- Teijin Pharma Limited

Transcription

CORPORATE
PROFILE
Kasumigaseki Common Gate West Tower, 2-1, Kasumigaseki 3-chome,
Chiyoda-ku, Tokyo 100-8585, Japan
http://www.teijin-pharma.com/
Product names and service names denoted with ® or TM are registered trademarks or trademarks of the
Teijin Pharma Limited in Japan and/or other countries in this brochure. Product names and service names used are
registered trademarks or trademarks of the Teijin Pharma Limited.
Other product names and service names may be protected as their trademarks and/or trade names.
2014 Teijin Pharma Limited All Rights Reserved
Leading the Way to Global Wellness
Originally founded as a healthcare-focused venture within the
Teijin Group, Teijin Pharma has established itself as a leader in
the industry by building on the Teijin DNA, which includes the
spirit to challenge new fields and a dedication to developing
unique solutions to complex issues. Since our establishment,
Teijin Pharma has remained strongly focused on resolving some
of the most difficult issues in the healthcare industry, including
finding solutions for illnesses that have no established cure,
illnesses for which treatment places a tremendous burden on
patients, and illnesses which are not recognized as such. As a
specialty healthcare company, it is our mission to develop
innovative solutions to leading issues in the industry while
working to improve patients’ quality of life.
Contents
Building our global presence as a
specialty healthcare company with
unique and innovative solutions
Message from the President
03
Industrial Technology
16
Corporate Philosophy
04
Customer & Market Services
18
Business Fields
06
Regulatory Compliance
20
Research & Development
14
Corporate Social Responsibility
22
The Pharmaceutical and Home Healthcare
businesses are the most important features of
Teijin Pharma, serving as the two pillars of our
company. In addition to providing products and
services focusing on bone and joint diseases,
respiratory diseases, and cardiovascular and
metabolic diseases, our aim is also to develop
unique healthcare solutions by maximizing the
synergy of these two businesses.
The main focus of the Pharmaceutical business
is maximizing the speed of growth of febuxostat,
our hyperuricemia treatment developed in-house.
The limitation on classifying febuxostat as a
long-term prescription drug in Japan was lifted in
April 2012, just in time to accelerate its sales
growth. Global marketing of febuxostat began in
2009, starting with the US and Canada, then later
growing to approximately 40 countries, including
Taiwan, South Korea and 15 countries in Europe.
Deployment of febuxostat is now planned to
increase to a total of 117 countries, and testing
facilities are being added to the pharmaceutical
manufacturing plant at Iwakuni, Japan in preparation for production on a global scale. Also, in
addition to being a market leader in the bone and
joint domain, we will expand our focus to include
the muscle domain.
In the Home Healthcare business, where we are
the leader in the Japanese market in Home
Oxygen Therapy (HOT) and Sleep Apnea Syndrome
(SAS) CPAP devices, we are working to improve
the quality of life for patients with new products
and services. Overseas, we are continuing to hold
to our existing strategy, with business infrastructures being developed in the US, Spain and South
Korea showing good performance.
Up to now, our main focus has been in the fields
of respiratory diseases, bone and joint diseases,
and metabolic and circulatory diseases. Now,
however, we are looking to create new areas of
business by building synergy between our work in
the Pharmaceutical and Home Healthcare
businesses. One challenge we are taking on is the
development of new medical devices and regenerative medicines as solutions to aid in the
rehabilitation of stroke patients. In addition, we are
working to strengthen Group synergy through
research that brings together Teijin’s medical and
material technologies. Our strength as a material
manufacturer enables us to take a unique approach
to development in this regard.
It is the achievements of the generations before
us that have created the Teijin Pharma of today,
and we have a responsibility to build upon those
achievements by evolving all our global activities
and never losing our entrepreneurial spirit. Also, as
one of the core business groups of Teijin, we have
a responsibility to meet the expectations of the
Group as a whole. To do so, we must maximize
our current businesses while taking care to
properly nurture new ventures. We must look at
medicine, medical devices and value-added
services together as a whole. It is there that we
are certain to find the possibilities of new healthcare solutions, and that is where we will find the
unique value of Teijin Pharma.
Hiroshi Uno, D.V.M.,Ph.D.
President, Teijin Pharma Limited
Our Top Priority:
Improving the Quality of Life
At Teijin Pharma, we are keenly aware of patients’ strong desire for total health, both in body
and mind. Over the years, such patients have taught us the joys of being thanked for the work
we have accomplished. This type of hands-on connection with patients is one of the strengths
of Teijin Pharma, which is involved with patients in both of our two core businesses of
Pharmaceutical and Home Healthcare.
Our goal is to help as many patients as possible acquire a positive life attitude and achieve
happiness. Teijin Pharma continues to take on new challenges as we work to improve the
quality of life, backed by not only the latest medical technology but also an emotional
investment in patient health.
Teijin Group Synergies for Breakthrough Solutions
Firmly aware that technological breakthroughs provide the
platform for corporate growth, the Teijin Group has established
a research and development strategy for the Group overall, and
continues to strengthen the bonds between group companies.
Healthcare has been appointed a priority technology area, and
as such, the Teijin Group is pouring efforts into next-generation
pharmaceuticals, new home healthcare devices and cuttingedge medical materials. In particular, we are endeavoring to
achieve early market entry in the field of medical materials.
