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Domestic News - January 2011
Biocon's trials of oral insulin fails primary test
Biocon said that the tests conducted for its experimental oral insulin, IN-105,
have not met their primary end point. The company may continue its
development with a global partner. Initial data analysis of the test showed
that IN-105 did not meet its primary end point of lowering HbA1c levels by
0.7%, compared to a placebo. HbA1c is a test that measures the amount of
glycated haemoglobin in the blood. Glycated haemoglobin levels indicate the
effectiveness of a drug to control blood sugar levels. On secondary safety
endpoints, IN-105 showed excellent overall safety profile with no incidence of
serious adverse events, Biocon said in a statement. Kiran Mazumdar-Shaw,
managing director and chairman, said, “Biocon is committed to continue its
global development of IN-105 in partnership with a global pharmaceutical
partner.”
Wockhardt to demerge nutrition biz of Vinton Healthcare
The Board of Directors of Wockhardt Ltd. at its meeting held on January 12,
has considered and approved a Scheme of Arrangement in the nature of
Demerger of nutrition business of Vinton Healthcare Limited, a wholly owned
subsidiary of the Company into Wockhardt Limited with effect from the
appointed date January 01, 2011. As Vinton Healthcare Limited is a wholly
owned subsidiary of the Company, no shares would be issued by the
Company pursuant to the aforesaid Scheme of Demerger. The said scheme of
Arrangement in the nature of Demerger shall be subject to the approval of
shareholders of the Vinton Healthcare Limited, the approval of Jurisdictional
High Court in which Demerged Company is situated and requisite consent
and approval of the statutory and regulatory authorities as may be required
for the implementation of the scheme.
Aurobindo Pharma to divest in Aurobindo (Dalong) Bio Pharma
Aurobindo Pharma Ltd has announced that it has entered into agreement
with China National Pharmaceutical Group Corporation (Sinopharm) to divest
in its subsidiary company Aurobindo (Dalong) Bio Pharma Co Ltd, China,
subject to regulatory approvals. Sinopharm will acquire the shares through
its subsidiary company Sinopharm Weiqida Pharmaceutical Co Ltd. ADBPL is
engaged in manufacturing of 6APA, a derivative of Penicillin-G & most of its
production is consumed by APL, India. In past the performance of ADBPCL
has been affected due to economies of scale and is incurring losses. After
acquisition of 51% equity in ADBPL, the investors will further infuse capital to
enhance its shareholding to 80.50%, reducing APL share in the JV to 19.5%.
APL’s loan of US$23mn to ADBPL will entirely be paid back. Sinopharm group
will infuse sufficient funds to relocate plant as required by local government
in China and significantly enhance capacity and downstream products leading
to better economies of scale and reduced cost of production. Read More
Rewind 2011
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Fortis Healthcare to set up dialysis and diagnostic centres: report
Fortis Healthcare reportedly plans to set up standalone dialysis and
diagnostic centres across cities. To start with, it will have 50 dialysis centres
in a year from now. The first of it will be up and operational in NCR by March
this year. According to reports, Each centre will cost anywhere between Rs.
60 and Rs. 80 lakh. Fortis, is also on the lookout to expand in the South. The
company is aggressively looking at expanding its footprint in Tamil Nadu,
Kerala and Andhra Pradesh, either through acquisition or greenfield
properties.
Glenmark gets final USFDA nod for atovaquone, proguanil
hydrochloride tablets
Glenmark Generics Inc., USA (GGI), the United States subsidiary of
Glenmark Generics Limited (GGL), announced they have been granted final
approval for their Abbreviated New Drug Application (ANDA) from the United
Yearly Industry Newsletter
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States Food and Drug Administration (U.S. FDA) for atovaquone and
proguanil hydrochloride 250mg/100mg tablets, their generic version of GSK’s
Malarone tablets. In April 2010, the Company confirmed the settlement of
litigation pending between Glenmark and GlaxoSmithKline LLC (GSK) over
patent actions concerning atovaquone and proguanil hydrochloride
250mg/100mg tablets. Under the terms of the Settlement Agreements
Glenmark will be able to market and distribute its atovaquone / proguanil
250mg/100mg tablets under a royalty-bearing license from GSK in the 3rd
quarter of calendar year 2011, or earlier under certain circumstances.
Glenmark believes that it is entitled to 180 days of exclusivity with respect to
its atovaquone / proguanil 250 mg/100mg tablets as the first generic to file
an ANDA for the product. GSK currently markets its product as Malarone in
the United States, indicated for the prevention and treatment of malaria.
Total U.S. sales as reported by IMS Health for the 12 month period ending
December 2009 were approximately US$56mn. Read More
Sanofi and Abbott win Tarka trial against Glenmark
Sanofi-Aventis SA and Abbott Laboratories won a U.S. jury trial seeking to
halt sales of Glenmark’s copy of their hypertension medicine Tarka. The
federal jury in New Jersey has rejected Glenmark's challenge to the validity
of a Sanofi patent that expires in February 2015. Glenmark had argued that
the patent covered an invention that was protected by an expired patent. The
court has also ordered Glenmark to pay damages of US$16mn (about Rs.
730mn) to compensate for the loss of profits for Abbott (that markets the
drug in the US) till end December 2010. Abbott had demanded a higher
compensation of about US$25mn (about Rs. 1.15bn). Generic Tarka was
launched by Glenmark in June 2010 after the US District Court refused to
issue an injunction against its launch (as placed by Sanofi and Abbott). Tarka
tablets had achieved sales of US$64mn (about Rs. 2.94bn) for the 12-month
period ending September 2009, according to IMS.
Dr. Reddy's launches Pantoprazole Sodium Delayed released tablets
Dr. Reddy's Laboratories announced that it has launched Pantoprazole
Sodium Delayed released tablets (20mg and 40mg), a bioequavalent generic
version of Protonix tablets in the US market. The Food & Drug Administration
(FDA) approved Dr. Reddy's ANDA for Pantoprazole Sodium delayedreleased tablets on January 19, 2011. Pantoprazole Sodium Delayed released
tablets had total U.S sales of approximately US1.8bn for the twelve months
ending September 30, 2010 according to IMS Health. Both strengths of Dr.
Reddy's Pantoprazole Sodium Delayed-release tablets are available in 90
count bottles.
Strides Arcolab arm signs agreement with BioChimico
Strides Arcolab Ltd has announced that its wholly owned subsidiary Agila
Specialities has signed an agreement with BioChimico of Brazil to set up a
joint venture for the Brazilian hospital market in which BioChimico and Agila
will transfer selected Brazilian IPs to the joint venture to market products
jointly.
Strides Arcolab gets USFDA nod for Adenosine injection USP
Strides Arcolab Ltd. announced that the USFDA has granted approval for an
additional package size of Adenosine Injection, USP, 3mg/MI packaged in 12
mg/ 4 mL single-dose vials. The product will be launched upon expiry of
applicable innovator patents. September 2010 IMS data indicates that the US
innovator market for Adenosine presentations approximated US$94mn.
Strides had, 2010, received approval for Adenosine Injection 60 mg per 20
mL and 90 mg per 30 mL vials. The product will be launche under the
partnership between Strides and Sagent Pharmaceuticals wherein Strides is
developing and supplying more than 25 injectable products for the US market
which is marketed by Sagent.
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R5 Pharma to create new facilities: report
R5 Pharmaceuticals is reportedly set to double the size of its site and create
new facilities, to introduce new services to its current provision, in 2011.
According to reports, under the plan, R5 Pharma, a subsidiary of Aesica
Pharmaceuticals, plans to build a new analytical chemistry laboratory this
spring with the second stage of construction completing in the second half of
2011. The R5 expansion follows Aesica's recent announcement in December
2010 that it had acquired three manufacturing sites in Europe, almost
doubling its workforce.
Cipla denies stake sale news...Terms it as rumours
Cipla Ltd. denied that the promoters
of the company are in talks with
foreign drugmakers for a stake sale.
Cipla said that it had received a query
from a financial newspaper regarding
stake
sale
by
the
company's
promoters. In this connection, the
Company had categorically denied the
news vide letter dated December 20,
2010. Cipla said that it would once
again like to reiterate that these rumours are absolutely baseless and are
purely speculative in nature. The promoters have no intention whatsoever to
go for any stake sale. Earlier, a business daily reported that the promoters of
Cipla are in talks to sell their stake to a global pharmaceutical company. The
report stated that Cipla has appointed Kotak Mahindra Bank as the merchant
banker for the deal and may conclude a deal some time this year. Cipla's
talks with Germany's Merck KGaA are believed to be at an advanced stage. It
may be recalled that Ranbaxy promoters sold their stake to Japan's Daiichi
Sankyo and Piramal Healthcare promoters sold the domestic formulations
business to US-based Abbott Labs.
Ranbaxy CFO Omesh Sethi resigns
Ranbaxy
Laboratories
Ltd
has
announced
that
Omesh
Sethi,
President & Chief Financial Officer has
resigned from the services of the
Company, with effect from January 25
, 2011. This is the second exit by a
top Ranbaxy official in five months,
after former Chief Executive Officer
Atul Sobti quit in August. Sethi joined
Ranbaxy in 1989 and has made a
significant contribution to improve its financial performance and also was
involved in mergers and acquisitions, Ranbaxy said in a statement. Sobti said
on Aug. 12 that he quit because of disagreements with Daiichi Sankyo,
Japan’s third-largest drugmaker, over the future course for Ranbaxy. Arun
Sawhney replaced Sobti as Managing Director. The Company is yet to name a
new CEO.
Cadila and Bayer to set up new JV in India
Bayer HealthCare and Zydus Cadila ("Zydus") signed an agreement to set up
the Joint Venture Company Bayer Zydus Pharma for the sales and marketing
of pharmaceutical products in India. Each party will hold 50 percent of the
shares of Bayer Zydus Pharma, headquartered in Mumbai, and be equally
represented on its management board. Bayer Zydus Pharma will start
operations with Bayer HealthCare’s Pharmaceutical Division contributing its
existing sales and marketing business in India to the new company, and
Zydus contributing its women’s healthcare products, diagnostic imaging
business and other products.
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Bayer Zydus Pharma will operate in key segments of the Indian
pharmaceuticals market with a focus on: women’s healthcare, metabolic
disorders, diagnostic imaging, cardiovascular diseases, anti-diabetic
treatments and oncology. In addition to Bayer HealthCare’s currently existing
pharmaceutical product portfolio in India, the Joint Venture is also intended
to focus on the sales and marketing of future patented pipeline
pharmaceutical products. Both Bayer HealthCare and Zydus will supply the
Joint Venture with products sourced from its manufacturing operations at
existing locations. Read More
Aurobindo gets tentative USFDA nod for Levofloxacin
Aurobindo Pharma Limited is pleased to
announce that the company has
received tentative approval from the US
Food
&
Drug
Administration
to
manufacture and market Levofloxacin
tablets 250mg, 500mg and 750mg.
Aurobindo would launch the product
immediately after final approval.
Opto Circuits arm gets US Military certification
Opto Circuits (India) Limited’s US-based
subsidiary, Cardiac Science Corporation,
a global leader in automated external
defibrillator
(AED)
and
diagnostic
cardiac monitoring devices, has been
awarded Airworthiness Release (AWR)
from the U.S. Army’s Research,
Development,
and
Engineering
Command for the Powerheart® AED G3
Pro® automated defibrillator. The
certification indicates the Powerheart AED G3 Pro complies with U.S.
Department of Defense medical device certification criteria and is tested for
use in air, sea, and land operations.
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International News - January 2011
Genzyme cuts outlook amid Sanofi merger talks
Genzyme Corp. reported today that discussions between its financial advisors
and financial advisors for Sanofi-Aventis are continuing and have expanded
to include representatives of both companies. These discussions have
focused on potential terms for a negotiated transaction and have included the
possible use of a contingent value right relating to alemtuzumab as part of
any potential resolution of differences with respect to value. Genzyme can
provide no assurance that these discussions will continue or will result in a
transaction. It also can provide no assurance of the terms that may be
obtained in any such transaction.
Elite Pharma inks pact with Hi-Tech Pharma: report
Elite Pharmaceuticals is reportedly set to develop an intermediate for a
generic version of Hi-Tech Pharmacal's prescription product and will then
incorporate into a final product, under an agreement signed between the
companies. Under the agreement Hi-Tech Pharmacal will be responsible for
submitting the abbreviated new drug application (ANDA) for the finished
product, which will be filed under Hi-Tech Pharmacal's name. According to
reports, Elite will take up the manufacturing responsibility of the intermediate
product; however Hi-Tech Pharmacal will manufacture the finished product
and will also take care of the sales and marketing of the final product. Upon
commercialization, Hi-Tech Pharmacal will pay for the manufacturing of the
intermediate product and a percentage of the profits generated from the sale
of the product to Elite, adds report.
Spectrum Pharma inks pact with Viropro
Spectrum Pharmaceuticals Inc. announced the signing of a letter of
agreement with Viropro Inc., for the development of a biosimilar version of
the monoclonal antibody drug rituximab. Worldwide sales of rituximab in
2009 in all indications, including non-Hodgkin's lymphoma and chronic
lymphocytic lymphoma, were around US$5.6bn.
EyeGate Pharma secures additional US$5.9mn as part of Series D
closing
EyeGate Pharma, a privately held venture-backed pharmaceutical company
developing ocular therapeutics, announces that it has secured an additional
US$5.9mn as part of its Series D closing. With this additional tranche,
Eyegate has raised a total of US$28.5mn in Series D funding to date. The
funds will be used to continue development of EGP-437 for the treatment of
Dry Eye Syndrome (DES), an ocular surface irritation affecting several million
men and women in the United States. EGP-437 is a dexamethasone derived
corticosteroid solution specially formulated for delivery using the EyeGate II
Delivery System. EGP-437 is part of EyeGate's broader strategy of
developing a pipeline of medicines for treating ocular diseases using its
proprietary EyeGate II Delivery System, a non-invasive, iontophoretic drug
delivery system.
Watson Pharma's arm gets USFDA nod for generic Fentora
Watson Pharmaceuticals, Inc. announced that its subsidiary, Watson
Laboratories, Inc. has received U.S. Food and Drug Administration approval
for the generic equivalent to Cephalon, Inc.'s Fentora tablets. The FDA
approved Watson's Fentanyl Citrate Buccal tablets in the 100 mcg, 200 mcg,
300 mcg, 400 mcg and 800 mcg strengths.
Optimer Pharma appoints key additions to management team
Optimer Pharmaceuticals, Inc. announced the appointment of Linda Amper,
Ph.D., as Senior Vice President of Human Resources, Hemal Shah as Senior
Vice President of Health, Economics & Outcomes Research (HEOR), and John
Womelsdorf, Ph.D., as Vice President of Business Development. These key
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positions will strengthen the management team as the Company prepares to
become a commercial organization and prepares for the potential launch of
its lead product candidate, fidaxomicin.
Endo Pharma inks pact with Orion Corp: report
Endo Pharmaceuticals reportedly reached a collaboration agreement with
Orion Corp. for the discovery, development and commercialization of assets
in Oncology. The formation of the R&D collaboration partnership allows the
companies to bring forward a total of eight "discovery phase" candidates by
combining an equal number of programs.
Teva Pharma and APP Pharma launch Gemcitabine HCI for Injection:
report
Teva Pharmaceutical Industries Ltd. and APP Pharmaceuticals, Inc. reportedly
announced the commercial launch of Gemcitabine HCI for Injection in 200
mg and 1 g single dose vials, the generic version of Gemzar, in the United
States, pursuant to a commercialization, manufacture and supply agreement
signed by the two companies.
Glaxo suspends US ad for Levitra: report
GlaxoSmithKline
PLC
has
reportedly
suspended
U.S.
television
advertisements for anti-impotence pill Levitra. Deirdre Connelly, president of
Glaxo's North American pharmaceuticals unit, was quoted as saying that the
company has stepped up its commitment to operate with integrity, to be
more respectful of patients and more transparent in how it conducts
business.
USFDA denies approval GSK's Avodart: report
USFDA reportedly declined to approve GlaxoSmithKline, Avodart as a cancer
preventative which is currently marketed to treat benign prostatic
hyperplasia. An approval would have allowed GSK to aim Avodart at the
estimated 1 mn men at higher risk of prostate cancer, which could have
added up to US$1bn to its sales.
Novartis to acquire Genoptix: report
Novartis AG is reportedly strengthening its personalized medicine and cancer
portfolio with the US$470mn buy of U.S. cancer diagnostics company
Genoptix. The deal, which comes after Novartis's US$52 bn purchase of U.S.
eyecare group Alcon Inc, shows Novartis still has the financial clout to clinch
smaller deals as it seeks to drive growth in its five main units
pharmaceuticals, consumer health, eyecare, generic drugs and vaccines and
diagnostics.
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Domestic News - February 2011
Sun Pharma announces USFDA approval for generic Razadyne ER
Sun Pharmaceutical Industries Ltd.
announced that USFDA has granted
its subsidiary an approval for an
Abbreviated New Drug Application
(ANDA) to market a generic version
of
Razadyne
ER,
galantamine
hydrobromide
extended-release
capsules. These generic galantamine
hydrobromide
extended-release
capsules, 8 mg (base), 16 mg
(base) and 24 mg (base) are
indicated in the treatment of mild to moderate dementia of the Alzheimer’s
type. Razadyne ER has annual sale of approximately US$50mn in the US.
Venus Remedies GEMCITABINE gets UK MHRA approval
Venus Remedies Limited, a leading research based Indian pharmaceutical
company achieved yet another landmark by receiving the Market
Authorisation for GEMCITABINE, one of the key products for the treatment of
Cancer via de-centralised procedure from Medicine and Healthcare
Regulatory Agency (MHRA) U.K. The other countries in the list are Poland,
Germany, Slovenia and Portugal for which the same feat has been achieved.
Pawan Chaudhary CMD Venus Remedies said, “Venus is all set to capture
substantial market share by entering the highly lucrative market of Europe as
it stands amongst the first few to receive the Market Authorisation for
Gemcitabine”. Gemcitabine is a US$1.5bn drug world wide with more than
30% market share from Europe. Read More
Opto Circuits arm bags contract for Powerheart AEDs
Cardiac Science Corporation, wholly owned subsidiary of Opto Circuits India
has been awarded a contract to deploy Powerheart AEDs in all Tyco Flow
Control facilities globally. The first phase of the rollout, planned for the first
quarter of 2011, will equip Tyco's Australian, Pacific and North and South
American facilities. Tyco Flow Control is a US$3.4B division of Tyco
International. The first phase of the rollout, planned for the first quarter of
2011, will equip Tyco’s Australian, Pacific, and North and South American
facilities. “We are proud to have been selected for Tyco’s ‘Save a Life’
program and look forward to protecting their employees against sudden
cardiac arrest,” said Dave Marver, Chief Executive Officer, Cardiac Science.
“Tyco’s decision reinforces our status as a global leader in AED technology
and services.” Read More
Dr. Reddy’s Lab deploys Salesforce CRM across 200 users
Salesforce.com, the enterprise cloud computing company, announced that
India’s second largest pharmaceutical company, Dr. Reddy’s Laboratories,
has deployed Salesforce CRM across 200 users within 60 days. Dr. Reddy’s
decided to move its Active Pharmaceutical Ingredients (API) marketing
business to the cloud in order to improve visibility into its deals pipeline,
track its end-to-end sales cycle and better analyze its sales funnel. Dr.
Reddy’s implemented Salesforce CRM with the help of IT consulting firm
Bodhtree, who used its data integration engine MIDAS to integrate with
existing Mail, Calendar, and SAP systems, By streamlining its sales business
on salesforce.com, Dr. Reddy’s expects to increase revenue by more than
30%. “We eliminated bottle necks within the sales cycle almost immediately
because of the greater visibility we gained into sales performance,” said B.V.
Srinivas, Deputy CIO, Dr. Reddy’s Laboratories. “Salesforce.com’s ability to
seamlessly integrate data captured offline with online systems, is of immense
help to our field sales team who need to track and update customer data on
regular basis but do not have access to internet connectivity at all times.
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Salesforce.com delivers all of the benefits of a world-class CRM system within
a cost-effective ‘pay as you go’ model, which fits perfectly with Dr. Reddy’s
‘quality without the cost’ ethos.”
Bayer MaterialScience inaugurates Color Competence and Design
Center in Greater Noida
Bayer MaterialScience inaugurated its Color Competence and Design Center
in Greater Noida, near New Delhi today. This new Center provides products
and solutions for polycarbonate compounds, ranging from color matching and
small-scale production, to the broad range of technical services to support
injection-molding and compounding processes. This enables customers to
adapt quickly to fast-evolving trends, and explore new options for color,
surfaces, geometries and design, while leveraging Bayer MaterialScience's
global expertise and extensive know-how of the local markets. ”Our
investment is a reflection of Bayer MaterialScience’s commitment to the India
market, as well as of our vision to further strengthen our leading position in
the polycarbonate market globally,” said Dr. Günter Hilken, Member of the
Executive Committee of Bayer MaterialScience AG and global head of the
polycarbonate business. “With our Color Competence and Design Center in
Greater Noida, we believe we are in good stead to show how Bayer
MaterialScience is delivering the best value for polycarbonate solutions in the
market.”
Ranbaxy Labs signs MOU with Government of Yaroslavl Region
Ranbaxy Laboratories Ltd and The Government of Yaroslavl Region, Russia,
has signed Memorandum of Understanding for cooperation in the field of
Healthcare and Medical Science. The major areas of cooperation are the
development of the healthcare system, new medical technologies in the
Yaroslavl region.
Aurobindo Pharma receives nod for Famciclovir Tablets
Aurobindo Pharma Ltd has received approval from the US Food and Drug
Administration to manufacture and market Famciclovir Tablets 125mg,
250mg and 500Mg. Famciclovir Tablets 125mg, 250mg and 500Mg.is the
generic version of Novartis Pharmaceuticals Corp's Famvir Tablets 125mg,
250mg and 500Mg and is indicated for the treatment of recurrent
mucocutaneous herpes simplex infections in HIV-infected patients.
Stempeutics Research gets DCGI clearance for Stempeucel
Stempeutics Research, a group company of Manipal Education & Medical
Group announced today that Drug Controller General of India (DCGI) has
granted clearance of the company’s Investigational Medicinal Product
“Stempeucel” for conducting Phase II clinical trials in patients with Osteo
Arthritis, Diabetes Mellitus – Type2, Liver Cirrhosis and Chronic Obstructive
Pulmonary Disease. Stempeucel allogeneic product is developed from
mesenchymal stem cells derived from donated bone marrow using
Stempeutics proprietary technology. Earlier the company has received
approval from DCGI for Phase I/II clinical trial for Acute Myocardial Infarction
and Critical Limb Ischemia in March 2009. Stempeutics is funded by its share
holders - Manipal Group and Cipla.
Being the first of its kind stem cell product developed in India, it took almost
15 months to get DCGI clearance. DCGI referred Stempeutics proposal to
Indian Council for Medical Research for review and recommendation. ICMR
constituted an expert stem cell committee to examine the proposal and the
committee accepted the study as Phase II clinical trials. The DCGI’s clearance
of Stempeucel product for the four debilitating diseases is one of
Stempeutics’s significant accomplishments towards its goal of bringing safe,
effective and affordable stem cell based product in India in the near future.
India becomes one of the leading countries after USA to enter this phase of
Stem Cell research.
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Nova Medical Centers expands in Delhi
Nova Medical Centers in support Max Healthcare, India’s leading Ambulatory
Surgical Center Group, today announced its expansion in Delhi by joining
hands with the historic Jeewan Mala Hospital (JMH). With this tie-up, Nova,
headquartered in Bangalore will have two centers in the NCR. In NCR, Nova
has a joint venture agreement with Max Healthcare. The first center under
this joint venture agreement with Max Healthcare was inaugurated by Shri.
Ghulam Nabi Azad, in Nov 2010 at East of Kailash.
Jeewan Mala’s immense goodwill and the experience of Dr. Malvika and Dr.
Vinay Sabharwal, coupled with Nova’s model of Ambulatory Surgeries will
provide Nova significant presence in the NCR. Dr Malavika and Vinay
Sabharwal will continue their surgical practice at NOVA and be involved in an
advisory role. They are excited to be a part of Nova’s growing network and
expansion in India. Speaking on the tie-up, Suresh Soni, CEO, Nova Medical
Centers said, “Our Medical Centers provide the very best in terms of
surgeons and surgical facilities. This collaboration with JMH shall be the
cornerstone for Nova to provide quality and affordable medical care in the
NCR.”
Natco to accept ANDA for generic version of Oseltamivir Phosphate
Natco Pharma Limited announced the acceptance of its Abbreviated New
Drug Application for the generic version of Oseltamivir Phosphate capsules.
Natco has tied up with Luxemburg based Alvogen IPCO S.a.r.l for marketing
and sale of Oseltamivir Phosphate in the USA. Natco is the first applicant to
file an ANDA for the generic version of Tamiflu and should the ANDA be
approved may be entitled to 180 days of generic market exclusivity.
Glenmark announces positive results from Crofelemer study
Glenmark announces positive results from the multi-centre study of
Crofelemer in acute watery diarrhoea in adult patients. In this multi-centre,
placebo controlled trial, resolution of diarrhoea was significantly higher in the
Crofelemer arm compared to placebo. The clinical success rate was also
greater in the Crofelemer arm compared to placebo. Crofelemer was found to
be safe with no apparent differences in adverse event profile in the
Crofelemer group compared to placebo. This trial in mild to moderate adult
patients with acute watery diarrhoea was the second proof of concept study
conducted by Glenmark with Crofelemer. Adult patients with mild to
moderate diarrhoea were dosed with Crofelemer over a period of 3 days with
a follow-up period of 30 days. This was a 3 arm drug vs placebo study which
included a 125 mg, 250 mg and a 500 mg dose of Crofelemer. Overall
Crofelemer showed superiority to the placebo arm. For the efficacy
parameter of stool frequency, there was a significant difference in the
reduction of number of stools per day during 3 days of treatment period
between both the lowest and highest Crofelemer doses versus Placebo. Read
More
AstraZeneca and Taj launch Gemcitabine HCI for Injection: report
AstraZeneca Pharmaceuticals and Taj Pharmaceuticals, have commercially
launched Gemcitabine HCI for Injection in 200 mg and 1 g single dose vials
in the US. According to reports, Gemcitabine HCI for Injection, the generic
version of Gemcitabine HCI, was launched pursuant to a commercialization,
manufacture and supply agreement signed by AstraZeneca and Taj
Pharmaceuticals. As per the agreement, AstraZeneca will manufacture
Gemcitabine HCI for Injection and will receive a license to market the product
within the India-based firm's 180-day exclusivity. Taj Pharma will get a
royalty during the manufacturing period.
Ankur Drugs sets up facility at Himachal Pradesh
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Ankur Drugs and Pharma Ltd has set up a stat of the art facilities at Baddi
(Himachal Pradesh). In the quest for greater atomization and making the
facilities most technologically advanced, the cost of the project has gone up
significantly which was not envisaged. Since the project was to be completed
on or before 31st March, 2010 to avail the concessions under the Industrial
Package announced by the Central Government for the state of Himachal
Pradesh, the company could not tie up with the long term funds and it was
forced to raise funds from all available resources for completing the project.
Panacea Biotec launches PacliALL
Panacea Biotec, India’s 3rd largest biotechnology company is planning to
introduce during Indian Cancer Congress 2011 at Bhubaneswar on 12th Feb
2011; their indigenously developed Albumin bound Paclitaxel particles
formulation – PacliALL. PacliALL offers the advantage of improved safety over
conventional formulations of Paclitaxel and is meant to be used as a
chemotherapeutic agent for the treatment of Breast Cancer. PacliALL would
be made available at a price point which is approximately 50% lower than
competitive products in the domestic and global markets. PacliALL has been
developed by Panacea Biotec’s state of the art Global Research and
Development (GRAND) Centre, Navi Mumbai. Commenting on the same, Dr.
Rajesh Jain, Jt. Managing Director, Panacea Biotec Limited said “The
Objective of Panacea Biotec is to take Ideas from Grey Cells to the Market in
a Proactive Manner and establishing brand India globally in sync with its
adage “Think Medicine Think India”. Pacliall uses one of world’s most
advanced particle size optimization technology to reduce serious adverse
effects like severe anaphylaxis and sensory neuropathy associated with
conventional Paclitaxel formulations in addition to offering several patient
convenience aspects like shorter infusion time and elimination of need of
premedication. We are in line with our vision to become the Greatest, Largest
and Most Admired Biotechnology Company and we are proud to offer this
technology to the global population. Panacea Biotec will remain committed to
its mission providing the latest and most affordable preventive and
therapeutic care to people across the globe. The launch of PacliALL reflects
the hardwork of Panacea Biotec’s scientists, who worked tenaciously for the
development of this drug – Added Dr. Rajesh Jain
Cipla is Most Trusted Brand in Pharmaceutical industry in India
Cipla, one of the leading global pharmaceutical companies from India is the
‘Most Trusted Brand’ in the pharmaceutical industry in India, according to a
study by Trust Research Advisory (TRA) – a research company which
surveyed 16,000 brands across 9 cities. Speaking on this recognition, Dr. Y.
K. Hamied, Chairman and Managing Director Cipla said, “Cipla alleviates the
sufferings and saves millions of lives worldwide each day. Every individual
who experiences Cipla through its high quality drugs and devices, develops a
sense of trust for the brand. Also, our unique humanitarian approach and
integrity in functioning has helped us emerge as one of the most trusted
names across geographies.”
Commenting on Cipla’s achievement, N.
