have driven 31 projects in seven focus countries (Bangladesh, China, El Salvador, India, Malaysia, Tanzania and
Zambia), organizing clinics, providing distance learning for healthcare
professionals, educating people with diabetes and raising diabetes
awareness. The countries were selected by WPP after analysis of the
diabetes care situation in each country, diabetes awareness and
knowledge, and diabetes care infrastructure. All projects must be
sustainable: they must be affordable and practical enough for longterm operation.
• Highlighting the risk of chronic diseases, especially to lower
income groups;
• Educating about disease prevention and management;
• Helping to sustain a healthy lifestyle: regular check-ups, nutrition
and exercise at health camps;
• Building activist communities.
Experts in cardiology, endocrinology and orthopedics have developed India-specific guidelines for better management of various
chronic disorders. Some 4,000 HelpyourbodyTM activists have
enrolled 20,000 doctors, who are conducting detection camps
across India to disseminate knowledge and induce action from the
recipient population. Ninety diagnostic centers across 47 Indian
cities are providing specialized tests for chronic illnesses and limited
free testing. In November 2009, HelpyourbodyTM launched a Mumbai
initiative, to enroll 3,500 doctors across Maharashtra and Tamil
Nadu.
Piramal Chairman Mr. Ajay G. Piramal said: “If existing interventions
are used together as part of a comprehensive integrated approach
by the government, the private sector and the civil society, the goal
of preventing chronic diseases can be achieved.”
HelpyourbodyTM has also partnered with the Self Employed Women´s
Association (SEWA), whose health workers have been trained by the
HelpyourbodyTM team to create awareness and prompt the target
population to pursue medical intervention so as to manage their
lifestyle disorders better. A pilot is being conducted by the health
workers across Ahmedabad district, targeting 1,000,000 people.
The Associated Chamber of Commerce and Industry of India
(ASSOCHAM) is also a partner in the HelpyourbodyTM campaign,
which is also supported by the WHO and Indian Government.
Display of prevention messages developed by medical
students. (Piramal Healthcare)
115
Pfizer Global Health Partnerships
Sanofi-aventis: Diabetes Prevention
Oncology, tobacco control
Pfizer
Various partners
Since 2006
www.pfizerglobalhealth.com
Diabetes
sanofi-aventis
Handicap International, Santé Diabète Mali
Since 2006
Pfizer has a responsibility to direct its resources and expertise to
address the world’s most enduring health challenges. Cancer is one
of these challenges and Pfizer recognizes that only by working
together with those who share a vision of a healthier world can we
make a significant impact toward eradicating this disease that has
outlived too many generations.
In 2006, sanofi-aventis launched pilot programs to help improve diabetes disease management in developing countries, in conjunction
with the NGO Handicap International, Santé Diabète Mali and other
local NGOs in Africa, Asia and Latin America. Several projects were
set up in 2007 in Burundi, India, Kenya, Madagascar, Nicaragua,
Philippines and Thailand. The program aims to help local health care
systems to manage the disease better, prevent the onset of complications and so avoid the subsequent need for surgical interventions
such as amputation.
Pfizer’s Global Health Partnerships (GHP) Program is one approach
it is taking to tackle the global cancer epidemic. Through GHP, Pfizer
is investing USD 47 million over four years (2007-2010) in the growth
of 32 promising cancer- and tobacco-control organizations united by
the shared mission of accelerating the pace of progress in the fight
against cancer. In 47 countries, 30 of which are low or middle
income, our partners are leaders in their regions, employing new
approaches to reducing cancer or tobacco use. Together, our partners explore promising practices and innovations to deliver on the
promise of a healthier world for generations to come.
Since the beginning of the program, Handicap International has
trained 600 health professionals, who in turn have treated 3,000
patients.
One of the most important goals of GHP is to foster a culture of
results-oriented discovery and innovation. While each partner is
encouraged to innovate and test new models, they also receive critical assistance from the Johns Hopkins Bloomberg School of Public
Health to improve the implementation, measurement, and evaluation
of their work.
The Global Health Partnerships involves:
• Building the evidence for enhancing care;
• Screening to save lives;
• Navigating patients through complicated systems of care;
• Building awareness about the harm of tobacco use;
• Developing tobacco control capacity;
• Protecting nonsmokers from secondhand smoke;
• Helping smokers quit.
Education program about diabetes in Mali.
(Gil Corre, sanofi-aventis)
116
Treating diabetes in the Philippines.
(Handicap International, sanofi-aventis)
Sanofi-aventis: Impact Epilepsy Program for
Developing Countries
Sanofi-aventis: Mental Health Disorders
(Schizophrenia)
Epilepsy
sanofi-aventis
Santé Sud, IENT, KAWE, IFMT
Since 2004
Access - Pricing, Capacity Building - Training
Cambodia, Kenya, Laos, Madagascar, Mali
Schizophrenia
sanofi-aventis
Health Ministries & universities
Since 2008
Access - Pricing
Mauritania, Morocco, Vietnam
Sanofi-aventis, one of the major actors in the fight against epilepsy in
the developed world, is also committed to the treatment of epilepsy
worldwide using its two major treatments, Gardenal® and, more
importantly, Depakine® / valproate Winthrop within a tiered pricing
policy.
Sanofi-aventis, one of the major actors in the central nervous system
therapeutic field in the developed world, is developing new programs
to help provide better care for schizophrenia - one of the most severe
mental disorders – in developing countries. There, these psychotic
patients not only suffer from the disabling and potentially life-threatening symptoms of their illness, but they are also victims of ignorance, discrimination and social stigma. Sanofi-aventis, which has a
broad portfolio of anti-psychotics medicines, is committed to help
treat this disease with its Largactil®, Nozinan®, Piportil L4® and
Solian® products.
In Mali, sanofi-aventis is working with Santé Sud and the Association
des Médecins de Campagne (AMC) which have created the Réseau
Action Recherche contre l´Epilepsie (RARE). More than 2,500
patients have been diagnosed and treated, thanks to these NGOs´
highly motivated general practioners whose close relation with
patients is a key success factor, helping to destigmatise this disease.
This program started at the end of 2007 in Madagascar with the
training of 10 GPs and the creation of a specific network, the REM
(Réseau Epilepsie Madagascar).
Five further programs are underway:
• Kenya (with the Kenya Association for the Welfare of People with
Epilepsy): in 2009, 295 health care professionals have been
trained thanks to the multi-partnership developed by the KAWE
and 11,000 patients treated;
Two pilot programs have been set up in Mauritania and Morocco in
cooperation with the national health ministries and universities, combining information, education and communication, training and medicines at preferential prices. The program has also been endorsed by
the World Association for Social Psychiatry (WASP).
The first stage of a similar program has been ongoing in Vietnam
since the end of 2008.
• Ghana, with the International League Against Epilepsy that trained
174 health professionals;
• Cameroon where an agreement has been signed mid 2009 with
the Ministry of Health to develop a new program;
• Cambodia, where support has been provided to create the first
association in the country to combat epilepsy. Five training sessions have been already developed and 108 health professionals
from 10 provinces have been trained;
• Laos with the IFMT (French Institute of Tropical Medicine).
Child under treatment for cancer in Honduras.
(Gil Corre, sanofi-aventis)
117
Sanofi-aventis: My Child Matters
Staying Away from Tobacco for a Healthy Life
Childhood cancers
sanofi-aventis
International Union Against Cancer UICC
Since 2004
Tobacco control
Pfizer
Beijing University Medical School
Since 2006
China
www.pfizer.com
In 2004, sanofi-aventis and the International Union Against Cancer
(UICC) launched a mobilization and awareness program called ‘My
Child Matters’, to fight against childhood cancers in emerging countries. The objective is to encourage institutions (hospitals, NGOs,
etc.) to develop pragmatic approaches to improve awareness, early
diagnosis, access to care and treatment, pain control and better
management of the social and cultural aspects of the disease for
both children and families.
China, with approximately 350 million smokers, produces and consumes more cigarettes than any other country in the world. Pfizer
China anticipated its parent company´s global tobacco control initiative (see Global Health Partnerships) by supporting the Chinese government´s efforts to promote smoking cessation through a series of
community awareness and education programs, notably a threeyear smoking cessation initiative by the Beijing University Medical
School called ‘Staying Away from Tobacco for a Healthy Life’.
This program has already been launched in 16 developing countries
– Bangladesh, Bolivia, Egypt, Honduras, Indonesia, Kenya, Mali,
Morocco, Peru, Philippines, Rumania, Senegal, Tanzania, Ukraine,
Venezuela and Vietnam – via 26 pediatric oncology projects. In 2008,
8 new childhood cancer projects have been launched in Burkina
Faso, Colombia, Côte d’Ivoire, Pakistan and Paraguay.
In 2006, Pfizer organized an anti-smoking poster design competition
with the Medical School of Beijing University, with an evaluation panel
of officials from the Ministry of Health and China´s Center for Disease
Control, as well as faculty members. Winning designs were distributed to 4,000 health care professionals in the University´s affiliated
hospitals. Pfizer also distributed 10,000 copies of the Tobacco
Control Manual to university faculties and health professionals within
the University.