Additionally, with a strong belief in the merits of joint technical
research, Teijin Pharma has been conducting joint research
with materials research teams of the Teijin Group. Among
products already developed through such joint research are
Antup, a percutaneous tape preparation which utilizes
materials from the Films Business Group, and Rhinocort, a
treatment for allergic rhinitis developed through the use of
plastics formation and mechanical engineering technology. In
the Home Healthcare business, Teijin Pharma receives backup
and support in the development of new devices, including
computer simulations and evaluation of components through
cooperation with the Teijin Group IT team. These types of
synergistic collaborations among the Teijin Group companies
provide a powerful asset for Teijin Pharma, and are leading to
the development of breakthrough medical solutions.
Healthcare
Business Group
Teijin Pharma Limited
Teijin Home Healthcare Ltd.
Teijin Group‘s
Corporate Philosophy
High Performance Fibers
Business Unit
Carbon Fibers & Composites
Business Unit
Quality of Life
In Harmony
with Society
The Teijin Group’s purpose is to
enhance the quality of life through a
deep insight into human nature
and needs, together with the
application of our creative
abilities.
Electric Materials &
Performance Polymer Products
Business Group
Advanced Fibers & Composites
Business Group
Films Business Unit
Resin & Plastic Processing
Business Unit
Empowering
Our People
Products Converting
Business Group
New Business Development
Business Unit
IT Business Group
04 • TEIJIN PHARMA •
• TEIJIN PHARMA • 05
Teijin Pharma is introducing unique medical solutions on a
global scale in the three target categories of bone and joint
diseases, respiratory diseases and cardiovascular and
metabolic diseases, building on the organic ties between our
Pharmaceutical and Home Healthcare businesses.
BUSINESS
FIELDS
Bone and Joint Diseases
Respiratory Diseases
Cardiovascular and Metabolic Diseases
From In-house Venture Business
to Leading Company
Pharmaceutical Business
Specialty Pharmaceuticals,
from the Ground Up
Teijin Pharma’s Pharmaceutical business was
created through the bold vision and strong
leadership of top management. We have been
introducing aggressive initiatives for growth,
including investing in R&D for new drugs,
building new markets and so forth. Starting from
nothing, Teijin Pharma has remained focused on
its goals of providing the world with innovative
treatments, and we have made clear progress as
a research and development company. At
present, we are focusing on the three target
categories of bone and joint diseases, respiratory
diseases and cardiovascular and metabolic
diseases. We aim to provide unique solutions in
each of these categories as a specialized
pharmaceutical company.
Market Launch of Two New Products: Febuxostat and Somatuline ®
Teijin Pharma has recently launched two breakthrough drugs: febuxostat, a drug developed
in-house treating hyperuricemia, in May 2011, and Somatuline, a drug for treating acromegaly and
pituitary gigantism, in January 2013. The first new drug to treat hyperuricemia in nearly 40 years,
febuxostat is positioned as a key product in our global strategy, with plans to expand to 117
markets including China, Central and South America, the Middle East and North Africa. At the
same time, expectations are high for this product to serve as the foundation for further synergies
with our Home Healthcare business in the field of cardiovascular and metabolic diseases.
FUTURE & SYNERGY
Our Rehabilitation Field:
Born from Our Pursuit to Improve
Patients’ Quality of Life (QOL)
Home Healthcare Business
Bone
and
Joint Diseases
Respiratory
Diseases
Cardiovascular
and
Metabolic Diseases
3 Target Categories
In the 1970s, Teijin Pharma researchers began
working on developing oxygen concentrators in
response to demand for oxygen units that
incorporated an oxygen enriching membrane.
The project was a succession of challenges, not
only in terms of product development but also
due to the need to establish a service network
and acquire approval for insurance coverage. The
success of project members laid the foundation
for home healthcare in Japan. And today, Teijin
Pharma’s Home Oxygen Therapy (HOT) is
considered a benchmark model in the domestic
market, establishing Teijin Pharma as a leader in
the home healthcare industry in Japan.
On Top in the Domestic Market, CPAP Is Now Making Fast
Headway Overseas
In addition to HOT, which holds the top position in the domestic market in terms of
service and share, Continuous Positive Airway Pressure (CPAP) treatment for SAS is also
exhibiting tremendous growth. CPAP is showing exciting potential in expanding our
growth in the cardiovascular and metabolic diseases category, in hand with the new drug
febuxostat, developed in-house. In addition to utilizing our networks in North America,
Europe and Asia to participate in the existing markets of developed countries, we are also
actively engaged in creating new markets in developing and newly industrialized nations.
Having full control of your limbs, walking and eating — motor skills which are
essential for a good QOL. However, the medical treatment currently available in the
field of bone and joint diseases doesn’t allow for the full recovery of motor skills of
patients who have suffered damage to the central nervous system, even if bone
and joint tissue has been successfully restored. Responding to this issue, we are
expanding the treatment available in the field of bone and joint diseases to cover
central nervous system damage as part of our pursuit to improve patients’ QOL. The
first step of this process for our rehabilitation field began in April 2013 with the
marketing of WalkAide, an electrical stimulation device which supports and
improves walking for those who suffer from foot drop due to strokes. At present,
we are developing a robotic rehabilitation device to provide motor training to
patients afflicted by paralysis in the upper limbs, and aim to market the device at
the earliest possible opportunity. Furthermore, to meet expectations in the
rehabilitation field for commercially viable regenerative treatments in the future,
we will provide comprehensive solutions by synergizing our Pharmaceutical and
Home Healthcare businesses.
BUSINESS FIELDS
BONE AND
JOINT DISEASES
As a leading company, Teijin Pharma has built a strong platform in
the bone and joint diseases field over the past 30 years, including
the recent launch of Synvisc® for the treatment of osteoarthritis
knee pain, in addition to our core osteoporosis products. The
introduction of SAFH
SAFHS ® (Sonic Accelerated Fracture Healing
System) achieves a synergy between our Pharmaceutical and Home
Healthcare businesses.