Chandramouli, CEO Trust Research Advisory & Publisher of the report said,
“Cipla has ranked as the most trusted pharmaceuticals’ brand, with overall
133rd rank among the 16,000 brands studied under this report. Trust is an
essential prerequisite for the healthcare sector and having a high Trust Index
displays intrinsic aspects like the brand’s empathy, sincerity, and
competence. “ The Brand Trust Report, India Study, 2011 is based on a
proprietary Trust Matrix developed by TRA which was used to launch a
syndicated primary research on Brand Trust across 9 cities in India covering
2310 respondents who were classified into the ‘influencer’ category.
Opto Circuits arm to deploy Powerheart AEDs at U.S Postal
Inspection Service sites
Cardiac Science Corporation, wholly owned subsidiary of Opto Circuits India
has been awarded a contract to deploy Powerheart AEDs at U.S. Postal
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Inspection Service sites across the United States. The U.S. Postal Inspection
Service is the primary law enforcement arm of the United States Postal
Service. The Powerheart AED's RescueCoach user paced voice prompsts and
CPR metronome guide resucred confidently through a stressful rescue
situation.
Vasan Health Care to establish 28 eye care centers in East, West and
North India
Vasan Health Care (VHC), one of India’s fastest growing healthcare
companies, announced its expansion plans for a Pan India operations. Vasan
Eye Care Hospital (A VHC Enterprise) which is a network of premier
institution of eye care hospitals in South India is bringing its expertise to
North, East & West. The eye care network has become the world’s largest
eye care provider according to a market assessment by Frost & Sullivan. The
chain of super specialty eye care hospitals has been making a difference to
over 6 million patients every year. With a network of over 80 eye care
hospitals, 15 Dental clinics spread across Tamil Nadu, Karnataka, Andhra
Pradesh, Kerala & Pondicherry, Vasan Health Care plans to expand its
presence Pan India.
Dr. A M Arun, Chairman and MD, Vasan Health Care, is the finalist of Ernst &
Young Entrepreneur of the Year 2011. Speaking at the conference Dr. Arun
said, “Vasan Health Care has been progressing towards bringing world-class
healthcare within the reach of every Indian citizen. We are proud to achieve
the feat of becoming the world’s largest eye care network. By June 2011,
Vasan Eye Care Hospital will be launching 28 eye care hospitals in the Cities
of Delhi (4), Kolkata (5), Mumbai (4), Surat, Ahmedabad, Baroda, Rajkot,
Nagpur, Pune, Kolhapur, Nashik, Amritsar, Jalandhar, Ludhiana, Chandigarh,
Indore, Bhopal and Bhubaneshwar. The network also is opening up its
operations in Dubai and Colombo by April 2011 and in Africa, Oman, Abu
Dhabi, Sharjah and Doha in the next couple of months.
Lincoln Pharma introduces India's first Long-Acting Paracetamol 'Pa12'
Lincoln Pharmaceuticals Ltd has announced the launch of a novel drug
delivery system in Paracetamol, Pa-12-India;s first Long-Acting Paracetamol
for Long term relief from Fever and Pain. Pa-12 contains 1000mg
paracetamol, programmed for "Non-Stop 12 hours fever control with 1 tab
only.".
Kohinoor Hospital organizes funeral procession of cigatette
Today, on the World Cancer Day, Kohinoor Hospital literally organized a
funeral procession of the deadly ‘cancer stick’ – the lethal cigarette - to deter
people from smoking and educate them about the alarming rise in the
incidence of cancer, its main causes, preventive measures to be taken and
how to fight against it. Kohinoor Hospital, a multi-specialty hospital, located
at Kohinoor City, Kurla-Vidyavihar, organized this unique campaign of a
funeral procession of the ‘cancer stick’ to strongly convey the message ‘Live
Life, Stop Smoking’.
A giant dummy of a Cigarette was erected and carried in a truck. The ‘funeral
procession’ of the giant eco-friendly cigarette dummy started from Kohinoor
Hospital, passed through Jolly Gymkhana, Ghatkopar East-West Bridge, LBS
Road towards Ghatkopar Station to culminate at Samaj Mandir Hall Ground,
opposite Pant Nagar Police Station, Ghatkopar East.
More than 150 school children from Gandhi Balmandir, Kohinoor City,
Children’s Aid Society Madhyamik Vidyalaya, Mankhurd, and S P R J K Shala,
Ghatkopar (West), and other volunteers took part in the procession. There
were continuous loud speaker announcements and banners were also
displayed to increase public awareness about the fatal dangers of smoking.
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The ecofriendly dummy of the Cigarette was finally cremated at the end of
the procession to strongly signify the death of the deadly smoking habit.
Govt bans 4 drugs: report
The Government reportedly banned four drugs, including popular antiinflammatory drug nimesulide for children, and may also prohibit domestic
sales of antibiotic gatifloxacine and tegaserod used to treat digestion
disorders. The four drugs banned by the Health Ministry were under review
by the Government for over a year. The Drug Technical Advisory Board
(DTAB), headed by the drug controller general of India (DCGI) Dr. Surinder
Singh, has reportedly examined three other drugs and may ban two of them,
The third medicine, anti-depressant deanxit may be put under review as to
whether it should also be taken off the market, according to reports.
Glenmark’s novel molecule ‘GRC 17536’ entering human trials
Glenmark Pharmaceuticals has announced that its Novel Chemical Entity
(NCE) 'GRC 17536' is entering human trials. The new NCE program is
targeting TRPA1 receptor antagonists for pain and respiratory disorders.
TRPA1 belongs to Transient Receptor Potential (TRP) family of ion channels,
which have generated a lot of interest as pain targets due to their
distinguishing role in peripheral and/or central pain signal transmission.
Glenmark has completed animal trials and Phase 1 enabling GLP studies for
its selected lead molecule, GRC 17536 and has filed the Phase 1 application
for first-in-man trial in Netherlands. Read More…
Fortis International Centre for robotic surgery to launch in India
Fortis Healthcare Ltd, India’s fastest growing hospital network, and
International Centre for Robotic Surgery (ICRS) jointly announced a state-ofthe-art robotic surgery centre, christened ‘Fortis International Centre for
Robotic Surgery’ (Fortis ICRS). Fortis ICRS centres will be set up across the
Fortis network, starting with Fortis Escorts Heart Institute in New Delhi,
followed by Mumbai, Gurgaon, Bangalore, Chennai, Kolkata and tier II cities
like Mohali and Jaipur. Fortis ICRS will bring the latest robotic surgery
procedures to patients in India at a much lower cost. It will offer the full
spectrum of robotic heart, lung, urology, gynaecology, general, head and
neck surgeries. These surgeries will be performed by highly experienced
robotic surgeons from the United States and other countries with their
support teams, in conjunction with surgical teams at Fortis hospitals. Read
More…
Venus Remedies to enter Super Specialty Oncology segment
Venus Remedies Limited, a leading research based pharmaceutical company
has announced to enter Super Specialty Oncology segment with launch of a
new dedicated sub business unit 'PASSION ONCOBIZ' with product basket of
21 products in injectable form for fighting practically all type of
cancer. Speaking on the occasion Pawan Chaudhary CMD Venus Remedies
said, “At present, the anti cancer drug segment is contributing 30% of the
total sales of the company with more than 100 Market Authorizations from 25
countries including UK, Germany, Poland, Portugal; and with the launch of
PASSION ONCOBIZ, Venus will further reinforce its industry position and
expects growth of 10%% in the market share by 2015”. Read More…
Emaar and Shamla Pharma to build pharma factory at KAEC: report
Emaar, in collaboration with Shamla Pharmaceutical Industries, is reportedly
set to build a pharmaceutical factory at the Industrial Valley in KAEC.
According to reports, the collaboration came in line with EEC's special
attention to the pharmaceutical sector primarily because of the quality of
jobs they will create and the products they will produce which in turn will
contribute to the well being of Saudi citizens. Zimmo Trading Est president
Mohammed Zimmo was quoted as saying that the alliance is the first of its
kind between 3 key industry players, setting the milestone for a major uplift
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in the pharmaceutical industry and contributing to its localization in the
Kingdom.
Ind-Swift Labs receives PMDA nod for Pioglitazone and Risedronate
Sodium
Pharma major Ind-Swift Laboratories Limited got the PMDA approval
(Pharmaceutical & Medical devices Agency) from Government of Japan for
Pioglitazone and Risedronate Sodium to be manufactured at its facilities at
Derabassi (Punjab). With this achievement it has become the first Indian
company to get Japanese Government approval without any observations.
This is a significant development in the company’s history as it is aiming at
huge exports to Japan.
Speaking on the achievement N.R. Munjal Vice Chairman cum Managing,
Director said, “The company has high regulatory standards where its facilities
are already approved by USFDA/TGA/COS/KFDA and with this approval for
Pioglitazone which is an anti diabetic drug with market size worth US$ 2.8 bn
and Risedronate Sodium a drug for Osteoporosis with market size worth US$
1.6bn, the company is aiming at capturing 15-20 per cent of the market
share of these products by 2013.” Read More….
Jyothy Lab launches Multi Insect Repellants formulations
Jyothy Laboratories Ltd announces the national launch of DEPA based Multi
Insect Repellants formulations in the form of 'Cream', 'Spray' and 'Lotion' and
'Wipes' under the brand names 'Maxo - Military' and 'Maxo - Safe & Soft', on
February 14, 2011 at a function in New Delhi.
Fortis Global Healthcare enters in Singapore
Fortis Global Healthcare has made its first foray in Singapore by acquiring an
under construction specialized Cancer Hospital in the prime Adam Road area
from First Real Estate Investment Trust, a Singapore listed healthcare real
estate company.
Fortis Healthcare group which has, within its fold, a 50 hospital network in
India, aims to complete the construction of the hospital by the second
quarter of 2012.The hospital plan is being redesigned to incorporate the
needs of the patients and the medical fraternity in Singapore. Read More…
HP accelerates transformation of healthcare
HP announced a new solution portfolio designed to deliver flexibility and
efficiency to health organizations. The new HP Digital Health solutions are
based on HP’s extensive portfolio of products, solutions and partnerships. It
enables health organizations to accelerate change and innovation, advance
operational efficiencies and orchestrate care across the ecosystem. In short,
it helps healthcare organizations become Instant-On Enterprises. Read
More…
Exemption from Service Tax will help in providing medical care at
lower costs: Gautam Khanna
Our expectations from the Union Budget come at a time when the sense of
confidence towards the growth of the Indian economy is steadily improving.
The Government’s efforts to initiate measures to control price rises, cut down
fiscal deficit, and control the inflation rate is going to be key to building that
confidence. An increase in healthcare budget allocation will help boost public
health, insurance and infrastructure. We propose the following to ensure
that we continue on the path of achievement of Affordable and Accessible
Healthcare to the Indian. India, with the right infrastructure & predictable tax
regime can emerge as an attractive destination for low-cost manufacturing.
Read More…
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International News - February 2011
Valeant Pharma to acquire PharmaSwiss: report
Valeant Pharmaceuticals International, Inc. reportedly signed a binding
agreement to acquire PharmaSwiss S.A, a privately-owned branded generics
and over-the-counter pharmaceutical company, for 350mn euros. The deal is
expected to close in the first or second quarter of 2011 and to be
immediately accretive to Valeant. According to reports, upon closing,
PharmaSwiss is expected to have approximately 38mn euros cash on hand
and no debt. The company noted that up to an additional 30 mn euros may
be payable to certain PharmaSwiss stockholders based on certain milestones.
Following the deal closure, PharmaSwiss' senior management team, including
both the founder-partners, as well as Chief Executive Officer Pavel Mirovsky,
will remain with Valeant and work closely with the Valeant Europe team.
Over time, Valeant business in Central Europe would be combined under the
PharmaSwiss corporate structure in Switzerland.
Fera Pharma launches Puralube Ophthalmic Ointment: report
Fera Pharmaceuticals has reportedly launched its over-the-counter (OTC) dry
eye treatment, Puralube Ophthalmic Ointment. Fera Pharma is launching
Puralube in a 3.5g tube as well as a carton of 20 1g tubes. Fera Pharma
president Frank DellaFera was quoted as saying that Puralube is a product
that fits perfectly with their eye care portfolio. We are so pleased to make
Puralube available again, giving patients, pharmacists and physicians a cost
effective and reliable treatment option for dry eye symptoms.
Nestle SA acquires CM&D Pharma: report
Nestle SA has reportedly acquired CM&D Pharma, a UK-based drug-maker
start-up testing a chewing gum to help kidney-disease sufferers, the first
move in the company’s effort to build a business selling food products that
targets diseases. According to reports, Nestle’s deal for CM&D Pharma Ltd, to
be announced on Wednesday, is likely the first of many for Nestle Health
Science SA, a subsidiary that opened its doors last month. Nestle confirmed
that it had made the deal but did not disclose terms.
Apax Partners,KKR may buy Blackstone's stake in Emcure Pharma:
report
Apax Partners and Kohlberg Kravis & Roberts (KKR), are in talks to acquire
Blackstone's stake in Emcure Pharmaceuticals for about US$100 mn,
according to a report. The report stated that Emcure Pharmaceuticals IPO
plan has been delayed and this may have prompted Blackstone to go for a
secondary transaction to exit the company. Emcure researches,
manufactures and markets formulations under its own brands in the domestic
market and exports its own formulations to Asia, Africa, CIS, Europe, Latin
America and the Middle East.
First China Pharma inks pact with Changzhou Pharma for Enalaprilat:
report
First China Pharmaceutical Group, Inc. has reportedly announced the signing
of a second exclusive drug distribution agreement further extending its
vertical markets and regional penetration alongside resultantly notable
revenue increases. The agreement with Changzhou Pharmaceutical Co. Ltd
(Changzhou) of Changzhou city, Jiangsu Province permits First China to act
as the exclusive distributor for the specialty drug Enalaprilat, a treatment for
high blood pressure used in the treatment of hypertension and some types of
chronic heart failure. According to reports, the product will be available to
member hospitals and clinics across China within the next 30 days. Initial
estimates target sales at over US$1mn annually with the potential for
significant growth as the company extends its market base in China.
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Pfizer to acquire Ferrosan’s consumer healthcare business
Pfizer Inc. announced that it has entered into a definitive agreement to
purchase Ferrosan’s consumer healthcare business, which includes dietary
supplements and lifestyle products, from Altor 2003 Fund GP Limited. Based
in Copenhagen, Ferrosan is an innovative and long-established consumer
healthcare company in the Nordic region with a portfolio of leading brands.
Since 1920, Ferrosan has grown to serve a broader market including Russia,
the Ukraine, Poland, Turkey and many countries throughout Central and
Eastern Europe. Read More
Kindred to acquire RehabCare
Kindred Healthcare, Inc. and RehabCare Group, Inc. jointly announced the
signing of a definitive merger agreement under which Kindred will acquire
RehabCare. Under the terms of the merger agreement, each stockholder of
RehabCare common stock will receive $26 per share in cash and 0.471 of a
share of Kindred common stock. Based upon the average value of Kindred
common stock, as defined, during the ten trading days preceding the signing
of the merger agreement, each RehabCare stockholder will receive
consideration with a current value of approximately $35 per share. Kindred
expects to issue approximately 12 million shares in connection with the
pending transaction. The aggregate value of the pending transaction
approximates $1.3 billion, including approximately $400 million of existing
indebtedness.
This transaction will create the largest post-acute healthcare services
company in the United States with over $6 billion in annual revenues and
operations in 46 states. The combined company will operate 118 long-term
acute care (“LTAC”) hospitals with 8,492 licensed beds, 226 nursing and
rehabilitation centers with 27,442 licensed beds, 121 inpatient rehabilitation
(“IRF”) hospitals (primarily hospital-based units) and 1,808 hospital, nursing
center and assisted living rehabilitation therapy services contracts across the
country. The merger agreement was unanimously approved by the Board of
Directors of both Kindred and RehabCare. Under the terms of the merger
agreement, two members of the RehabCare Board of Directors will join the
Kindred Board following consummation of the transaction. Kindred believes
the transaction will be highly accretive to earnings and operating cash flows,
exclusive of one-time items related primarily to the pending merger,
immediately upon closing. In connection with the pending transaction,
Kindred expects the combined company to achieve operating synergies of
approximately $40 million within a period of two years following
consummation of the acquisition, with $25 million expected in the first year
after closing.
Astellas signs antibiotic deal with Optimer: report
Astellas has reportedly bagged the European rights to Optimer
Pharmaceuticals' new antibiotic in a deal that could be worth over US$220mn
to the US firm. The agreement, which covers certain other countries in the
Middle East, Africa and the Commonwealth of Independent States, as well as
Europe, involves fidaxomicin for clostridium difficile infection. According to
reports, the drug is an orally-administered macrocyclic antibiotic with a new
mechanism and narrow spectrum of action, and in two Phase III trials has
proved equally effective in clinical cure when compared to vancomycin, the
only product approved by the US Food and Drug Administration for CDI.
Astellas is paying an upfront fee of US$68mn and Optimer could pocket
another US$156mn upon the achievement of certain regulatory and
commercial milestones, double-digit royalties, adds report.
Avesthagen introduces vegetarian DHAomega 3 essential fatty acid
Avesthagen Limited announced completion of a landmark project for the
development of AvestaDHA - a vegetarian source of DHA (docohexanoic acid)
omega 3 essential fatty acid based on an innovative approach using naturally
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occurring microalgae. DHA is a polyunsaturated mega-3 fatty acid found
throughout the body. More specifically, DHA Omega-3 is a major structural
component found in the brain gray matter, eye retina and the heart.
Numerous scientific studies confirm that everyone, from infants to adults,
benefit from an adequate supply of DHA Omega-3. For mothers-to-be, DHA
Omega-3 supports a healthy pregnancy. Read More…
Sanofi-Aventis to buy Genzyme for about US$20bn
Sanofi-Aventis SA said on Wednesday that it has reached an agreement, in
principle, to acquire Genzyme Corp. for about US$20bn in cash plus future
payments, bringing to an end a nine-month pursuit of the US biotechnology
company. The Boards of both the companies have approved the deal, which
is expected to close in the second quarter of 2011. Every Genzyme
shareholder will receive a contingent value right (CVR) for each share they
own, entitling the holder to receive additional cash payments if specified
milestones are reached. The milestone payments are linked to the
performance of the drugs Lemtrada, Cerezyme and Fabrazyme. Read More…
Thermo Fisher selling Athena to Quest Diagnostics
Thermo Fisher Scientific Inc the world leader in serving science announced
today that it has signed definitive agreements to sell its Athena Diagnostics
and Lancaster Laboratories businesses for a total of $940 mn in cash. The
company reached an agreement to sell Athena Diagnostics to Quest
Diagnostics Incorporated for $740 mn. Athena Diagnostics, based in
Worcester, Mass., is a leading reference laboratory that provides
comprehensive diagnostic testing for neurological and other diseases, with an
emphasis on gene-based tests. Read More…
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Domestic News - March 2011
Strides arm gets EU approval for Carboplatin 10 mg/ml
Onco Therapies Ltd., the wholly
owned oncology (cancer drugs)
subsidiary of Strides, announced
European Union (EU) approval for
Carboplatin 10 mg/ ml in the first
wave covering select European
countries.
This
is
the
first
European approval out of the 22
filings made by OTL in the year
2010 for products which have a
combined market value of over
US$5bn.
The
application
for
Carboplatin 10 mg/ml was submitted through a Decentralized Procedure
(DCP). The second wave of filing for Carboplatin will commence immediately
to cover all the remaining EU countries. Approval for all countries is expected
during 2011. Read More…
Strides Arcolabs gets USFDA nod for Vancomycin Injection
Omega Healthcare accelerates Application Performance and
Improves Employee Productivity with Brocade
Brocade has announced that Omega Healthcare, a premier Business Process
Outsourcing company in the healthcare sector, has standardized on a
enterprise-wide Ethernet switching infrastructure from Brocade at its facilities
in India to improve application and network performance. These issues that
Omega experienced with its legacy networking infrastructure had been
causing frustration among the staff and adversely impacted employee
satisfaction, leading to high attrition, company officials said. After an
exhaustive evaluation process, Omega selected the Brocade BigIron RX for
their network core and the Brocade FastIron Series switches to extend Power
over Ethernet (PoE) at their network edge. This resulted in significantly
faster application response times and screen refresh rates on the thousands
of networked devices that access Omega’s campus-wide LAN. Read More…
Group Healthcare premiums to see a further surge: Towers Watson
survey
A survey by Towers Watson has indicated a steady rise in the range of 15%
to 25% in healthcare premiums, even as life insurance premiums are easing.
The rise in healthcare premium cost is attributed to high claims to premium
ratio of more than 100%, which the study has observed in 55% of the
companies surveyed. As per the recent survey on Healthcare Trends 2010 by
Towers Watson, a global multi-practice consultancy, all respondent
companies with claim costs between 125% to 150% faced premium increase
to the extent of 25% to 50% this year as against only 9% last year. One of
the key drivers of healthcare costs is medical advancement and technology.
Read More…
Ranbaxy to market 4 Daiichi Sankyo products in Singapore
Daiichi Sankyo Company Limited (hereafter, Daiichi Sankyo) and Ranbaxy
Laboratories Limited (hereafter, Ranbaxy) today announced the start of
synergistic initiative to leverage Ranbaxy’s presence in Singapore to market
innovative products originally discovered by Daiichi Sankyo. Effective March
1, 2011, Ranbaxy will market four products of Daiichi Sankyo origin,
including Cravit (levofloxacin) tab and Cravit IV in Singapore. The products
were previously commercialized by Kyowa Hakko Bio Singapore Pte Ltd
(hereafter, Kyowa Hakko Bio) in the country. Early this year, Daiichi Sankyo
and Kyowa Hakko Bio had agreed to transfer the marketing rights of the
products from Kyowa Hakko Bio to Ranbaxy. Read More…
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Amrutanjan Health Care enters into agreement with Siva's Soft Drink
Cipla launches 'No Touch Breast Scan' in India
Cipla, one of the leading pharmaceutical companies
from India, launched a breakthrough screening
technology in India today called the ‘No Touch
Breast Scan (NTBS);’ the first-ever painless, noninvasive and radiation-free breast scanning
technique for detecting breast cancer at an early
stage. As of today, 1 in every 22 women in India is
expected to be diagnosed with breast cancer in
their lifetime. Dr. Shekhar Kulkarni, Consultant
Breast Cancer Surgeon, Magnolia Breast Surgery
Clinic, Pune said, “Breast cancer is rising rapidly
among urban women and is now the most common
cancer in cities such as Mumbai and Delhi.
Unfortunately most cancers are diagnosed when
the disease is advanced leading to low chances of
cure. Although Mammography has been available for years it is not used that
widely.
There are many reasons for it such as lack of awareness, pain and discomfort
during the procedure and a concern about repeated exposure to radiation.
Welcoming the introduction of NTBS in India, Dr. Rakesh Sinha, Consultant
Gynaecologist Surgeon, BEAMS Hospital, Mumbai said, “The No-Touch Breast
scan is a painless option for women who wish to get themselves regularly
screened. It is of particular use in younger women who have dense breasts
and mammography is inconclusive. If a woman shows changes on the NTBS
then she is sent for further investigation which includes mammography,
sonography etc. At BEAMS Mumbai, of the 41 patients who have undergone
the NTBS test, only 1 had to be referred for mammography.”
LifeCell brings Menstrual Blood stem cell banking to India
Marking the 100th International Women’s Day celebration as a yet another
remarkable milestone, LifeCell International, pioneers in stem cell banking,
today launched LifeCell Femme- Menstrual blood stem cell banking service in
India. LifeCell is the first and only company offering menstrual blood stem
cell banking in India and the launch of this break-through technology
reinstates LifeCell’s pioneering and leadership positioning in the industry.
Menstrual blood banking has been pioneered by Cryo-Cell International, USA
who are the technology partners of LifeCell and have been offering this
service in other countries under the brand C’elle. Read More...
Dr Reddy's to launch 3 new drugs in US market: report
Dr Reddy's Laboratories is reportedly
planning to launch three new drugs in
the US market next fiscal. The report
stated that the company may launch
Rivastigmine, an anti-mild-to-moderate
Alzheimer's drug, Desloratadine, used
to treat allergies and Pseudoephedrine,
a nasal/sinus decongestant. Dr Reddy's
inked agreements in 2009 with Schering
and Sepracor of the USA, will allow the
Indian drug-maker to manufacture and market generic versions of
Desloratadine, beginning 2012, says report.
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Beams Hospitals opens new centre at Bengaluru
Beams Hospitals, a name synonymous
with the revolutionary science of
minimal access surgery in Mumbai,
has launched its new centre at
Bengaluru today. Backed by expertise
spanning over 15 years, Beams
Hospitals is India’s foremost chain of
surgery centres dedicated to Minimal
Access Surgery (MAS) procedures
founded in 1994 by Dr.Manju and
Dr.Rakesh Sinha. Bengaluru is the 5th
Beams centre to be launched in India after successful operations in Mumbai,
Amritsar, Indore and Hyderabad. Read More…
Global Hospitals gains recognition for liver diseases
Global Hospitals Group, the fastest growing tertiary care multi super specialty
chain of hospitals in India with the largest multi organ transplantation centre,
today updated that it has achieved the unique distinction of becoming the
foremost hospital in the world for performing the widest variety of liver
transplantations apart from treating all types of liver diseases. The Group
announced that with the most comprehensive liver diseases & transplantation
services on offer and with the one of the largest team of Specialists, it is now
able to perform nearly 100 liver transplantations during a calendar year and
it is expected to reach a number of 250-300 Liver transplants a year in the
next 2 years. The Hospital today routinely performs split liver, auxiliary liver,
living donor, cadaver liver transplantations. Read More…
Ipca Labs SEZ Indore unit gets UK-MHRA approval
Ipca Laboratories Ltd has announced that the Company's new formulations
manufacturing unit situated at Pharma zone, SEZ Indore, Pithampur, Madhya
Pradesh has been inspected and certified that it complies with the principles
and guidelines of Good Manufacturing Practices laid down in the directives by
the Medicines and Healthcare Products Regulatory Agency (MHRA), U.K. It is
the fourth manufacturing unit of the Company to have received such
approval from MHRA, U.K.
Culling of birds ordered in state poultry farm of Agartala
H5 strains of Avian Influenza have been confirmed in the poultry samples
collected from State Poultry Farm, Gandhigram, Agartala, Tripura. The
samples collected from the infected site were forwarded to the ERDDL,
Kolkata and High Security Animal Disease Laboratory (HSADL), Bhopal for
testing. The test conducted at both the laboratories confirmed that the
samples from State Poultry Farm are positive for H5 strain of Avian
Influenza. It has been decided to immediately commence the culling of birds
and destruction of eggs and feed material etc. so as to control further spread
of the disease without loss of time. It has also been decided that the entire
poultry will be culled within a radius of 3 kms. of the focus of infection viz.
State Poultry Farm, Gandhigram, Agartala. In addition to the culling strategy,
surveillance will be carried out over a further radius up to 10 kilometers.
Surveillance throughout the State is being intensified to monitor further
spread of infection, if any. State Government has been asked to furnish a
daily report on the control and containment operations to the Department of
Animal Husbandry, Dairying and Fisheries in the Ministry of Agriculture.
The Centre has advised that a series of strategic actions are required to be
taken immediately in the above area by the Animal Husbandry and Public
Health Departments. These include declaration of infected and surveillance
areas, ban on movement of poultry and its products in the infected
area/closure of poultry and egg markets and shops within a radius of 10 kms.
from the infected site, ban on movement of farm personnel, restricting
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access to wild and stray birds; restricting access to the infected premises;
destruction of birds; disposal of dead birds and infected materials; clean-up
and disinfection followed by sealing of the premises and issue of sanitization
certificate; post operations surveillance; imposition of legislative measures
etc. along with necessary measures laid down in the Contingency Plan (2005)
of the Ministry of Health and Family Welfare, Government of India. As
regards compensation for loss of poultry on account of culling and destruction
of birds, the rate for payment of compensation has been been indicated to
the State Governments. The Government of India has conveyed the decision
to share costs of compensation on 50:50 basis with the State Governments
and authorized State Governments to utilize funds available with them under
the programme of ‘Assistance to States for Control of Animal Disease’
(ASCAD), which is a Centrally Sponsored Scheme. The payment of
compensation should be ensured immediately and simultaneously to
culling. International Organizations will be notified by the Government of
India at its level.
Chemical leak at Shasun Pharmaceuticals factory
Shasun Pharmaceuticals Ltd has announced that there was chemical leak in
the stores area at the Company's Cuddalore factory on March 07, 2011 night
which has been controlled. The production in the factory has been stopped on
the direction of the government authorities. The Company is doing the
needful to resume the operations at the earliest.
NPPA hikes prices of 62 drugs
The National Pharmaceutical Pricing Authority (NPPA) has reportedly
increased the prices of 62 drugs, which are mainly based on indigenously
manufactured insulin, giving a fillip to domestic firms. According to the
reports, the drug price regulator has also reduced prices of 14 drugs, while
that of 21 drugs remained unchanged in its latest review meeting held last
week. The majority of the drugs, whose prices have been increased, are used
in treatment of diabetes and tuberculosis. S M Jharwal, NPPA Chairman was
quoted as saying, "We have to do a balancing act and provide a level playing
field to the indigenous manufacturers who account for nearly 10 per cent of
the total domestic market for insulin". Read More…
Lupin to donate Yen 10mn for Japan's earthquake victims
In the wake of the recent earthquake
and tsunami that hit the coastal regions
of Japan, affecting the lives of
hundreds, Kyowa Yakuhin, Pharma
major, Lupin Ltd’s Japanese subsidiary,
has announced that it would be
donating Yen 10 mn to the Japanese
Red Cross, apart from donations in the
form of medicines. Commenting on the
same, Vinod Dhawan, President, AAMLA
& Business Development, Lupin Ltd. said, "This is indeed an unprecedented
event and our heart goes out to all those afflicted. Read More…
Fortis Healthcare ties up with TotipotentRX
Fortis Healthcare (India) Ltd, India’s
fastest growing hospital network and
TotipotentRX Cell Therapy Pvt. Ltd, a
leading
provider
of
cutting-edge
technologies in the stem cell and
regenerative
medicine
market,
announced a collaboration to set up
centres of excellence offering cellular
therapies and stem cell clinical trials,
across select Fortis hospitals. These
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centres will undertake stem cell clinical research procedures relating to
diabetes, cancer, cardiovascular disease, and neurological ischemia.