In 2008, 12,875 children benefited from this program and 2,849
health professional were trained.
In 2007, Pfizer and Beijing University hosted a four day Tobacco
Control Summer Camp for students from 16 leading medical schools
nationwide in China. In 2008, a smoke free hospital initiative was
launched in 20 hospitals in Beijing and Shanghai.
Diabetes screening camps help raise awareness and detect
many cases of diabetes. This one took place in Kenya, arranged
by WDF partner Diabetes Management & Information Centre.
(Novo Nordisk)
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The World Diabetes Foundation
Diabetes
Novo Nordisk
WHO & Health Ministries
Since 2002
www.worlddiabetesfoundation.org
The World Diabetes Foundation (WDF) was established by Novo
Nordisk in 2002 through a grant of up to DKK 650 million, to be
spent over a 10-year period. In March 2008, the shareholders
approved an additional endowment of up to DKK 575 million, for a
total of up to DKK 1.2 billion (USD 227 million) in the period 20012017. The WDF has grown into a leading international funding
agency, devoted solely to funding projects for diabetes care and prevention in the developing world.
To date, WDF has funded 219 projects in 90 countries, focusing on
diabetes awareness, education and capacity-building. At present,
156 projects are ongoing.
Diabetes screening, awareness camps and clinics supported by the
WDF bring diagnostic equipment and trained staff to detect diabetes
and easily preventable and treatable complications, such as diabetic
foot problems and eye complications such as retinopathy, cataracts
and glaucoma that can lead to unnecessary blindness.
To date, at least 4,320,950 people have been screened for diabetes
in 7,454 screening camps. More than 258,000 (documented cases)
people have been treated at the 1,848 established clinics and microclinics funded by the Foundation. More than 47,700 cases of diabetic retinopathy have been detected. Training health care professionals in proper screening and care of diabetic foot and eye conditions is essential for preventing avoidable amputations and blindness. To date, the WDF has supported the training of 18,782 doctors, 15,527 nurses and 37,269 paramedics.
Patients with diabetes in Malaysia. (Novo Nordisk)
119
ADDITIONAL
HEALTH INITIATIVES
120
In 2008, the World Health Organization called for a revitalization
of primary health care, a people-centered approach, as an
efficient and cost-effective way to strengthening health systems
in vulnerable societies. Many programs implemented by the
research-based pharmaceutical industry are dedicated to
improving health in developing countries through better primary
health care, health promotion and prevention, community
engagement and empowerment, rather than tackling specific
diseases. These initiatives aim to improve general health
practices, make them more sustainable and therefore help build
health independence.
Capacity building programs aim to strengthen the ability to
deliver effective health care, primarily by training local doctors,
nurses, midwives or other health workers and by providing them
with distance learning tools to help them update their
professional knowledge. Some capacity building programs also
providing material support such as laboratory equipment or
renovation of health center buildings. Other programs are
designed to improve the efficiency and integrity of supply chains
for medicines and other medical products, including helping to
fight against counterfeits.
Many programs also aim to educate patients or the general
population about various health threats. Some programs provide
health care and other forms of support to abandoned or
orphaned children, while others are aimed at helping patients and
former patients to re-enter their communities.
121
Arogya Parivar Program – A Rural Health Initiative
AstraZeneca Product Donations
Multiple diseases
Novartis
Rural Connect
Since 2006
Access - Pricing, Education
India
www.novartis.com
Multiple diseases
AstraZeneca
Since 2000
Access - Donation
www.astrazeneca.com
In 2006, Novartis’ Consumer Health and Sandoz divisions launched
an initiative in India to address the neglected health needs of rural
populations. The Arogya Parivar (healthy family) program started with
pilot sites in the states of Uttar Pradesh and Maharashtra. It combines healthcare education with access to affordable medicines
through local pharmacies. The initiative aims to build a sustainable
business that improves access to healthcare among the underserved
millions in rural India by providing locally available and affordable
health solutions. This ‘social business’ approach represents a mix of
corporate citizenship and creative entrepreneurship.
AstraZeneca´s product donation and patient assistance programs
make its medicines available to those who cannot afford them, either
free-of-charge or at reduced prices. In 2009, AstraZeneca donated
a total of USD 786 million in product. The total spend on charitable
contributions was USD 96 million (this includes the figure for
‘employee commitment’ which is defined as ‘total company spend to
support employee working days committed to company endorsed
community activities’. The Employee Commitment figure does not
represent a value assigned to the employee time committed).
In the pilot phase, products focused on tuberculosis, other respiratory infections, coughs, colds, allergies, skin and genital infections,
malnutrition in mothers and children, diabetes, intestinal worms and
digestive problems - all important health challenges in these communities. The intent is to collaborate with third parties to broaden the
product portfolio to include medicines for additional therapeutic
areas and items such as anti-malarial bed-nets. To be included,
products need to be easy-to-use, relevant and have instructions in
local languages. Packages are reduced in size so that weekly individual treatment costs are kept below USD 1.25. As of end of 2009,
the portfolio included 56 products addressing 11 disease areas.
Because transport and communication in rural India are difficult, a
decentralized model was adopted, organizing the 500 health advisors and supervisors in autonomous ‘cells’. They are not Novartis
employees, but are trained to ethical standards set by Novartis.
The initial phase of Arogya Parivar l addressed 120 of India’s more
than 600 districts, selected using criteria ranging from population
and purchasing power to transportation infrastructure and density of
private doctors. By the end of 2009, Arogya Parivar had increased
the number of cells to cover a population of around 42 million villagers (28,000 villages) in 13 states and 190 districts. The system
includes 22,00 rural physicians and 18,000 pharmacies linked to
cities for their supplies.
Arogya Parivar health advisors speak to villagers about diseases and
help them recognize symptoms. Periodic health camps bring in doctors to do examinations and make referrals to a treating doctor. A
single health camp can attract from 200 to 2,000 people.
Women field workers in rural India. (Novartis)
122
Boehringer Ingelheim Cares Foundation
Boehringer Ingelheim : Strengthening Healthcare
Capacity
Multiple diseases
Since 2002
Access - Donation
Over 100 developing countries
Multiple diseases
Botswana & Papua New Guinea Ministries of Health & other partners
Since 2005
Botswana, South Africa, Uganda, Venezuela
http://www.boehringeringelheim.com/wecare/en/subpages/our_worldwide.asp
The Boehringer Ingelheim Cares Foundation in the USA provides
product donations to assist patients in need worldwide through its
partnerships with AmeriCares, Catholic Medical Mission Board,
Direct Relief International, MAP International and National Children’s
Cancer Society. These donations assist in times of disaster, daily
struggle or civil conflict around the world and across the USA. The
BICF is also a member of the Partnership for Quality Medical
Donations, a partnership of non-governmental organizations and
pharmaceutical and medical supply manufacturers committed to
advancing effective drug and medical supply donation practices.
For years, Boehringer Ingelheim has been involved in health educational activities and training of health personnel in the field of
HIV/AIDS and other diseases in various parts of the world.
Opened in 2005, the Boehringer Ingelheim Training and Facilitation
Unit in Gaborone, Botswana trains general practitioners, physicians,
occupational health specialists, nurses, pharmacists, pharmacy
technicians, medical store managers and healthcare managers. In
2006, the first pharmacy student from Botswana started at Rhodes
University, Grahamstown, South Africa under a Botswana government program funded by Boehringer Ingelheim. Beneficiaries are
required to work in the public sector after completing their studies.
Boehringer Ingelheim also helped the Government of Botswana to
build an Infectious Disease Care Clinic (IDCC) at Gumare which
opened in 2007.
The Boehringer Ingelheim Lung Institute at the University of Cape
Town has been set up to support clinical trials in infectious and respiratory diseases. Through its Student Education Program with the
University of Cape Town, South Africa, Boehringer Ingelheim provides full financial support for medical students from disadvantaged
backgrounds.
In Uganda, the company helps the Community Health and
Information Network (CHAIN) in HIV/AIDS prevention, and care and
treatment seminars and training. This has helped to strengthen the
advocacy strategies at national and community level. The aim is to
broaden CHAIN´s activities among vulnerable populations.
In Venezuela, the company provides training to the doctors at the
respiratory care centers in Chacao neighborhood and the Pérez de
León Hospital in Caracas. The hospital also receives free medicines
and equipment.
Capacity building programs aim to strengthen the ability
to deliver effective health care by training health workers,
providing material support and improving the efficiency of
supply chains for medicines. (Keri Oberg, Boehringer Ingelheim)
123
Bristol-Myers Squibb Medical Product Donations
Ghana Surgical Skills Training Center
Multiple diseases
9 specialized NGO partners
Since ?
Access - Donation
www.bms.com/foundation/reducing_health_disparities/donations/
Multiple diseases
Johnson & Johnson
International Aid, West African College of Surgeons
Since 2005
Ghana
www.jnj.com
Bristol-Myers Squibb has a long history of partnering with non-profit
organizations, donating medical products to support long term
health care programs in developing countries as well as addressing
immediate needs to provide emergency disaster relief.