Sodium Hyaluronate Treatment
Onealfa, developed in-house as the first
vitamin D 3 drug in tablet form, is a frontrunner
in the field of osteoporosis drugs, while
Bonalon, in-licensed from overseas, has
become a first-class drug for treating osteoporosis. Furthermore, we have expanded the
applicability of Bonalon through the in-house
development of Bonalon Bag and Bonalon
Jelly, and the addition of Synvisc, a sodium
hyaluronate treatment to relieve osteoarthritis
knee pain, has further strengthened our
product pipeline in this field.
SAFHS ®: The Bridge between Our
Two Core Businesses
The impetus behind the product development of SAFHS was a presentation of
venture businesses in New York. Although
the working model for SAFHS had shown
promising results, the mechanism behind
its success was unknown. Thus,
members from the Home Healthcare
business requested that scientists in the
Pharmaceutical business conduct basic
research in this area, leading to the
acquisition of key data for product
development. Furthermore, pharmaceutical medical representatives (MRs) who
were well regarded in the field of bone
and joint diseases handled product
presentations to doctors. Both MRs and
home healthcare managers provide
explanations to patients, with home
healtcare staff handling the management
of equipment. Teijin Pharma believes that
even for complex projects, it is best when
the synergies between businesses can
overcome organizational boundaries. That
is the Teijin DNA.
Synvisc®
Onealfa ® and Bonalfa ® :
Developed from Ideas Given by
Physicians
Osteoporosis Treatment
Teiroc ® and Bonalon ® are trademarks of Merck Sharp &
Dohme Corp.
Synvisc ® is a trademark of Merck Genzyme Corp.
Onealfa®
Bonalon®
Sonic Accelerated Fracture Healing System
TEIJIN DNA
SAFHS is the first fracture healing system in
the world that utilizes sonic pulses to speed
up healing. SAFHS has been recognized for its
high efficacy in healing new fractures and
complex fractures with just a short 20-minute
treatment per day, as well as reducing the
time needed to repair bone joints and contributing to the quick rehabilitation of patients.
The Onealfa project was started based on
a comment from a physician, who
suggested that if renal patients had low
vitamin D activation function, it might be
possible to treat them with a product using
active vitamin D directly. The results of the
research that followed led to the in-house
development of an active vitamin D3 drug
for treating not only patients with renal
failure, but osteoporosis patients as well.
Lots of feedback from doctors, who noted
that patients using Onealfa experienced
improvements in skin inflammation, led to
We Aim to Be a Leading
Company in Locomotive Disorders
through Further Synergies
the drug. The information provided by
doctors encouraged Teijin Pharma to
develop Bonalfa, an active vitamin D3 drug
for treating skin disorders. Listening to
comments from all sources is another vital
part of the Teijin DNA.
Bonalfa® for psoriasis treatment
Bonalon® Jelly for the treatment of osteoporosis
Life Cycle Management
of Products
Initially, patients taking Bonalon once
a day were required to take the
prescription with a glass of water
upon awakening, and refrain from
lying down for 30 minutes, a
requirement that led some patients
to stop treatment. In an effort to
reduce the burden on patients and
increase efficacy, research was
begun on ways to reduce the number
of required doses, resulting in the
development of Bonalon Once
Weekly by a licenser. While, in
addition to the completion of the
in-house development of Bonalon
Bag and Bonalon Jelly, we are also
continuing to work on the production
of pharmaceuticals that improve
patient compliance.
With Onealfa and Bonalon, our two drugs for osteoporosis, and the sodium hyaluronate treatment
Synvisc for osteoarthritis knee pain, Teijin Pharma has established itself as a leading pharmaceutical company in the field of bone and joint diseases. Our next step is to expand into the field of
orthopedic disorders to include musculoskeletal disorders as well. As part of this effort, we are
establishing a global research network, dispatching research scientists overseas and sponsoring
symposiums that provide a forum where leading researchers in both basic and clinical science can
meet to share ideas. Additionally, based on the success of SAFHS, we aim to create further
synergies between the Pharmaceutical and Home Healthcare businesses, including new research
in rehabilitation devices, aiming to be a world-leading company in the field of locomotive disorders
as well.
SAFHS®
BUSINESS FIELDS
RESPIRATORY
DISEASES
In the field of respiratory diseases, Teijin Pharma’s Home Healthcare
business stands out as an industry leader in providing Home Oxygen
Therapy (HOT). In the Pharmaceutical business as well, Teijin Pharma
has continued to develop key products for treating respiratory
diseases, including Mucosolva
Mucosolvan ®, which has successfully reached
over 30 years of continuous sales.
TEIJIN DNA
Providing Patients with the Best
Products in the World
Airway Mucolytic Agent
Our strong pipeline of pharmaceuticals in the
field of respiratory diseases includes the
airway mucolytic agent Mucosolvan, which
has maintained a solid position in the market
for over 30 years, Alvesco, an inhaled
corticosteroid for asthma, the bronchodilator
Spiropent, and Atrovent, a treatment for
bronchial constriction. We continue to
develop drugs which cater to a wide range of
respiratory diseases, such as asthma, COPD
(chronic obstructive pulmonary disease) and
allergic rhinitis.
Mild SansoTM
Continuous Improvements in
Oxygen Concentrators
Working to Help Patients of
All Ages
Alvesco®
CPAP (Continuous Positive
Airway Pressure) Device
Therapeutic Oxygen
Concentrator
SLEEPMATE®
NIP NASAL® V
patients with the best solutions in the
world, without limiting ourselves to Teijin
Pharma products. That is part of the
Teijin DNA.