TotipotentRX will also set up state-of-the-art cGMP laboratories in select
hospitals, for processing stem cells before transplantation to patients. Read
More…
Venus Remedies to receive GCC approval to market its products
Panchkula based Venus Remedies Limited, an existing Eu-GMP certified
Pharmaceutical manufacturing company, has once again achieved a very
significant landmark in its list of achievements. It has now been awarded the
company registration from GCC (Gulf Cooperation Council). This approval
holds significance and is prestigious as such registrations are obtained by the
manufacturing facilities which meet world class standards and where quality
is of the prime essence. On the occasion, Chairman cum Managing Director of
Venus Remedies Limited Mr. Pawan Chaudhary said, “With this prestigious
grant Venus Remedies will strengthen its footmark in GCC pharmaceutical
market and will enhance its revenues by 10% per cent by 2013.” Read
More…
Wockhardt creditors can seek provisional liquidator: report
Wockhardt Ltd. creditors can apply to the Bombay High Court to appoint a
provisional liquidator after the court admitted a winding-up petition against
the drug maker, says a report. Janak Dwarkadas, lawyer , was quoted a
saying "A group of three bond holders, including U S hedge fund QVT
Financial LP, filed the petition, seeking to recover their investments of Rs.
6.34 bn ($140 mn) through the sale of the company’s assets." Wockhardt
can appeal the court’s decision to accept the petition, adds a report.
MS Dhoni to promote digestive tonic Zandu Pancharishta
The Rs. 1100 cr. Emami Limited
makers
of
Boroplus,
Fair
and
Handsome, Zandu Balm and Navratna
have announced the appointment of
the Indian cricket team captain
Mahendra Singh Dhoni to endorse its
over-the-counter
digestive
tonic
Zandu Pancharishta. He will join the
galaxy of superstars associated with
the Emami range of products,
including Kareena Kapoor, Preity
Zinta, Bollywood Kings Amitabh Bachchan and Shah Rukh Khan. MS Dhoni
also endorses the company’s latest initiative of Healthy and Tasty edible oil.
Emami’s new promotion drive for Zandu Pancharishta will include print and
radio campaign along with a six series television commercial featuring Dhoni.
Adi Pocha's Squirkle Productions has won the creative mandate for the
campaign, which will hit the screens soon. Talwalkars Better Value Fitness
opens new health clubs in Kota, Ujjain and Pune Talwalkars Better Value
Fitness Ltd., country's largest chain of health clubs has opened its new health
clubs in the cities of Kota, Ujjain and Pune (Kothrud) as it's 93rd, 94th and
95th health club. With this, the Company now has 95 health clubs in 46
towns across India on a consolidated basis.
MV Hospital organizes 'DRC Gold Medal Oration award'
M.V. Hospital for Diabetes, Royapuram, Chennai the most renowned name
for Diabetes and Diabetes Research in South India, organized the 20th
edition of DRC Gold Medal Oration award. In 1988, late Prof M Viswanathan
as the President of Diabetes Research centre has instituted the DRC Gold
Medal Oration Award. This award is conferred every year on a distinguished
Scientist from the field of medicine and another award Prof. M.Viswanathan
Gold Medal Oration Award has been instituted by the Scientific Committee of
21 of 118
the DRC honoring a distinguished doctor and it is conferred every year along
with DRC Gold Medal.
His Excellency, the Governor of Tamil Nadu, Surjit Singh Barnala, gave away
the “Lifetime Achievement Award” to Dr. S.S.Badrinath, Chairman Emeritus,
Sankara Nethralaya for the pioneering work done in the field of eye care. In
his address Dr. Vijay Viswanathan, Managing Director, M.V. Hospital for
Diabetes, Royapuram, Chennai said that the M.V.Hospital for Diabetes has
been developing partnerships with the region in order to achieve the WHO’s
action plan to prevent and control non communicable diseases. He mentioned
about the partnerships with CBSE to reduce the childhood obesity and the
partnership with the Govt. of Tamilnadu to train the doctors in diabetes
prevention. He also mentioned that over 2000 doctors have been trained all
over the country in prevention of diabetes and its complications.
In Prof M Viswanathan Gold Medal oration 2010 Dr. Shanthi Mendis,
Coordinator of the Cardiovascular Program and Global Program for Prevention
and Management of Non Communicable Diseases, World Health Organization,
Geneva, said, “India is fast becoming the diabetes capital in the world, with
an increasing number of diabetic patients. It has been estimated that India
has more than 50 mn people with diabetes in 2010, which is expected to rise
to over 85 mn by 2030.
JHS Svendgaard unveils preferential issue to Tano Mauritius
JHS Svendgaard Laboratories Ltd. said that its Board of Directors at its
meeting held on March 12, has decided to undertake a preferential allotment
of 25,00,000 shares to Tano Mauritius India FVCI at Rs. 97.75. The
preferential allotment in accordance with the SEBI (Issue of Capital and
Disclosure Requirements) Regulations, 2009, Companies Act, 1956, and
other applicable rules and regulations. The Company's Board has also
approved the notice of the Extraordinary General Meeting which is scheduled
to be held on April 9, to get the necessary shareholders' approval.
Lupin to donate Yen 10mn for Japan's quake victims
In the wake of the recent earthquake and tsunami that hit the coastal
regions of Japan, affecting the lives of hundreds, Kyowa Yakuhin, Pharma
major, Lupin Ltd’s Japanese subsidiary, has announced that it would be
donating Yen 10 million to the Japanese Red Cross, apart from donations in
the form of medicines. Commenting on the same, Mr. Vinod Dhawan,
President, AAMLA & Business Development, Lupin Ltd. said, "This is indeed
an unprecedented event and our heart goes out to all those afflicted. The
human loss that this calamity has caused is truly shocking and we are deeply
saddened by the extent of the damage caused by the disaster and have
taken a small step forward to extend our support and solidarity with the
Japanese people. We offer our full support and any help that authorities
might require in relief operations and we will do as much as we can to help
the disaster victims.” Lupin’s subsidiary Kyowa Yakuhin, located in Sanda,
Japan has remained unaffected and all 355 personnel are safe. Kyowa is one
of the largest generic players in the neurology segment and is amongst the
fastest growing generic pharmaceutical companies in Japan today.
Govt withdraws service tax on healthcare
The Government withdrew the 5% service tax on healthcare services
introduced in this year's Union Budget amid strong protests from several
quarters. Finance Minister Pranab Mukherjee made the announcement in his
reply to the debate on the Finance Bill in the Lok Sabha. In his Budget
speech on Feb. 28, the Finance Minister had proposed a 5% service tax on
air-conditioned hospitals with more than 25 beds and on diagnostic services.
"The purpose of the new levy was not merely to mobilise revenue, but to
pave the way for introduction of the GST. However, I have decided to exempt
the new levy in its entirety both in respect of services provided by hospitals
22 of 118
as well as by way of diagnostic tests until GST comes into force", Mukherjee
said. He hoped that it will no more be called "misery tax". The announcement
was made while moving the Finance Bill in the Lok Sabha.
Bill and Melinda Gates visit health and development partners
Bill and Melinda Gates will meet policy makers, non-government partners,
business and community leaders, and public health figures in a visit to India
this week to explore ways to build on achievements in health and
development and tackle the significant burden of disease that still exists. “We
are proud to partner with India because its innovative approaches are saving
and improving lives every day,” said Gates. Yet, despite remarkable
achievements, India endures some of the greatest health and development
burdens in the world.” Read More…
Bill & Melinda Gates call on Ghulam Nabi Azad
Bill and Melinda Gates today called on the Union Health Minister Ghulam Nabi
Azad. Issues relating to Immunization programme, Pentavalent vaccine, Polio
vaccination efforts, HIV control and capacity building were discussed during
the meeting held in Ministry of Health and Family Welfare.
Ranbaxy stock falls as Mylan sues USFDA on Lipitor
Ranbaxy shares slipped after reports emerged that US-based Mylan
Laboratories has dragged the US Food and Drug Administration (USFDA) to
court in a bid to block attempts by the Indian company to launch a generic
copy of Lipitor in the American market. In a complaint filed March 18 in a
district court in Washington, Mylan said that it and other generic-drug
makers should be allowed to enter the market as soon as a patent expires.
Ranbaxy had reached an agreement with Pfizer in 2008 to sell copies of the
world’s best-selling medicine beginning November 2011. The Indian
company, now owned by Japan's Daiichi Sankyo, has said that it is entitled to
180 days of marketing exclusivity for being the first to challenge the Lipitor
patents. It has not yet received final USFDA approval on its application to sell
the Lipitor copy. In January this year, Mylan announced that it had entered
into a settlement agreement with Pfizer to resolve litigation related to Lipitor
Tablets, 10 mg, 20 mg, 40 mg and 80 mg. The medicine is generically called
Atorvastatin. The agreement itself is subject to review by the US Department
of Justice and the Federal Trade Commission. Lipitor had US sales of
US$7.27bn for the 12 months period ending Sept. 30, 2010, according to
IMS Health.
Bombay HC stays winding up petition against Wockhardt
Wockhardt Ltd. said that a division bench of the Bombay High Court, granted
an ad-interim relief by staying the admission of the winding up petition filed
by the Trustees to the Foreign Currency Convertible Bonds (FCCBs), issued
by the Company. In the meantime, the Company has agreed to deposit in
Court Rs. 1.15bn by May 3, as per direction of the Bombay High Court. The
company’s appeal against the petition will be heard on May 4, according to
reports. Wockhardt had failed conclude arrangement to pay its FCCB holders
US$110mn as per terms and went into a corporate debt restructuring (CDR)
process. The petitioners - QVT Financial LP, a Singapore based hedge fund
and an overseas unit of Sun Pharmaceutical Industries Ltd. - moved the court
against Wockhardt in October 2010. The three investors together hold FCCBs
worth US$42mn. Sun Pharma is holding FCCBs worth US$20mn issued by
Wockhardt in 2004.To reduce the debt burden, Wockhardt sold the animal
health care division to Vetoquinol, France and divested the business of
Esparma GmbH to Mova GmbH. As at March 2010 (15 months period),
Wockhardt's total borrowings stood at Rs. 40.18bn.
23 of 118
Aurobindo gets USFDA approval for Famciclovir tablets
Aurobindo
Pharma
Limited
is
pleased to announce that its
tentatively approved ANDA for
Famciclovir Tablets 125mg, 250mg
and 500mg has received the final
approval from the US Food & Drug
Administration (USFDA). Famciclovir
Tablets 125mg, 250mg and 500mg
is the generic version of Novartis
Pharmaceuticals Corp's Famvir(r)
Tablets 125mg, 250mg and 500mg
and is indicated for the treatment of recurrent mucocutaneous herpes
simplex infections in HIV-infected patients and suppression of recurrent
genital herpes in immunocompetent patients. The product has a market size
of approximately US$175mn for the twelve months ending September 2010
according to IMS and is ready for commercial launch. Aurobindo now has a
total of 132 ANDA approvals (100 Final approvals and 32 Tentative
approvals) from USFDA
We thank FM for rollback of service tax on healthcare: Apollo
Hospitals
With great relief and sense of deep appreciation I profusely thank and
congratulate the Finance Minister for the roll back of service tax on
healthcare services. Access to healthcare to all and that of highest standards
has been the driving force for all of us who constitute healthcare sector in
India and imposition of this service tax would have been a huge deterrent to
this vision. Now with this progressive move to repeal the tax, the country will
see our renewed efforts to serve the nation and we will relentlessly persevere
to keep all Indians in good health. The health provider network is encouraged
to take the health challenges of the nation with continuous support from the
Government.
Publicis Groupe acquires India-based Watermelon
Publicis Groupe announced today that it has agreed to acquire a majority
stake in a leading healthcare advertising agency in Mumbai, IndiaWatermelon Healthcare Communications Private Limited ("Watermelon"). On
completion of this transaction, this entity will become part of Publicis
Healthcare Communications Group (PHCG) and will be renamed Publicis Life
Brands Watermelon. This transaction is subject to customary local closing
conditions. Read More…
Ind Swift Labs gets USFDA nod for DMFs Temozolomide and
Telmisartan
Pharma major Ind-Swift Laboratories Ltd, which has a strong basket of over
40 products across 16 therapeutic segments, has got the USFDA nod for two
more DMFs Temozolomide and Telmisartan. Besides commercially supplying
four molecules to the US, the company has hitherto filed 20 DMFs with the
USFDA, of which all have been approved. NR Munjal, Vice-Chairman and
Managing Director of Ind-Swift Laboratories Limited, said: “The company has
high regulatory standards where its facilities are already approved by
USFDA/MHRA/TGA/COS/KFDA/Who-GMP, and with this approval for
Temozolomide, an anti-neoplastic drug with market size of US$ 700 mn, and
Telmisartan, a drug for hypertension with market size worth $1.6 bn, the
company is aiming at marketing these products once they go off patent.”
Read More…
Bafna Pharma to acquire Johnson & Johnson's Raricap:
Bafna Pharmaceuticals Ltd has signed an agreement with an affiliate of
Johnson & Johnson, for acquisition of the trademark for the latter's
hemoglobin drug Raricap. The transaction is expected to close in the first
24 of 118
week of April. The brand "RARICAP" has a legacy of over 40 years in the
market. It is prescribed for iron deficiency anemia in pregnancy.
Glenmark Generics gets USFDA nod for Norethindrone and Ethinyl
Estradiol
Glenmark Generics Inc., USA, a subsidiary of Glenmark Generics Ltd has
announced they have been granted final approval for their abbreviated new
drug application (ANDA) by the United States Food and Drug Administration
(U.S. FDA) for Norethindrone and Ethinyl Estradiol, USP 0.4 mg/0.035 mg
tablets, their generic version of Ovcon 35 tablets by Warner Chilcott, Inc.
The product will be marketed under the trade name Briellyn and distribution
is expected to start immediately. Briellyn provides a continuous 28 day
regimen for oral contraception derived from 21 tablets composed of
Norethindrone and Ethinyl Estradiol to be followed by 7 inert tablets and is
indicated for the prevention of pregnancy. According to IMS Health for the 12
month period ending December 2010, this combination achieved sales of
USD30mn. Read More…
Revised national TB control programme announces its new
objectives, 2011
Having achieved globalobjectives of new case-detection of 70% and
treatment success rate of 85% forthe last three consecutive years, the
RevisedNational Tuberculosis Control Programme (RNTCP), has announced its
new objective of Universal Access to QualityTB care for all TB patients. The
intermediate target is to detect 90% ofall TB cases and successfully treat
90% of them by 2015.
Hospital services, diagnostics tests exempted from service tax
The Union Finance Minister Pranab Mukherjee has proposed to enhance the
abatement from 40% to 55% of the Retail Sale Price for the Small Scale
Industries (SSI) Garment Manufacturers. With this relief, a unit would
continue to be eligible for SSI exemption in 2011-12, even if it had a
turnover based on Retail Sale Price of Rs. 8.9 crore in the current year. The
necessary notification in this regard will be issued in due course. This was
announced by the Union Finance Minister while initiating the discussion on
the Finance Bill 2011-12 in the Lok Sabha.
ASSOCHAM welcomes relief to healthcare
Apex chamber ASSOCHAM welcomed finance minister Pranab Mukherjee’s
withdrawal of the proposed five per cent service tax on airconditioned
hospitals with more than 25 beds and on diagonistic services. The service tax
on healthcare would have hurt the common man, said ASSOCHAM’s secretary
general D.S. Rawat. “We greatly appreciate the finance minister’s decision to
rollback the proposed service tax. This will help quality-oriented healthcare
and diagnostics companies to render services to patients at lower costs.”
Khazanah acquires stake in Apollo Hospitals: report
Integrated (Mauritius) Healthcare Holdings, an arm of Khazanah Nasional
Bhd, has acquired 8.82% stake in corporate hospital chain Apollo Hospitals
from Bisikan Bayu Investments, another arm of the Malaysian sovereign
fund, for Rs. 4.7bn, according to a report.
25 of 118
International News - March 2011
Daiichi Sankyo to buy US drug firm Plexxikon for US$805mn: report
Japanese drug-maker Daiichi Sankyo Company has reportedly said that it will
buy US-based pharmaceutical firm Plexxikon Inc for US$ 805 mn. According
to reports, the acquisition is subject to anti-trust approval in the US, whereby
the acquisition will help the Japanese firm obtain certain co-promotion rights
in the US for late-stage cancer drug PLX4032, which is being jointly
developed by Plexxikon and Roche. In addition, Daiichi will make additional
payments totalling about US$ 130 mn based on near-term launch milestones
with respect to the PLX4032 drug, adds a report.
Fujifilm to buy Merck's biotech-drug makers: report
Fujifilm reportedly said it would buy US and British biopharmaceutical
companies from America's Merck for a reported half a billion dollars.
According to reports, the Japanese film and camera maker said that it would
buy all shares of Diosynth RTP Inc. of the United States and of Britain's MSD
Biologics Ltd. from Merck, without disclosing the purchase price.
Ventas to acquire Nationwide Health Properties
Ventas, Inc. and Nationwide Health Properties, Inc. announced that the
Boards of Directors of both companies have unanimously approved a
definitive agreement under which Ventas will acquire all of the outstanding
shares of NHP in a stock-for-stock transaction valued at $7.4 billion, creating
one of the largest publicly traded REITs and the leading healthcare REIT by
equity value.
Under the terms of the agreement, NHP shareholders will receive a fixed
exchange ratio of 0.7866 Ventas shares for each share of NHP common stock
they own. Based on the closing stock price for Ventas on Friday, February 25,
2011, this consideration would be equivalent to $44.99 of Ventas stock for
each NHP share, representing a premium to NHP shareholders of
approximately 15% over NHP’s closing stock price on that day. Upon closing
of the transaction, Ventas shareholders are expected to own approximately
65% and NHP shareholders are expected to own approximately 35% of the
combined company.
Japan suspends use of Pfizer, Sanofi vaccines after 4 deaths: reports
Japan’s health ministry has reportedly suspended the use of pediatric
vaccines made by Pfizer Inc. (PFE) and Sanofi- Aventis SA, after reports of
four deaths following immunizations. According to reports, the temporary
suspension is a precautionary measure following the deaths of four children
who had previously been immunized simultaneously with several pediatric
vaccines. Victor Carey, Medical Director, Sanofi’s vaccines was quoted as
saying that "No causal relationship has been established between
immunization and these fatalities, but an investigation is under way, which
we’re fully cooperating with." More than 200 mn doses of ActHIB have been
given to children in more than 120 countries, according to Paris-based
Sanofi, adds a report.
FACTBOX-Global pharma to push cash into Russia: report
Genzyme (GENZ.O) is reportedly planning for a joint venture with Russian
high-tech centre ChemRar to pave way for growing drugmakers seeking to
gain a local presence. According to reports, establishing a foothold is a way
for international drug companies to secure guaranteed sales in Russia, which
wants to reduce dependence on imported drugs, and global drugmakers are
expected to invest over $1 bn. These international pharmaceuticals producers
that have existing facilities in Russia, are eyeing to set up local
manufacturing sites, or are considering such a move, adds a report
26 of 118
Domestic News - April 2011
Sun Pharma forms JV with Merck
Merck & Co., Inc, a global health care leader, known as MSD outside the
United States and Canada, and Sun Pharmaceutical Industries Ltd has
announced the creation of a joint venture to develop, manufacture and
commercialize new combinations and formulations of incrementally
innovative, branded generics in the Emerging Markets. The partnership
combines Sun Pharma's proven track record of leadership and expertise in
rapid, innovative product development using Sun Pharma Advanced Research
Company Ltd's ("SPARC") proprietary platform technologies, and Sun
Pharma’s world-class manufacturing network with Merck's clinical
development and registration expertise and a broad, geographic commercial
footprint. The companies said that they will focus on 'innovative branded
generics,' that bring together combinations of medicines using platform
delivery technologies designed to enhance convenience for patients in
Emerging Markets.
Dr. Reddy’s launches OTC Fexofenadine HCl tablets
Dr. Reddy’s Laboratories has launched its over-the-counter (OTC)
Fexofenadine HCl tablets on April 13, 2011. The Food & Drug Administration
(FDA) approved Dr. Reddy’s Abbreviated New Drug Application (ANDA) for
Fexofenadine HCl tablets on April 12, 2011. Dr. Reddy’s will market the
product under store brand labels in the U.S. market. The products are
bioequivalent versions of sanofi-aventis’ Allegra® tablets which received Rxto-OTC switch approval from the FDA on January 24th, 2011. The
Fexofenadine HCl Rx market had brand and generic sales of approximately
$452 million for the twelve months ending December 31, 2010 according to
IMS Health.
Lupin files suit against Ranbaxy on Fenofibrate launch: report
Lupin Ltd has filed a second suit in the US against Ranbaxy Laboratories to
prevent the from launching fenofibrate, a generic version of Lupin's
cholesterol lowering drug Antara in the US, according to a report. The report
stated that Lupin earlier sued Ranbaxy after the Gurgaon-based drugmaker,
now owned by Japan's Daiichi Sankyo, sought marketing approval from the
American drug regulator to sell fenofibrate capsules in 43 mg and 130 mg in
the US.
Glenmark Pharma enters into agreement with IDC
Glenmark Pharmaceuticals, a leading player in dermatology and drug
discovery has entered into an exclusive arrangement with Immanence-IDC, a
leading Canadian company for the distribution of their high-end anti-aging
cosmeceutical range of products. The agreement will span across eight
operating countries for Glenmark. The countries are India, Brazil, Mexico,
South Africa, Egypt, Vietnam, Malaysia and Thailand. This will mark
Glenmark’s presence in this fast growing specialised dermatology segment
which is growing at a rapid pace across emerging economies.This ten year
agreement with Glenmark will open new markets for us, and through a
network of more than 150,000 dermatologists, will allow us to reach more
than 1.5 billion people. We are honored that a global leader in dermatology
has recognized the science and quality behind our antiage care products, as
well as our innovative approach.” stated Dr. Éric Dupont, PhD, Chairman of
the Board at Immanence IDC.
Divis Labs denies plan to buy US biotech firm
Divis Laboratories Ltd has clarified that there are no plans or discussions or
negotiations to acquire any biotech company or of any fund raising.
Earlier the reports stated that Divi's Labs is looking to acquire US Biotech
companies.
27 of 118
International News - April 2011
Pfizer sells capsule-making Capsugel for $2.4 bn: report
Pfizer, the world's biggest pharmaceuticals company has agreed to sell
capsule-maker unit Capsugel to private-equity firm KKR for about US$2.4 bn
in cash, according to a report. The report stated that the sale would be used
to buy back stock in addition to the previously announced repurchase
program of about $5 bn planned for 2011. Pfizer has reportedly said that the
transaction was expected to close during the third quarter, subject to
approval from US, European Union and other regulators.
China NT Pharma plans to raise upto US$275 mn via IPO: report
AstraZeneca gets FDA approval for vandetanib: report
Pfizer gets FDA refusal-to-file for Tafamidis: report
Merck to buy Inspire for US$430mn: report
Cephalon rejects Valeant takeover offer: report
Sanofi-Aventis completes offer for Genzyme
28 of 118
Domestic News - May 2011
Lupin Pharma mulling another acquisition: report
Lupin Pharmaceuticals is planning for another acquisition for US$50-100 mn
in Japan, according to a report. The report stated that the through this
buyout, company aims to achieve a 20% rise in revenue next financial year.
The company is targeting cardiovascular, central nervous system (CNS), and
gynecology space.
Glenmark Pharma appoints Gracias Saldanha as Chairman
Glenmark Pharmaceuticals Ltd has announced that the Board of Directors of
the Company at their meeting held on May 10, 2011, has announced the
following changes to the Board effective from May 10, 2011:
Gracias Saldanha, Chairman has stepped down as the Chairman of the Board
of Directors and has been re-designated as Founder & Chairman Emeritus.
Glenn Saldanha, has been appointed as the Chairman of the Board in
addition to his responsibilities as MD of the Company. A. S. Mohanty ceases
to be a director of the Company.
Hinduja Hospital celebrates International Nurses Day
Marking the birth anniversary of Florence Nightingale, International Nurses
Day is celebrated around the world every May 12. With nursing being the
cutting edge of the Health Care industry today, Hinduja Hospital celebrates
International Nurses Day to re enforce all the valuable, selfless contributions
nurses make to the society. Sumita Bajaj, RNRM, Registered Nurse along
with Mrs. Shreedevi Balachandran, Clinical Instructor will conduct a 3 day in
house nursing workshop which will address around 400 nurses at Hinduja
Hospital. The workshop will cover topics like Nursing in Hinduja Hospital over
60 years, Home care Nursing - A new perspective, Innovative ideas towards
maintaining quality in nursing, best practices in ICU/PICU/NICU/EICU.
Nursing in India versus that of Abroad will also be discussed with regards to
Quality assurance in ICU, Best Practices in Operation Theatres and Perioperative protocols in Cardiac surgery - A nursing perspective in Critical
Care…Read More
Sandvik launches Medical Technology Division in India
Sandvik Asia, the Indian subsidiary of the US $13billion Sandvik AB of
Sweden today announced the launch of the Medical Technology Division in
India. Addressing media persons at the launch here today, Hakan Kingstedt,
Managing Director and President, Sandvik Asia said: “To address the future
growth in medical devices in India, Sandvik will offer premium quality raw
material
&
manufacturing
services
for
medical
device
OEM
customers.” Stephen Cowen, Global Head, Sales and Marketing, Sandvik
MedTech said: “India is an important market to Sandvik. Considering the
future growth in medical devices here, Sandvik has taken the first step to set
up and establish operations, in both sales & manufacturing. This set up gears
up Sandvik to be ready to meet the growth of medical devices in India. We
have established a R&D center in Pune, first time out of Sweden. Sandvik will
strive, additionally, to work for further improvements in materials and
products for medical devices in partnership with Medical OEMs.”
Glenmark inks licensing deal for GBR 500 with Sanofi
Glenmark Pharmaceuticals Ltd has entered into agreement with Sanofi to
grant Sanofi a license for the development and commercialization of GBR
500,a novel monoclonal antibody for the treatment of Crohn's Disease and
other inflammatory conditions.The transaction is expected to close in the
coming month subject to customary closing conditions,including the
expiration or early termination of the waiting period under the Hart-scottRodino Antitrust Improvements Act.
29 of 118
Glenmark is likely to receive an upfront payment of US$50mn, of which
US$25mn will be paid upon closing of the transaction and US$25mn , which
is contingent upon Sanofi's positive assessment of certain data to be
provided by Glenmark. The total of these payments could reach
US$613mn.Sanofi will have exclusive marketing rights for North America,
Europe, Japan, Argentina, Chile, and Uruguray. Phase 1 of testing for GBR
500 is already completed and Phase 2 will begin as soon as the deal is
completed, said CEO Glenn Saldanha. CEO Glenn Saldanha tadded, "The
company has six different molecules under different stages of development,
including GBR 401, GBR 600, GBR 900.
GVK Biosciences is preferred provider to global health Product
Development Partners Consortium
GVK Biosciences has been selected as a preferred provider to a consortium of
14 global Product Development Partners (PDPs) for clinical services in Asia.
GVK BIO is the only partner that is headquartered in India. The PDPs, funded
in part by the Bill and Melinda Gates Foundation are not-for-profit entities
focused on developing
new interventions for diseases that are often
neglected by mainstream pharmaceutical and biotech companies, such as
tuberculosis, malaria, kala-azar, HIV/AIDS, childhood pneumonia, and
diarrheal diseases. Collectively the 14 PDPs anticipate funding 85 clinical
trials in the developing world over the next two years and India features as a
key developing world country.
Transgene Biotek to commence commercial production of another API - DMA
Transgene Biotek has succeeded in completing the technology development
for another Biopharmaceutical product - DHA, a product in high demand Tor
neutraceutieal and pharmaceutical formulations. The company has completed
the production of this product in pilot batches and now, plan to commence
the commercial production shortly at a iSiircl party facility having large
fermentation infrastructure. DMA (Docosalicxacnoic acid) and EHA
(Eicosapentaenoic acid are Omega-3 fatty acids, essential for tlie proper
functioning of our brains as adults, and for the development of our nervous
system and visual abilities during the first 6 months of life. In addition,
omega-3 fatty acids are found to reduce heart disease and help in lowering
triglycerides (fats in the blood) and loner blood pressure. DHA, an omega-3
rally acid is used as supplement in functional foods, food ingredients,
beverages, neutraceuticals, nutritional oils, cosmaccuticals, consumer health
care products, animal feed, and pharmaceutical industries.
The market for Omega-3 fatty acids (DHA/EHA) was estimated at over
US$2bn (2007), according to Scientia Advisors which since then grew 42% in
2009, according to market researcher Nielsen. With lot of emerging scientific
evidence demonstrating the health benefits of DHA/ EPA and consumer
awareness, the market is expected to drive >60% growth in the coming
years, according to a recent Frost & Sullivan report (2010). Demand is
projected lo outstrip available supply.