Trauma is a major health care problem and one of the leading causes of death in West Africa. In 2005, International Aid, Johnson &
Johnson and the West African College of Surgeons opened the
Ghana Surgical Skills Training Center at Korle bu Hospital in Accra,
and conducted the first Advanced Trauma Operative Management
(ATOM) course in West Africa. Since then, the center has hundreds
of surgeons in the region. The center is now offering 16 different
courses and engaging with several prestigious academic institutions.
During the past six years, BMS has donated USD 256 million of medical products, valued at wholesale, to support programs throughout
the world. In 2009, BMS product donations totaled over USD 13.2
million.
BMS donations have reached more than 125 countries. The company´s efforts usually are undertaken in collaboration with national ministries of health and local non-profit community organizations. The
program supports community-based outreach programs aimed at
enhancing health care access and prevention. Most importantly,
health care product donations address needs at the community level
in resource-limited communities, with limited access to comprehensive health care. The BMS donation program also helps to transport
medicine to remote locations and to administer medicines appropriately.
ATOM is guided by three key objectives: 1) improving the level of care
for severely injured trauma patients in West Africa, 2) forging professional exchanges between trauma surgeons in the U.S. and surgeons in West Africa, and 3) training surgeons in West Africa on the
techniques of advance trauma operative management. ATOM-certified surgeons are using their newly acquired skills to transform the
way patients receive care in Ghana and West Africa, saving more
lives and improving the health of the patients. This model program
has recently been opened to surgeons from East Africa.
There are two main areas where the company´s product donations
are used:
Health Care Infrastructure Support: With a number of international
non-profit organizations, this program supports a wide range of
community-based health care infrastructure initiatives in regions
around the world;
Disaster Relief: This effort is focused solely on supplying needed
medicines following major disasters, either natural or man-made (see
Emergency Relief Efforts).
124
GlaxoSmithKline & Leonard Cheshire Disability
in Sri Lanka
GlaxoSmithKline: Nurse Training in Tamil Nadu
Disability
GlaxoSmithKline
Leonard Cheshire Disability
Since 2004
Sri-Lanka
www.gsk.com
Nurse training
GlaxoSmithKline
Direct Relief International, Sri Ramakrishna Math
Since 2007
India
www.gsk.com
GlaxoSmithKline supports Leonard Cheshire Disability (LCD) in Galle,
southern Sri Lanka. Following the devastating tsunami in 2004, LCD
set up the Disability Resource Centre, the first of its kind in the area
to support disabled peoples access to health and rehabilitation services, inclusive education and livelihood opportunities.
In the aftermath of the devastating Indian Ocean tsunami of 2004,
GSK is providing USD 133,509 of funding from June 2007 to June
2009 to help Sri Ramakrishna Math, a local NGO in the Chennai
region of Tamil Nadu, to enroll an additional 420 local girls in its
Nursing Training Course. Sri Ramakrishna Math Chennai, in partnership with Direct Relief International, had already conducted extensive
relief work in the area immediately after the tsunami, providing medicines, food, shelter and clothing.
Part of the project focuses on increasing young disabled people´s
involvement in the community, mobilizing them to campaign for a
better future. Achieved through self-help groups, it will allow them to
advocate for their own rights. This will be complimented with a push
to help improve partnerships with local governments and non-governmental organizations (NGO), ensuring the long-term sustainability
of disabled facilities.
Help from GSK will enable Leonard Cheshire Disability to support
500 people with disabilities access crucial faculties and services. It
will also increase awareness of these services to 1,000 family members of people with disabilities. It is further hoped that 200 young
people with disabilities will take part in their ‘Young Voices
Programs’, a global initiative campaigning for the implementation of
the United Nations Convention on the Rights of People with
Disabilities.
The impact of the tsunami in the coastal regions was significant, with
an estimated 500 fatalities and 150,000 people displaced from their
homes, which created a huge extra demand for trained health professionals. Sri Ramakrishna Math Chennai developed its Nursing
Assistant Training Course to help address staffing shortages and
strengthen the local healthcare infrastructure as part of a long-term
relief and rehabilitation strategy.
The girls are selected from very poor, outlying agricultural and fishing
villages. Many of them have completed their secondary schooling
but, due to family financial restrictions, are unable to continue further.
In most cases, they are the first in their families to receive higher education and the nurse training gives them hope of employment outside the depressed traditional fishing and agricultural industries.
The success of the project is reflected in the high demand for their
skills on completion of their training. The newly-qualified nurses have
been quickly absorbed into nearby hospitals, where they are able to
earn a decent salary and receive free room and board, thus raising
their own economic status.
125
GlaxoSmithKline: Reinvestment in LDC Communities
GlaxoSmithKline: Saloum Islands Health Project,
Senegal
Healthcare infrastructure
GlaxoSmithKline
WHO, UNFPA & other partners
Since 2009
Cambodia, Democratic Republic of Congo, Ethiopia, Myanmar,
Rwanda, Sudan
www.gsk.com
Multiple Diseases
GlaxoSmithKline
Senegal Ministry of Health
Since 2007
Senegal
www.gsk.com
GlaxoSmithKline has committed to reinvest 20% of its profits from
sales of its medicines in Least Developed Countries (LDCs) back into
projects that address priority healthcare challenges, provide support
to governments to remove barriers that stop patients accessing
quality healthcare, and strengthen basic healthcare infrastructure.
The Saloum Islands, which have a population of 30,944 inhabitants
spread across 16 islands, have the worst health indicators in Senegal
and have also experienced severe cholera epidemics. The situation
is made worse by conditions of poor hygiene and low health coverage due mainly to the remoteness of the islands.
In 2009, GSK selected six LDCs for reinvestment: Cambodia,
Democratic Republic of Congo, Ethiopia, Myanmar, Rwanda and
Sudan. The initial activities are targeted primarily on improving maternal, newborn and child health – high priorities for the ministries of
health and essential for achieving the Millennium Development Goals
(MDGs), specifically goal four (reduce child mortality) and goal five
(improve maternal health).
The Saloum Islands Health Care partnership Project between
GlaxoSmithKline and the Ministry of Health and Medical Prevention
of Senegal was started in July 2007 for an initial three year period.
GSK has committed GBP 500,000 over four years, 2007-11.
In total, GSK reinvested GBP 512,000 in 2009 and allocated another GBP 300,000 to programs that are yet to start. Activities include
expanding a network of business format franchise nurse-run clinics
to improve access to quality basic healthcare and essential medicines in Rwanda, water sanitation programs in the schools of suburban areas in Myanmar and a one year program in 2010 to provide
motorcycle ambulances for pregnant women in Sudan.
126
The aim of the project is to support and strengthen the primary
health care delivery system at district level, to increase access to
quality healthcare in the rural communities of Dionewar, Djirnda and
Bassoul. Interventions and activities address the specific healthcare
needs and priorities as identified by the district health services, in
consultation with the communities. These include improving sanitation and water supply on the islands, training healthcare workers,
deployment of additional staff (e.g. midwives), training of volunteer
sanitation and hygiene officers, setting up health committees, installation of solar panels to supply electricity for clinics, upgrading of
health huts, procurement of equipment and medicines and purchase
of emergency ambulance boats. Two years into the project, sanitation coverage has increased from 32% to 80%.
Global Pharma Health Fund
Health Training at Egypt´s National Training Institute
Multiple diseases
Merck KGaA
Global Pharma Health Fund & multiple partners in recipient countries
Since 1985
www.gphf.org
Multiple diseases
Pfizer
Egypt Ministry of Health, Project HOPE
Since 2006
Egypt
www.pfizer.com
The Global Pharma Health Fund e.V. (GPHF) is a charitable organization initiated and funded exclusively by donations from Merck
KGaA, Darmstadt Germany. In 2007, it took over the work of the former German Pharma Health Fund, which was set up in 1985. The
organization aims to improve health care in the context of development assistance, in particular the use of the GPHF-Minilab® in the
fight against counterfeit drugs. GPHF-Minilab® is a mobile mini-laboratory for rapid drug quality verification and counterfeit medicines
detection protecting the health of millions of people anywhere in
developing countries. It allows quick, reliable testing of more than 52
standard medicines, showing whether or not the right quantity of
active ingredient is present. They have been selected on the basis of
prevailing prescription practices, public health interest and existing
counterfeit case reports, the current short list consisting of common
antimicrobials, antihelminthics, antiretrovirals, antimalarials, antituberculosis and some other medicines. The GPHF-Minilab® is specifically designed for use in developing countries which are heavily
affected by counterfeit medicines and lack facilities for effective medicine testing. To date, more than 350 Minilabs have been supplied to
health facilities in more than 70 countries already mostly in Africa and
Asia.