Inhaled Corticosteroid for Asthma
Mucosolvan®
NPPV (Noninvasive Positive
Pressure Ventilation) Device
In the Home Healthcare business, Teijin
Pharma enjoys the unique position of
being both a manufacturer and a service
provider. Our strong foundation in
technology enables Teijin Pharma to
discuss engineering issues on an equal
foothold with our partner manufacturers,
without sacrificing the flexibility to jump
into new areas. Our aim is to build on the
strengths of our partnerships to provide
Similar to HOT, Mucosolvan has been a
key member of our lineup in the field of
respiratory diseases for nearly 30 years.
During research on the usage and clinical
effects of this product, it was discovered
that more than 60% of patients with
chronic respiratory disorders such as
COPD and asthma had difficulties
expectorating morning phlegm. In
response, we developed the Mucosolvan
L Capsule, a sustained release capsule to
be taken once a day after dinner for
greater morning effectiveness. Likewise,
Developed in-house by Teijin Pharma, the
Hi-Sanso series of oxygen concentrators has
maintained a leading share in the HOT market.
Other key products in our lineup include NIP
NASAL (a series of noninvasive positive
pressure ventilators), CPAP devices for SAS
patients and monitoring equipment.
Gets Underway in
Countries Worldwide
we have developed an aerosol form of the
inhaled corticosteroid Alvesco, so that it
can be used even by children and the
elderly, who often have reduced inhalation
capabilities. We are working on a web site
to share detailed product information,
disease-related information and suggestions for effective pharmaceutical use.
Working to improve life for all patients is
also part of the Teijin DNA.
The first oxygen concentrator
produced on the domestic market,
Teijin Pharma’s Mild Sanso offered
quiet operation and achieved
impressive growth as a rental unit.
This epoch-making product can be
considered the fountainhead for the
market of home healthcare in Japan.
At the heart of this machine was
oxygen membrane technology,
developed in-house by Teijin Pharma.
Over the years, models have
become smaller, quieter and more
energy efficient. Even today, Teijin
Pharma continues to look for ways to
further improve the market-leading
Hi-Sanso series.
In 2008, Teijin Pharma acquired the three U.S. companies of Associated Healthcare Systems, Inc.;
Braden Partners L.P.; and Home Therapy Equipment, Inc., enabling us to establish a sales network
for home healthcare in the North American market. In 2009, Teijin Pharma established Esteve Teijin
Healthcare S.L. as a joint venture with Spain’s Laboratorios del Dr. Esteve S.A., creating a focal
point for respiratory disease-related home healthcare in the European market. In Asia, Teijin
Pharma set up Yuyu Teijin Medicare Inc. as a joint venture with Korea’s Yuyu in 2006, marking
Teijin’s first overseas foothold for the Home Healthcare business. Not only has this joint venture
provided home healthcare treatment and successfully obtained national insurance coverage for
such services, it has also helped Teijin Pharma acquire the No.1 share in the Korean HOT market.
We plan to continue this insurance-focused strategy in other Asian countries as well.
Hi-SansoTM
BUSINESS FIELDS
CARDIOVASCULAR
AND METABOLIC
DISEASES
Cardiovascular and metabolic diseases are a key area where the
synergistic effects of the Pharmaceutical and Home Healthcare
businesses are expected. The hyperuricemia treatment febuxostat
febuxosta
and CPAP therapy for SAS, two major solutions in each area, are
already setting the course for growth.
TEIJIN DNA
The Discovery of Febuxostat
Began with a Liberal Research
Environment
Teijin Pharma provides a wide-ranging product
pipeline in the field of cardiovascular and
metabolic diseases, starting with the hyperuricemia treatment febuxostat, a highly anticipated drug expected to play a key role in our
global strategy, as well as Tricor and Solmiran
to treat metabolic disorders and Antup, a
percutaneous patch preparation for dilating
coronary arteries in patients with angina or
myocardial infarction.
Anti-hyperlipidemic Agent
pH Dependent
Disintegrating EPA Agent
Tricor®
Solmiran®
Anti-hyperuricemia Agent
Air-permeable Tape for
Ischemic Heart Disease
When research commenced on a new
anti-hyperuricemia drug, our interest in the
project was low due to the small size of
the target market and lack of novelty in
the drug mechanism. Only the strong
enthusiasm of the participating researchers could keep the project going. After
promising initial results were obtained, our
interest in and awareness of the project
began to snowball, inspiring further
progress. One of the key factors to
success was Teijin Pharma’s research
environment that encourages informal
discussions and research networking. This
liberal environment led to one small idea
being transformed into a major new
pharmaceutical. Respecting employees for
their ideas is part of the Teijin DNA.
High Hopes for AutoSet CS-A as
a New Treatment for Heart Failure
Feburic®
Antup®
Over the past few years, AutoSet CS-A
has become a hot topic in the cardiovascular diseases field, as it may provide a new
option for treating heart failure. Expected
to improve the quality of life of patients
suffering from chronic heart failure,
AutoSet CS-A has received high marks
from members of the medical field and
patients alike. It was the creative thinking
and strong conviction of a single project
manager that led to the development of
treatment methods utilizing AutoSet CS-A.
Keeping an ear tuned to latent medical
needs and introducing novel solutions
without clinging to tradition is also part of
the Teijin DNA.
The Second Teijin Group
Fellow
The Teijin Group Fellow program was
established by the Teijin Group to
encourage research and technological
developments and enhance
employee motivation. In 2009, Mr.