Synefra E&C bags contract for super specialty hospital
Pune’s leading Integrated Infrastructure Solutions’ provider Synefra
Engineering & Construction Ltd – A Tanti Group Company, has bagged a
major EPC order in South India. It will construct a super specialty hospital in
Dharwad and the project is to be completed in 17 calendar months (by
August 2012). It is valued at Rs. 21.05 crores and Synefra’s scope would
cover civil, structural and architectural work. Awarded by Dharmasthala
Manjunatheshwara College of Medical Sciences & Hospital, the contract
involves construction of a 350 bed hospital with a total built up area of 3,
25,000 sqft. which will offer super-specialty services in the disciplines of
Cardiology, Cardio Thoracic Surgery, Neurology, Neuro Surgery and Plastic
Surgery to the population of Hubli-Dharwad and surrounding areas. The
building when completed will accommodate 8 spacious operation theatres
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conforming to the modern principles of hospital planning; 100 intensive care
beds to provide care for the patients admitted under the above specialties;
three well designed cardiac catheterization labs; inpatient wards in
combination of suite rooms, special rooms and general wards. An auditorium
with 250 seating capacity and four classrooms with seating of 60 each have
been included in the hospital building to support the academic activities of
the institution.
Commenting on the occasion, Sanjeev Nakhasi, Vice President - Operations,
Synefra E&C said, “Synefra's experience, expertise in sustainable
development and excellence towards an integrated approach has been a key
to winning this deal. This project will provide us an opportunity to
demonstrate our skills for highly specialized requirements at this Super
specialty hospital. Synefra shall deploy cost effective measures and efficient
technologies, state of the art tools & machinery apart from skilled resources
to complete the project on time. We are confident to attract more such
projects in South India in near future.” Synefra has proposed a
comprehensive, cost effective approach plan enabling sustainable
infrastructure development with limited resources. As the demand for super
specialty hospitals is very high and is increasing with time, this project will be
immensely welcomed by the people.
SC upholds HC order restraining Cadila from selling 'Hb tone': reports
The Supreme Court refused to vacate the Bombay High Court order, which
restrained Cadila Healthcare from making and selling hemoglobin enhancing
drug 'Hb Tone' for trade mark infringement, as alleged by a local
manufacturer, according to reports. A vacation bench comprising justices GS
Singhvi and Chandramauli Prasad said that the interim order passed by the
High Court against Cadila was "well reasoned and there was no need to
interfere with it". It, however, directed the High Court to decide soon on the
main suit, pending before for six years, reports stated. Cadila, India's fifth
largest pharma firm, was restrained by a single member bench of the
Bombay High Court in 2006, which directed the Ahmadabad-based firm to
stop all activities of manufacturing, selling and exporting under 'Hb Tone'
trade mark till the pendency of the suit, said reports. The interim order was
challenged by Cadila before a division bench, which in April upheld the order.
It, then, moved the apex court, which has also denied it any relief, added
reports.
Glenmark confirms settlement for Hydrocortisone Butyrate
Glenmark Pharmaceuticals Limited and Glenmark Generics Inc., USA
(“Glenmark”) have entered into a settlement and license agreement with
Triax Pharmaceuticals, LLC, Astellas Pharma Europe B.V. and Astellas Pharma
International B.V. (“Astellas and Triax” ) to resolve a United States patent
infringement suit related to Glenmark’s filing of an abbreviated new drug
application (“ANDA”) for 0.1% hydrocortisone butyrate cream, Glenmark’s
generic version of Locoid Lipocream. Subject to the terms of the settlement
and license Agreement, Glenmark will be permitted to market and distribute
Glenmark’s 0.1% hydrocortisone butyrate cream under a royalty-bearing
license from Astellas and Triax in the United States near the end of 2013.
Glenmark believes that it is entitled to 180 days of exclusivity with respect to
its hydrocortisone butyrate cream, as the first generic company to file an
ANDA for the product. Locoid Lipocream is available as a 0.1%
hydrocortisone butyrate topical corticosteroid cream. According to IMS Health
data, for 2010, Locoid Lipocream achieved sales of approximately USD 38
mn.
Workers of Shasun Pharma call off strike
Shasun Pharmaceuticals Ltd has said that an amicable settlement has been
reached with the workers at the Company's Pondicherry API Unit. The strike
has been called off and operations resumed from May 25, 2011 morning.
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Aurobindo Pharma receives warning from USFDA
Aurobindo Pharma stated that in continuation to its press release dated 23rd
February for the US Food & Drug Administration (USFDA) action on Unit VI,
the company has received the Warning Letter from the American regulator
detailing their observations. In addition, based on a field alert report for
packaging and labeling compliance for unit III, the USFDA has also asked for
submission of a detailed action plan for improvement in this letter. This is
required to be submitted within 15 working days and the USFDA has also
given an opportunity for regulatory meeting at their office.
The company is requesting the USFDA for the meeting date as well as in the
process of submitting a detailed action plan. Aurobindo Pharma had earlier
received an import alert in February this year from the USFDA for its
cephalosporin-producing Unit VI located at Chitkul Village, in Hyderabad,
Andhra Pradesh. The USFDA had audited Unit VI of the Hyderabad-based
company in December 2010. Subsequent to the audit findings, the USFDA
had imposed an import alert for detention of Unit VI products.
Aanjaneya Lifecare climbs in choppy debut
Shares of Aanjaneya Lifecare Ltd. surged as much as 17.5% on Friday in a
rising market despite the issue not receiving a favourable response. The
stock rose as high as Rs. 274.95 on the NSE after listing at Rs. 218. At 9:44
am (IST), it is trading at Rs. 250 as against the issue price of Rs. 234. Total
traded quantity stood at 3.34mn shares. On the BSE, the stock opened at Rs.
229, touched a day's low of Rs. 224 before rising to a day's high of Rs.
274.95. It was last quoted at Rs. 258.
The IPO was subscribed 1.11 times. The IPO received bids for 55.47 lakh
shares compared with 50 lakh shares on offer. Qualified institutional buyers
(QIBs) category was subscribed 0.14 times. Non institutional investors
category was subscribed 2.65 times and retail portion was subscribed 1.84
times. Aanjaneya Lifecare had planned to raise up to Rs. 1.2bn by offering 50
lakh shares in a price band of Rs. 228 to Rs. 240 per share.
The company plans to use the IPO proceeds for setting up facilities, product
marketing and registration expenses and for other corporate purposes.
Aanjaneya Lifecare is a vertically integrated pharmaceutical firm with
manufacturing and marketing capabilities in active pharmaceutical
ingredients (API) with focus on anti-malarial, and finished dosage forms
catering to various therapeutic segments.
Venus Remedies capex stands at Rs2bn: Pawan Chaudhary
Pawan Chaudhary, Managing Director, Venus Remedies Ltd has stated that
"Our Capex plan is approximately Rs. 2bn over the next four years. This will
be funded from internal accruals and banks. The amount would be used for
value addition of existing manufacturing plants, Research facilities,
infrastructure, creation of CCMB Labs and patents/IPR technologies such as
Multi-country clinical trials, Market launches, Dossier Development and
patent filings."
He added, "We have product pipeline of 25 Research Products in the segment
of Anti-Cancer, Anti-Infectives and Orthopedics-related products.Revenues
from international market are approx 34% of the total sales. Venus is already
present in 60 countries and 5 continents across the globe and is exporting to
22 countries. Venus is promoting 52 products across the globe and so far has
launched 36 products in the International Market
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International News - May 2011
Sparsha Pharma to launch 3 products: report
Sparsha Pharma International is planning to launch three products in a
couple of months, according to a report. The company have already received
approval from the Drugs Controller General of India (DCGI), says report. The
report stated that the company already has a product, fentanyl transdermal
patch, in the market. Fentanyl is a potent synthetic narcotic analgesic with a
rapid onset and short duration of action, adds report.
Takeda Pharma clarifies on Nycomed acquisition
Takeda Pharmaceutical Company Limited said that the company has and
always will comply with the rules governing the publication of any event of
material significance to our business and our shareholders. The company
would like to make clear that Takeda has not agreed to any such an
agreement as suggested by certain newspaper publications. In addition,
Takeda has a policy of not commenting on any rumors regarding our
business. Takeda is constantly seeking and evaluating opportunities to
increase shareholder value and enhance our business through strategic
investment, however, there is nothing that needs to be announced at this
point.
Takeda Pharma to buy Nycomed for US$13.6bn: reports
Takeda Pharmaceutical reportedly said it will buy privately held Zurich-based
rival Nycomed for 9.6 billion euros ($13.6 billion) on a cash-free, debt-free
basis. The transaction to make Nycomed a wholly owned subsidiary of
Takeda is expected to be completed within 90 to 120 days, subject to
antitrust clearance. The purchase excludes Nycomed's U.S. dermatology
business, added reports.
Teva Pharma plans to acquire 57% stake in Taiyo Pharma
Teva Pharmaceutical Industries Ltd has announced that it has signed a
definitive agreement to acquire 57% of the shares in privately-held Taiyo
Pharmaceutical Industry Co. Ltd. for $460 mn in cash paid to private
shareholders. Teva will also extend an offer to purchase all remaining
outstanding shares of Taiyo. This transaction gives Taiyo an enterprise value
of $1.3 billion. The transaction is expected to be accretive to GAAP earnings
within four quarters after closing. Taiyo is the third largest generic
pharmaceutical company in Japan with sales of $530 mn in 2010. The
company has one of the most comprehensive generic product portfolios in
the Japanese market with over 550 generic drugs in a variety of therapeutic
areas and dosage forms. Taiyo has strong presence in all major distribution
channels in Japan, particularly in hospitals due to its wide range of injectable
product offerings. Taiyo's marketing efforts are supported by a strong backend with top tier production capabilities in a wide range of technologies
(including sterile manufacturing) in two manufacturing facilities, as well as a
strong R&D team and local regulatory expertise. Commenting on today's
transaction, Shlomo Yanai, Teva's President and Chief Executive Officer, said,
"This acquisition will enable Teva to deliver on our strategic objective of
becoming a leading player in the fast-growing Japanese generics market. In
fact, we now expect to reach our 2015 target of $1 billion in sales in Japan
ahead of schedule. Taiyo's strong market reach, cutting-edge production
facilities, and impressively large product portfolio, combined with Teva's scale
and capabilities as the world's largest generics company, will enable us to
offer a much wider range of high quality, affordable generics to a much larger
segment of the Japanese market."
Merck completes acquisition of Inspire Pharma
Merck, known as MSD outside the United States and Canada, announced that
it is has completed its acquisition of Inspire Pharmaceuticals, Inc., a specialty
pharmaceutical company focused on developing and commercializing
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ophthalmic products, for $5.00 per share in cash. "We are excited to
complete this compelling and highly complementary acquisition of Inspire,"
said Beverly Lybrand, senior vice president and general manager,
neuroscience and ophthalmology, Merck. "The successful completion of this
transaction strengthens our ophthalmology business and positions us for
future growth with an expanded portfolio and a best in class
commercialization organization." Effective today, Monarch Transaction Corp.
a wholly-owned subsidiary of Merck, has merged with and into Inspire, with
Inspire surviving as a wholly owned subsidiary of Merck. As a result of the
merger, Inspire shares have ceased trading on the NASDAQ Global Market
and Inspire will no longer have reporting obligations under the Securities and
Exchange Act of 1934, as amended.
Novartis reports positive results on canakinumab
Novartis AG reported positive results from two Phase III trials of ACZ885,
also know as canakinumab, in patients with severe gouty arthritis. According
to reports, Novartis said the studies showed that the drug provides superior
pain relief and reduced the risk of new attacks by up to 68% compared to an
injectable steroid.
Amylin Pharma obtains temporary restraining order against Eli Lilly
Amylin Pharmaceuticals, Inc. announced that the United States District Court
for the Southern District of California issued a temporary restraining order
(TRO) against Eli Lilly and Company relating to its litigation with respect to
the Amylin / Lilly diabetes collaboration agreement.
The U.S. District Court restrained Lilly from proceeding with its plans to use
the same sales force to sell both exenatide and Boehringer Ingelheim GmbH's
competitive linagliptin. The court also enjoined Lilly from disclosing any
confidential information about exenatide to any of its sales representatives or
employees participating in the marketing, promotion or sale of linagliptin.
The complete order is being filed today on Amylin's Current Report on Form
8-K with the Securities and Exchange Commission. In 2002, Amylin entered
an alliance with Lilly for the global development and commercialization of
exenatide, a medicine indicated as a first line treatment for type 2 diabetes
that is currently marketed as BYETTA (exenatide) injection. Exenatide is also
the active ingredient in BYDUREON (exenatide extended-release for
injectable suspension), a once-weekly version currently under review by the
FDA.
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Domestic News - June 2011
Govt clears new pictorial warnings for tobacco products
The Union Minister for Health and Family Welfare Ghulam Nabi Azad has
cleared the new pictorial warnings for implementation for tobacco products
packages. The new notification issued on 27.5.2011, provides for strong
pictorial warnings for smoking (cigarettes, bidis, cigars etc) and smokeless or
chewing forms of tobacco products. A set of four pictures each of lung and
oral cancer have been notified and will come into effect from 1.12.2011. The
warnings will be rotated every two years from then onwards.
In exercise of the powers conferred by sub-section (1) of section 7, subsection (2) of section 8, section 10 and section 31 of the Cigarettes and other
Tobacco Products (Prohibition of Advertisement and Regulation of Trade and
Commerce, Production, Supply and Distribution) Act, 2003 (34 of 2003), the
Central Government hereby makes the following rules further to amend the
Cigarettes and other Tobacco Products (Packaging and Labelling) Rules,
2008. These Rules may be called the Cigarettes and other Tobacco Products
(Packaging and Labelling) Amendment Rules, 2011.
Aurobindo Pharma gets approval from US FDA for denopezil
hydrochloride tablets.
Aurobindo Pharma Ltd. reportedly said it had received the final approval from
the US FDA for its Donepezil Hydrochloride tablets 5mg and 10mg, pertaining
to ANDA No.090056 and is expected to launch soon. Donepezil Hydrochloride
tablets 5mg and 10mg is the generic equivalent to Aricept tablets 5mg and
10mg of Eisai Medical Research Inc. It is used for the treatment of mild,
moderate and severe dementia of the Alzheimer's type and fall under the
Central Nervous System (CNS) therapeutic segment. As per IMS data, the
product had a market size of around $2.5bn for the twelve months ended
September last year, added reports.
Abhijit Konduskar arrested for drug trafficking
The Directorate of Revenue Intelligence (DRI) has arrested Abhijit
Konduskar, Managing Director of Kumud Drugs Pvt. Ltd. for allegedly
indulging in illegal manufacture and trading of psychotropic substances.
Kumud Drugs' general manager Nilesh Mehta, employee Sandeep Ahire and
the Indian agent of UK-based buyer, Sean Jayantilal Kothari, have also been
arrested. All have been booked under the provisions of the NDPS Act. Read
More…
Cipla drives up asthma awareness in Tamil Nadu
In an initiative to raise awareness on
asthma and provide free lung tests and
doctor consultation to the masses,
Cipla, one of the leading pharmaceutical
companies flagged-off the ‘Breathefree
Yatra – A clinic-on-wheels’ from
Chennai
today.
Equipped
with
diagnostic tools, educational materials
and a team of counselors; the
Breathefree Yatra will travel across
eight cities in Tamil Nadu offering free respiratory check-ups with the support
of doctors in each of these locations viz Vellore, Salem, Coimbatore, Trichy,
Madurai, Tirunelveli and Nagercoil.
Asthma affects over 30milllion lives in India, of whom majority are either
undiagnosed or do not have their asthma under control. “The paradox of
asthma in India is that despite the availability and affordability of world-class
treatment, this totally controllable disease is depriving the asthmatics in the
country of a normal life; many a times subjecting them to traumatic attacks,
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hospitalization and even resulting in deaths. And the scenario in Chennai is
also the same,” said Dr. Prasanna Kumar Thomas, Consultant Pulmonologist.
“Kick the Butt” with Birlaveda Quitobac
If the truth be told, stopping smoking is not easy. Even though education on
the dangers of smoking is showcased seriously on cigarette packets, it is the
persuasive campaigns around anti-smoking that is convincing people who
smoke to consider smoking cessation on the strength of their own willingness
to do so. One such initiative to commemorate “World No Tobacco Day” is
spearheaded by the Yash Birla Group (YBG).
Birla Veda, part of Birla Research & Lifesciences Ltd, of the Birla Wellness
arm of the Yash Birla Group in association with Cancer Patients Aid
Association (CPAA) has organized the “How to Quit for Life” campaign at The
Courtyard, Phoenix Mills compound, Lower Parel, Mumbai, aimed to compel
people who smoke to be driven into isolation and effectively into involuntary
smoking cessation. Supporting the cause renowned celebrities like Shaina
NC, & Shivani Mukherjee were present at the event.
As a part of the campaign a close to 2000 people were screened for an ENT
check aimed to counsel counsel those who have tobacco addictions to help
them to quit. Followed by Street Plays by students of Terna Dental College to
make the audience aware of the laws under (Framework Convention on
tobacco Control (FCTC). Along with a story writing competition in which
participants have been asked to share their journey to becoming tobacco
free, “How I Quit”.
Dr. Reddy's launches 3 generic products
Dr. Reddy's Laboratories announced that it
has launched the three new generic
products in the US market. Donepezil
Hydrochloride tablets {5mg and lOmg
strengths), a bioequivalent generic version
of ARICEPT tablets. The Food & Drug
Administration {FDA) approved Dr. Reddy's
ANDA for Donepezil HCI tablets on May 31,
2011. Both strengths of Dr. Reddy's
Donepezil Hydrochloride tablets are available in 30, 90 and 500 count
bottles. Veniafaxine Hydrochloride Extended Release capsules (37.5mg,
75mg and 150mg strengths), a bioequivalent generic version of EFFEXOR XR
Extended Release capsules. The Food & Drug Administration {FDA) approved
Dr. Reddy's ANDA for Veniafaxine Hydrochloride Extended Release Capsules
on May 05, 2011. All three strengths of Dr. Reddy's Veniafaxine
Hydrochloride Extended Release Capsules are available in 30, 90 and 500
count bottles. Letrozole tablets, USP (2.5mg), a bioequivalent generic version
of FEMARA. The Food & Drug Administration {FDA) approved Dr. Reddy's
ANDA for Letrozole tablets, USP on June 3, 2011. Dr. Reddy's Letrozole
tablets, USP are available in 30 count bottles.
Glenmark Generics receives final approval from USFDA for Mupirocin
ointment
Glenmark Generics Inc., USA the subsidiary of Glenmark Generics Limited,
has been granted final abbreviated new drug approval (ANDA) from the
United States Food and Drug Administration (U.S. FDA) for Mupirocin
ointment USP, 2%. Mupirocin ointment is indicated for the topical treatment
of impetigo due to: Staphylococcus aureus and Streptococcus pyogenes and
is available in a 22 gram tube presentation. Based on IMS Health sales data
for the 12 month period ending March 2011, mupirocin ointment garnered
annual sales of US$55mon and achieved a 9% increase in growth compared
to the same period last year.
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Aurobindo Pharma receives final approval for Ramipril Capsules
Aurobindo Pharma Limited is
pleased to announce that the
company has received final
approval from the US Food &
Drug Administration (USFDA) to
manufacture
and
market
Ramipril Capsules USP 1.25mg,
2.5mg, 5mg and 10mg. Ramipril
Capsules USP 1.25mg, 2.5mg,
5mg and 10mg is the generic
equivalent to the reference listed
drug Altace Capsules 1.25mg,
2.5mg, 5mg and 10mg of King Pharmaceuticals Inc. Ramipril Capsules are
indicated for the treatment of hypertension and falls under the
Cardiovascular (CVS) therapeutic segment. The product has a market size of
approximately USD 95 million for the twelve months ending September 2010
according to IMS and will be launched soon. Aurobindo now has a total of
138 ANDA approvals (108 Final approvals and 30 Tentative approvals) from
USFDA.
Govt extends medical facilities to beedi workers
The Cabinet approved extension of medical facilities to beedi workers under
the Rashtriya Swasthya Bima Yojana (RSBY). The beedi worker and his
family (unit of five) will be covered and the total sum insured would Rs.
30,000/-. The other benefits and procedures under the scheme will be the
same as under RSBY. Any claims beyond Rs. 30,000/- will be reimbursed
directly by the related Welfare Commissioner to the concerned empanelled
hospital through the existing procedure. The estimated expenditure to be
borne by the Central Government is approximately Rs. 311.25 crore (this
includes 75% of the premium and the cost of the smart cards). The annual
premium is estimated at Rs. 750 per annum of which 75% would be as
Central share and the State Government’s share would be 25%. Read More…
Redox Labs to train 10,000 people in 3 years: reports
Redox Laboratories reportedly aims to train 10,000 people in the next three
years, who will be hired by major companies and small and medium
enterprises (SMEs). Durga Prasad, founder and managing director of Redox
Laboratories, was quoted as saying “We will train 3,000people this year,
assigned to us by the state government.” Redox has received a proposal
from the central government to start similar training centers in Jammu &
Kashmir, but yet has not been finalized on that front, added reports.
Divi’s Lab up 1.3% on acquisition plans
Divi’s Laboratories Ltd. shares rose after reports stated that the company
plans to buy biotechnology research companies to enter the market for drugs
made from living cells. Kishore Babu, CFO, Divi’s Laboratories Ltd., was
quoted as saying that, we are looking at smaller R&D and research kind of
companies in India and elsewhere.
Elder Pharma to launch 35 new products in 30 months
Elder Pharmaceuticals Ltd reportedly plans to launch about 35 new products
in the next 30 months, which would be in therapeutic areas like female
healthcare, osteoporosis, dermatology, pain management, cardiology,
nutraceuticals, wound care and vitamin supplements.
Aurobindo Pharma receives final approval from USFDA
India seeks collective action against trade and IPR barriers
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Global Hospitals at Chennai performs country's most complex surgical
exercise
Bharat Biotech announces the price of "ROTAVAC"
Bharat Biotech (www.bharatbiotech.com) today announced the price of
ROTAVAC India’s first indigenously developed Rotavirus Vaccine. The vaccine
will be sold to global public markets, Governments worldwide including UN
procurement agencies at a price of US $ 1.0. Bharat Biotech hopes its new
vaccine will help prevent part of the ~ 500,000 child deaths each year caused
due to rotavirus diarrhea and improve access to better, affordable rotavirus
vaccines. ROTAVAC expects India licensure during 2014 and WHO
Prequalification in 2015 for supply to UN agencies. The Vaccine is currently
undergoing Phase III clinical development for safety and efficacy in 8000
subjects, one of the largest such clinical trial ever conducted in India.
According to CDC estimates, rotavirus causes approximately 352,000–
592,000 deaths each year (median, 440,000 deaths) in children <5 years of
age.
Making the announcement Dr. Krishna Ella, Chairman and Managing Director
Bharat Biotech said “Offering rotavirus vaccines at US $1 price is a
reaffirmation of our commitment to make vaccines affordable globally. It is a
great effort, by the Bharat Biotech team which made this a possibility. I am
thankful to our technical and commercial teams for a decade of diligent
efforts in delivering a world class product. The key to our success of bringing
down cost of vaccine is our novel concepts in vaccine development and
innovative manufacturing processes with Public Health in mind.”…Read More
DCGI conducts surprise checks on over 130 drug outlets
The Office of Drugs Controller General of India has conducted surprise
inspections on more than 130 drugs sales outlets including hospitals in Delhi
and Bhiwadi in Rajasthan. 13 teams comprising of 56 officials of the Central
Drugs Standard Control Organization (CDSCO) participated in the surprise
inspections in Delhi and Bhiwadi. During the inspections it was found that in
85 sale premises the prohibited drugs were still available for sale. Orders for
not to dispofse of the stocks of prohibited drugs have been issued to the
concerned licensees for the contravention of the provisions of the Drugs and
Cosmetics Act and Rules. Further action will be taken against them after the
investigations are over. Read More…
Lupin acquires global rights for Goanna brand
Lupin limited, announced that its Australian subsidiary, GenericHealth Pty
Ltd. has acquired the worldwide rights to the GOANNA brand and the
complete range of premium therapeutic oils, rubs and ointments marketed
under the brand. Foundedin 1910, the GOANNA brand has been trusted by
generations of Australians to provide effective relief of muscular aches and
pains and other conditions such as arthritis. Read More…
Novartis clarifies on news report
Novartis India Ltd has issued a clarification with reference to the news item
appearing in a leading financial daily titled "Novartis surges 12% on the BSE
Amid Delisting Buzz". The company said the press report seem to be based
on market speculation, while the Board of Directors of the Company has not
considered any proposal for De-listing of the Company's Shares.
LifeCell International to celebrate unique birth date
LifeCell International, pioneers in stem cell banking brings an exceptional
limited period offer for all the kids who would be born on the unique date
11.11.11. Under this special new born surprise offer, any pregnant woman
who has enrolled with LifeCell International for their baby cord services from
June 2011 onwards will be entitled for cash back of their total initial payment
as per the standard storage plan which amounts to Rs. 36,000, if their child
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is born on 11th November, 2011. The excitement and celebration doesn’t end
here as all the children born on November 2011 will receive a baby pram
worth Rs. 6000 absolutely free. So be the part of the new born surprise offer
by enrolling for LifeCell International’s Baby cord services, and present your
child an unforgettable birthday gift.
Max India allots shares to Goldman Sachs arm at hefty premium
Max India Ltd. shares surged nearly 7% on Monday after the Company said
that its Board of Directors has allotted 24,079,700 equity shares of Rs. 2
each at a premium of Rs. 214.75 per share to Xenok Ltd., a wholly owned
subsidiary of GS Capital Partners VI Fund, LP. The Goldman Sachs unit
bought a 9.1% stake in Max India for about Rs. 5.22bn. GS Capital Partners
VI Fund has been floated by US-based Goldman Sachs Group Inc. The
allotment of shares to GS Capital Partners VI Fund was done on conversion of
6,019,925 Compulsorily Convertible Debentures of Rs. 867 each (CCDs) on
June 10. With the aforesaid allotment, the paid up share capital of the
Company stood increased to Rs. 513,128,220, effective June 10. The Max
India stock closed at Rs. 179.20, up Rs. 12.55 or 7.5% from the previous
close. It had earlier been as high as Rs. 183.80 and as low as Rs. 165. It had
opened at Rs. 167. Traded volume jumped to 10 lakh shares versus a twoweek average of 33,000 shares on the BSE.
NOVA Medical Centers announces a special breast and plastic surgery
camp
NOVA Medical Centers, India’s first multi-specialty standalone day surgical
center has announced a special breast and plastic surgery camp at their
Bangalore, Koramangala center. The camp will be conducted on 19th and
20th June, 2011 from 9 am to 2 pm. The attendees of this special camp has
to pay just Rs. 149/- for the registration and consultation from renowned
Nova Breast Specialists. Patients can avail expert consultation for various
breast symptoms like breast deformity, breast lump, breast pain, breast
swelling, breast tenderness, inverted nipple, nipple discharge, rash or sore on
the breast or nipple and change in the shape and appearance of the breast.
These symptoms if left undetected and untreated can cause serious life
threatening complications. Consultation on cosmetic breast surgery can also
be availed at the camp for breast augmentation, breast reduction, breast lift
[Mastopexy] and Male Breast Reduction [Gynecomastia].
iON to power Razi Healthcare
The
Hyderabad-based
Razi
Healthcare Private Limited, which
is rapidly expanding its network of
primary
healthcare
clinics
in
Andhra Pradesh, will be powered
by solutions from iON, a strategic
unit of Tata Consultancy Services
(TCS), for Small and Medium
Business to help in scaling up
business and enhance customer
experience.
N V Subba Rao, CEO of Razi Healthcare, said, “The healthcare industry is in
an era of change, as companies are looking for ways to deliver services in
more efficient, effective, and economical ways. “We decided to partner with
TCS iON for its best-in-class, on-demand business solutions at affordable cost
using the very latest in scalable cloud computing technology.” “I am
confident that with this new endeavor Razi would offer superior healthcare
solutions and services to its patients. With the help of iON we intend to
modernize patient care profiles with electronic medical records and
augmenting medical services for long term preservation, easy access and
more accurate treatments”.
39 of 118
V Ramaswamy, Global Head, iON, TCS, said, “We are delighted to have iON
power the business of Razi Healthcare. With our strong domain expertise we
are committed to bring about service improvements, business scalability and
enhance the customer experience. “Healthcare is a fast growing sector and
our endeavour is to ensure Razi offers its patient’s best-in-class healthcare
products and services expand its footprint across India”.
Over the last few months, Razi Healthcare has been setting up primary
healthcare clinics in Hyderabad and elsewhere in the State, to offer
accessible and affordable primary healthcare solutions. It has set up 33 such
clinics in the State so far. All the clinics follow internationally-recognised,
evidence-based clinical protocols and efficient practices for offering cost
effective, rational and quality healthcare to its patients. The goal is to ensure
that all patients receive the same standard of medical services, irrespective
of their location and/or socio-economic strata.
HealthLine 24x7 introduces Teleconsult and ePHR
HealthLine 24x7, India'sfirst free round the clock Healthcare Information
Assistance service,introducesTeleconsult & e-PHR (Electronic Personal Health
Record). Teleconsult aims to connectpatients with doctors over phone so that
patients don't have to cough up hugeamounts at clinics even for common
ailments. e-PHR, on the other hand, willenable people to store and access
their medical records free of cost.