Pfizer works with the Egyptian Ministry of Health and Project HOPE
to equip Egypt´s National Training Institute (NTI) to provide state-ofthe-art training for physicians, nurses and health professionals in
Egypt and the Middle East in Infection Control, Family Medicine,
Ophthalmology, Urology, General Surgery, Research Methodology,
and Healthcare Management. Pfizer also helped upgrade laboratories and training equipment. Nearly 15,000 physicians have been
trained through 220 training courses and 21 symposia. Project
HOPE has asked Pfizer to help extend the project for an extra year,
to expand the current Emergency Medical Services modules (Basic
Life Support and Advanced Cardiac Life Support), to cover
Emergency Medical training, including Mass Casualty management
and Pediatric Emergency Services. As Project HOPE supported the
NTI´s accreditation by the American Heart Association, Pfizer will
support additional accreditations related to these new courses.
Pfizer will also support the development of distance learning options
for new and existing courses. Pfizer will also help introduce leadership and management training in the NTI training curriculum. In 2007,
NTI established some revenue generating capacity but these efforts
need to be expanded and so Pfizer will help to develop a sustainability strategy and plan for the NTI.
127
Healthy Communities, Healthy Ecosystems
Initiative Accès: Access to Primary Health Care in Mali
Multiple diseases
Johnson & Johnson
WWF & other partners
Since 2003
Education
Democratic Republic of Congo, Kenya, Nepal
www.jnj.com, www.wwf.org
Multiple diseases
Novartis
Mali Ministry of Health, Mali Ministry of Social Development
Since 2001
Mali
Since 2003, J&J has supported the innovative ‘Healthy
Communities, Healthy Ecosystems’ projects run by the World Wide
Fund for Nature (WWF) in East Africa, the Congo Basin and the
Eastern Himalayas. Over the past year in the Congo, the WWF has
conducted sex education and HIV/AIDS training in eight villages,
established five wildlife management committees as well as two primary schools reaching 400 students. A Congo community health
center also was renovated and restocked. In Nepal, improved cooking stoves have been installed to reduce pressure on forests and
improve community health. J&J funding also has assisted in protecting freshwater streams from degradation in Khata, Nepal.
Since 2001, the Novartis Foundation for Sustainable Development
partners with the Ministries of Health and Social Development to
improve the access to primary health care services in rural areas of
Mali. Poor rural populations in Mali are faced with multiple obstacles
when seeking healthcare such as mobilizing resources within their
family and community to be able to overcome the great distance to
the nearest health center.
Recent activities in Kenya include building a dispensary clinic for target communities, provision of safe drinking water and family planning
education by newly trained health care workers from the Ministry of
Health and Family Health International. Mobile clinics reach villages
that have no access to quality health care, and people are receiving
prenatal and postnatal care, immunizations, nutritional counseling
and education about environmental health and conservation efforts.
To test a new approach, the Novartis Foundation has contributed to
the establishment of a health insurance scheme in the Municipality of
Cinzana of the Ségou region (the country’s largest rural community).
From the onset, the range of offered services included quality health
services (preventive and curative) as well as geographical accessibility to increase the attractiveness of enrollment. This pilot project is
today regarded as a reference for the whole country of Mali, because
the Cinzana health insurance scheme is the largest rural insurer in the
Ségou region.
Since 2007, the foundation, in cooperation with the regional authorities for health and social development, has expanded its activities to
12 health zones in the region of Ségou, covering 170,000 people in
210 villages. The main components of the Initiative consist of improving the quality of care, strengthening the organization and management of the health centers and enhancing the accessibility of services in the villages through health insurance schemes. Furthermore,
the project further improves the affordability of health services by providing access to micro-credits for women and by supporting incomegenerating activities such as jatropha, poultry and milk production.
In addition to fighting counterfeits, JPMA helps address
other issues related to the quality of pharmaceuticals, including
unregistered products, improperly labeled products and
substandard registered products. (JPMA)
128
Johnson & Johnson Burn Treatment Center (JJBTC)
in Soweto
JPMA: Anti-Counterfeiting Program in Cambodia
Multiple diseases
Johnson & Johnson
Chris Hani Baragwanath Hospital
Since 1990
South Africa
www.jnjsouthafrica.co.za/co_social.asp, www.chrishanibaragwanathhospital.co.za
Multiple diseases
JPMA
Cambodia Ministry of Health, Kanazawa University
Since 2006
Cambodia
In 1990, the company built the Johnson & Johnson Burn Treatment
Centre at the Chris Hani Baragwanath Hospital in Soweto, South
Africa. The JJBTC has 24 beds for adults and 26 beds for children,
an operating room, and multi-disciplinary facilities and treats about
1,500 people a year. This state-of-the-art unit treats more than 1,500
patients annually for serious and complicated burns, and has succeeded in reducing the mortality rate among critically ill patients. J&J
continues to support the facility with management support, essential
equipment, quality products, and education for nursing and medical
personnel. Less visible, but of equal importance, are the investments
and expertise provided at the community level with the establishment
of clinics and training of caregivers.
The Japan Pharmaceutical Manufacturers Association (JPMA),
Kanazawa University and the Cambodian Ministry of Health started a
joint project to combat counterfeit medicines in Cambodia in 2006.
Surveys conducted from 2006 to 2010 have detected counterfeit
drugs sold without packaging and substandard drugs, mainly from
local manufacturers and sold via illegal pharmacies. The surveys also
revealed that the national drug registration system was not functioning satisfactorily, with drugs marketed without registration, labeled
with incorrect registration numbers, or registered but non-compliant
with specifications.
The JPMA is helping to build the capacity of the Cambodian National
Health Product Quality Control Center (NHQC) by transferring pharmaceutical evaluation technologies, the donation of analytical instruments, and on-site guidance by Japanese experts in pharmaceutical
science and technology and quality control. It is also pursuing collaborative research to correct or improve the problems and issues
associated with the counterfeit drug problem. To that end, the JPMA
has made a number of specific proposals to the the Cambodian
Ministry of Health.
The Cambodian counterpart of JPMA has acknowledged the counterfeit drug problem and is exerting its best efforts to solve the problem. Since the current project was started in 2006, the number of
unregistered drugs and illegal pharmacies has decreased. The JPMA
considers it feasible to improve the current regulatory situation in
Cambodia by closely monitoring the distribution of drugs in the market, to generate information which could help reinforce the drug registration system, license approval system, and GMP compliance.
The Japan Pharmaceutical Manufacturers Association (JPMA),
Kanazawa University and the Cambodian Ministry of Health
started a joint project to combat counterfeits medicines in
Cambodia. (JPMA)
129
JPMA: Strengthening Quality Control in Asia
LEEM Quality Control Program
Multiple diseases
JPMA
Thailand Ministry of Health, WHO
Since 1989
Bhutan, Cambodia, Laos, Thailand
Multiple diseases
LEEM
Centrale Humanitaire Médico Pharmaceutique CHMP
Since 2006
www.leem.org, www.chmp.org
The Japan Pharmaceutical Manufacturers Association (JPMA) helps
developing countries in Asia to establish efficient pharmaceutical distribution and quality control systems, via the following activities:
Counterfeit and substandard medicines are a major threat to health
in developing countries, many of which lack the technical resources
to identify inferior quality medicines. To help alleviate this situation,
the association representing the R&D pharmaceutical industry in
France, Les Entreprises du Medicament (LEEM), started a program
in 2006 to allow developing countries to send samples of suspect
medicines to France for analysis. To ensure impartiality, the LEEM
pays for samples to be analyzed by an independent expert body, the
Central Humanitaire Médico Pharmaceutique (CHMP).
Training in Japan: Since 1989, the JPMA has worked with the World
Health Organization to provide annual Quality Control training courses in Japan for Asian government quality control personnel. JPMA
provides practical training in medicines quality control at research
laboratories and manufacturing plants, with the help of its member
companies. This training strengthens the professional competence
of Asian regulatory personnel and helps improve the quality of medicines in developing countries in Asia. To date, JPMA has provided
training for 71 regulators;
Contracted training in third countries: JPMA also provides training for
government personnel from countries such as Bhutan, Cambodia
and Laos in a third country, such as Thailand. This approach is used
when there may be big differences between the standard of technical equipment in Japan and in the countries concerned. JPMA started in-country training in 2001 and has trained 24 regulators so far via
this type of course;
Donation of Analytical Instruments: A request from the Cambodian
National Laboratory for Drug Quality Control for High-Performance
Liquid Chromatographs equipment to improve controls for counterfeit and sub-standard medicines led to donations of analytical instruments by Eisai, Kyowa Hakko, Tanabe and JPMA. Retired employees helped set up the devices and train Cambodian staff to use
them;
The program focuses on francophone countries in Africa and is primarily addressed to health ministries, national medicine authorities
and state purchasing centers. To date, samples have been provided
by Burundi, Chad, Comoros, Congo, Egypt, Gabon, Guinea, Guinea
Bissau, Madagascar, Mauritania and Togo. Samples submitted for
evaluation must be either antiretrovirals or medicines purchased on
the street. In period 2007-08, a total of 116 samples were analyzed;
and the results showed that a non-conformity rate of 22%, up from
18% for the 2006-07 period. The 2009-10 exercise is not yet complete, but for the 58 samples analyzed in 2009, the ratio of non-conforming products had increased to 43%. The biggest categories of
medicines submitted for analysis are antimalarials, followed by antiinflammatories, anti-fever medications and pain killers.