Shiro Kondo was recognized as the
second Teijin Group Fellow for his
contribution to the development of
febuxostat. Researchers strive to be
selected as Fellows, which is not only
a tremendous honor but also
promises an environment in which
research can be conducted freely. At
present, Fellow Kondo and his
associates are conducting research
on drug delivery systems and medical
devices at the Kondo Research Lab.
Fellow Kondo (right) providing advice in the lab.
Adaptive Servo-Ventilator
CPAP Device with Automatic
Pressure Adjustment
AutoSet CS-A
At present, our lineup focuses on CPAP
devices for SAS therapy and the positive
pressure ventilator AutoSet CS-A for the
treatment of heart failure, two lines of
equipment expected to expand our share in
the cardiovascular diseases market. Additionally, public health insurance coverage for HOT,
which has played a leading role in our market
share thus far, was extended to cover chronic
heart failure in 2004, further boosting opportunities for Teijin Pharma in the HOT market.
Revolutionary Drug Febuxostat
Is Ready to Take on the World
The potential of febuxostat is being felt around
the world. Sales began in America in 2009
ULORIC, while the
under the brand name ULORIC,
drug has been launched in approximately 40
countries with plans to expand to 117 markets
including China, Central and South America,
the Middle East and North Africa. While only
permitted for gout treatment overseas at the
moment, the aim is to include hyperuricemia
treatment in the future.
Adenuric ®
Adenuri
Europe, etc.
Ulori ®
Uloric
Middle East
North America
Asia
North Africa
Feburic®
Japan, Asia & Israel
Central & South America
Oceania
SLEEPMATE®
RESEARCH &
DEVELOPMENT
Pharmaceutical Products Research Laboratories
(Iwakuni, Yamaguchi Prefecture)
Development of a Monitoring System
Using Information Technology
One of the core themes of the Home
Healthcare business is to provide the
same level of comfort and safety at home
as is available in the hospital. One
example of this is HOT Mimamori-ban
which provides 24-hour monitoring of the
operational status of oxygen concentrators
utilizing the cellular phone network. A
further example is NemLink, which
enables medical organizations to check
the operational status of equipment for
the treatment of SAS. At present, we are
working on developing a system for
tracking patients’ medical conditions at
home through an expanded communications infrastructure utilizing IT technology.
We Are Tackling Diseases with a Two-pronged
Approach of Pharmaceuticals and Medical Equipment
It is the mission of Teijin Pharma to alleviate the symptoms of all patients, even those
whose illnesses have not been categorized. Teijin Pharma’s unique insight on medicine
and the strength of our two core business areas enable us to come up with creative
solutions to medical issues, through both pharmaceutical products and medical devices.
actively engage in research and development. At the same time, we will
promote alliances with partners in Japan
and overseas to ensure we deliver
innovative solutions resulting from
crossovers between our two core
businesses, focusing on medical devices
in areas where pharmaceuticals are not
effective, and curing illnesses with
pharmaceuticals in areas where they
show the best results.
Developing Pharmaceutical and
Home Healthcare Solutions that
Benefit Patients and Society
In the past, neither SAS nor decreased
bone density were considered illnesses.
However, Teijin Pharma went forward in
focusing on solutions to these health
issues. Placing the utmost priority on
making a positive contribution to patients
and society, both our Pharmaceutical
business and Home Healthcare business
continued with research and development to provide unique products. Going
forward, we will maintain efforts to
Promoting Research in Integrated
Technology that Combines
Pharmaceuticals and Materials
Teijin Pharma makes use of the synergistic
research within the Teijin Group, including
discovering new technologies to combine
pharmaceuticals and materials. Believing
in the power of joint research, we
collaborate with materials research teams
to develop revolutionary products which
go against conventional practice by making
use of technologies from a wide range of
fields. Furthermore, the Teijin Group’s IT
team is involved in developing systems in
the Home Healthcare business through IT
technologies, including inter-system
coordination and the creation of contact
networks between offices and hospitals.
A Strong Track Record and Deep
Relationships Enhance Our
Alliances with Overseas Partners
Since its founding, Teijin Pharma has
worked to build trust with its Japanese
and international in-licensing and
out-licensing partners while maximizing
the fruits of its research and development
labors through strategic alliances. We are
convinced that breakthroughs emanate
from collaborations with our partners in
mutually synergistic relationships.
Therefore, for early-phase and exploratory
research, we proactively advance alliances
with corporations and research institutions
both in Japan and overseas to create
innovative solutions.
HOT Monitoring System
HOT Mimamori-ban ®
NTT DOCOMO Center
Teijin Institute for Bio-Medical Research
(Hino, Tokyo)
Home Healthcare Medical Devices
[In-Licensed]
[Out-Licensed]
Product
Licenser’s Name
Product
Licenser’s Name
Hi-Sanso PortableTM
SAFHS ®
Air Watch®
AirSep
Hi-SansoTM
2U/3R/3N
Yuyu Teijin Medicare Inc.
NIP NASAL®/SLEEPMATE®/
AutoSet
REMstar ®/Alice
MORPHEUS ®/
SLEEPWATCHER ®
WalkAide
®
Bioventus
iMetrikus
ResMed
Philips Respironics
Compumedics
Innovative Neurotronics
Pharmaceuticals
[In-Licensed]
Product
[Out-Licensed]
Licenser’s Name
Mucosolvan®
Spiropent ®
Atrovent ®
Laxoberon®
Bonalon®/Teiroc®
Alvesco®
Tricor ®
Synvisc®
Product
Licenser’s Name
Alfacalcidol
Ilsung, Minapharm, Martin Dow,
Astellas Pharma, Hind Wing,
Berli Jucker, DIPA, Pharmacon,
Somedico, Chanhduc, Sea Lion
Tacalcitol
Isdin/Esteve, Merck Sante,
Abiogen, Almirall Hermal, Ilsung,
Profex, Martin Dow
Nasal formulation
technology
Takeda Pharmaceuticals
International
Boehringer Ingelheim
Merck & Co.