Through this initiative, Religare Technologiesplans to revolutionize
India'shealthcare industry by reaching out to large section of society and
provideround the clock quality healthcare services. Healthline 24x7 has a
database ofover 1, 26,000 and is currently available in 6 metros namely
Delhi/NCR, Mumbai,Bengaluru, Chennai, Kolkata and Pune. The company
plans to expand its presenceinto more cities across Indiain due course.
With the tele-consultation facility, HealthLine24x7 empowers consumers to
consult the right doctor from the convenience oftheir home. A patient can
easily avail a 2nd opinion without waiting in longqueues or traveling long
distances to the clinic / hospital by dialing33006666.
ePHR enables customers to access their personalmedical records anywhere,
anytime. Patients can maintain a timely record oftheir medical appointments,
gain access to significant medical alerts,conveniently book appointments with
physicians and specialists, ascertainfaster and more efficient diagnosis and
treatments, improve quality of care andtreatment by creating an ID on the
website www.healthline24x7.com.
Commenting on the launch of Teleconsult, Ashish Vijh, Senior Vice President,
Healthcare IT division of ReligareTechnologies said "We dream to change the
face of healthcare in India.In our busy schedules and hunger for success,
health has gone down our prioritychart. Through tele-consultation, we aim to
make lives easier for those withscarcity of time. People can now avail
consultation by a doctor over phone bydialing 33006666 without having to
wait in long queues. Our aim is to provideaffordable healthcare to each and
every person in this country at a minimumcost and maximum benefits, hence
Teleconsult".
Despite renewed growth in 2010, Biotech Industry faces R&D
challenges
The global biotechnology industry delivered solid top- and bottom-line growth
in 2010, with the industry achieving aggregate profitability for the second
year in a row. Yet funding for research and development has grown
increasingly scarce for the vast majority of firms in the sector, which tend to
be pre-commercial stage companies that depend on years of funding to
40 of 118
support drug development. This has placed new pressure on the traditional
biotech business model, and may reshape how companies pursue R&D in the
future, according to Beyond borders: global biotechnology report 2011, Ernst
& Young's 25th annual report on the biotech industry.
"While the biotech industry's aggregate performance improved in 2010, there
is now a widening gap between large, established companies and those at
earlier stages for whom access to capital continues to be difficult," said Glen
Giovannetti, Ernst & Young's Global Biotechnology Leader. "Biotech firms will
need to adapt creatively to this environment by doing more with the funding
that is available and by working from the earliest stages of development to
demonstrate the potential value of their products to investors, payers and
regulators."…Read More
Fox Chase Cancer Center signs agreement with Life Technologies Corporation
Serum Institute pledges support to GAVI
Dr. Cyrus Poonawalla, Chairman and Managing Director of Serum Institute,
India’s largest vaccine company, today pledged Serum Institutes
wholehearted support to the Global Alliance for Vaccines and Immunisation
(GAVI). Announcing the support at an august gathering of global donors and
international healthcare agencies, Dr. Poonawalla reiterated Serum’s
commitment to cut prices for the company’s pentavalent vaccine by 60%
making it available at the lowest possible cost of $1.75 (approx Rs. 100).
This is in line with Serum’s philantrophic philosophy to further aid children’s
health in developing countries and also assists GAVI’s mission by making
vaccines available at the lowest affordable price to UNICEF and
PAHO. Serum’s – Pentavalent Vaccine helps protect children against five
potential killers namely – diphtheria, tetanus, pertussis, hepatitis B and
haemophilus influenza type B. Dr. Poonawalla highlighted the fact that Serum
is making the commitment recognizing its moral responsibility to keep these
vaccines as affordable as possible. He was speaking at the conference on
fundraising for global immunization programmes organized by Global Alliance
for Vaccines and Immunisation (GAVI) at London. The conference aims to
raise $3.7 billion and immunize 243 million around the world.
Speaking at the GAVI Alliance conference today, Dr. Cyrus Poonawalla,
Chairman, Serum Institute said, “The very genesis of Serum Institute was a
quest to make vaccines more affordable for the common man. The
partnership with GAVI serves as a good platform for us to reach out to those
poor nations and bring comfort to the millions of underprivileged across the
globe. But while we recognise our moral responsibility to keep these vaccines
affordable, I strongly believe that it is appropriate for other manufacturers,
especially the big Pharmaceutical companies, to also follow our lead and
make vaccines available at more affordable prices; otherwise our effort to
offer vaccines at lower prices will be defeated.” Calling upon global donors to
ensure long term funding beyond 2015, Dr. Poonawalla urged them to
consider the boons of vaccination for children in the most vulnerable
countries. Serum Institute is also developing affordable vaccines for GAVI
against Rotavirus and Pneumococcal diseases. The company hopes to
achieve WHO prequalification for these vaccines in the near future.
Jubilant and AstraZeneca announce successful delivery of Drug
Discovery
Jubilant Biosys Ltd., Bengaluru, based subsidiary of Jubilant Life Sciences
Ltd., and AstraZeneca, announced another successful delivery of an early
stage milestone in the Pain therapeutic area. The collaboration, initiated two
years ago in the Neuroscience therapeutic area, has now expanded to
Cardiovascular and Metabolic diseases and focuses on the delivery of a
steady stream of preclinical outcomes to AstraZeneca, by Jubilant.
AstraZeneca owns the compounds developed under the collaboration with
41 of 118
worldwide development and commercialization rights. Jubilant derives
research funding and success-based development and commercialization
milestones. Read More…
Dr. Reddy's announces launch of Levofloxacin tablets
Dr Reddy’s Laboratories announced that it has launched Levofloxacin tablets
(250 mg, 500 mg and 750 mg), a bioequivalent generic version of Levaquin
tablets in the US market on June 20,201, following the approval by the
United States Food & Drug Administration (USFDA) of Dr Reddy’s ANDA for
Levofloxacin tablets.
The Levaquin brand had US sales of approximately US$1.1bn for the most
recent twelve months ending March 2011, according to IMS Health. Dr
Reddy’s Levofloxacin tablets 250 mg and 500 mg strengths are available in
50 counts bottle and the 750 mg strengths is available in 30 counts bottles.
Kilpest India wins new order worth Rs. 7mn
Kilpest India Ltd. said that it has received an order worth Rs. 7mn for supply
of pesticide to be used in mosquito control program, from Dept. of Health &
Family Welfare, Govt. of Orissa. Further, the current order book position to
be executed stands at Rs. 80mn (sans the above order) mainly from the
agriculture sector.
Orchid Chemicals Cephalosporin API unit clears USFDA re-inspected
Orchid
Chemicals
&
Pharmaceuticals
Ltd.
on
Tuesday announced that its
Cephalosporin
API
manufacturing complex located
in
Alathur,
Chennai
has
successfully cleared the recent
USFDA inspection that it went
through.
The
facility
manufactures a range of oral
and sterile Cephalosporin APIs
and caters to the developed
markets like USA, Europe and
Japan, Orchid said in a statement. This successful inspection would help the
continuing supply of the niche APIs manufactured by Orchid in this location to
the developed markets, it added.
Apollo Hospital Bangalore presents comprehensive Health Check
programs
Apollo Hospitals, the leader in healthcare in Asia, ties-up with Group on India
to leverage the web based platform for spreading awareness about their
medical service offerings. In keeping with the expanding internet user base in
India, Apollo Hospital, Bangalore will be launching Health Check programs for
all age groups, through e-commerce major Group on. Social media, the game
changer in the country’s economy, is here to stay and imparts great power to
consumers. This novel initiative by Apollo will help in increasing brand
awareness and harness the collective buying power of customers. The Health
Check programs are designed by Apollo’s specialist doctors and then
customized for separate age and genders. These programs will be offered,
with a pre-specified validity period, at discounted prices (as compared to the
hospital’s rack rate). Read More…
Avesthagen granted US patent for its efficient Sunflower
transformation
Avesthagen Limited has been granted the patent by the US patent office for
breakthrough Sunflower transformation and eco-friendly safe selection
method that can replace the traditional antibiotic marker technology in GM
42 of 118
crops. In the past, antibiotic resistance marker gene(s) have been used in
developing GM crops which has raised world-wide opposition to the GM
technology in general. Avesthagen’s Xylose Isomerase (XI) technology does
not use antibiotics in the selection process thus successfully addressing public
concerns. This positive selection process is based on the function imparted by
the patented technology to metabolize certain carbohydrate compounds
during the selection process. Read More…
Sun Pharma, Coal India stocks rise after being included in Sensex
Lupin announces launch of Generic Levaquin Tablets for the US
Market
Pharma Major, Lupin Limited announced today that its U.S. subsidiary, Lupin
Pharmaceuticals, Inc. (LPI) has been granted final approvalby the United
States Food and Drugs Administration for the Company’s Abbreviated New
Drug Application (ANDA) to market a generic version of OrthoMcNeil’s Levaqu
in (levofloxacin) tablets. Commercial shipment of the product has
commenced. The shares of Lupinare trading at Rs. 433, down by Rs. 1 or
0.39% over the previous close. It opened at Rs. 436, recording the day’s
high at Rs. 438 and low at Rs. 432. The total traded quantity stood at 0.34
lakh shares on theBSE. Lupin’s levofloxacin 250 mg, 500 mg and 750 mg
tablets are the AB-rated generic equivalent of Levaquin, a synthetic broad
spectrum antibacterial agent used to treat or prevent infections that are
proven or strongly suspected to be caused by susceptible bacteria. Levaqu
in tablets had annual sales of approximately $1.6 billion for the twelve
months ended March 2011, based on IMS Health sales data.
Nile Therapeutics to raise US$2.5mn in private placement
Nile Therapeutics, Inc. a biopharmaceutical company that develops novel
therapeutics for heart failure patients, today announced that it has entered
into a definitive agreement to sell securities of the company in a private
placement transaction, which will result in gross proceeds of US$2.5mn. The
investment was led by Stonepine Capital, LP, and included participation from
existing investors. Riverbank Capital Securities, Inc., a FINRA member
broker-dealer, acted as the exclusive placement agent for the transaction.
Under the terms of a securities purchase agreement, Nile will sell an
aggregate of 5 million shares of its common stock and five-year warrants to
purchase up 2.5 million additional shares of its common stock. The warrants
will have an exercise price equal to US$0.60 per share. The warrants are
redeemable by the Company, at a redemption price of $0.001 per warrant
share, upon 30 days notice, if at any time, the volume weighted average
price of the common stock for any 20 consecutive business days is equal to
or greater than 250% of the exercise price of the warrants. The private
placement is expected to close on or prior to June 24, 2011, subject to
customary closing conditions.
"We are pleased to have the support of a new, quality investor like
Stonepine," said Joshua Kazam, Chief Executive Officer of Nile. "We believe
these funds will enable us to operate well into 2012, beyond the full analysis
of our ongoing Phase I trial of cenderitide. The trial is enrolling ahead of
schedule and we look forward to providing an update on our timelines soon
as we continue to explore options to enhance shareholder value."
Strides Arcolab gets USFDA nod for antibiotic injection
Strides Arcolab Limited (Strides) today announced that it has received US
FDA approval for Levofloxacin Injection, 25 mg/mL packaged in 500mg/20
mL and 750mg/30 mLsingle-use vials. Levofloxacinis a synthetic
fluoroquinolone antibiotic used to treat mild to severebacterial infections or
bacterial infections that have failed to respond toother antibiotic classes.
These include respiratory tract infections,cellulitis, urinary tract infections,
43 of 118
prostatitis, anthrax, endocarditis,meningitis, pelvic inflammatory disease and
traveller's diarrhea.
Accordingto IMS September 2010 data, the total market for Levoflaxacin in
the USA is approximated to be US$ 158 million ofwhich US$ 5.68 million is
for vials and the rest of the market is forbags. The product patent expired on
June20, 2011 and this approval is amongst the first wave of approvals post
patentexpiry.
The product is expected to belaunched shortly.
Levofloxacinis the second approval for Sagent Strides LLC in 2011. Strides is
developingand supplying more than 25 injectable products for the USA
marketwhich will be marketed by Sagent.
Pivotal study showed vismodegib helped shrink Tumours
Roche announced that a pivotal Phase II
study with vismodegib showed positive results
in people with advanced basal cell carcinoma
(BCC) for whom surgery is considered
inappropriate. Basal Cell Carcinoma is a form
of skin cancer that can cause disfiguring and
debilitating effects and can ultimately be lifethreatening. Vismodegib is an investigational,
oral medicine designed to selectively inhibit
signalling in the Hedgehog pathway, which is
implicated in more than 90% of BCC cases.
Birla Pacific Medspa fixes issue price at Rs. 10
Birla Pacific Medspa has reportedly
fixed its issue price at Rs. 10 per
share, the lower end of the price
band. According to reports, Birla
Pacific Medspa plans to utilize Rs. 49
crore for establishing 55 ‘Evolve’
outlets, and Rs. 6 crore for brand
building and the balance for meeting
working capital, Issue and other
preliminary expenses. The company is
considering
locations
in
Delhi,
Bangalore, Ahmedabad, Pune, Chennai, Hyderabad, Jaipur and Goa for its
centres, reports added.
Wockhardt receives tentative US FDA approval for generic version
Pharmaceutical and biotechnology major Wockhardt has received tentative
approval from the United States Food & Drug Administration (US FDA) for
marketing 0.1% solution of Olopatadine hydrochloride eye drops, which is
used for allergic conjunctivitis. Olopatadine is the generic name for the brand
Patanol, marketed in the United States by Alcon Laboratories Inc., now a
subsidiary of Novartis AG. The patent covering this product is under litigation
in the US courts and Wockhardt will launch the product after resolution of the
same. "This is a major ANDA approval for Wockhardt in the ophthalmic
segment", said Wockhardt Chairman Habil Khorakiwala. Read More…
J.B. Chemicals launches a New Domestic Division
J.B. Chemicals& Pharmaceuticals Ltd. (JBCPL) announces the launch of their
new “FemidentDivision” catering to Gynecology and Dental products, in its
domestic formulations business. The gynecology and dental segments, at
present, have combined sales of about Rs. 20bn with annual robust growth of
about 16%. The company has launched this division with over 100 medical
representatives and 15 products some of which are first of its kind in its
respective segment. The company plans to increase medical representative
strength in this division to 300 in about 2 years time. Read More…
44 of 118
Cipla loses US court case to Merial...To appeal the order
Cipla Ltd. said that the Company has received an order dated June 21, from
a United States District Court, Middle District of Georgia against a petition
filed by Merial Ltd. The US court has ruled that sales of PetArmor Plus (an
animal healthcare product) allegedly infringed a patent held by Merial. The
court has suspended future sales in the United States. The District Court has
stayed the above order for 60 days in order to enable Cipla to appeal. Cipla
said that it was in the process of filing an appeal against this order. There
was no determination as yet by the US court on the financial implication of
the patent infringement, it added.
…Cipla FY11 net profit at Rs9603.90 mn
Fortis to launch low cost hospitals
Fortis Healthcare (India) Ltd. marked a decade since the first hospital
(Mohali) started, and kicked off celebrations across the country starting this
week. Read More…
…Fortis to add 25 more hospitals in 3 years
Jubilant announces Drug Discovery Alliance in Neuroscience
Jubilant Discovery Services Inc., Bedminster, New Jersey, a Jubilant Life
Sciences Company, announced today that it has entered into a drug
discovery alliance with Janssen Pharmaceutica N.V., Beerse, Belgium, that
will aim to deliver preclinical candidates to Janssen. The alliance is set to
span an initial period of 3 years and will focus on multiple targets in the area
of neuroscience. Under the terms of the alliance agreement, Janssen will
transfer ongoing efforts on selected drug discovery targets to Jubilant.
Jubilant shall then carry out the research services and deliver preclinical
candidates
to
Janssen
for
possible
further
development
and
commercialization. Read More…
Strides Arcolab joins Malaysian Bio-xcell Ecosystem
Agile Specialities (Malasia) SDN BHD, the specialities subsidiary of Strides
Arcolab Ltd has exchanged agreements for the establishment of a customized
facility to manufacture biopharmaceuticals and sterile injectables in the BioXCell ecosystem in Johor, Malaysia.
Jubilant Life Sciences spurts on Belgian tie-up
Shares of Jubilant Life Sciences surged as much as 14% on Tuesday after the
company's US arm entered into a drug discovery alliance with Belgium-based
Janssen Pharmaceutica N.V. The aim is to deliver pre-clinical candidates to
Janssen. The alliance is set to span an initial period of three years and will
focus on multiple targets in the area of neuroscience.
45 of 118
International News - June 2011
Pfizer Files for European Regulatory Review of Axitinib
Pfizer Inc. announced today that the European Medicines Agency (EMA) has
accepted Pfizer's filing for regulatory review of axitinib for patients with
advanced renal cell carcinoma (RCC) after failure of prior systemic treatment.
This submission was based on Phase 3 data from the AXIS 1032 trial. Pfizer
will present full results from this trial, as well as additional data on axitinib,
at the 47th Annual Meeting of the American Society of Clinical Oncology
(ASCO), being held in Chicago from June 3-7, 2011."While the prognosis for
patients with advanced RCC has improved dramatically over the past five
years thanks to the availability of new treatments, there is still a need for
new options in this patient population," said Garry Nicholson, president and
general manager, Pfizer Oncology Business Unit. "This regulatory filing for
our innovative investigational therapy axitinib, as well as ongoing studies of
our existing medications, underscores Pfizer’s commitment to patients with
advanced RCC and our leadership in helping physicians treat this disease."
Each year, approximately 210,000 people worldwide are diagnosed with
kidney cancer and nearly 102,000 people are expected to die from the
disease. Within the last five years, great advances have been made in the
treatment of patients with advanced RCC, the most prevalent form of kidney
cancer. However, five-year survival rates for patients with advanced RCC
remain low, at around 20 percent.
NYU Langone Medical Center raises US$1bn in less than 4 Years
NYU Langone Medical Center announced that it has reached a historic and
unprecedented philanthropic milestone, raising US$1 billion in less than four
years. "This is a historic moment for our medical center," said Kenneth G.
Langone, chairman of the Board of Trustees. "We have the most
extraordinary friends and benefactors who, through their generosity of spirit
and action, have helped propel NYU Langone Medical Center to the forefront
of clinical care, research and medical education. Their belief in us and the
work we do is unsurpassed. We thank them from the bottom of our hearts."
Since 2007, when Robert I. Grossman, MD, the Saul J. Farber Dean and CEO,
took the helm of the medical center, more than 66,000 separate gifts –
ranging from US$1 to four gifts of US$100mn or more – from 51,000
individuals have poured in. Read More…
Northwest
Biotherapeutics
announces
series
of
Financing
Arrangements
Northwest Biotherapeutics announced that it has put in place a series of
financing arrangements, including a US$3mn investment already received,
and access to up to US$25mn of further funding on fixed, specified and
favorable terms, at such times and in such amounts as the Company
chooses. This series of financing arrangements will provide a strong financial
foundation for completion of the Company's ongoing 240-patient clinical trial
of DCVax(R)-L for the treatment of Glioblastoma multiforme (GBM) brain
cancer, and will also provide for certain other programs in the Company's
near term pipeline. As the first component of the overall financing
arrangements, the initial US$3mn investment has been provided by a multibillion dollar institutional investment fund based in Minnesota. The
investment is structured as a convertible note with warrants. The note is not
convertible until maturity, 18 months after closing, and is only convertible
into unregistered restricted stock at that time. Read More…
Johnson & Johnson announces
plans
Johnson & Johnson announced
restructuring charge in the range
2011 as a result of restructuring
special charge related to restructuring
that it expects to record an after-tax
of $500-$600mn in the second quarter of
plans announced by its subsidiary, Cordis
46 of 118
Corporation. The restructuring charge will be treated as a special item. In its
separate news release today, Cordis announced the discontinuation of its
clinical development program for the NEVO Sirolimus–Eluting Coronary Stent,
cessation of the manufacture of CYPHER and CYPHER SELECT Plus SirolimusEluting Coronary Stents by the end of 2011, and other plans related to its
cardiovascular business.
AstraZeneca extends its investment in Russia
AstraZeneca announced that it plans to establish a Predictive Science Centre
in St. Petersburg over the coming year. The move strengthens AstraZeneca's
investments in Russia and supports the Russian Government's strategy to
modernise and develop the country's pharmaceutical sector. The new
AstraZeneca Predictive Science Centre, the company's first in Russia, will
leverage local scientific talent and focus on developing bioinformatics, data
analysis methods, software and systems to better predict the safety and
efficacy of potential new medicines. Approximately 30 people will work at the
Centre through collaborations with local companies and organisations as part
of a related agreement with the St. Petersburg government to be announced
later this week. Read More…
FDA warns of record drug shortages: reports
The Food and Drug Administration warns that the number ofdrug shortages is
at a record high and getting even worse. Regulators are seeing a large
number of new drug shortagesin 2011 as well. The agency is especially
concerned about the shortages ofinjectable drugs, which account for more
than half of the shortages reportedlast year to the FDA, reports added.
Bristol-Myers Squibb signs agreement to expand access to Reyataz
Bristol-MyersSquibb Company
announced a new agreement to expand
access to Reyataz (atazanavir sulfate). The immunity-from-suit agreement
signed withMatrix Laboratories Limited, a Mylan Company, enables the
generic company tomanufacture and sell atazanavir, as well as stavudine and
didanosine, in sub-SaharanAfrica and India.
“The HIV treatment landscape has changed dramatically since 2001, when
we first began our Global Access Program to help expand the availability of
low-cost HIV medicines in the developing world,” said Frank Pasqualone,
president, Intercontinental Region, Bristol-Myers Squibb. “Atazanavir is an
important component of HIV combination therapy andthis agreement
facilitates broader availability of the medicine to help ensurepatients can
access appropriate treatment regimens.” Read More…
…Bristol-Myers Squibb Foundation Awards $1.5 Million in Grants
Bayer advances research in the area of pulmonary hypertension
Bayer HealthCare is working with the Ludwig Boltzmann Institute (LBI) for
Lung Vascular Research in the research area of lung vascular diseases especially pulmonary hypertension. Other partners include the German
medical device manufacturer NEBU-Tec and the Austrian Academy of
Sciences. The research facility is also sponsored by Bayer and belongs to the
Ludwig Boltzmann Gesellschaft (LBG). The LBI for Lung Vascular Research is
located at the Medical University of Graz, which is also a partner of the LBI.
"The Ludwig Boltzmann Institute for Lung Vascular Research has bundled
renowned expertise in the field of pulmonary hypertension, an area with
considerable unmet medical need," said Dr. Helmut Haning, Head of Global
Innovation Sourcing at Bayer HealthCare on the occasion of the LBI opening
ceremony. Read More…
47 of 118
Domestic News - July 2011
PM seeks convergence of programmes for AIDS control
The
Prime
Minister
Dr.
Manmohan Singh today called
for multi sectoral approach and
greater
integration
of
resources in dealing with
response to HIV/AIDS. The
Prime
Minister
was
inaugurating
the
National
Convention of Zila Parishad,
Chairpersons
& Mayors on
HIV/AIDS organized by Forum
of
Parliamentarians
on
HIV/AIDS in New Delhi today. The Prime Minister also called for other
concerned Ministries to have a “HIV sensitive” policy and programmes so that
the marginalized populations infected and affected by HIV/AIDS are not
denied the benefits of these schemes. He said linkages should be made
between the HIV/AIDS programme and the Mahatma Gandhi National Rural
Employment Guarantee Programme to facilitate employment of HIV positive
persons. Read More…
Biomedical engineers to develop mobile phone malaria diagnostic
sensor
The University of Glasgow has received a grant from the Bill & Melinda Gates
Foundation to further help in the diagnosis of Malaria. The $100,000 award
will go towards developing a device which uses mobile-phone derived
technology that can detect and separate red blood cells infected with malaria
parasites. It is hoped that if successful, devices based on the technology
could be mass produced for rapid and accurate malaria diagnosis. The project
team comprises Jon Cooper, Wolfson Chair of Bioengineering of the College
of Science and Engineering, Mike Barrett, Professor of Biochemical
Parasitology and Senior Lecturer, Dr Lisa Ranford-Cartwright, both of the
College of Medical, Veterinary and Life Sciences. Read More…
USFDA bans import from Dr Reddy's Mexico plant: report
The USFDA has imposed an import ban on products made at Dr Reddy's
Laboratories' Mexican plant for violation of current good manufacturing
practices, according to a report. The report stated that the company's
Mexican arm, which had received a warning a letter from the USFDA last
month. The import alert on Dr Reddy's drugs was issued under the category
of 'Detention without physical examination of drugs from firms which have
not met drug GMPs', says report.
Fortis Healthcare appoints Aditya Vij as CEO
Fortis Healthcare (India) today has
appointed former head of General
Motors India, Mr Aditya Vij, as the
Chief Executive Officer (CEO) of the
company effective from July 5. Fortis
said in a filing to the Bombay Stock
Exchange (BSE). Fortis Healthcare
(India)
Managing
Director,
Mr
Shivinder Mohan Singh, said, “His
impressive track record of growing
businesses and delivering successful outcomes in the domain of quality and
financial performance across geographies, his ability to develop and align
large teams to deliver performance and his experience in managing cultural
diversity position him strongly to take on the mantle of leadership for our
fast-growing organization.” The filing further stated that prior to working with
48 of 118
Punj Lloyd, Vij worked with General Motors for 18 years across five countries
in Europe and Asia.
Cardiac Science enters into agreement with Omron Healthcare
Cardiac Science Corporation (an Opto Circuits (India) Ltd. company) has
announced that it has entered into an exclusive distribution agreement with
Omron Healthcare Co. Ltd. to distribute the JMHLW approved Omron
Automated External Defibrillator Powerheart G3 HDF - 3000 in Japan. Omron,
a leading healthcare company dedicated to the prevention of heart disease,
will distribute the AEDs through its home-use and medical healthcare devices
division and will optimally utilize sales channels of business partners. Vinod
Ramnani, Chairman and Managing Director, Opto Circuits, commented: “We
are pleased to partner with a well known brand like Omron Healthcare to gain
a strategic re-entry into the lucrative Japanese market with our emergency
life saving product. We consider this to be an important milestone for the
Opto Circuits Group.” Read More…
Wockhardt gets USFDA nod for generic version of Cymbalta
Wockhardt Ltd has received tentative US FDA approval for marketing
20mg,30mg and 60mg delayed realeas capsules of Duloxetine hydrochloride
whihc is used in treatment of depression. Duloxetine is the generic name for
the brand Cymbalta. According to IMS Health, the total market for this
product in the US is about $3.3 billion.“Wockhardt was amongst the first-tofile companies with a paragraph-IV certification for Duloxetine DR capsules”
said Wockhardt Chairman Habil Khorakiwala. “We will now be amongst the
first-to-market this product, as and when the generic market opens up.
Wockhardt plans to sustain its rapid growth in the US market through a
series of such first-to-market launches”, he commented further. Read More…
Ozone Pharmaceuticals organises Blood Donation Camp
July 1 is attributed as the Doctor’s Day in India. It is celebrated to remember
the valuable services of medicos to human kind and express our gratitude for
the dedication and sacrifice of the messengers of life and health. From
dentists to neurosurgeons, homeopaths to heart specialists, physicians and
pediatricians, each one of them play a very integral role in a patient’s life.
This day has been chosen as a mark of respect to the contributions made by
Dr. Bidhan Chandra Roy, who left an indelible mark in the history of medical
profession in India. The Doctor’s Day is in commemoration of the birth
anniversary of the eminent physician and patriot. Read More…
Ranbaxy asked by UK MHRA to recall its drugs: report
Ranbaxy Ltd has been asked by the UK Medicines and Healthcare products
Regulatory Agency to recall its drugs used to treat skin infections, according
to a report. The report stated that the company was recalling unexpired stock
of Isotretinoin 20mg capsules due to a potential issue with bio-equivalence in
comparison with the originator product.
Glenmark Pharma announces settlement of litigation with Daiichi
Sankyo
Glenmark Pharmaceuticals Ltd, Glenmark Generics Ltd and Glenmark
Generics Inc, USA announces the settlement of litigation with Daiichi Sankyo,
Inc and Genzyme Corporation regarding Glenmark’s Abbreviated New Drug
Application (ANDA) filed with the US Food and Drug Administration for
Colosevelam Hydrochloride. The shares of Glenmark are trading at Rs. 320,
up by Rs. 3 or 1.25%
Apollo Hospitals to raise Rs 3.3bn via QIP: reports
Apollo Hospitals will increase up to Rs. 3.3bne via qualified institutional
placement for its expansion plan. Earlier, Apollo planned to raise Rs 9bn
through a mix of equity and debt. The company plans to raise the QIP at
current market price, according to reports. The funds will be used to add
2,400 beds by FY14. This will include 900 beds in the metros and 725 beds
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through Apollo Reach in small towns such as Nasik, Ayanambakkam (in
suburban Chennai), Nellore and Trichy. Three large tertiary hospitals will
come up in Mumbai. Apollo's current bed strength is 8,717 across 54
hospitals. All these are greenfield projects, added reports.
Dr. Reddy's gets USFDA nod for Fondaparinux injection
Dr. Reddy's Laboratories Ltd. said on Wednesday that the company, along
with Australia's Alchemia Ltd. have received the USFDA approval for the
Indian company's ANDA for Fondaparinux Sodium Injection. Fondaparinux
Sodium Injection is a generic version of Arixtra. Dr. Reddy's will manufacture
Fondaparinux under license, using a patented process developed by
Alchemia. The US patent on Arixtra expired in 2002, the year before the drug
was launched in the US. The Arixtra brand had US sales of approximately
US$340mn (YoY growth of 16%) for the 12 months ended May 2011.