Supply of Reference Substances to ASEAN Countries: Reference
substances are extremely pure active ingredients of drugs that are
indispensable for assaying the content of pharmaceutical substances in medicine. Since 1992, JPMA has provided free reference
substances to support a UN/WHO program which helps ASEAN
countries to assay commercially available medicines. This project is
now managed by the Bureau of Drugs and Narcotics (BDN), Thai
Ministry of Public Health. JPMA now funds acquisition of substances
from within the ASEAN region.
JPMA helps developing countries in Asia to establish efficient
pharmaceutical distribution and quality control systems. (JPMA)
130
Medical Product Donations Fellowship Program
Merck Medical Outreach Program
Multiple diseases
Johnson & Johnson
PQMD
Since ?
Ghana & other countries
www.jnj.com
Multiple diseases
Merck & Co. Inc.
Various US-based voluntary organizations
Since 1958
Access - Donation
www.merck.com
In countries where pharmaceuticals, medical equipment, and other
supplies are difficult to acquire on a regular basis, medical products
donations become a major means of obtaining these critical commodities. The Partnerships for Quality Medical Donations (PQMD)
estimates that in countries where medical products are in short supply, medical donations account for as much as half of all medical
supplies. Johnson & Johnson supports the Medical Product
Donations Fellowship Program. The fellowship supports research in
evaluating current distribution techniques of medical product donations and identifying new distribution approaches in Ghana and other
donor nations.
Founded in 1958, the Merck Medical Outreach Program (MMOP) is
the primary mechanism through which Merck donates its pharmaceuticals and vaccines for humanitarian assistance in the developing
world and in support of disaster relief and emergency situations
worldwide. This program enables Merck to donate critical pharmaceutical and vaccines to a limited number of qualified, US-based, private voluntary organizations (PVOs) for use in their on-going, humanitarian programs in the developing world.
Donations of Merck medicines (with the exception of Mectizan®
(ivermectin) and Gardasil® [Human Papillomavirus Quadrivalent
(Types 6, 11, 16, 18) Vaccine Recombinant] for which there are separate and dedicated programs) are made primarily through six qualified PVOs - AmeriCares, Catholic Medical Mission Board (CMMB),
Direct Relief International, IMA World Health, MAP International and
Project HOPE.
In 2009, Merck donated USD 45.7 million in market value of medicines and vaccines through well-established partnerships to help
patients throughout the developing world. These donations supported sustained chronic-care health activities,,enabled immunization
programs, provided disaster assistance worldwide and reached
many thousands more worldwide through the ongoing medical programs of our partner private voluntary organizations (PVOs).
In addition, Merck donated USD 606 million worth of Mectizan®
(ivermectin) for the treatment of river blindness and the prevention of
lymphatic filariasis through the Merck Mectizan® Donation Program
and USD 26 million worth of Gardasil® through the Gardasil®
Access Program.
131
Nurse Training in East Africa
Nurse Training in Somalia
Multiple diseases
Johnson & Johnson
Aga Khan University
Since ?
Kenya, Tanzania, Uganda
www.agakhanhospitals.org/nairobi/index.asp
Multiple diseases
Johnson & Johnson
SOS Children´s Villages
Since ?
Somalia
www.sos-usa.org
Johnson & Johnson supports the Advanced Nursing Studies (ANS)
and the Enrolled Nurses to Registered Nurses (ER-RN) programs at
the Aga Khan University Health Sciences campus in Nairobi, Kenya.
The program provides quality education and greater standards of
evidence-based care to nurses and midwives from Kenya, Tanzania,
and Uganda, to further develop their professional skills. The training,
which includes some distance-learning approaches, prepares nurses to become registered nurses. More than 500 nursing students
have benefited from this program.
When the civil war broke out in Somalia in 1990, SOS Children´s
Villages started a major medical emergency relief and food program.
The SOS Hermann Gmeiner School was converted into an emergency clinic where adults and children injured in the war were cared
for, and the mother and child clinic became part of the emergency
relief program. To date it remains the only functioning maternity ward
and gynecological care facility in the country. In order to provide SOS
as well as other interested youths in Somalia with a professional
training, the SOS Vocational Training Centre offers a three-year stateapproved training for nurses or midwives.
Johnson & Johnson is funding several SOS programs including a
nursing class in Mogadishu, which provides training for 20 student
nurses in surgery, orthopedics, trauma, midwifery and HIV/AIDS prevention education. The company supports further health programs in
a number of other SOS sites in Africa.
The R&D-based pharmaceutical industry also supports primary health care programs and capacity building, including the training
of doctors and nurses. (Boehringer Ingelheim)
132
Red Cross Children’s Hospital, Cape Town
Regional Hospital Management Program
Multiple diseases
Johnson & Johnson
Red Cross Children’s Hospital Cape Town
Since ?
South Africa
www.jnj.com
Multiple diseases
Johnson & Johnson
Singapore Management University
Since 1997
Asia
www.jnj.com
The Red Cross Children’s Hospital is a leading center for pediatric
services located in Cape Town that provides comprehensive health
care to children and adolescents. Johnson & Johnson supplies educational, product and financial support. The company also funded
the development of an educational center at the hospital, which educates hospital staff, as well as members of the Western Cape community on health-related issues.
The Johnson & Johnson Regional Hospital Management Program
helps Asian hospital managers to improve their management and
operations skills so their hospitals can deliver better health care services. Based in Singapore, the Regional Hospital Management
Program is run jointly with Singapore Management University. Each
year, professors from leading Singaporean and US teaching institutions review modern hospital management principles and techniques
with 50 senior hospital administrators from different Asian countries
during a five-day seminar. Since its inception in 1997, 368 hospital
administrators from 305 different health care institutions have participated in the program.
133
Otsuka Welfare Clinic
Phelophepa Healthcare Train
Multiple diseases
Otsuka Pharmaceutical
Local partners
Since 2003
Pakistan
www.otsuka-global.com
Multiple diseases
Roche
Colgate, Transnet Foundation
Since 1994
South Africa
www.roche.com
In June 2003, Otsuka Pharmaceutical set up the ‘Otsuka Welfare
Clinic’ to help serve the health needs of refugees in Peshawar, in
Pakistan´s Northwest Frontier District state. Medical doctors, pharmacists, nurses and other medical professionals provide free treatment each day to some 300 patients requiring medical assistance.
The Phelophepa healthcare train provides basic healthcare services
to poor patients in remote rural areas of South Africa. The train is
now 16 cars long and provides a pharmacy, cancer screening and
education, psychology and dental and eye clinics, as well as diabetes and smear tests. It serves more than 45,000 people a year and
has reached nearly 13 million in total since its inception in 1994. The
train is run by the government-owned Transnet group. The Transnet
Foundation funds about two-thirds of the train´s running costs and
provides staff, rail access and rolling stock. Roche is the lead outside
sponsor which includes other corporations such as Colgate.
Phelophepa also improves rural health education through its EduClinic. Sixteen people are nominated at each stop to complete fiveday courses in basic health and hygiene. Many are traditional healers, people who could have felt threatened by the train´s work.
Examinations and screenings are free, but nominal fees are charged
for services such as prescriptions and glasses. A fund of pooled
donations means, however, that no one unable to pay is refused
treatment.
134
Roche Employee Secondment
Tanzanian Training Center for International Health
Multiple diseases
Roche
Various local partners
Since 2006
www.roche.com
Multiple diseases
Novartis
Swiss Tropical and Public Health Institute, Tanzania Ministry of Health
Since 2003
Tanzania
www.healthtrainingifakara.org
In 2006, Roche launched a secondment policy to enable its employees to contribute their skills and expertise to help developing countries. The policy allows Roche employees to experience a unique
personal development opportunity while contributing their skills and
expertise to help make a real difference in health related projects in
the world´s poorest countries. The Roche Secondment Policy is
open to full-time employees who have had a minimum of five years
service with Roche. Each secondment lasts 3-18 months, with secondees continuing to receive their salary from Roche during this period.
Skilled human resources are the backbone of any performing healthcare system. Many developing countries, however, face a big shortage of qualified healthcare personnel. The Tanzanian Training Centre
for International Health (TTCIH) aims to strengthen the Tanzanian
healthcare system through sustainable human resources development. Together with Tanzania’s Ministry of Health and Social Welfare
and the Swiss Tropical and Public Health Institute, the Novartis
Foundation for Sustainable Development developed a comprehensive concept to redesign the former Clinical Officer Training Center
(COTC) in Ifakara. Apart from renovation and improvements in equipment, management was strengthened and a solid governance system was established.
In 2009, we approved one new secondment. A manager from Roche
Germany was seconded to a project focused on diabetes in Ethiopia.
The TTCIH is steered by a semi-autonomous Board of Governors
with members from both the public and private sector. It offers not
only high level medical training (Assistant Medical Officer program),
but also has an extended course program, specifically in mother and
child health. To increase its financial self-reliance, the center offers its
training facilities to external course providers.