Takeda (Germany)
Fournier, ASKA
Sanofi
®
Somatuline
PHA (ITM-058)*
Ipsen
Production technology for
whooping cough vaccine
GlaxoSmithKline Biologicals,
Sanofi Pasteur
CRTh2 antagonist (PTR-36)*
Pulmagen
Febuxostat
(TMX-67)
Takeda Pharmaceuticals U.S.A.,
Ipsen, SK Chemicals,
Astellas Pharma, Menarini,
Algorithm, Neopharm
Others
Rottapharm, Angelini, Dong Wha,
Shanghai Pharmaceuticals
*In development
Transmission
Oxygen
concentrator
Patient’s Home
Information Center
Dispatching Researchers to
Top Labs of Cutting
Edge Research
Bio-Medical Engineering Laboratories
(Hino, Tokyo)
Teijin Pharma continuously sends researchers to collaborate with venture businesses, universities
and research institutions abroad. Our researchers, who have accumulated extensive overseas
experience, also actively work on global partnership projects. Talented scientists from around the
world gather at top-notch, cutting-edge laboratories, and the relationships formed during their stay
provide our researchers with a scientific network, leading to valuable information exchange for
research activities. Moreover, leading scientists from both Japan and overseas, including Teijin
Group Distinguished Fellow Dr. Ei-ichi Negishi, Teijin alumnus and 2010 Nobel Prize Laureate in
Chemistry, provide research and technical strategy guidance on a regular basis. Receiving direct
advice from front-line scientists is a powerful motivator for Teijin Pharma researchers.
• TEIJIN PHARMA •15
In Pursuit of a Better
etter Production System for
Exceptional Product Quality andd a Stable Supply
In order to contribute to patients’ quality of life, we are constantly working to
improve our production process in order to efficiently produce a stable supply of
high-quality pharmaceuticals and medical devices.
Establishment of Seamless
Technology from the R&D Stage
to Production
INDUSTRIAL
TECHNOLOGY
As a pharmaceutical project moves from
the R&D stage to trial product production
and then full-scale manufacturing, the
production process requires an expansion
of scale and the establishment of the ideal
production system. In order to deliver
high-quality pharmaceuticals to patients as
quickly as possible, research facilities,
technological development departments
and production factories work in close
contact to implement manufacturing
technology that is both fast and accurate.
Iwakuni Pharmaceutical Factory
mented a system to assure product
quality that conforms to the Good
Manufacturing Practice quality control
standards used worldwide.
Improving Product Quality through
Tie-Ups with the World’s Top
Manufacturers
The Importance of Supply Stability
In the production of medical devices as
well, Teijin Pharma is dedicated to using
the same high standards for product
quality as are used in the production of
pharmaceuticals. We are confident that our
focus on product quality in medical devices
is second to none. Not only are quality
assurance activities implemented in our
own factories, but we also make regular
visits to the factories of our subcontractors
who supply parts and products, allowing us
to verify processes and quality. Feedback
from Teijin Pharma contributes to the
improved product quality of our suppliers,
as well as a stronger relationship of trust.
It is the mission of Teijin Pharma to
provide patients with a stable supply of
the medical products they need. As part of
our efforts, we have implemented a
system for sourcing materials from
multiple vendors whenever possible.
Additionally, we have adopted a Business
Continuity Plan that will help us maintain
our production system even in emergency
situations, such as following an
earthquake or other natural disasters.
Proactive Research on New Manufacturing Technology and Systems
for Ensuring Product Quality
Shift to Overseas Production
and Development as
Part of Our Global Strategy
Creating an Optimized Assembly
System from the Ground Up
In the medical devices production
process, the human element has a
tremendous impact on product quality. To
achieve a “dedication-to-quality” mindset
among manufacturing employees, we
have implemented a consulting system for
the production lines. Backed by specific
advice from experts, factory employees
have started taking independent action to
improve their operational environment,
including implementing more effective
ways to assemble products and use tools.
Such “Kaizen” efforts have led to constant
improvements in line operations.
Production of oxygen concentration units utilizes the cell
production method. Every effort has been made to
improve the production environment, including the
introduction of touch panels to display operational steps
and quality requirements. Additionally, workstations can
be adjusted to match the height of employees. Quality
inspections of products from subcontractors are also
conducted here.
Chemical technology and manufacturing
technology are progressing day by day,
and accreditation systems for product
quality also continue to evolve. At Teijin
Pharma, we have established a system for
implementing cutting-edge technology and
assuring product quality, with the goal of
providing a stable supply of high-quality
pharmaceuticals. We have also imple-
To prevent product contamination and to boost productivity, Laxoberon (above) is produced on a fully automated,
dedicated production line from the materials mixing stage to packaging. A state-of-the-art inspection machine has
been added to the packaging line for further improvements in quality control. We also place top priority on creating
an environment where employees can produce pharmaceutical products safely.
Iwakuni Medical Factory
The new drug febuxostat is expected to play a key role in boosting Teijin Pharma’s role in the global
market. In order to attain a stable supply of this product, we are establishing supply chains in
multiple locations. In the Home Healthcare business, we have begun operations in earnest in the
US, Spain and Korea, allowing us to obtain a firm grasp of local needs. The next step will be to
determine how to promote Teijin Pharma to our greatest advantage with our subsidiaries and
providers in each of these countries. In order to provide the most appropriate support in each
region, we need to establish production and research bases overseas as well, rather than simply
provide products and information from Japan. In our two core businesses of Pharmaceutical and
Home Healthcare, Teijin Pharma is poised to take the next step: the globalization of production.