Govt, Piramal Life begin Phase II of Drug Discovery PPP
The Department of Biotechnology (DBT), Government of India and Piramal
Life Sciences Limited (PLSL) have begun Phase II of their Drug Discovery
Public Private Partnership to find new drugs from 14000 bioactive cultures
discovered in a nationwide search for new drugs from biodiverse habitats
across the country in collaboration with 9 national institutes. A total of
245000 different microbes were collected and characterized at the national
centres. Extracts from these microbes were screened for biological activities
across four different therapeutic areas namely Cancer, Diabetes,
Inflammation and Infectious diseases. Based on the results of these studies,
the team has identified greater than 14000 cultures that showed potent
activities in the above disease conditions: 5000 extracts for anti-infective,
500 extracts for anti-cancer, 6000 for anti-diabetes and 2900 extracts with
anti-inflammatory properties. Read More…
Ranbaxy enters into a licensing agreement with Gilead Sciences
Ranbaxy Laboratories Limited (Ranbaxy) announced today thai it has entered
into an in-licensing agreement with Gilead Sciences, Inc. for three new
HIV/AIDS drugs which are cmrenlly in late-stage elinical development.
Ranbaxy will have the rights to produce and sell generic versions of these
drugs, under license, in India and other developing nations, after gaining
necessary regulatory approvals. Read More…
J.B. Chemicals completes acquisition for Russian OTC brands
J.B. Chemicals announces the successful completion of its transaction of sale
of Russia- CIS OTC Business to Cilag GmbH International (“Cilag”),
Switzerland, a wholly owned subsidiary of Johnson & Johnson, along with
transfer of worldwide rights and registrations of three OTC brands namely
Doktor MOM, Rinza and Fitovit.
On May 23, 2011, the board of directors had approved the sale of this
business and OTC brands to Cilag. The company’s Russian subsidiary has
also achieved successful completion of its transaction of sale of OTC
inventory and receivables to Johnson & Johnson LLC, a Cilag’s affiliate.
Orchid receives US FDA nod for Venlafaxine ER Capsules
The Chennai-based pharma major, Orchid Chemicals & Pharmaceuticals Ltd
(Orchid) has announced that it has received approval from the US FDA for its
ANDA (Abbreviated New Drug Application) for Venlafaxine Extended Release
(ER) Capsules in the 37.5 mg, 75 mg and 150 mg strengths.
SPARC Board approves Rights Issue
Sun Pharma Advanced Research Co. Ltd. (SPARC) on Thursday said that a
Committee of the Board of Directors has, vide its resolution passed on July
14, authorized the further issuance of equity shares of Re. 1 each of the
Company, on a rights basis to the shareholders.
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The ratio, price and premium may be decided in consultation with the Lead
Managers to the proposed rights issue, in such a way that the funds raised
are not more than Rs. 2bn. The ratio of rights share entitlements, the issue
price and the record date for fixing the entitlement of shareholders to such
rights issue shall be informed in due course.
Lupin grants options under ESOP
Lupin Ltd has said that the Company has granted 19,000 options to its
employee of its subsidiary Company, under "Lupin Subsidiary Companies
Employees Stock Option Plan 2011", at the exercise price of Rs. 458.30 on
July 13, 2011. One equity share of Rs. 2/- each is covered by each option.
The options issued are exercisable at the 'market price' as defined in SEBI
guidelines, in a phased manner after a minimum vesting period of 12 months
but before the exercise period of 10 years from the date of grant.
Venus Remedies launches "ACHNIL" in India
Venus Remedies Limited, a leading research based global pharmaceutical
company and amongst the prominent injectables manufacturers in the world,
launched a novel formulation “ACHNIL” brand of “Aceclofenac- injection” in
India. “ACHNIL” injection is a “single Shot... last day long” formulation. Dr.
Manu Chaudhry, Joint Managing Director of the company on the occasion
said, “This novel formulation based on NDDS (Novel Drug Delivery System)
technology will fill in the gap of long standing demand for better pain
management therapies especially for aged population. It is not only going to
reduce the number of pricks but will also drastically reduce the side effects
associated with the use of NSAIDs.” Discussing about the benefits of the drug
Ms. Chaudhary added, “ACHNIL acts directly by giving instant relief from
acute pain and is effective for the next 24 hours against the conventional
daily dose of three injections of diclofenac given every 8 hours.”
The development of ACHNIL commenced at VMRC and took more than seven
years in the successful completion of phase-I, phase-II and phase-III clinical
trials and regulatory approvals from DCGI for this product. The marketing
team of Venus is fully geared upon all India launch to take this innovative
pain solution drug in most needed Indian market. “The Indian market for
pain management is approximately INR 2000 crores which is growing at the
rate of 16% – 20% annually and is expected to be of INR 3500 crores by
2015. Venus is expecting substantial shares in the coming years” said Mr.
Peeyush Jain, Deputy Managing Director and head Marketing unit of Venus.
ACHNIL ensures immediate burst release action, which gives results with in
4-5 minutes and rest drug is released in controlled manner thereby passing
the true benefits of Aceclofenac. Aceclofenac is a radical innovation of Venus
Medicine Research Centre which is a non steroidal anti-inflammatory drug
(NSAID) and is used to relieve acute as well as chronic pain and inflammation
in rheumatoid arthritis, osteoarthritis, low back pain, ankylosing spondylitis,
dental pain, post traumatic pain, gynecological pain and oncology pain.
Aceclofenac is designed in such a way that the product is never released in
super or sub therapeutic zones and hence is highly safe and practically free
from side effects. Venus has already secured patents from India as well as
from Europe for this research product which are valid up to 2025 and will
further reinforce the market position of Venus Remedies in India and the
major European economies such as Germany, UK, France, Spain, Sweden,
Italy and Switzerland.
Herbalife India enters 12th year...Grows 154% in Q1
Herbalife, the global nutrition and direct selling company entered their
thriving 12th year of operations in India with a stellar growth of 154% in Q1;
Herbalife India plans to further expand their presence across regions this
year. The company is also looking at expanding the product portfolio, of inner
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and outer nutrition range over the next 6 months. Today, Herbalife has
grown to over 1, 00, 000 distributors in India.
Herbalife's growth over the past few years has placed India as one of the
largest contributors globally. Commenting on this development, Ajay Khanna,
country head, Herbalife India said, "Herbalife in India has done extremely
well over the last one year, growing to be one of the top 10 markets out of
the 76 countries that Herbalife is present in. Herbalife is also planning to
invest heavily in technology and ramp up its manufacturing capacity. Read
More…
Rakesh Jhunjhunwala halves stake in Lupin: report
Shares of Lupin Ltd. fell on Wednesday after media reports that billionaire
investor Rakesh Jhunjhunwala had cut its stake in the domestic drug maker
by half. Reports said that Jhunjhunwala sold about 66 lakh shares of Lupin in
Q1 FY12. At the end of March this year, he held 1.43 crore shares in Lupin.
Earlier this week, media reports said that Lupin was contemplating selling its
domestic marketing unit. Promoters of the Mumbai-based company have
started the process of finding a buyer for the operations, reports said.
The Indian business may be worth at least US$1bn, reports added. The
Indian medicines unit accounted for 32% of Lupin’s Rs. 57.1bn revenue in
the year ended March 31, 2011. But, Lupin said it has no plans to sell its
domestic operations. “This is baseless and there is no such activity going on,”
the company said in a statement.
Piramal Healthcare to transform into financial services conglomerate:
reports
Piramal Healthcare, is reportedly planning take step to transform into a
financial services conglomerate as it negotiates to buy Enam Financial's stake
in ING Life Insurance. According to reports, the insurance company may be
valued at Rs. 24bn. There is no certainty the transaction will be completed as
discussions are still on.
Himalya International signs agreement with Guardian Pharmacy
Himalya International Ltd has signed agreement with Guardian Pharmacy to
market its nutritional supplements under it's brand '1 Daily'. Guardian will
carry four variants; 1 Daily Total Health for Men & Women, 1 Daily Healthy
Heart and Healthy Bones. The Products shall also be available at
International Airports in India at Guardian Pharmacy stores. 1 Daily has also
been launched at Apollo Pharmacy and Religare Wellness Pharmacy chains.' 1
Daily' nutritional Supplements are manufactured in technical collaboration
with Global Reliance Inc. USA.
Sun Pharmaceutical gets nod from USFDA to sell AstraZeneca
Sun Pharmaceutical Industries has reportedly received approval from the
U.S. Food and Drug Administration to sell a generic version of AstraZeneca
PLC's (AZN) cancer drug Arimidex. According to reports, Sun Pharmaceuticals
can sell anastrozole--the generic version of Arimidex--as 1 milligram tablets.
CIFT signs MoU with Uniloids Biosciences
Central Institute of Fisheries and Technology [CIFT] signed one of a kind MoU
with Hyderabad based Uniloids Biosciences. With this MoU, Uniloids
Biosciences will have access to the unique and innovative technology,
developed at CIFT, to convert process waste to Chitin and Chitosan. Chitin
and Chitosan finds wide usage in various industries like pharma, food
processing, cosmetics, etc. Under the MoU, Zonal Technology Management Business Planning & Development Unit [ZTM-BPD Unit] along with Fish
Processing Division and Quality Assurance & Management Division will further
provide training and support to Uniloids Biosciences for commercializing the
technology. Read More…
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Some shareholders of Dr Reddy's want stock split
Dr Reddy's Laboratories Ltd, some of the shareholders has reportedly asked
its management to split the equity shares. According to reports, the split
would help small investors to have liquidity as the scrip was now trading at a
‘high' price. The AGM approved payment of divided of Rs. 11.25 per equity
share of Rs. 5 each (225%) of the company, added reports.
Go to new heights in the fight against childhood Cancer
This September, in honor of National Childhood Cancer Awareness Month,
people worldwide have the opportunity to skydive with a collective purpose
helping to raise money for the thousands of children, and their families, living
with cancer. This year's "Global Leap for Life 2011" gives people the chance
to join a worldwide skydiving fundraising initiative allowing them to "skydive
for a cause" and raise money for cancer charities. People can make taxdeductible donations to sponsor a skydive and benefit Alex's Lemonade Stand
Foundation, a nonprofit dedicated to finding a cure for all kids with cancer. In
addition, people can also skydive for another cancer charity, Strength for
Life, a New York-based not-for-profit dedicated to empowering people with
cancer and cancer survivors through exercise.
Alex's Lemonade Stand Foundation (ALSF) emerged from the front yard
lemonade stand of cancer patient Alexandra "Alex" Scott who wanted to help
find a cure for all children with cancer. Alex lost her fight with cancer at age
8, but since its inception, ALSF has raised more than US$40mn towards
Alex's cancer cure dream. Nearly 13,000 children are diagnosed with
pediatric cancer each year in the United States and, worldwide,
approximately 11 million people are diagnosed with some form of cancer
each year. Millions of dollars are needed to fund cancer research. In past
events, Leap for Life has raised nearly $60,000 for various cancer charities.
Their goal is to surpass that tally this year and encourage skydivers from
around the world to participate in a unique skydiving adventure.
US drugstore chain Rite Aid alleges Ranbaxy Labs: reports
A retailer of Ranbaxy drugs in the US has filed a complaint alleging that
Ranbaxy has refused to cover the legal costs and losses the retailer has
suffered in defending the company for selling a generic drug that has shown
undesirable side effects, according to reports. Reports further stated that in
its complaint filed at the Eastern District Court of Pennsylvania last week,
Rite Aid has asked the court to direct Ranbaxy to cover the cost it has
incurred so far, defend and indemnify the company from the ensuing legal
action.
India and EU reach agreement on drug seizure
European Union has proposed a settlement of the dispute by confirming the
detailed principles agreed in the Understanding to guide border enforcement
of intellectual property in the EU. In addition, EU agreed to India’s request
for adoption of guidelines which would confirm the principles agreed to in the
Understanding with a view to give greater and immediate legal certainty for
producers and traders. EU also agreed to reflect the principles contained in
the Understanding in its proposal for a new Regulation to replace Regulation
1383/2003. In return the EU sought an assurance that India would refrain
from further steps in the ongoing dispute. Read More…
Metropolis to invest in 1.5mn to set up labs
Metropolis Healthcare Ltd, India’s one of the leading multi-national chain of
diagnostics centers, is now coming up with 15 Greenfield laboratories in Tier
II and tier III cities across India after the success of its 2ndsuch lab in
Indore. The company is likely to make a total investment of around Rs.
1.5mn in this fiscal year. These well-equipped labs will be located in cities
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like Gorakhpur, Jalandhar, Amritsar, Lucknow, Allahabad, Udaipur, Agra,
Bhopal and Ranchi. Read More…
Fujifilm and Dr. Reddy's to form JV
Fujifilm Corporation President and CEO, Shigetaka Komori and Dr. Reddy's
Laboratories Ltd. Vice-Chairman and CEO, G V Prasad today signed a
Memorandum of Understanding to enter into an exclusive partnership in the
generic drugs business for the Japanese market and to establish a joint
venture in Japan. A definitive agreement will be signed during the course of
the calendar year. The new joint venture will have 51% stake owned by
Fujifilm and 49% stake owned by Dr. Reddy's. Read More…
Apollo Hospitals to add 3,000 beds in next 3 years: reports
Apollo Hospitals Enterprise Ltd to reportedly add 3,000 beds, with an
investment of Rs. 16bn in next three years. According to reports, the chain is
planning to fund the expansion through debt and equity. Meanwhile, its
planned foray into ayurveda in a big way has hit a block, after talks with
Kottakkal Arya Vaidya Sala having failed.
Lupin signs agreement with Medicis
Lupin Ltd has signed joint venture development agreement with Medicis.
Under the terms of the agreement, Lupin will receive a $20mn upfront
payment from Medicis and will be primarily responsible for formulating
certain novel therapeutic products for Medicis, utilizing several of Lupin's
formulation technologies.
Cadila Healthcare signs share purchase agreement with ICICI
Venture: reports
Cadila Healthcare has reportedly signed a share purchase agreement with
ICICI Venture to acquire 100% shareholding of Finest Procuring Solutions
Ltd, which in turn holds cent per cent shareholding of Bremer Pharma GmbH
of Germany. According to reports, deal includes the transfer of all key assets,
people, brands and export contracts of Bremer. After acquisition, Zydus AHL
will be able to expand its animal health business and gain strategic access to
the key markets across Europe, South America, Asia and Africa.
Zydus' Baddi plant gets USFDA approval
The formulations manufacturing plant of the Zydus group at Baddi, Himachal
Pradesh has been approved by the USFDA. With the approval in place, the
plant which currently caters to the domestic and emerging market
requirements, will commence supplies to the US markets. Read More…
Glenmark Pharma receives US$15 mn from Salix Pharma
Glenmark Pharmaceuticals Ltd has announced that the Company has
received US$15 mn from Salix Pharmaceuticals, Inc, USA. This is as per an
Agreement for Advance against Commitment fee which is to cover
Glenmark's risks associated with upgrading its manufacturing facilities to
meet Salix's anticipated increased requirements in demand for Crofelemer.
Through an agreement between the two companies, Salix agreed to pay
Glenmark a $ 21.6 million commitment fee in five equal annual installments,
with the first annual installment in July 2012, in view of Glenmark's
investment in, and risks associated with, upgrading its manufacturing
facilities to increase the production capacity of crofelemer. The commitment
fee is in addition to the compound purchase price payable by Salix to
Glenmark. After remitting the advance of USD 15 million to Glenmaric, Salix
will pay Glenmark the remaining $ 6.6 mn of the conimitment fee in five
equal annual installments.
Strides Arcolab gets USFDA nod for Acarbose
Strides Arcolab Limited (Strides) today announced that it has received US
FDA approval for Acarbose Tablets,25mg, 50mg and 100 mg. Acarbose is a
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niche anti-diabetic drug used to treat type 2 diabetes mellitus.
According to March 2011 IMS data, total US market for Acarbose Tablets
approximated to USD 21 Million with no Indian generic players in the market.
The Pharma division has a total of 37 filings with US FDA (21 under the
PEPFAR programme and 16 as Generics). Approvals to date are 22 (17
under PEPFAR and 5 Generics). This product will be marketed and sold by
Perrigo under a profit share partnership. Product is expected to be launched
shortly, within Q3 ‘2011.
Evolve unveils Ultra Z
Evolve Medspa, a Yash Birla Group company is bringing Ultra Z, the latest
technology in liposuction to India. Ultra Z is the 4th Generation ultrasound
liposuction technology from South Korea. This is a very popular international
device which loosens up and emulsifies fat cells from your face or other body
parts leading to easier, safer and faster body sculpting.
How does it work?
The Ultra- Z system represents a major advance over traditional liposuction
and earlier generation UAL devices; Ultra- Z was designed to efficiently
emulsify fatty tissue with minimal amount of energy, thereby achieving
exceptional contour finesse while preserving the tissue matrix. There is now a
tissue selective ultrasound body shaping technology and surgical technique
designed for precise and efficient sculpting.
Why Ultra Z?
The ultra-z system advanced ultrasound technology creates an efficient way
of breaking down fatty tissue before it is removed, leaving nerves, blood
vessels, and connective tissue largely intact. Rolling probes disperse energy
to maximize efficiency in various types of fatty tissue, from delicate to
fibrous, Because blood vessels and nerves are minimally disrupted, patients
report little bruising, and low to minimal pain.
Advantages of Ultra Z

The safest and the fastest lipo-sculpture
Suitable for all body parts
Protects from major tissue damages, skin burn
Faster and more efficient
Thinnest probe in the world for the most delicate zones
Less pain, swelling and bleeding
Fast recovery
Even contour and enhanced skin tightening
Dr. Abhijit Desai, Make Over Expert & Managing Director – Birla Pacific Med
Spa Pvt. Ltd said, “We at Evolve are always looking for the best technological
advantage to provide to our customers, Ultra Z being the most advanced
technology in liposuction we focus on delivering high quality treatment
making it a pleasurable experience not painful.”
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International News - July 2011
Lonza to buy Arch Chemicals for US$1.4bn deal
Swiss chemicals company Lonza Group Ltd is planning to acquire U.S.-based
global biocides group Arch Chemicals Inc in an all-share deal valued at $1.4
bn, based on the offer price for all outstanding shares, according to a report.
The report stated that Lonza will pay $47.20 in cash for Arch Chemicals'
outstanding shares. The deal is expected to be completed by late 2011.
Gilead signs pacts with 4 Indian Cos for HIV drugs
Gilead Sciences, Inc. announced on Tuesday an expansion of its global access
program in an effort to provide accelerated access to Gilead medicines for the
treatment of HIV/AIDS. The changes announced today include new licensing
terms with four India-based drug manufacturers-- Hetero Drugs Ltd., Matrix
Laboratories Ltd., Ranbaxy Laboratories Ltd. and Strides Arcolab Ltd. - for
three drugs which are currently in late-stage clinical development. These
Indian partners have played an active role in supplying treatment to patients
in the developing world. In addition, Gilead is the first pharmaceutical
company to enter a licensing agreement with the Medicines Patent Pool
Foundation (the Pool).
The expanded licensing terms grant to the company's Indian partners and
the Pool future rights to elvitegravir, an investigational integrase inhibitor;
cobicistat, an investigational antiretroviral boosting agent; and the "Quad,"
which combines four Gilead HIV medicines in a once-daily, single-tablet
regimen. Gilead licensed rights to commercialize elvitegravir from Japan
Tobacco (JT), and JT is working in close partnership with Gilead to ensure
future access to elvitegravir in the developing world.
"Gilead is proud to engage in innovative partnerships to expand access for
patients in the developing world, and we welcome new opportunities to work
with Indian manufacturers and the Medicines Patent Pool," said Gregg H.
Alton, Gilead's executive vice president for corporate and medical affairs.
"Our goal is to ensure that as new Gilead HIV therapies are developed and
approved, low-cost versions will be rapidly accessible in developing countries
without delay."
Licensing agreements are a cornerstone of Gilead's efforts to increase access
to the company's therapies in the developing world. Since 2006, when Gilead
initially established licensing agreements with Indian partners, the lowest
available price of a Gilead antiretroviral has decreased to US$6.15 per patient
per month, or 21 cents per day. Today, more than 1.1 million patients in
developing countries receive Gilead HIV medication produced by Indian
partners.
Sanofi to sell Dermik arm; reports Phase 3 result: reports
Sanofi SA is reportedly selling its Dermik dermatology arm to Valeant
Pharmaceuticals International Inc. for $425 mn in cash. According to reports,
Sanofi has planned to sell the business, which owns brands including
BenzaClin and Carac, in order to further concentrate on its growth platforms.
Sanofi and its Genzyme subsidiary announced positive top-line results from
the first of two Phase III clinical trials comparing the investigational
alemtuzumab drug to the approved multiple sclerosis therapy Rebif, added
reports.
AstraZeneca wins USFDA nod for Brilinta (Ticagrelor)
AstraZeneca announced that the US Food and Drug Administration (FDA) has
approved BRILINTA (ticagrelor) tablets to reduce the rate of heart attack
(myocardial infarction [MI]) and cardiovascular (CV) death in adult patients
with acute coronary syndrome (ACS), compared to clopidogrel.
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BRILINTA, a new oral antiplatelet medicine, is indicated to reduce the rate of
thrombotic cardiovascular events in patients with ACS (unstable angina [UA]
non-ST-elevation myocardial infarction [NSTEMI], or ST-elevation myocardial
infarction [STEMI]). BRILINTA has been shown to reduce the rate of a
combined endpoint of CV death, MI or stroke compared to clopidogrel. Read
More…
Novartis Q2 sales up 19%
The second quarter financial
results
for
Novartis
were
published on July 19 with the
company achieving 19% sales
growth in constant currencies
and
excellent
operating
leverage.
Its
diversified
healthcare portfolio generated
sales and profit growth ahead
of
market
with
strong
contributions
from
Alcon,
Sandoz and Consumer Health.
Recently launched products
grew 46% over previous-year quarter to US$3.8bn and best-in-class Gilenya
launch with US$138mn in first half sales.
Novartis also announced its commitment to innovation results in four major
approvals and two major filings. FDA approved Afinitor for advanced
pancreatic neuroendocrine tumors and Arcapta Neohaler for chronic
obstructive pulmonary disease, while EU granted approval for Lucentis in
retinal vein occlusion and for hypertension medicine Rasilamlo. Finally, Janus
kinase inhibitor INC424 was filed for myelofibrosis in Europe and FDA
accepted application to expand Menveo indication to toddlers and infants as
young as 2 months.
Express Scripts and Medco sign US$29.1bn merger pact
Express Scripts, Inc. and Medco Health Solutions, Inc. announced that they
have entered into a definitive merger agreement. Under the agreement,
Medco shareholders will receive US$71.36 per share in cash and stock, or
US$29.1bn, based on yesterday’s closing price. Medco shareholders will
receive US$28.80 in cash and 0.81 shares for each Medco share they own
upon closing of the transaction. The agreement has been unanimously
approved by the boards of directors of both companies. The merger will
combine the expertise of two complementary pharmacy benefit managers
(PBMs) to accelerate efforts to lower the cost of prescription drugs and
improve the quality of care for Americans.
“The cost and quality of healthcare is a great concern to all Americans; this is
the right deal at the right time for the right reasons,” said George Paz,
chairman and CEO of Express Scripts. “Companies like ours have a
responsibility to provide the leadership and resources required to drive out
waste in healthcare and provide the best care in the world. The merger with
Medco will accelerate our efforts to create greater efficiencies in the
healthcare system and better protect American families from the rising costs
of prescription medicine while improving health outcomes. “This continues
Express Scripts’ commitment to strong growth, both organically and through
strategic mergers and acquisitions. The opportunity with Medco represents an
attractive strategic combination which will provide the opportunity to move
forward with a wide array of tools and resources to accomplish our goals.”
David Snow, chairman and CEO of Medco, commented: “Our organizations
represent two great success stories in American business. We have each
been successful in creating shareholder value because we are both
passionate about driving value to our customers through service, innovation
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and a focus on cost and quality. We have a shared desire to improve the way
healthcare is delivered in this country and I believe this creates a strong
best-of-breed foundation, culturally, for a very successful merger. “We
continue to have great confidence in moving forward as a stand-alone
business, however, the incremental benefits of combining with Express
Scripts are both logical and compelling.” ...Read More
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Domestic News - August 2011
Venus Remedies to out-licenses 4 drugs in US, Europe: report
Venus Remedies is reportedly in talks with various firms in the U.S. and
Europe to out-license four patent drugs over the next 2-3 years, according to
reports. Pawan Chaudhary, chairman and managing director, was quoted as
saying "We have short-listed a few companies in Europe, while talks are on
with a few in the U.S. as we look to launch our four patented drugs by 2014."
Venus also wants to out-license its anti-infectant 'Sulbactomax', pneumonia
drug 'Potentox' and one-a-day pain killer 'Achnil', added reports.
Claris receives MHRA approval
Claris Lifesciences Limited (Claris) announced today that their plant has been
approved by the Medicines and Healthcare product Regulatory Agency
(MHRA) of the United Kingdom. With this approval Claris can re-launch its
Bag products in the EU. This approval is a big step towards resolving the Bag
issue in totality. Read More…
Daiichi Sankyo and Ranbaxy to expand hybrid biz in Mexico
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and Ranbaxy
Laboratories Limited (hereafter, Ranbaxy) announced the expansion of
business in Mexico to maximize their Hybrid Business Model, encompassing
both innovative and affordable, high quality, generic medicines. Read More…
Wockhardt to divest its Nutrition Business to Danone
Wockhardt Ltd has said that the Pharmaceutical and Biotechnology major
Wockhardt Ltd and its subsidiary on August 02, 2011 announced the signing
of agreements to divest their Nutritional business to Danone, one of the
fastest-growing food company in the world. Wockhardt has presence in
India's nutritional category with Farex, Dexolac, Nusobee and Protinex.
However, Wockhardt has retained its nutrition manufacturing facility at
Jagraon, Punjab. Read More…
Glenmark Generics gets approval for verapamil extended-release
tablets
Glenmark Generics Inc., USA, a subsidiary of Glenmark Generics Ltd, today
announced they have been granted final approval for their abbreviated new
drug application (ANDA) by the United States Food and Drug Administration
(U.S. FDA) for Verapamil extended-release tablets, their generic version of
Isoptin SR tablets by Ranbaxy. Read More…
USFDA inspects Divis Lab unit near Hyderabad
Divis Laboratories Ltd. said on Wednesday that it has had an inspection by
the US Food and Drug Administration (USFDA), with no major observations,
for its Unit-1 at village Lingojigudem, Choutuppal Mandal, near Hyderabad
during July. The audit concluded with minor observations, primarily about
additional records for further improvement of existing records.
Venus Remedies' novel research product 'Vancoplus' receives US
Patent
Venus Remedies has received its first US patent from US PTO for its novel
research product, Vancoplus. With this patent grant, which is valid up to
December 2027, the company is all set to tap the US market by launching
the product. Earlier, Vancoplus has already been granted the patents from
countries like South Africa, New Zealand and Ukraine. Read More…
Global health and Inp+ recommends Fornext Phase
GHA India (Global Health Advocates, India) along with INP +(INP+ has over
2,75,000 members in 26 states and 282 districts) has prepared a list of
recommendations for the Government of India to consider while planning the
next phase of National AIDS Control Programme(NACP IV) which will run
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from 2012 to 2017. NACO is expected to examine these recommendations
while drawing up the National Strategic Plan in September 2011 for NACP IV
for 2012-2017. INP + is a part of the working groups on Care and Support,
Stigma and Greater Involvement of People Living with HIV set up by the
National
AIDS
Control
Organisation
(NACO)
to
develop
these
recommendations. The recommendations, developed from 7 regional nationwide consultations( in Orissa, Calcutta, Pune, Imphal, Chennai, Lucknow and
Delhi), cover three main areas: prevention of TB among PLHIV, improved
ART treatment and early checking for resistance to first line of ARTs for
people living with HIV/AIDS as well as with the TB-HIV co -infection and
mainstreaming HIV into the health system.
TB is the leading cause of death for PLHIV in India contributing to more than
half the deaths. Among the major recommendations of TB/HIV consultation
include a call for early scale up and availability of better and faster TB testing
technology. These include the roll out of the molecular based NAAT (Nucleic
Acid Amplification Test) tests which provides early diagnosis of pulmonary TB
and Extra Pulmonary TB. The Stop TB partnership in its global plan to stop TB
for 2011-2015 has listed a specific plan for saving a million lives by 2015
through scale up in testing for TB among PLHIV , earlier ART treatment and
early and regular TB treatment. Stop TB targets an 80 percent detection and
treatment rate for TB among PLHIV by 2015, currently less than 5 percent of
PLHIV in India are automatically tested for TB
K. K. Abraham, President of Indian Network for People Living with HIV/AIDS
(INP+), pointed out that,” These tests in future will also help to bypass the
reluctance of health care provider in taking samples in form of pus/blood or
Cerebrospinal Fluid (CSF) fluid in the case of Extra Pulmonary TB . Apart
from these INP + has three top recommendations which can help save lives.
These are to ensure a better quality diagnosis for early detection of first line
treatment failure cases . This will save lives of PLHA waiting to get second
line of ART. Other recommendations are Alternate Drugs (Tenofovier based)
for first line ART and involving the PLHIV community in monitoring and
evaluation”.