In 2009, the training center’s net income amounted to USD 260,000
from course fees, rent (accommodation, seminar rooms) and other
services – excluding grants from third parties.
Apart from financial self-reliance, the ultimate goal is also to develop
the TTCIH into one of the leading training centers in Tanzania and
East Africa.
135
EMERGENCY
RELIEF EFFORTS
136
The research-based pharmaceutical industry has historically
played an important role in providing relief to people affected
by disasters – both natural (drought, earthquakes, floods,
storms, tsunamis, etc.) and man-made (wars and other
conflicts) – which can have a particularly devastating impact on
poor developing countries.
In emergency situations, survivors face the threat of fastspreading diseases, generally resulting from a lack of proper
sanitation, reduced or inadequate supplies of clean water and
the lack of adequate medical facilities. To meet immediate lifesaving needs, pharmaceutical companies move quickly to
provide doses of lifesaving emergency medicines (antibacterial and antibiotic medicines, insulin, vaccines, etc.), and
also help to train local health workers, to help avert major
disease outbreaks in the affected communities.
inappropriate and caused disposal problems for recipient
communities. To help ensure that only medicines which are
needed are sent to a particular disaster site, and in the right
quantities, many pharmaceutical companies have longestablished working partnerships with specialized aid NGOs.
These include Americares, Direct Relief International, Catholic
Medical Mission Board, Heart to Heart International,
International Aid, International Health Partners, IMA World
Health, MAP International, Medical Teams International,
Project HOPE and TULIPE.
Pharmaceutical companies are also committed to helping
address longer-term health concerns related to disasters and
work closely with government authorities and disaster relief
organizations to determine ongoing requirements.
Coordination of emergency aid is essential; in the past, wellmeaning but inexperienced donors sent medicines that were
137
Emergency Relief Efforts
(This list provides an overview of individual company actions around the world. It is not intended to be exhaustive.)
Abbott
• In Bolivia in April 2009, Abbott and other pharmaceutical companies helped the non-profit organization Direct Relief International respond to an outbreak of dengue fever and Coqueluchoide Syndrome,
a respiratory illness similar to whooping cough. The outbreaks occurred following flooding of the country's Beni River during heavy rains. Abbott contributed more than USD 56,000 worth of antibiotics that
will help provide treatment for 3,000 cases of Coqueluchoide Syndrome.
www.abbott.com
• In response to the earthquake in Haiti in January 2010, Abbott provided USD 5 million in grant funding
and donations of critical diagnostic, nutritional and pharmaceutical products, working directly with
humanitarian aid organizations including Direct Relief International and Partners In Health. Abbott products were on the ground and in use immediately following the earthquake in Haiti as a result of earlier efforts in 2009 to work with Direct Relief to strategically pre-position essential products in Haiti to
prepare for potential natural disasters. As a result of this work, several health centers in Haiti were able
to provide an initial quantity of Abbott rehydration solutions, antibiotics and nutritional products to
people in need following the earthquake. Abbott continues to work with partner organizations to
assess and respond to ongoing needs for longer-term recovery efforts.
AstraZeneca
www.astrazeneca.com
• In 2009, when typhoons Ketsana and Parma hit the Philippines, causing widespread devastation,
AstraZeneca donated medicines to the relief effort and 15 employees did voluntary work with the
Philippine army, helping over 1,000 flood victims. The company responded similarly with donations to
the local relief effort when earthquakes hit Indonesia and when the typhoon struck Taiwan,
AstraZeneca Asia Pacific made a USD 200,000 donation to the local Red Cross.
• At a global level, the company also made a further contribution of USD 240,000 to the Red Cross
Center in Kuala Lumpur, Malaysia, established in 2006 by the Red Cross with USD 700,000 of funding
from AstraZeneca. The Center continues to play an important role in disaster relief in the Asia Pacific
region. With pre-positioned emergency supplies, the Center was able to respond quickly to the events
in 2009, distributing hygiene kits to thousands of people in need in the affected areas. AstraZeneca’s
2009 donation, coupled with one of USD 200,000 that the company made in 2008, has enabled the
Red Cross to maintain appropriate levels of emergency relief stock at the Center.
• In January 2010, following the earthquake in Haiti, AstraZeneca donated medicines and contributed a
total of USD 500,000 to the British Red Cross Emergency Appeal. The company also committed an
additional USD 500,000 to support a longer-term disaster recovery program that will give the people
of Haiti the help they need to re-build their lives and their communities.
Bayer HealthCare
• Bayer HealthCare provides emergency assistance for victims in disaster areas.
www.bms.com
• The Boehringer Ingelheim Cares Foundation (BICF) in the USA provided product donations to AmeriCares, Catholic Medical Mission Board, Direct Relief International and MAP International to support emergency relief efforts in Haiti, following the earthquake in January 2010. The BICF will continue to work with
our partners and the Partnership for Quality Medical Donations to assess ongoing needs in Haiti.
• In 2010, Bristol-Myers Squibb donated nearly USD 6 million in medicines, including antibiotics and
analgesics, in response to the earthquake in Haiti. In addition, the Bristol-Myers Squibb Foundation
committed more than USD 700,000, including cash donations to the American Red Cross, the
Catholic Medical Mission Board and Partners in Health, while providing a two-for-one match for U.S.
and Puerto Rico employee donations to organizations assisting in relief efforts. The Bristol-Myers
Squibb Foundation also committed a special match for U.S. and Puerto Rico employee donations to
organizations assisting in relief efforts in response to the earthquake in Chile.
• The Foundation also focuses on providing funding support to international relief partners to facilitate
their timely responses with humanitarian aid to unforeseen natural disasters. Cash donations to Project
HOPE helped victims of the the 2009 earthquake in Indonesia; those to Direct Relief International were
instrumental in addressing natural disasters in the Philippines, Vietnam and Indonesia by providing
water, health care, shelter and sanitation; and aid to AmeriCares have helped prepare for future emergencies in India, Sri Lanka, El Salvador and Turkey.
138
• In response to the several natural disasters in South East Asia in 2009 - floods in Philippines, Vietnam,
Laos and Cambodia, the tsunami in Samoa and earthquake in Indonesia - GlaxoSmithKline supported recovery efforts through product and in-kind donations, employee and matched giving contributions, volunteer efforts and cash donations. The value of aid provided (cash, product and in-kind donations) for all countries stands at USD 2.01 million. GSK is also supporting longer-term recovery efforts,
for example, GSK Indonesia is working with one of our partners, AmeriCares, to provide a new water
facility and medical assistance to a hospital in Padang, Indonesia. GSK Vietnam is also working with
the Red Cross with on longer-term recovery efforts focusing on rebuilding and repairing health centers
and providing healthcare treatment for victims of storm damage in Vietnam.
GlaxoSmithKline
www.gsk.com
• Following the earthquake in Haiti in January 2010, GSK medicines valued at USD 1.4 million were provided from stocks held in warehouses of non-profit partners, such as AmeriCares, Direct Relief
International, Health Partners International of Canada and International Medical Assistance. These
medicines were mainly oral and topical antibiotics, including Bactroban, Zovirax, Augmentin, Ceftin,
Zinacef and Zantac. As Haiti’s needs continue to evolve, GSK has not placed a limit on the value of its
product donations. The company has also committed approximately USD 408,000 (GBP 250,000) to
the British Red Cross to help meet the water and sanitation needs of those affected by the disaster.
• Following the earthquake of January 2010, the Johnson & Johnson Family of Companies has contributed to the disaster relief effort in Haiti with cash and product donations. Beyond supporting immediate needs, Johnson & Johnson is supporting long-term recovery and rebuilding efforts focused on
health care services addressing the needs of women and children.
• Following the major earthquake that struck Haiti in January 2010, Japanese pharmaceutical companies provided cash, medicines and other assistance worth more than USD 8 million. Pharmaceutical
companies contributing to this aid included Astellas, Chemo-Sero-Therapeutic Research Institute,
Chugai, Daiichi Sankyo, Dainippon Sumitomo, Eisai, Kissei, Kyowa Hakko Kirin, Maruishi, Maruho,
Minophagen, Mitsubishi Tanabe, Nippon Shinyaku, Nippon Kayaku, Novartis Pharma K.K., Ono,
Otsuka, Pfizer Japan, Sanofi-Aventis K.K., Santen, Sanwa Kagaku Kenkyusho, Shionogi, Takeda,
Toyama Chemical, Wyeth K.K. (now part of Pfizer) and Yakult Honsha.
Johnson & Johnson
www.jnj.com
JPMA
• Following the earthquake in Haiti in January 2010, Lilly provided USD 250,000 in cash to support relief efforts.
Its employees have contributed a further USD 225,000 to date, which the company will match dollar-fordollar. Lilly has also shipped product donations worth USD 4.4 million, notably antibiotics, insulin and neuroscience medications. In addition, the company contributed USD 100,000 for earthquake relief in Chile.