CUSTOMER &
MARKET SERVICES
Providing Better Solutions through
the Synergistic Effects of Our Two
Businesses
The collaboration between our Pharmaceutical and Home Healthcare businesses
began with the integration of sales offices,
which not only created an environment
that facilitated information exchange, but
also improved communication among
employees. Particularly in the field of
cardiovascular and metabolic diseases,
Gathering Information from the Field
and Providing Appropriate Product
Usage Information to the Market
Developing Comprehensive Services
that Prove Our Worth as a Member of
the Medical Team
Drawing on the advantages of our two specialty
Pharmaceutical and Home Healthcare businesses, we are
maximizing the synergistic effects of these two businesses,
while placing a strong emphasis on knowledge and
communication, essential skills for on-site healthcare.
Developing Professional Staff
Who Are Innovative Thinkers
On the frontline of Teijin Pharma sales
activities are 750 medical representatives
(MRs) in the Pharmaceutical business and
350 field representatives in the Home
Healthcare business. We place top
priority on educating these 1,100
individuals to develop a truly professional
team that can recommend the most
effective uses for pharmaceuticals and
medical devices, including diagnostic and
treatment methods. Our home healthcare
sales staff are composed of certified
MRs. In the future, we plan to rotate
sales staff between our two core
businesses and foster human resources
who are highly capable of recommending
both pharmaceuticals and medical
devices.
To increase the effectiveness, safety and
quality of pharmaceutical products, it is
essential to obtain field data from clinical
usage following market launch. At Teijin
Pharma, product managers handle all the
information related to products obtained
from specialists in each field, healthcare
specialists and patients. The information
needed for proper product usage is
provided to all medical personnel through
close cooperation between drug development, product development, technology
and sales divisions. We are also proactively compiling evidence required for
proper product usage.
staff from both businesses work together
to organize joint lectures and symposia,
and also work in tandem when conducting
explanatory meetings at medical offices.
By providing information from two
different perspectives, Teijin Pharma
employees are able to provide a greater
wealth of information, which not only
broadens the range of treatment options
but also allows for the discovery of more
ideal medical solutions.
By jointly conducting lectures and symposia, employees from Teijin
Pharma’s two core businesses are able to provide participants with a
wider range of information.
Customer Centers for HOT, CPAP
Devices and SAFHS®
Our Top Priority: Improving
Patients’ Quality of Life
Teijin Pharma set up Customer Centers in
Fukuoka and Osaka to enhance our
support system in the Home Healthcare
business. In addition to specialized
operators who respond to questions and
concerns regarding HOT, CPAP devices
and SAFHS, permanent members of staff
who possess extensive knowledge and
experience, including former sales staff
members, provide additional guidance and
respond to difficult inquiries. A 24-hour,
365-day system has been set up to
provide HOT support, with dedicated
phone lines for oxygen cylinder orders.
The proper, continuous use of medical
equipment is a key in preventing
re-hospitalization, and thus can be
considered essential for improving
patients’ quality of life. As such, Teijin
Pharma implements a wide range of
support activities to ease patients’ minds
and help them maintain a normal lifestyle.
We recognize that initial support during
installation of equipment is the key to
encouraging proper and continuous usage.
For HOT units, this guidance is provided
by Teijin Pharma nurses, who visit the
patient’s home and provides detailed
instruction. We also provide phone
support for CPAP devices and travel
support services when needed.
Customer center staff members respond to inquiries and emergency
situations.
Support is tailored to meet the needs of individual patients,
improving their quality of life.
Home Healthcare Team Organization
Our team, which is comprised of sales staff, home care
staff, nurses, laboratory technicians and office staff,
provides support to home healthcare professionals and
patients. Sales staff are certified as MRs, while home care
staff, who are tasked with setting up and checking
equipment, are required to undergo training and in-house
technical accreditation. Nurses are responsible for
inspecting equipment usage and status at patients’ homes,
and laboratory technicians, as SAS professionals, handle
support for medical institutions and education for our staff.
Nurses
Home
care staff
Sales
staff
Laboratory
technicians
Information from doctors helps improve the safety and effectiveness
of pharmaceutical products.
Office
staff
Training System for Medical Representatives (MRs)
To ensure MRs are of the standard they should be, Teijin Pharma continues building an MR training and
professional development program designed to meet the needs of patients and medical personnel
through MRs able to effectively provide information. Upon entering the company, new MRs are
provided with introductory training spanning several months tailored to their experience and abilities. All
MRs are required to attend monthly training sessions to obtain the latest industry information. We also
offer a wide range of training based on years of work experience, particular products and selected
institutions. To raise the effectiveness of on the job training, Teijin Pharma places great emphasis on the
training of supervisors and tutors, who mentor and guide their junior counterparts.
Emergency Response System Leads to Enhanced
Security and Trust
Teijin Pharma has created an Emergency Response Manual based on our experiences
in emergency response. In the event of a natural disaster or other emergencies, the
Emergency Response Support IT System quickly compiles patient data. Patients can
enjoy extra peace of mind knowing that response staff and spare oxygen cylinders are
available at our service offices nationwide.
Delivery of oxygen cylinders commenced the day after the Tohoku earthquake in March
2011. Within two days, the oxygen cylinders had arrived in Sendai, with oxygen
concentrators swiftly delivered to northern Japan for use at evacuation shelters with
electric power or to replace damaged concentrators.