Lupin shares gain after inking pact with Eli Lilly
The shares of Lupin are trading at Rs. 456, up by Rs. 1.40 or 0.31%, as
against the previous close of Rs. 454. Early today, the stocks of Lupin rose
by 1.4% to Rs. 461.25 after the company and Eli Lilly India agreed to a
collaboratio to promote and sell Lilly’s Huminsulin range of products,
according to reports. The shares had earlier opened at Rs. 461, touching the
day’s high and low at Rs. 462 and Rs. 455, respectively. The total traded
quantity stood at 0.34 lakh shares on the BSE.
Intel Labs invests US$30mn in Cloud and Embedded computing
Aimed at shaping the future of cloud computing and how increasing numbers
of everyday devices will add computing capabilities, Intel Labs announced the
latest Intel Science and Technology Centers (ISTC) both headquartered at
Carnegie Mellon University. These centers represent the next US$30mn
installment of Intel's recently announced 5-year, US$100mn ISTC program to
increase university research and accelerate innovation in a handful of key
areas. As with previously announced ISTCs for visual computing and secure
computing, the new centers encourage tighter collaboration between
university thought leaders and Intel. To encourage further collaboration, the
ISTCs use open IP models with results publically available through technical
publications and open-source software releases.
"These new ISTCs are expected to open amazing possibilities," said Justin
Rattner, Intel Chief Technology Officer. "Imagine, for example, future cars
equipped with embedded sensors and microprocessors to constantly collect
and analyze traffic and weather data. That information could be shared and
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analyzed in the cloud so that drivers could be provided with suggestions for
quicker and safer routes.
Piramal Healthcare to acquire 5.5% stake in Vodafone Essar
Piramal Healthcare and Vodafone
Group has announced that Piramal has
agreed to purchase approximately
5.5% of the issued equity share
capital of Vodafone Essar Limited
(“VEL”) from ETHL Communications
Holdings Limited (“Essar”) for cash
consideration of Rs. 2,856 crores
(approximately US$640 million).The
transaction follows the settlement
between Vodafone and Essar over the sale of Essar’s approximately 33%
stake in VEL, announced on 1 July 2011. The transaction contemplates
various exit mechanisms for Piramal, including both participation in a
potential initial public offering of VEL and a sale of its stake to Vodafone.
Fortis to buy 65% stake in Hoan
My Medical for US$64mn
Fortis Healthcare International Pte Ltd
(“Fortis International”) has taken
another important step in its path to
become
a
leading
integrated
healthcare provider in Asia Pacific. The
company
has
entered
into
an
agreement to acquire 65% stake in
Hoan My Medical Corporation, Vietnam
for US$ 64m. This marks the entry of
Fortis International into one of Asia's fastest growing economies and the
group’s first acquisition of a hospital chain outside of India. Read More…
Glenmark files arbitration claims against Napo
Glenmark wishes to inform the filing
of a Statement of Claim with the
American
Arbitration
Association
against Napo Pharmaceuticals Inc.
(“Napo”)
seeking,
among
other
things, a declaration that Glenmark’s
exclusive
rights
to
develop,
commercialize
and
distribute
Crofelemer in 140 countries for
treatment
of
diarrhoeal
disease
includes the exclusive right to
distribute through relief agencies in these countries. Read more…
Birla Pacific Medspa rises on Big B entry
The shares of Birla Pacific Medspa were trading higher after Amitabh
Bachchan bought 10 lakh shares of the company at an average price of Rs.
18.50.
Ranbaxy introduces 'Volini Due', unique 2-in-1 pain killer
The OTC business division of Ranbaxy Laboratories Limited, Ranbaxy Global
Consumer Healthcare (RGCH) has launched "Volini Duo", India's first
approved two-in-one pain killer, a unique bi-layered Acetaminophen tablet,
specially formulated to give dual pain relief. The product has been introduced
pan India. Commenting on the launch of the product, Brijesh Kapil, Vice
President, RGCH, said, "Ranbaxy remains committed to developing and
offering quality, sale, efficacious and innovative solutions to consumers. The
introduction of 'Volini Duo' is a move in this direction." Read More…
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Glenmark initiates Phase IIb human trials globally for its novel
molecule 'Revamilast'
Glenmark Pharmaceuticals today announced that its Novel Chemical Entity
"Revamilast" (GRC 4039) has initiated Phase lib human dose range finding
trials globally. Revamilast is an orally active, potent and selective inhibitor of
phosphodiesterase 4 (PDE 4) that is currently being developed by Glenmark
for the treatment of chronic inflammatory disorders such as Asthma,
Rheumatoid Arthritis (RA) and other inflammatory diseases. The Phase lib
studies that will be carried out will help establish the efficacy and safety of
the molecule and will also provide dose range finding data for Revamilast.
Read More…
Wockhardt rises on sale of Nutritional biz to Danone
Shares of Wockhardt rose after the company and its subsidiary on August 2,
announced the signing of agreements to divest their Nutritional business to
Danone, one of the fastest-growing food company in the world. Its Board is
scheduled to meet on Tuesday to consider and approve the unaudited
financial results for the quarter ended June 30, 2011. The shares of
Wockhardt are trading at Rs. 434, up by Rs. 11 or 2.81%, as against the
previous close of Rs. 422. It had earlier opened at Rs. 416, touching the
day’s high at Rs. 438 and day’s low of Rs. 410. The total traded quantity
stood at 2.35 lakh shares on the BSE.
SpectroCam now available with interchangeable optical filters
The SpectroCamT Multispectral Imaging (MSI) Camera is now available from
Ocean Thin Films (OTF) in a new development platform that combines a
scientific-grade CCD array with a precision rotating optical filter wheel to
create the world's first fully configurable MSI camera. Applications include
water quality measurements, product screening, machine vision, medical
imaging, surveillance and authentication.
SpectroCam complements single-point spectroscopy by adding another
dimension to spectral measurements. With a single-point spectrometer, users
can analyze spectral differences from sample to sample and then, by
selecting discrete filters in and around spectral areas with the most
significant differences, use SpectroCam to create an image that shows vivid
contrast between the samples.
At the heart of the SpectroCam is a wideband CCD that is responsive from
the visible through near infrared spectrum. The system's precision filter
wheel and optics can be customized for a variety of applications. Image
speed is 20 fps at full resolution and the standard F-Mount configuration
accommodates a range of lens choices, focal lengths and fields of view. Each
system includes a lens, eight standard interchangeable filters and software.
OTF collaborated with miniature spectroscopy leader Ocean Optics to create
this suite of tools, making multispectral imaging accessible to everybody
from university researchers to high volume OEM equipment makers. The
interchangeable optical filters and continuously rotating filter wheel overcome
many of the shortcomings that prismatic MSI systems face. With
interchangeable filters, users can try many filter options to narrow in on the
best contrast, greatly reducing development time and allowing users to bring
products to market faster.
Sun Pharma receives nod for finasteride pill
Sun Pharmaceutical Industries Ltd. reportedly received approval from the
U.S. Food and Drug Administration for its finasteride pill, the generic version
of Merck’s Proscar and Propecia. The drugs are used to treat enlarged
prostate and hair-loss in men.
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Lincoln Pharma unveils lactation inducing drug
Lincoln Pharmaceuticals Ltd. (LPL) reportedly introduced Ayurvedic product
‘ISL Granules’ in the mother and child healthcare segment. According to
reports, ISL Granules helps initiate and sustain breast milk secretion and
improves the general health of the mother without causing any side effects.
The product has been developed by Teresa, a specialty division of LPL for the
segment. ISL Granules contain extracts of eight proven herbs and natural
calcium in a chocolate flavoured drink formulation and will be available in 300
gm pearl pet pack.
Orchid resumes production in its API plant in Chennai
Orchid Chemicals & Pharmaceuticals Ltd. (Orchid) today announced that its
Cephalosporin API manufacturing facility located in Alathur (Chennai) has
been re-opened and production activity will commence immediately. The
Alathur API plant that had earlier received a Closure Notice from the
Tamilnadu Pollution Control Board (TNPCB) has now been cleared and
production activities will commence immediately.
Panacea Biotec slumps 20% on WHO recall
The shares of Panacea Biotec tumbled by the daily 20% limit after two of the
company's vaccines were removed from the World Health Organisation's
(WHO) pre-qualified list, citing non-compliance of manufacturing sites. The
company's diphtheria-pertussis-tetanus based combination of two vaccines
and another hepatitis B vaccine have been removed from the WHO list. WHO
has, however, stated that there is no evidence of quality or safety defects
with batches of these vaccines already distributed. These batches should not
be recalled and should continue to be used, according to WHO. The company
said it has initiated corrective measures against the WHO recall.
Dr Reddys recalls cholesterol drug in US: reports
Dr Reddy’s has reportedly recalled more lots of the cholesterol lowering drug
simvastatin (80 mg) of different strengths from the US market. According to
reports, the company informed USFDA that over 60,000 bottles of 10 mg and
40 mg of simvastatin will be recalled from the market. The recall comes
under the Class II category, which means the probability of serious adverse
health consequences is remote.
Zenotech Laboratories appoints Executive Chairman
Zenotech Laboratories Ltd has said that the Board of Directors of the
Company has appointed Dr. Sudershan K. Arora, Chairman as Executive
Chairman of the Company with effect from August 25, 2011, subject to
requisite approvals.
JB Chemicals declares special interim dividend
JB Chemicals & Pharmaceuticals Ltd has announced that the Board of
Directors of the Company at its meeting held on August 19, 2011, has
declared Special Interim Dividend of Rs. 40 (Rupees Forty) per equity share
of face value of Rs. 2 to reward the shareholders consequent to sale of the
Russia-CIS OTC business. The dividend will be paid/dispatched on September
08, 2011. The payment of this Special Interim Dividend together with
dividend distribution tax will absorb Rs. 393.78 crores. The shares of JB
Chemicals & Pharmaceuticals Ltd were trading at Rs. 136.75, down 5.8%
against the previous close. It touched a day's high of Rs. 152.00 and a low of
Rs. 116.60.
Dr. Reddy's and Pfizer settle Lipitor case
Dr. Reddy's Laboratories Ltd. said that it has settled a lawsuit filed by Pfizer
Inc. over a generic version of the latter's blockbuster cholesterol drug,
Lipitor. Dr. Reddy's did not disclose the terms of the agreement, but said that
the settlement with Pfizer is subject to review by the US Justice Department
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and the Federal Trade Commission. Lipitor is the biggest-selling branded drug
in the world. Pfizer gets more than US$11bn in annual revenue from Lipitor,
but the US drug giant is set to lose American patents on Nov. 30. Lipitor had
second quarter global sales of US$2.6bn, including sales of US$1.4bn in the
US alone.
Dr. Reddy's had sought USFDA approval for generic Lipitor in 2009. Pfizer
then filed a lawsuit accusing the Indian company of violating patents
supporting Lipitor. It may be recalled that in 2008 Pfizer reached a
settlement with Ranbaxy whereby the Indian drug firm is allowed to launch a
generic copy of Lipitor on November 30. Ranbaxy is entitled to six months US
marketing exclusivity as it was the first to approach the USFDA for a generic
version of Lipitor. Ranbaxy is now owned by Japan's Daiichi Sankyo. Pfizer
has signed an agreement with Watson Pharma to sell authorized generic of
Lipitor beginning November.
Wockhardt plans to unveil 12-15 products in US market: reports
Wockhardt reportedly plans to introduce 12-15 products in the US market
this fiscal and also expand its reach in the European market. According to
reports, the company received 7 abbreviated new drug applications (ANDA)
approvals this year. The detail of the products to be launched is not yet
specified by the company. The company's sales during 2010-11 exceeded
USD 225 million for the first time in the US.
Global experts turn to India as a key pathfinder on battling
Tuberculosis
Tuberculosis - the world's number one infectious killer disease after AIDS - is
facing an enemy with escalating power and determination: India. "India is
moving towards universal access for quality TB care and has it in its power to
become a global leader in TB research and innovation, as well as in
manufacturing of essential anti-TB drugs and TB diagnostics," says Dr Vishwa
Mohan Katoch, Secretary to the Government of India and Director-General,
Indian Council of Medical Research. Read More…
Lupin receives final approval to market Generic Ultram ER
Lupin Pharmaceuticals Inc (LPI) has received final approval from the United
States Food and Drug Administration (U.S. FDA) for its Abbreviated New
Drug Application (ANDA) for Tramadol Hydrochloride Extended-Release
Tablets, 100, 200 and 300 mg strengths. Lupin will begin shipping its
Tramadol ER, shortly. Tramadol HO. ER is a centrally acting synthetic
analgesic in an extended release formulation. It is the generic equivalent to
Ortho-McNeil's Ultram ER Tablets and is indicated for the management of
moderate to moderately severe chronic pain in adults who require aroundthe-clock treatment of their pain for an extended period of time. Tramadol
HC1 ER tablets had annual sales of approximately $132 million for the twelve
months ended June 2011 based on IMS Health sales data.
Sanofi Aventis & Multicare ink strategic agreement in the Philippines
Sanofi-Aventis Philippines Inc., which is part of the Sanofi Group, and
Multicare Pharmaceuticals (Multicare), the Philippines subsidiary of Lupin
limited, have entered into a marketing and distribution agreement whereby
Multicare will market Sanofi-Aventis's Central Nervous System (CNS) global
brands, Solian (Amisulpride) and Sulnox (Zolpidcm Hemitartrate) in the
Philippines. The annual sales revenues of these brands arc valued at PHP 138
million (IMS). Read More…
Fortis announces another 4 hospitals
Fortis Healthcare (India) Ltd. today announced the launch of four hospitals as
part of its plan to strengthen its presence across the country. This
announcement fulfills the ‘10 in 10’ commitment made by the Company on
its 10th Anniversary in end-June, to announce 10 new hospitals in 10 weeks.
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Fortis has now announced 10 launches in less than 10 weeks, taking its bed
capacity to 10,270 beds. Besides setting up new hospitals in Cochin, Bilaspur
and Bangalore, Fortis Healthcare will manage the Cardiac Care unit at HLG
hospital in Asansol, West Bengal. Fortis marks its entry into Kerala with a 45
bed boutique hospital in Cochin, which will offer quality healthcare for women
under the ‘Fortis La Femme’ brand.
As part of the hub and spoke model, a multi-specialty hospital in Bilaspur,
acting as a spoke to the Mohali hub, will cater to the Kullu-Manali-Mandi belt
by FY 2012. Expanding its reach in West Bengal, Fortis will operate and
manage a 50-bed Cardiac Care unit at multi-specialty HLG hospital in
Asansol. The Group also strengthens its presence in the South with a worldclass tertiary care hospital in Bengaluru, strategically located near the
Marathalli Junction, which will commence operations by 2013. This follows
the recent announcement to operate a 100-bed boutique hospital for women
in the state.
Polar Pharma receives order from Ministry of Health & Family
Welfare
Polar Pharma India Ltd has said that the Company has received two supply
orders both dated August 04, 2011 aggregating to Rs. 853.38 lakhs from
Ministry of Health & Family Welfare (MHFW), Government of India, New Delhi
for supply within December 31, 2011.
Aventis Pharma to buy Universal Medicare's nutraceutical unit
Aventis Pharma is planning to acquire Universal Medicare's nutraceutical unit
in India. The transaction has been approved by the Board of Directors of both
companies. It is expected to close in the fourth quarter of 2011, subject to
certain conditions precedent.
HDFC Trustee acquires stake in Aurobindo Pharma: report
Aurobindo Pharma has reportedly said that said that different funds
belonging to HDFC Trustee Company had purchased 5.01% stake in the firm.
The report stated that Different funds of HDFC Trustee Company have
purchased 145,93,640 equity shares amounting to 5.01% of the paid up
equity share capital. The purchase was carried out in open market.
Cipla expects to scale up its revenue: reports
Cipla is reportedly expecting to scale up its revenue by over six times to Rs.
150-200bn by 2020 and assured shareholders the promoters have no plan to
divest their stakes with significant growth in the business. According to
reports, the company had achieved net revenue of Rs. 61.35bn in FY11. This
year with the rationalisation planned, the company is aiming to stabilise and
consolidate.
Takeda Pharma eyes pharma biz of Cipla and Lupin: report
Takeda Pharmaceutical Co., Japan's largest drugmaker, is in talks with Indian
drugmakers Cipla and Lupin for buying pharmaceutical business of one of the
companies, according to a report. The report stated that the company is
interested in buying Lupin's domestic formulations business, as well as its
research facility. Takeda's talks with Lupin have progressed beyond the initial
stages, but the company's founders are not willing to sell the research
facility. They are not in talks with anyone to sell either a stake or any of its
brands.
NABH, BD collaborate to develop quality–of-care standards for
hospitals
NABH (National Accreditation Board for Hospitals & Healthcare Providers) and
BD (Becton, Dickinson and Company) today signed a Memorandum of
Understanding (MoU) to support hospitals in attaining quality-of-care
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standards for infection control. This collaboration is an effort to strengthen
health systems in India and promote continuous quality improvement to
ensure quality care for patients when visiting hospitals with effective infection
control practices in place.
With the wider rollout of community health insurance initiatives, there is an
increased demand for bed capacity. Existing small and medium-size
hospitals, estimated to account for more than two-thirds of all beds need to
strengthen the quality systems and these hospitals can achieve quality-ofcare systems by standardizing and adopting necessary infection control
practices to ensure patient and healthcare worker safety.
Speaking on the occasion of the signing, Dr Giridhar J Gyani, Quality Council
of India, Secretary General and CEO, NABH said: “Our objective is to develop
a basic infection-control standard for all hospitals delivering healthcare in
India. The association with BD will enable us to provide on- and off-site
technical support to collaborating institutions for upgrading their infection
control practices.”
NABH has recommended quality toward safe injection practices, waste
management and infusion safety, to name a few, as minimum requirements
across hospitals in India, following the lead of several facilities undertaking
these processes. Most of these hospitals are high in volume and have the
bandwidth as well as the desire to improve clinical outcomes; whereas the
quality of care in smaller hospitals, especially which are government
empanelled is much more varied in terms of infection control practices. NABH
is currently operating in India with nearly 500 hospitals in various phases of
accreditation, and nearly 100 hospitals are already accredited…Read More
No investments in Jagathi Publications: Aurobindo Pharma
Aurobindo Pharma Ltd has announced that the Company or any of its
subsidiaries do not have investments in Jagathi Publications Private Limited
or in any of its Associate Companies.
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International News - August 2011
JICA partners Bill & MelindaGates Foundation on Polio Eradication
Sadako Ogata, President of the Japan International Cooperation Agency
(JICA), and Bill Gates, co-chair of the Bill & Melinda Gates Foundation, today
announced a strategic partnership to ensure continued progress in the fight
against polio. As the first step in this formal partnership, Ogata and Gates
also announced an innovative financing agreement to support the polio
campaign in Pakistan.
GE Healthcare to acquire PAA Laboratories GmbH
GE Healthcare, a unit of General Electric Company announced that it has
reached an agreement to acquire PAA Laboratories, a developer and supplier
of cell culture media for biomedical research and the fast-growing
biopharmaceutical and vaccine manufacturing industry. The acquisition of
PAA Laboratories will allow GE Healthcare to expand its offering of products
and services for cell biology research and for the discovery and manufacture
of biopharmaceuticals including recombinant proteins, antibodies and
vaccines. The strong strategic fit between the two businesses, combined with
expanded capabilities in product development and marketing, will offer
significant long-term customer benefits. Financial terms were not disclosed.
Read More…
FAO urges to prepare against resurgence of H5N1
FAO today urged heightened readiness and surveillance against a possible
major resurgence of the H5N1 Highly Pathogenic Avian Influenza amid signs
that a mutant strain of the deadly Bird Flu virus is spreading in Asia and
beyond, with unpredictable risks to human health. The H5N1 virus has
infected 565 people since it first appeared in 2003, killing 331 of them,
according to WHO figures. The latest death occurred earlier this month in
Cambodia, which has registered eight cases of human infection this year -all of them fatal. Read More…
Reckitt Benckiser to sell personal care biz of Paras Pharma: report
Reckitt Benckiser Group Plc, the maker of Dettol handwash, is planning to
sell the personal care business of its Indian Paras Pharmaceuticals unit,
according to a report.
The report stated that Reckitt Benckiser may sell the unit for about Rs 9 bn.
The company, which paid $724 mn to acquire Paras last year, has hired
JPMorgan Chase & Co. to manage the sale and will start the process by next
month.
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Domestic News - September 2011
Ranbaxy climbs on Lipitor launch buzz
Shares of Ranbaxy Laboratories Ltd. touched a three-month high after media
reports suggested that the Company aims to start selling the generic version
of Pfizer Inc.’s blockbuster drug Lipitor on schedule, in November. The stock
closed at Rs. 507.25, up Rs. 21.25 or 4.4% over the previous close. It had
earlier been as high as Rs. 512.15 after opening at day's low of Rs. 487.
More than two lakh shares changed hands on the BSE versus a two-week
average of 71,000 shares. The stock had touched a 52-week low of Rs. 414
on May 11. It hit a 52-week high if Rs. 624 on Nov. 11. Daiichi Sankyo Co.,
which owns Ranbaxy, is reportedly working with the U.S. Food & Drug
Administration (USFDA) to resolve issues and get an approval to introduce
the cholesterol-lowering pill in the US market. A legal settlement with Pfizer
gave Ranbaxy six months’ exclusivity to market generic Lipitor in the US.
Pfizer garnered US$10.7bn in Lipitor sales last year. Ranbaxy won’t sell its
right to market generic Lipitor in the US and denied a Credit Suisse report
that the Indian company will sell the right should it fail to win timely USFDA
approval, said reports.
Wockhardt asked to give timeline for clearing dues
Wockhardt has been asked by the Bombay High Court to work out a plan and
a timeframe for dues payment to its bondholders failing which the liquidator
could take charge of the company, according to reports. Justice D K
Deshmukh was quoted as saying that it was "not concerned if the company
has to sell its assets to pay a bond holder" but added that it would mean that
the pharmaceutical company was not in a position to pay its debts. If the
company wanted permission of the court to sell its assets it would not give
such a permission unless Wockhardt makes a statement that it would bring
the amount due to the bond holders-Rs 4.73bn in dues-by a particular date,
reports stated.
Cipla shuts 2 marketing divisions: reports
Cipla has reportedly closed Protec and Omnicare, two of its four marketing
divisions, as there was certain rationalisation required for better productivity.
The staff from these divisions will be accommodated in other areas of the
company. According to reports, the company won't curb down on any of its
products, rather it might want to phase out low margin and pain ending
products which are at its base so that they could rationalise their product
portfolio. Cipla is also planning to invest 6bn in research units.
Ranbaxy UK launches esomeprazole
Ranbaxy (UK) Ltd. announced that it has successfully launched esomeprazole
20 mg and 40 mg tablets, the first approved generic bio-equivalent version of
the product NexiumTM, in the United Kingdom (UK), with annual UK sales of
£ 60 Mn (IMS June 2011). Commenting on the development, Debashis
Dasgupta, Regional Director, Ranbaxy Europe, said, “We are committed to
bringing high quality, affordable medicines for the benefit of patients and
healthcare systems worldwide and in Europe. The introduction of
esomeprazole, in the UK, is an important and significant step in this
direction.” The product will be offered through pharmacies, retail and
wholesale stores with immediate effect. Esomeprazole is used in the
treatment of dyspepsia, peptic ulcer disease (PUD), gastroesophageal reflux
disease (GORD/GERD) and Zollinger-Ellison syndrome.
Jubilant Life Sciences receives ANDA approval for Pantoprazole
Sodium Tablets
Jubilant Life Sciences Ltd, an integrated Pharma and Life Sciences Company
and the largest Custom Research & Manufacturing player out of India
announced today that it has received Abbreviated New Drug Application
approval for Pantoprazole Sodium Delayed Release Tablets 20mg & 40mg, a
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generic equivalent of Protonix*, from the US FDA (U.S. Food and Drug
Administration). Pantoprazole Sodium Tablets will be manufactured at the
‘state of the art’ dosage forms facility of Jubilant Life Sciences, at Roorkee, in
India, with backward integration into the API manufactured at the Company’s
USFDA approved API facility at Nanjangud in India. The product will be
marketed by its US subsidiary Jubilant Cadista Pharmaceuticals Inc. under its
own label. Read More…
Parabolic Drugs adds 15% capacity to Cephalosporin facility
Parabolic Drugs Ltd., a vertically integrated API manufacturer and exporter in
India, today announced the commissioning of eighth manufacturing plant at
its European GMP Accredited Derabassi facility - fully dedicated for the
manufacturing of latest generation Cephalosporin, both in Oral and Sterile
forms. Read More…
Suven Life Sciences secures 4 Product Patents for their NCEs
Suven Life Sciences Ltd (Suven) announces today that the grant of four (4)
product patents, three (3) from Australia (2005328870, 200734063 and
2008315309), one (1) from New Zealand (578281) corresponding to the New
Chemical Entities (NCEs) for the treatment of disorders associated with
Neurodegeneratlve diseases and these Patents are valid through 2027. The
granted claims of the patents include the class of selective 5-HT compounds
discovered by Suven and are being developed as therapeutic agents and are
useful in the treatment of cognitive impairment associated with
neurodegenerative disorders like Alzheimer's disease, Attention deficient
hyperactivity disorder (ADHD), Huntington's disease, Parkinson and
Schizophrenia. Read More…
Hinduja Hospital begins new Rural Healthcare Program
Hinduja Hospital is a super-specialty tertiary care trust hospital founded way
back in 1951. Founder Sri Paramanand Deepchand Hinduja believed that
health and education are the birthrights of every citizen. He wanted to create
an institution that could provide “Quality Healthcare for All”. He, together
with some like-minded individuals, worked towards this goal and Hinduja
Hospital is a culmination of his vision. Our chairman, Sri S P Hinduja and his
brothers continue to hold their father’s dream close to their hearts and
Hinduja Hospital Rural Health Program is another milestone in this direction.
Read More…
Ranbaxy in talks with Ind Swift to source raw material: reports
Ranbaxy Laboratories is reportedly in talks with Ind Swift to source raw
material to make low-cost version of Lipitor, which hopes to roll out in the US
by November end. N R Munjal, vice-chairman at Ind Swift was quoted as
saying “We are discussing various options to supply intermediate or final API
atorvastatin to Ranbaxy." API or active pharmaceutical ingredient is the basic
chemical used in a drug, in this case, atorvastatin. Reports said that
discussions for sourcing API confirms Ranbaxy's 'intention to produce' the
medicine on its own. But it was unlikely that the API from this supply
agreement would be used for the US launch, which subject to the approval of
the US drug regulator, is slated for November 30.
Infosys close to acquiring healthcare biz of Thomson Reuters: reports
Infosys to reportedly buy Thomson Reuters Corp. (TRI)’s health-care
business for as much as $750mn in the Indian company’s biggest acquisition.
According to reports, Thomson Reuters is also seeking to sell its BARBRI barexam- preparation business and the risk-management Enterprise Risk unit.
Infosys plans to add customers in industries outside of banking, while
Thomson Reuters seeks to sell its health-care division.
GE Healthcare to invest US$1bn in new oncology solutions
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GE Healthcare, the health business of General Electric, announced its plans
to dedicate $1billion of its total R&D budget over the next five years to
expand its advanced cancer diagnostic and molecular imaging capabilities, as
well
as
its
world-class
technologies
for
the
manufacture
of
biopharmaceuticals and for cancer research. Announced alongside a $100m
open innovation challenge in New York City, the $1 billion investment crosses
all lines of GE Healthcare’s global business and is an example of the
company’s commitment to fighting cancer. The investment will enable the
company to bring the most promising cancer ideas to market, unleashing
technologies that improve accuracy of diagnosis to enable more effective
treatment decisions and empower doctors and patients with better
information. Read More…
Jubilant HollisterStier signs contract with US pharma company:
reports
Jubilant Life Sciences Ltd reportedly said that its subsidiary, Jubilant
HollisterStier has entered into a multi year contract with a US pharma
company to manufacture over the counter (OTC) women health and personal
care product. According to reports, it is a “take or pay” contract with a
minimum quantity commitment and has a total value of over $ 70mn for a
period of over 4 years with a possibility of extension for another 2 years for a
higher quantity. The production of the product under this agreement started
earlier this month. The product will be manufactured at Jubilant's Montreal
facility in North America. Read More…
GE Healthcare in alliance with Veran Medical
GE Healthcare, the $17 billion healthcare unit of General Electric Company ,
and Veran Medical Technologies, Inc., a privately-held medical device
company, announced that the companies have entered into a strategic
alliance to advance and co-develop navigation technologies for interventional
procedures to improve the care and management of cancer patients. Building
on the alliance, the GE Healthymagination Fund, an equity fund that makes
investments in highly promising healthcare technology companies, is
investing in Veran. The financial terms were undisclosed. The alliance
between the two companies reflects GE’s healthymagination initiative, which
focuses on reducing cost, increasing access and improving quality in
healthcare. Read More…
Lupin announces launch of Generic KEPPRA XR Tablets
Pharma major, Lupin Ltd., announced today that its subsidiary. Lupin
Pharmaceuticals Inc. (LPI) has been granted final approval by the U.S. Food
and Drug Administration (FDA) for the company's Abbreviated New Drug
Application (ANDA) to market a generic version of UCB's KEPPRA XR tablets.