• Following the 8.8 magnitude earthquake that struck off the coast of the Maule Region of Chile on 27
February 2010, Merck made a contribution of USD 100,000 to support relief efforts by the American
Red Cross and World Vision.
Lilly
www.lilly.com
Merck & Co. Inc.
www.merck.com
• Following the devastating earthquake that struck Haiti on 12 January 2010, Merck has made an initial
contribution of USD 450,000 to assist relief efforts through the American Red Cross, U.S. Fund for UNICEF, Save the Children, The Jewish Renaissance Foundation, Project HOPE and Be The Change International. Merck is also donating needed medicines through the Merck Medical Outreach Program. To
date, Merck partners Direct Relief, Catholic Medical Mission Board, AmeriCares and MAP International
have already shipped or are planning to ship USD 2.6 million (market value) of donated Merck products.
• Merck also is allowing eligible employees who are licensed health professionals, allied health services
providers or qualified translators (Creole/French) to take one paid week of release time to participate
in disaster relief efforts with approved non-profit organizations on the ground in Haiti.
• Merck KGaA has contributed to the international relief effort following the earthquake in Haiti in January
2010 with a donation of 17,000 bottles of the company’s antibiotic Cephoral.
• In 2009, Novartis donated USD 32 million to major humanitarian organizations for emergency relief
operations. Novartis has also provided USD 3.5 million worth of emergency assistance following the
earthquake in Haiti in January 2010, including employee matching contributions.
Merck KGaA
www.merck.de
Novartis
www.novartis.com
139
Novo Nordisk
www.novonordisk.com
• After the earthquake in Haiti in January 2010, Novo Nordisk and Project Hope organized help for
people with diabetes. Novo Nordisk’s contribution included 50,000 vials of insulin. In addition, Novo
Nordisk donated USD 100,000 to the Danish Red Cross to support their relief work in Haiti.
• Following the torrential rains in Karnataka and Andhra Pradesh states in India in October 2009, the
Novo Nordisk employee volunteer program “Take Action!” collected and arranged for the basic necessities like food, drinking water, clothing and medical supplies for more than 500 families. A large number of employees volunteered to distribute aid in the affected areas.
• In response to the earthquake in Padang Sumatra Barat, Indonesia in September 2009, Novo Nordisk
employees raised funds and collected clothes which were eventually donated to the victims via the
Indonesian Red Cross Society. The Take Action! Team cooperated with local NGOs in providing emergency services, building temporary houses, schools and camps.
• Pfizer responded to several disasters in 2009 with financial and product donations, as well as Pfizer
employees’ time. When Typhoon Morakot hit Taiwan in September 2009, Pfizer provided USD 300,000
in support to the Red Cross of Taiwan and United Way of Taiwan. Pfizer employees also made cash contributions. In September 2009, Pfizer provided USD 100,000 in cash support to aid the relief efforts following flooding in the Philippines. This support was directed to ABS-CBN Foundation, GMA Kapuso Foundation, Philippine National Red Cross and World Vision. In October 2009, Pfizer responded to the
earthquakes in Indonesia with a USD 50,000 cash contribution to UPLIFT International. The company
also provided significant support to the colleagues and their families living in the affected area. Finally,
Pfizer launched a relief support program with the Ministry of Health of the Republic of Indonesia and a
state-owned insurance company P.T. Askes, that donated antibiotics, anti-inflammatories, pain killers,
infant formulas and follow-on milk.
Pfizer
www.pfizer.com
• Pfizer’s contribution to aid recovery and relief efforts in earthquake-ravaged Haiti consists of a package of product and monetary donations totalling USD 5 million in combined contributions, including USD
4.7 million in medicinal product donations to the following NGO partners: The Red Cross, Health Partners International of Canada, Americares, Project Hope, Direct Relief International and Heart to Heart.
A cash donation of USD 250,000 has been evenly split between the U.S. Fund for UNICEF and CARE.
Additionally, Pfizer employees and retirees in the United States and Puerto Rico have contributed at least
USD 370,000 which has been matched by the Pfizer Foundation, in line with Foundation guidelines.
• Roche is making substantial contributions to assist relief efforts following the earthquake in Haiti in
January 2010, including the donation via local authorities and specialized NGOs of critical medicines
which will assist more than 8,000 patients.
Roche
www.roche.com
sanofi-aventis
• To address emergency and post-emergency needs after the earthquake in Haiti on 12 January 2010,
sanofi-aventis mobilized rapidly alongside its partner associations: Aide Médicale Internationale,
CARE, Red Cross, Handicap International, Médécins du Monde and UNICEF, all specialized in emergency relief operations and already present in Haiti.
• To help them launch emergency relief actions, sanofi-aventis provided initial funding of EUR 100,000
and organized a sizeable donation of medicines and vaccines. To date, 440,713 boxes of medicines
and 568,300 doses of vaccines (with a market value of EUR 11.2 million) have been delivered. Sanofiaventis also allocated an exceptional EUR 1 million for the long-term support of its partners.
• An appeal was also launched among company employees and subsidiaries around the world, inviting
everyone to participate in the wave of solidarity for the people of Haiti. This raised EUR 450,000 from
the employees in 33 countries, matched by the company, and certain affiliates.
• A grand total EUR 2,015,000 has now been sent to the six NGO / IGO partners.
TULIPE (LEEM)
www.tulipe.org
140
• TULIPE is a non-profit organization created in 1982 by the French pharmaceutical association, Les
Entreprises du Médicament (LEEM). It brings together NGOs, government and industry to provide
appropriate medicine donations in emergency situations. It has developed special medical kits for use
by NGOs and the French Ministry of Foreign Affairs, adapted to their first-aid teams´ needs. In 2009,
thanks to its 58 pharmaceutical company members, TULIPE provided medicines worth EUR 897,900
at wholesale prices corresponding to 1,505,000 treatments, including emergency medical kits to meet
a variety of needs, for earthquake in Indonesia, for the cyclone in Philippines and for refugees in
Palestine and Sri Lanka.
COMPLETED PROGRAMS
Abbott
• Through a partnership with AmeriCares, Dartmouth University, and the University Clinical Center of
Kosovo (UCCK), Abbott supported efforts to improve neonatal survival in Kosovo. The Abbott Fund
provided AmeriCares with funding to help equip four patient units in the Neonatal Intensive Care Unit
at the UCCK in Prishtina, where a third of all infants in Kosovo are born. Funding also supported an
education exchange on neonatal resuscitation and stabilization. Results from 2007 showed a 15%
decline in the neonatal mortality rate.
• AstraZeneca’s partnership with the African Medical Research Foundation (AMREF) initially focused on
TB control and management in the Eastern Cape of South Africa, heavily affected by TB, HIV and malnutrition. AstraZeneca and AMREF worked with local communities in the Chris Hani district, helping
them to take action to promote good health and wellbeing. The program has seen increased knowledge, detection and defaulter tracing. The program came to an end in 2007.
www.abbott.com
AstraZeneca
www.astrazeneca.com
• In July 2003, AstraZeneca made a GBP 60,000 grant to BookPower, a non-profit organization which
provides medical and nursing text books at a subsidized price to students in English-speaking Africa,
the Indian sub-continent and the Caribbean. The AstraZeneca grant funded medical texts on
Cardiology, Endocrinology, Gastroenterology, Immunology and Infection. The program ended in 2005.
• Promoting Safe Motherhood in India: from 2005 to 2009, AstraZeneca worked with the Federation of
Obstetric and Gynaecological Societies of India (FOGSI) to improve female and maternal health
through educational activities, including professional conferences and public awareness campaigns.
• Thane, India, Bayer HealthCare donated enough polio vaccines to immunize 170,000 children, an
Bayer HealthCare
initiative that helped the WHO program defeat polio in the region.
www.bayerscheringpharma.com
• The BMS Foundation has supported various efforts to fight HIV/AIDS outside Africa, including Baylor
College of Medicine’s training programs for health professionals in Ukraine and Mexico. With Miramed,
it supported education programs in Russia and a pilot medical protocol for rescued sex trafficking victims. In Thailand, grants to the Population and Community Development Association and the Thai Red
Cross helped increase HIV/AIDS awareness in vulnerable populations. It has also supported pediatric
HIV/AIDS training in Vietnam.
www.bms.com
• The BMS Foundation helped the Catholic Medical Mission Board and the Pan American Health
Organization to scale up the Integrated Management of Childhood Illness (IMCI) in five Latin American
and Caribbean countries. The grant ended in 2006.
• The BMS Foundation helped the China Foundation for Hepatitis mount a two-year pilot program to
prevent mother-to-child transmission of hepatitis B and helped the Chinese Ministry of Health and the
Chinese Liver Foundation conduct rural hepatitis vaccination campaigns.
• Afrikids is an NGO working in Ghana which helps to protect vulnerable children’s rights, delivers basic
care, improves local facilities and offers education and micro-finance programs. GlaxoSmithKline supported Afrikids for 4 years from 2003, especially Operation Sirigu, which helped reduce the child
abuse, abandonment and infanticide that have been related to the “spirit child” phenomenon.