REGULATORY COMPLIANCE
Unified Management by
Using a Global Database
on Drug-related Side
Effects
In full compliance with pharmaceutical
laws, Teijin Pharma proactively compiles
data on adverse drug reactions from
medical institutions and partner companies in Japan and abroad, as well as from
published articles. The collected data is
compiled by the relevant division, and is
stored in a database to share with our
main partner companies from around the
world. Through this process, we are
investigating all information regarding the
safety and side effects of the products we
produce and providing safety information
around the world.
Safety and Quality Management System for Reliability Assurance for Pharmaceuticals and
Medical Devices (Following Market Launch)
Teijin Pharma
Compliance
Information
Medical institutions /
consumers (domestic)
We Place Utmost Priority on Safety
fety and
Product
ct Quality
Q lity Assurance
As
ce
At Teijin Pharma, we are serious about our commitment to
compliance. An independent division under direct control of the
president provides on-site support and is responsible for auditing
and assessing product liability and quality assurance. Following
market launch, we carry out research and regulatory compliance by
compiling and managing information regarding the quality and side
effects of our products.
Product Liability Assessment and
Quality Assurance Begins at the
R&D Stage
Not only does Teijin Pharma strictly
comply with laws, regulations and other
official standards, we impose our own
strict corporate rules to ensure compliance. As part of our regulations in the area
of R&D management, we have implemented the Teijin Group Product Liability
Assessment and Quality Assurance
(PLQA) System, which functions as a
quality assurance system for the research
General
Supervisor
Decisions on
compliance
action
Collection /
transmission
of data
Report
Instruction
Safety Dept.
Quality Dept.
Sales offices
Customer
service center
Partner companies
(domestic/overseas)
Literature
MHLW
PMDA
Overseas:
FDA, EMA
FDA: Food and Drug Administration
EMEA: European Medicines Agency
Sales and Compliance for
Febuxostat Go Global
and development stage. Evidence must
be submitted for each aspect of R&D, and
approval by the Compliance Division is
only granted after the reliability of the data
provided has been confirmed. Leading
issues discussed at internal decisionmaking meeting must receive approval of
PLQA assessment. This robust system of
checks creates a solid foundation for
assuring quality and reliability.
Reporting
Compliance Division
Efficacy
ac • Safety/Quality/
Safet /Q ali
Proper usage information
With the launch of our new drug febuxostat, we have expanded our network
from the US and EU to all corners of the globe. Similar to the domestic market,
risks in the global market include legal risks, product quality risks and safety
risks. However, individual risks vary depending on the country and region, and
thus it is essential to acquire the skills and information needed to handle risk
management and response in each region. One absolute requirement for
overseas risk management is to create partnerships with companies who are
committed to the implementation of quality and safety assurances. We must
also develop a system for the continuous monitoring of risk management
activity implementation by these partners. For PLQA assessment as well, it is
essential to monitor the risk management and risk response capabilities of our
partners around the world. In line with the global launch of febuxostat, we are
developing a true system of global compliance.
CORPORATE SOCIAL
RESPONSIBILITY
We Are Committed to CSR Activities, with Environmental
Stewardship as One of Our Leading Themes
As a corporation dealing with products that are directly linked to patients’ lives, we are fully aware
of the tremendous importance of conducting corporate social responsibility (CSR) activities.
Following the CSR Basic Policy of the Teijin Group, we are striving to contribute to the creation of a
sustainable society, strengthening our efforts to achieve environmental preservation and
environment-friendly design in the pharmaceuticals and medical devices we produce, from R&D to
manufacturing, sales and disposal.
Reducing the Environmental Burden
of Each of Our Business Divisions
In order to reduce CO2 emissions in the
manufacturing process, we have
introduced separate air conditioning units
and high-efficiency production systems
per production line in the clean rooms
where pharmaceuticals and medical
devices are produced. We have also taken
steps to redesign our packaging to reduce
waste. By replacing standard corporate
cars with hybrid cars and compact cars,
we are further reducing CO2 emissions
and fuel consumption.
Commitment to Environmentfriendly Design Leads to
Outstanding Eco Products
In addition to creating people-friendly
products that have universal designs, Teijin
Pharma is redesigning all products to be
more compact and energy-saving, while
achieving a reduced environmental burden
over the product life cycle through
improved longevity and recyclability. One
of Teijin Pharma’s Eco-Products is the
Hi-Sanso 7R oxygen concentrator, which
features not only a more compact design,
but also offers improved operability and
more energy-efficient performance.
Hi-SansoTM 7R
Efforts in and Impact of Teijin Group CSR Management
The Teijin Group’s commitment to CSR began in 1993 with the
establishment of a corporate philosophy which advocates “Enhancing the quality of life through a deep insight into human nature and
needs,” “Growing and evolving in harmony with society” and
“Empowering our people.” In order to fulfill these goals, we
established a basic policy for CSR, promoting the systematic
implementation of CSR activities throughout the organization. In
April 2005, a Group CSR Officer position was created, and shortand medium-term goals were established for key CSR issues, such
as compliance, risk management, ESH (environment, safety and
health), social contributions and so forth, dividing these topics into
the three categories of Basic CSR, Expansive CSR and Selective
CSR. We also clarified CSR responsibilities and implemented
activities that could be put into practice. In March 2011, we
announced our participation in the United Nations Global Compact,
a voluntary program that encourages businesses to comply with
principles in the areas of human rights, labor, environment and
anti-corruption. The CSR activities of the Teijin Group have received
high marks internationally, as indicated by inclusion in the Dow
Jones Sustainability Index, the FTSE4Good Index Series, and the
Ethibel’s Investment Register.

- Teijin Pharma Limited

Transcription

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