GlaxoSmithKline
www.gsk.com
• In February 2008, Phase III clinical trials showed that Dacart™ (chlorproguanil/dapsone/artesunate), a
candidate anti-malarial combination developed by GSK and Medicines for Malaria Venture, could significantly reduce hemoglobin in patients with glucose-6-phosphate dehydrogenase deficiency (which
affects 10-25% of people in sub-Saharan Africa). Consequently, GSK and MMV terminated development of Dacart™ GSK also withdrew its Lapdap™ chlorproguanil/dapsone combination. This disappointment highlights the complexity and risk of pharmaceutical R&D, but GSK remains committed to
fighting malaria.
• From 2001 to 2009, GlaxoSmithKline helped Mildmay International to strengthen HIV/AIDS healthcare in sub-Saharan Africa, through provision of appropriate training in Kenya, Nigeria, Tanzania, Uganda
and Zimbabwe.
141
COMPLETED PROGRAMS
Japan
Pharmaceutical
Manufacturers
Association (JPMA)
Merck & Co., Inc.
www.merck.com
• JPMA member companies Astellas, Asubio Pharma, Chugai, Daiichi Sankyo, Dainippon Sumitomo,
Eisai, Meiji Seika, Mitsubishi Tanabe, Otsuka, Shionogi and Takeda worked with the Japanese Ministry
of Health, Labor and Welfare, and the TDR Special Program for Research and Training in Tropical
Diseases in the JPMW Alliance, formed in October 1999, to help malaria R&D. Nearly 30,000 compounds were screened, of which 372 showed activity against malaria. Of these, 14 showed enough
promise to merit further research. This project finished in 2005.
• The Enhancing Care Initiative (ECI) was launched in 1998 with a five-year, USD 5 million grant from the
Merck Company Foundation, as a multidisciplinary collaboration to improve the care of people living
with HIV/AIDS in resource-limited settings, run by the Harvard AIDS Institute and the Francois-Xavier
Bagnoud Center at the Harvard School of Public Health. It worked in Brazil, Puerto Rico, Senegal,
South Africa and Thailand. See www.eci.harvard.edu.
• Schering-Plough, now part of Merck & Co., Inc., worked with the Ministry of Health and other partners
in Venezuela to establish a donation program for Hepatitis-C, providing PegIntron® medicine and
Protein Chain Reaction confirmatory tests, plus community education programs.
• In 2005, Schering-Plough, now part of Merck & Co., Inc., established a program with the Department
of Public Hygiene and Prevention to strengthen sexual and reproductive health services and education
in Laos. The company contributed USD 270,000 up to 2008.
• Schering-Plough’s Organon division, now part of Merck & Co., Inc., started the “Development of
Sexual and Reproductive Health Services for Thai Adolescents” program in 2004, to promote improved sexual and reproductive health among adolescents in Thailand.
• From 2001-2008, Merck partnered with the International Council of Nurses (ICN) and Elsevier Science,
the world´s largest publisher of nursing books, to created the ICN/Merck Mobile Library Program,
which provided traveling libraries of health education and reference materials help nurses working in
remote areas of the of developing countries gain access to critical quality healthcare information.
Merck KGaA
www.merck.de
Novartis
www.novartis.com
• The “Staying Healthy with Diabetes” program in Indonesia aimed to promote early diagnosis and
integrated efforts to prevent complications to improve the quality of life for people with diabetes. In
2004 and 2005, the Merck KGaA team in Indonesia successfully screened more than one million
people for diabetes.
• From 1996 to 2006, Chiron Vaccines, now Novartis Vaccines, donated 33.3 million doses of polio vaccine for international vaccination campaigns to support the Global Polio Eradication Initiative.
• Novartis used to donate intraocular lenses to NGOs for cataract surgery for patients with inadequate
means in developing countries. However, the division responsible for these lenses has been divested
from the Novartis group.
Pfizer
www.pfizer.com
• PEER (Providing an Enabling Environment for Research in health) was a joint R&D program by the
Pfizer Philippines Foundation, the Philippine Council for Health R&D and the University of the
Philippines National Institutes of Health, sponsoring Filipino research into various diseases including
childhood obesity, diabetes, tuberculosis and mycrobacterial infections.
• Pfizer worked with the Mexican Diabetes Association in Mexico City to help educate families with
youngsters with Type II diabetes to live with the disease.
• In 2002, Wyeth, now part of Pfizer, contributed USD 1 million to the Global Polio Laboratory Network.
Wyeth has also donated 10 million doses of vaccine for Haemophilus influenzae type b to immunize
3.3 million children.
• Wyeth, now part of Pfizer, has helped fund various clinical trials for its pneumococcal conjugate vaccine in developing countries, including the Gambia and South Africa, working with the UK Medical
Research Council, the Bill and Melinda Gates Foundation, the US National Institutes of Health, the US
Agency for International Development, the World Health Organization (WHO) and the South African
Medical Research Council.
142
COMPLETED PROGRAMS
• The Cambodia Treatment Access Program (CTAP) was launched in 2003 by the Cambodian Ministry
of Health, the National Centre in HIV Epidemiology and Clinical Research at the University of New
South Wales in Australia and Roche, to widen access to HIV healthcare, including antiretrovirals and
train healthcare professionals in Cambodia. Roche provided funding and ARVs for use in the program.
The Cambodian Government honored the partners with an Award of Recognition, in view of CTAP’s
considerable impact on HIV/AIDS treatment in the country, where HIV prevalence is now in decline.
Roche
www.roche.com
• CARE, the Cohort program to evaluate Access to antiretroviral treatment and Education, was designed
to provide antiretroviral medicines to people living with HIV/AIDS and serve as a model for providing
HIV healthcare in resource-limited countries worldwide. The program was launched in 2001 by
PharmAccess Foundation and Roche in Cote d’Ivoire, Kenya, Senegal and Uganda. Funding, diagnostic and monitoring tests, as well as support for training of healthcare professionals and education
for patients, were provided by Roche, which also donated ARVs for use in the program.
143
Acknowledgements
This publication is the fruit of the labors of many people, but the IFPMA would particularly like to thank the following
persons for helping to provide information:
Abbott
AstraZeneca
BayerHealth Care
Crucell
Eisai
Esteve
Gilead
GlaxoSmithKline
Johnson & Johnson
JPMA (Japan)
LEEM
Lilly
Merck & Co., Inc.
Merck KGaA
Novartis
Novo Nordisk
Otsuka
Pfizer
Piramal
Ranbaxy
Roche
sanofi-aventis
Sigma-Tau
TULIPE
ViiV
Matthew Bedella
Neil Mulcock
Diana Scholz, Denise Renmann, Ulrike Schroeder
Michael Rabbow
Christine Newman
Olga Popova
Simon Collier
Daniel Ortiz Llagues
James Read
Amanda Atkinson
Pamella Kyagonza
Hiroyuki Funakoshi
Béatrice Kressmann
Tristan Piguet
Patricia Fricke, Brenda Colatrella
Frank Gotthardt
Lyse Beauregard-Zollinger
Craig Ludwig
Hiroyuki Funakoshi (JPMA)
Deirdre Peterson
Pankaj Dikholkar
Shailesh Pednekar
Maria Vigneau, Vivian Beetle
Alain Aumonier
Marco Corsi
Christine Perrier
Scott Purdon
Photos
All photos are reproduced with the permission of the company and/or copyright holder concerned. These are named in
brackets after the caption.
Copyright May 2010 – International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
Layout by Imprimerie Genevoise SA, Geneva.
The International Federation of Pharmaceutical Manufacturers & Associations is the
global non-profit NGO representing the research-based pharmaceutical industry,
including the biotech and vaccine sectors. Its members comprise 25 leading
international companies and 45 national and regional industry associations covering
developed and developing countries. The industry’s R&D pipeline contains hundreds
of new medicines and vaccines being developed to address global disease threats,
including cancer, heart disease, HIV/AIDS and malaria. The IFPMA Clinical Trials
Portal (www.ifpma.org/ClinicalTrials), the IFPMA’s Ethical Promotion online resource
(www.ifpma.org/EthicalPromotion/) and its Developing World Health Partnerships
Directory (www.ifpma.org/HealthPartnerships) help make the industry’s activities
more transparent. The IFPMA supports a wide range of WHO technical activities,
notably those relating to medicine efficacy, quality and safety, and coordinates
industry participation in the WHO IMPACT initiative to combat counterfeit medicines.
It also provides the secretariat for the International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
The program information in this book is also available in searchable form in the
IFPMA website, at www.ifpma.org/healthpartnerships, and on the Global Health
Progress website www.globalhealthprogress.org.
Developing World
Chemin Louis-Dunant 15
Tel: +41 22 338 32 00
P.O. Box 195
Fax: +41 22 338 32 99
1211 Geneva 20
E-mail: [email protected]
Switzerland
Web: www.ifpma.org
© 2010 IFPMA P-0024-1 (EN)
2010

Developing World Health Partnerships Directory (2010 Edition)

Transcription

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