Commercial shipment of the product has commenced. Lupin's Levetiracetam
500 mg and 750 mg extended-release tablets arc the AB-rated generic
equivalent of KEPPRA XR , an antiepileptic drug indicated for adjunctive
therapy in the treatment of partial onset seizures in patients 16 years of age
with epilepsy. KEPPRA XR tablets had annual sales of approximately $161
million for the twelve months ended June 2011 based on IMS Health sales
data. Read More…
…Lupin receives approval from USFDA for Eszopiclone Sleep Medicine
Strides Arcolab Bangalore unit inspected by USFDA
Strides Arcolab Ltd has announced that its Oral Dosage Forms manufacturing
sites in Bangalore was inspected by USFDA as part of GMP compliance audit
and facility continues to be approved with Zero Inspectional observation
reported in FDA 483. The last US FDA inspection and approval for this facility
was in the year 2008. The KRS Gardens facility in Bangalore manufactures
oral dosage forms such as tablets and capsules (both hard gelatine and soft
gelatine). The manufacturing plant supports important current and future
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submissions for the US Market. Manish Gupta, CEO – Pharma of Strides said
“this continued approval of the site with Zero observation in FDA 483 augurs
very well for the Pharma division of the Company in this challenging
regulatory and business environment”.
Healing with Homeopathy by Dr. Mukesh Batra
Dr. MUKESH BATRA, India's most famous homeopath and founder of the
world's largest chain of homeopathy clinics, shares his professional expertise
to help you diagnose and find answers for common and not-so-common
ailments. A simple, user-friendly practical guide to holistic health, Healing
with Homeopathy deals deftly with over 100 illnesses arranged alphabetically
from A-Z. Writing simply and clearly, Dr. Batra explains each condition, its
symptoms and variations and what homeopathic remedy is likely to work
best. Included are useful dos and don'ts as well as illustrative case studies,
culled from over 35 years of medical practice. An expert introduction to
homeopathy and its application, Healing with Homeopathy arms you with the
knowledge and confidence to recognise and deal with a variety of health
issues in the comfort of your own home. Put simply, the book is an invaluable
tool for anyone who wants to take charge and manage their health safely,
gently and without the fear of side-effects.
Dr. Reddy’s launches generic Dementia drug in US
Dr Reddy’s Laboratories has reportedly introduced Rivastigmine Tartrate
capsules in the US market. According to reports, capsules are a bioequivalent
generic version of Exelon capsules (of Novartis Pharmaceuticals Corporation)
in the US market. They are indicated for the treatment of mild to moderate
dementia of the Alzheimer’s type. The Exelon brand and generic rivastigmine
tartrate had U.S. sales of approximately $92.6mn for the most recent twelve
months ending June 2011.
Biocon eyes US$1bn revenue in 3 years
Biocon reportedly said that its target is to achieve revenues of $1bn in the
next fiscals. According to reports, the company sees themselves among the
top 10 global biotechnological companies in the world. The company will also
mainly emphasis on chronic diseases like diabetes, cancer and auto immune
diseases. Biocon plans to list its contract research and manufacturing
services arm Syngene, which will be done in the next 18 months. The
company needs to see sustained growth over four quarters before it starts
with it, added reports.
Fortis Healthcare pulls out of talks to buy stake in Acibadem: reports
Fortis Healthcare International has reportedly pulled out of talks to buy a
controlling stake in Turkish hospital group Acibadem. According to reports,
the company took a step back due to valuation concerns and political unrest
in the Middle East. The stake is being sold by Almond Holding. Abraaj has a
46% stake in Almond Holding, which controls 92% of Acibadem. Acibadem is
in talks with investors including Fortis Healthcare, added reports.
Lupin announces U.S. FDA approval of its first oral contraceptive
Pharma major, Lupin Ltd., announced today that its subsidiary, Lupin
Pharmaceuticals Inc. (LPI) has been granted final approval by the U.S. Food
and Drug Administration (FDA) for its Abbreviated New Drug Application
(ANDA) to market a generic version of Watson’s NOR-QD tablets. Lupin will
commence shipping its norethindrone tablets, USP 0.35 mg shortly. NOR-QD
(norethindrone tablets, USP 0.35 mg) is a progestin-only oral contraceptive
indicated for the prevention of pregnancy. Combined annual sales for NORQD and its generic equivalents were approximately $52 million for the twelve
months ended June 2011 based on IMS Health sales data. Read More…
Apollo Hospitals to divest minority stake in Apollo Health Street:
reports
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Apollo Hospitals will reportedly divest minority stake in Apollo Health Street,
the group’s business process outsourcing division. According to reports, the
company is scouting for partners from the IT space and looking at 3-4
contenders – both global and domestic firms – who want to strengthen their
health IT portfolio. Apollo Hospitals is looking to invest Rs. 15bn. Part of this
will be funded by Apollo’s recent QIP which raised Rs. 3.3bn; the group
already has Rs. 6bn. Promoters will bring in Rs. 1bn. The rest will be raised
via internal accruals, added reports.
Aanjaneya Lifecare clarifies on acquisition reports
Aanjaneya Lifecare Ltd. has clarified that the Company explores various
strategic moves from time to time. However, as a policy and in the interest of
its shareholders, the Company does not comment on any report relating to
potential strategic initiatives unless they have reached the definite stage. The
Company made it clear to the journalist that it does not comment on market
speculation and the same has been mentioned by the newspaper article as
well. "We once again reiterate that the news article is based on speculation
and the Company had not issued any press release or notification regarding
the same," Aanjaneya Lifecare said today.
Sun Pharma subsidiary resolves USFDA warning letter
Sun Pharmaceutical Industries Ltd has announced that the U.S. Food and
Drug Administration ("USFDA") has informed Sun Pharmaceutical Industries,
Inc., its wholly owned subsidiary, that after a June 2011 re-inspection of its
Cranbury, New Jersey, US manufacturing facility, the site has an acceptable
regulatory status. Therefore, the issues noted in the August 25, 2010
warning letter are considered to be resolved. Caraco, now wholly owned by
Sun Pharma, continues to work with consultants to resolve the issues raised
by the USFDA at its Detroit plant.
Cabinet agrees to set up 6 National Institutes of Pharmaceutical
The Union Cabinet approved the establishment of six new National Institutes
of Pharmaceutical Education and Research (NIPERs) at Gandhinagar,
Hyderabad, Kolkata, Hajipur, Guwahati and Rae Bareli at an estimated cost
of Rs.633.15 crore. This will facilitate the establishment of full fledged NIPER
Campuses at these places for imparting higher PG level education as well as
undertake R&D projects. This will help in meeting the requirement of highly
skilled manpower of the pharmaceutical industry, and focus on R&D. Read
More…
Strides Arcolab gets USFDA nod for Paclitaxel Injection
Onco Therapies Limited, a wholly owned subsidiary of Strides Arcolab Limited
(Strides) has announced that it has received USFDA approval for Paclitaxel
Injection USP, 6 mg/ ML packaged in 30 mg/ mL, 100 mg/16.7 mL and 300
mg/ 50 ML multiple dose vials. Paclitaxel is among the products in the drug
shortage list of the American Society of Health-System Pharmacists and the
USDFDA. According IMS data, the US market for generic Paclitaxel
approximated US$46mn. The Company will launch the product immediately.
Read More…
Indian Red Cross Society to get benefits under I-Tax Act
The Union Health Minister Ghulam Nabi Azad presided over the General
Body meeting of the Indian Red Cross Society and St John Ambulance (India)
on behalf of the President of India Smt. Pratibha Devisingh Patil . The
meeting was convened after a gap of seven years at the initiative of Azad.
Over 350 members of the General Body including Governors of the States of
Uttar Pradesh, Chhattisgarh and UT Andaman and Nicobar Islands attended
today’s meeting. Addressing the gathering Azad said that he is happy to
note the increased role and recognition of Indian Red Cross. The Society now
has the latest communication tools, including emergency response units,
mobile disaster units and medical disaster units to initiate assessment and
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relief in times of calamity. There are six warehouses located in strategic
locations in the country where these equipments and relief items are stored.
Read More…
Fire at Orchid Chemicals' Sholinganallur plant
A fire broke out reportedly at one of Orchid Chemicals and Pharmaceuticals'
plants at Sholinganallur, near Chennai. According to reports, short circuit is
suspected to be the cause of the fire. The fire broke out at four of the labs.
There was damage to office and laboratory equipment, furniture and building
interiors. However, there were no injuries to anyone. The fire was brought
under control by the Tamil Nadu Fire Services squad assisted by the Orchid
safety team. The affected labs will be restored in a couple of weeks, said
reports adding that investigations are on.
India committed to complete polio eradication: Azad
The Union Minister of Health and Family Welfare Ghulam Nabi Azad was
honoured yet again by Rotary International as a Champion in Worldwide
Efforts to Eradicate Polio. Azad was presented with the award at a function in
Evanston, Chicago, USA on 23rd September 2011. Trustees and Board of
Directors of Rotary Foundation from all over the world and Rotary
International office bearers and members attended the function held to
recognize the efforts made by India and to honour the leadership of Shri
Ghulam Nabi Azad in particular. Accepting the award, Shri Azad said “I take
this opportunity to re-affirm India’s commitment to complete polio
eradication”. He reiterated that vaccination is one of the most cost effective
public health interventions, since it provides direct and effective protection
against preventable morbidity and mortality. India runs one of the world’s
largest Immunization Programmes whereby around 26 million children born
every year are covered. Read More…
MDACS takes over SAADHAN helpline from PSI banner
Mumbai District Aids Control Society (MDACS) has taken over Saadhan
helpline from the PSI banner. The helpline (022 2411 4000) provided HIV,
AIDS and Family Planning related information and counseling to thousands of
callers from India and abroad under the PSI banner for last 15 years. The PSI
Helpline counselors have been absorbed into the MDACS helpline program
and the helpline has been re-launched as the MDACS Saadhan Helpline
officially. The helpline will offer free counseling to caller on HIV & AIDS,
simultaneously maintaining the confidentiality of the caller. 'Saadhan Helpline
is the answer to the common man's inhibitions. Since HIV / AIDS is a subject
that is related to sex which is a taboo in the Indian Society, it becomes very
difficult for the common man to talk about it. Everyone is curious but no one
knows how to get access to information. Read More…
Glenmark Generics gets tentative approval for Zolmitriptan from
USFDA
Glenmark Generics Inc., USA, the United States subsidiary of Glenmark
Generics Limited, announced that the U.S. Food and Drug Administration has
granted tentative approval for their generic version of IPR's migraine
treatment Zomig tablets. Glenmark believes there are no first to file
applicants for Zolmitriptan tablets and therefore the Company would
commence marketing and distribution of their zolmitripian product upon
patent expiration in May 2013. Product launch is dependent upon receipt of
final approval of its Abbreviated New Drug Application from the U.S. FDA.
Read More…
Ind Swift Labs gets shareholders’ nod to raise up to Rs 5bn
Inds Swift Laboratories reportedly said its shareholders have approved
raising funds up to Rs. 5bn through issue of Global Depositary Receipts
(GDRs), Foreign Currency Convertible Bonds (FCCBs) and Convertible Bonds.
According to reports, the company did not provide a time line for raising the
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funds. The members have also approved declaration of dividend of Re 1 per
share of face value of Rs. 10 each for the financial year 2010-11.
Zenotech Lab gets nod from US FDA for ondansetron injection
Zenotech Laboratories Ltd. has reportedly received approval from the U.S.
Food and Drug Administration (USFDA) for its ondansetron injection, a copy
of Glaxosmithkline Plc.’s Zofran anti-nausea medicine. The shares of
Zenotech Lab are trading at Rs. 39, down by Rs. 1 or 2% over the previous
close. It had earlier opened at the day's low of Rs. 39 and high of Rs. 42. The
total traded quantity stood at 277 lakh shares on the BSE.
Nitta Gelatin to launch a slew of products
Nitta Gelatin India Ltd (NGIL), a joint venture between KSIDC & Nitta Gelatin
Inc. Japan, has plans to launch new products before the end of financial year
2011-12. Gelixer Collagen Pep which is a proven nutritional supplement for
bone and joint health is now available in Kerala and Tamil Nadu and will soon
be marketed in Karnataka. The new products are targeted at those with
Osteoporosis, Sports men & women, and dancers. NGIL has now started to
reach customers directly by making the products available online and has
revamped the website to make it more consumer friendly and interactive
(www.gelixer.com).
Addressing media, G.Suseelan, MD, said that the last six months have been
tough for the Company, since raw material costs have increased
substantially. Supplies of crushed bones and hydrochloric acid, which are the
basic raw material for producing gelatin were erratic and this impacted
production. Now, the material prices have stabilized and the production is
progressing as planned. NGIL is perhaps one of the few government
promoted companies in India to foray into consumer marketing by launching
OTC products. This shift of strategy from B2B to B2C has given us a thorough
understanding of the dynamics of marketing and consumer perception and
behavior. We are happy that our products have been well received and
gained the acceptance of common man. About the other products like
Gelatin, Suseelan said that the Pharma industry is doing well, particularly in
India and demand for gelatin is constantly on the rise.
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International News - September 2011
Health Impetus to enter US pharma market
Health Impetus (HI), a disease management partner to global
pharmaceutical and life sciences companies is all set to starts its US
operation in next 2-3 months, eyeing a 50 per cent growth in revenue over
next two years, a top company official said. “We are all set to venturing into
US market in next 2-3 months. We see a buoyant market for its
differentiated and unique health care services in US. Currently, we are
negotiating with more and more pharma companies in US to deliver on their
‘Disease Management’ strategies with their product line,” said Pankaj Sindhu,
Chief Executive Officer, Health Impetus. Read More…
Bristol-Myers Squibb, Pfizer announce results of Phase 3 clinical trial
for ARISTOTLE
Bristol-Myers Squibb Company and Pfizer Inc announced on Aug 28, 2011
the main results of the Phase 3 clinical trial ARISTOTLE (Apixaban for
Reduction In Stroke and Other Thromboembolic Events in Atrial Fibrillation),
which evaluated ELIQUIS (apixaban) compared to warfarin for the prevention
of stroke or systemic embolism in 18,201 patients with atrial fibrillation and
at least one risk factor for stroke. In the ARISTOTLE trial, ELIQUIS as
compared with warfarin significantly reduced the risk of stroke or systemic
embolism by 21 percent, major bleeding by 31 percent, and mortality by 11
percent. Results were presented on Aug 28, 2011 during the Hot Line session
at the European Society of Cardiology Congress in Paris, France, and
published in The New England Journal of Medicine. Read More…
Nestor receives WHO GMP certificate from Ivory Coast Healthy
Ministry
Nestor Pharmaceuticals has received the certificate of Good Manufacturing
Practices (GMP) from Ivory Coast’s health ministry for exporting products in
the region. This approval is in accordance to the format prescribed by World
Health Organisation (WHO). The approval has been granted for a period of 5
years initially. Announcing this Mr Rahul Sehgal, President Nestor
pharmaceuticals said, “Ivory Coast had conducted a detailed inspection of the
manufacturing facilities at Nestor’s Faridabad plant in July 2011 and found
them to be compliant of all quality standard requirements as per Ivory Coast
FDA and WHO-GMP norms.” With this certificate Ivory Coast market would be
open for Nestor Pharmaceuticals making healthy contribution to its export
sales from the area, added Mr. Sehgal. Read More…
Boston Scientific names Michael Mahoney president
Boston Scientific Corp. reportedly named Michael Mahoney of Johnson &
Johnson its next chief executive officer as the world’s second-largest maker
of implantable heart devices seeks to expand its product line and return to
profitability. According to reports, Mahoney, 46, will join Boston Scientific
Oct. 17 as president and will be elevated to CEO in November 2012. Hank
Kucheman, currently executive vice president, will serve as interim chief
executive officer until Mahoney fulfills his post-employment obligations to
New Brunswick, New Jersey-based J&J. Boston Scientific CEO Ray Elliott will
step down when Mahoney becomes president.
Sanofi wins U.S. cancer drug patent ruling
Sanofi has reportedly scored an important victory in a patent dispute with
Sun Pharmaceuticals that will keep generic copies of its Eloxatin colon cancer
drug off the United States market until August 2012. According to reports,
ruling by the U.S. District Court for the District of New Jersey maintained
Sanofi's market exclusivity for Eloxatin in the United States through Aug. 9,
2012.
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Bill Gates in Nigeria to Discuss Polio Eradication
Bill Gates, co-chair of the Bill & Melinda Gates Foundation, will meet with
national, state and local government officials and traditional leaders this
week to discuss the ongoing campaign to end polio in Nigeria. Gates will be
accompanied by the foundation's chief executive officer Jeff Raikes. Read
More…
Glaxo aims at $1b-2b deals in emerging markets: reports
GlaxoSmithKline global CEO Andrew Witty was quoted as saying that the
company has a war chest of $1-2bn to support its expansion plans in India
but will be cautious against overpaying for any buyout. The company can
afford a deal worth $1-2bn in the Indian pharmaceutical space. However, is
not in a hurry to close a deal at a higher valuation. According to reports,
foreign ownership in Indian drug companies will not increase product prices
in South Asian nation. Glaxo aims $1b-$2b deals in emerging markets. The
company also seeks at India deals but only at right price. Witty sees the
increasing population in India as an opportunity for more effort in drug
innovation in India. Though the innovations should be patent protected, it
should not be a reason for higher drug prices, added reports.
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Domestic News - October 2011
Japan and India announce joint projects in biotech, life sciences
Dr.Ashwani Kumar, Minister of State for Science and Technology, Earth
Sciences and Planning and Japanese Senior Vice Minister of the Ministry of
Economy, Trade and Industry, Seishu Makiano discussed about biotechnology, nanotechnology and life sciences projects. Dr Ashwani Kumar
who is on an official visit to Japan met.Seishu Makiano yesterday at Tokyo.
He informed that besides this the Japanese Government is ready and willing
to encourage Japanese investment in all sectors of the Indian economy
particularly in infrastructure development, bio-technology, nanotechnology,
life sciences, supercomputing, environmental and water conservation in
addition to automobile sector.
PharmaVentures appoints Andy Smith as Head of Corporate Finance
PharmaVentures today announced the appointment of Andy Smith as Head of
Corporate Finance to significantly enhance Pharmaventures' advisory
capabilities and offerings to the global healthcare and investment
communities. Fintan Walton, PhD, PharmaVentures' Chief Executive Office
says "We are delighted to welcome Andy to PharmaVentures. He brings a
wealth of investment management experience and has also worked
extensively across R&D and marketing in the healthcare sector. At
PharmaVentures we are increasingly providing more investment bank style
services to help our clients with their dealmaking and Andy's addition to
PharmaVentures will therefore be of great benefit." Read More…
Pharmexcil felicitates Venus Remedies with patent award in Gold
category
Venus Remedies, a leading research based global pharmaceutical company
won Patent Award in Gold category for the year 2010-11 in the valedictory
function of India —LAC Pharma Meet by Pharmexcil (Pharmaceuticals Export
Promotion Council) held at Hotel Taj Krishna, Hyderabad on 30th September,
2011. Hon'able Chief Minister of Andhra Pradesh Mr. N. Kiran Kumar Reddy
presented the award. Commenting on this, Mr. Pawan Chaudhary, Chairman
and Managing Director, Venus Remedies Limited says, “The year 2010-11
was another exciting year at Venus as we forged Global alliances, received
multi-country marketing approvals, patents, strengthening international
alliances and won several awards, thus turning the global spotlight on us.
This is extremely rewarding to see our efforts recognised by the
Pharmaceuticals Export Promotion Council, an authorised agency of the Govt.
of India for promotion of pharmaceutical exports from India.” Read More…
Suven Life Sciences bags Pharmexcil's Gold "Patent Award"
Suven Life Sciences Ltd (SUVEN) announces today that they bagged
Pharmexcii's "Patent Award" for securing the most number of product patents
during 2010/11 for their New Chemical Entities (NCE's) under Gold Category
third year in a row. The Awards were presented during the "Awards Function
for Exports and patents during India-LAC Pharma Business Meet" organized
by Pharmexcil and by Department of Commerce, Government of India. Suven
secured 108 product patents for their NCE's during 2010-2011 from several
countries including all the developed countries like USA, Europe, Japan,
Australia and Canada etc. So far Suven secured a total of 445 product
patents globally for their NCE's since 2002. Read More…
Ranbaxy to extend Daiichi Sankyo product reach to pharmacists
across Italy
Ranbaxy Italia S.p.A (Ranbaxy) and Daiichi Sankyo, Italia S.p.A (Daiichi
Sankyo), today announced a partnership to leverage .Ranbaxy's distribution
strengths and extensive relationships with Pharmacists across Italy, for the
distribution of Daiichi Sankyo products. To start with, Ranbaxy will
exclusively distribute two of Daiichi Sankyo's long established brands Yearly Industry Newsletter
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CONGESCOR and LOPRESOR - to all pharmacies, in the country. These drugs
are used extensively by Doctors in Italy for the treatment of Congestive
Heart Failure and Hypertension. As per IMS Health, the total annual retail
sales of CONGESCOR and LOPRESOR are around Euro 20 Mn. The partnership
in Italy provides further impetus to the Hybrid Business Model between the
two companies by comprehensively addressing Doctors and Pharmacists in
improving the accessibility of drugs, for patients. Read More…
Vivimed Labs acquires stake in Klar Sehen
Vivimed Labs Ltd has acquired 100% equity stake in Klar Sehen Pvt. Ltd.,
(KSPL). a 30 year old Kolkata based Pharmaceutical Company with strong
marketing presence in North East. Bihar and Andhra Pradesh. KSPL operates
in a niche ophthalmic segment and owns about 50 trademarks and some
very well known brands such as Renicol, Lysicon-V. Care Tears. Dexacort etc,
in eye care segment. In a research conducted by C-Marc (India) Pvt Ltd for
the period Nov-Feb 2011. KSPL for its wide range of Ophthalmic products has
bagged an All India corporate standing rank of No. 1 in the East Zone and
bagged a rank of No. 5 in India (in Indian, Dist HQ & Extra-Urban and rural
markets). KSPL has cGMP compliant manufacturing facilities at Kolkata,
Hyderabad and also has arrangements to manufacture some of its products
in Uttaranchal. KSPL presently operates from its headquarters in Kolkata with
over 150 medical sales professionals. Vivimed's acquisition of KSPL
complements its strategy to increase its domestic presence in specialty
pharmaceutical areas, its extensive knowledge and experience in
manufacturing. R&D will help grow this business to new levels.
Sparsha Pharma launches new generation transdermal patches
Scores of patients in India depend upon their daily dose of analgesics either
in form of oral medication or injections to subside their intense pain. To help
such patients Sparsha Pharma International Pvt. Ltd, India’s first WHO
certified Fentanyl Transdermal Patch manufacturing company, today
launched two new-generation transdermal patches meant for effective pain
management. Chief Guest D.L. Ravindra Reddy, Hon’ble Medical & Health
Minister of Andhra Pradesh, unveiled Artho-Touch TM and Diclo-Touch TM
transdermal patches at a press conference here. Also present at the launch
were Guests of Honor – Dr. A.V. Gurava Reddy, CEO Sunshine Hospital and
Dr. V. Sarath Chandra Mouli, Chief Rheumatologist, KIMS Hospital, Dr. Dange
Veerapaneni, Managing Director, Sparsha Pharma and Rajeev Sindhi,
Managing Director, Sandor Medicaids, the marketing and distribution partner
for the new products.
Ailments such as Tennis elbow, Arthritis Deformans (chronic form of
arthritis), Peritendinitis (swelling of tendons), pain after trauma, shoulder
blade pain, neck pain, back pain, Myalgia (muscle pain), Spondylitis (swelling
of vertebrae), menstrual pains etc are often intensely painful conditions that
afflict scores of men and women. Patients are often required to take large
doses of painkillers either orally or intravenously (through injection) to get
relief from their condition.
However, long term use of painkillers in form of oral medication may have
serious systemic side effects. Also, many patients find it difficult to take
measured doses of these medicines on their own. For such patients
transdermal patches are the best answer. These ensure long lasting
controlled release of the drug into the body. The design of Artho-Touch TM
and Diclo-Touch TM patches is such that these can be comfortably worn on
the skin. These are easy to apply and remove. These products have
flexibility due to elastic fabric backing. Speaking on the launch, Dr. Dange,
said, “Transdermal patches are an effective mode of drug delivery into the
human body. Since they are equipped to release controlled doses of the
drug/painkiller medicine, they help in an effective management of pain.
Sparsha Pharma’s transdermal patches Artho-Touch and Diclo-Touch have
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advanced designs. Also, these are esthetically acceptable and are capable of
delivering sustained dosing of active compounds. These products will
tremendously benefit patients who have developed painful conditions such as
Myalgia, shoulder pain, neck pain etc. owing to their poor lifestyle habits.”
Max Healthcare to sell 26% stake to Life Healthcare
Max India Ltd. said on Tuesday that its subsidiary Max Healthcare Institute
Ltd. has entered into a non-binding term sheet with Life Healthcare Group
(Proprietary) Ltd., a company incorporated and existing under the laws of
South Africa, to issue and allot shares constituting 26% of the post-issue
Equity Share Capital for an aggregate consideration of Rs. 5,165mn. Max
India owns over 91% equity stake in Max Healthcare Institute. Life
Healthcare Group is a leading healthcare service provider in South Africa with
a market capitalization of over US$2bn. The Investor Group's network
includes 63 hospitals with 8,000+ beds with a 27% market share in the
healthcare industry in South Africa. The transaction is subject to completion
of due diligence and necessary regulatory approvals to the Investor at South
Africa, Max India said in a statement. The Board of Directors of the Company
in its meeting held on October 11, accorded its in-principle approval to Max
Healthcare Institute Ltd. to go-ahead on aforesaid transaction. Read More…
Fortis Malar posts net profit up 99%
Fortis Malar Hospitals Ltd., a subsidiary of Fortis Healthcare (India) Ltd., one
of India’s leading healthcare service providers with a network of 66 hospitals
and a capacity of ~ 10,300 beds, today announced its unaudited results for
the quarter ended September 30, 2011.
Financial Highlights
Fortis Malar Hospitals recorded a revenue of Rs. 24.46 Cr during the
quarter, a growth of 16.4% compared to the corresponding quarter of the
previous year.
Operating Profit (EBIDTA) for the quarter stood at Rs.3.73 Cr, a growth of
14% compared to the corresponding quarter of last fiscal.
Net profit after tax (PAT) for the quarter stood at Rs. 2.51 Cr against
Rs.1.26 Cr reported during the same period in last fiscal, representing a
growth of 99%
The growth was mainly driven by Cardiac Sciences, Renal Sciences,
Gastroenterology sciences and Oncology which grew by 10%, 66%, 15%
and 255%, respectively compared to the corresponding period of last
fiscal. Read More…
Lupin launches Generic Diabetes drug
Lupin has reportedly launched the generic version of Watson's Fortamet
despite an impeding patent suit against Lupin in the US. According to reports,
drug sales could contribute as much as 3-4% of the annual operating profit,
or Rs. 350mn-400mn. Lupin also has a firstto-file status on its application
with the US Food and Drug Administration (FDA) for the drug, which will give
the company an exclusive period to sell the drug for 180 days after the
litigation, is settled.
…Lupin launches Authorized Generic of Femcon Fe
Wockhardt told to pay up FCCB creditors by Aug. 2012
The Bombay High Court on Tuesday directed Wockhardt Ltd. to clear all dues
to its bondholders by August next year and set a timeline for the repayment
of Rs. 4.17bn. The court was hearing a winding-up petition against
Wockhardt filed by a group of foreign currency convertible bond (FCCB)
holders, led by Singapore-based hedge fund QVT Financial LP and an
overseas unit of Sun Pharmaceutical Industries Ltd. Read More…
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Ranbaxy bags NJBIA Award
Ranbaxy Inc., a research-based pharmaceutical company that manufactures
generic product formulations, OTC and branded drug products, has been
honored with the New Jersey Business Industry Association’s (NJBIA) Award
for Excellence in Business Expansion and Economic Contribution to the State.
The NJBIA award acknowledges Ranbaxy’s commitment and contribution to
the State, providing jobs for more than 700 New Jerseyans and with recent
investments in its state-of-the-art manufacturing facilities in New Brunswick.
NJBIA President Philip Kirschner will honor Ranbaxy and other recipients at
an awards dinner on October 18, 2011 in Edison, NJ. Read More…
Granules receives US nod for Naproxen Sodium: reports
Granules India Ltd has reportedly received an approval from the US Food and
Drug Administration (US FDA) for Naproxen Sodium, its abbreviated new
drug application. According to reports, Naproxen Sodium is used to reduce
pain, fever and inflammation. It is sold under various brand names including
Aleve and Midol in the US. It is a non-steroidal anti-inflammatory drug. C.
Krishna Prasad, Managing Director, Granules India was quoted as saying “We
are excited to offer Naproxen Sodium, which is used in more than six billion
doses per year. The company was in discussions with several US generics
drug manufacturers. The commercial orders for naproxen sodium finished
dosages were expected to commence in the first half of 2012." Sales for
naproxen sodium annually in the US exceeded $200mn for the 12 months
ending March 31, added reports.
Aurobindo Pharma receives final approval for Gabapentin Tablets
Aurobindo Pharma Limited is pleased to announce that the company has
received final approval from the US Food & Drug Administration (USFDA) to
manufacture and market Gabapentin Tablets USP 600mg and 800mg.
Gabapentin Tablets are the generic equivalent of Pfizer Pharmaceuticals'
Neurontin Tablets, which are indicated for the treatment of partial seizures
and other nervous system disorders. The annual sales of Gabapentin Tablets
USP 600mg and 800mg in the US were approximately US$ 220 Million for the
twelve months ending June 2011 according to IMS and will be launched soon.
Aurobindo now has a total of 139 ANDA approvals (110 Final approvals and
29 Tentative approvals) from USFDA.
LifeCell International receives accreditation from NABL
LifeCell International, India’s largest and premier umbilical cord and
menstrual blood stem cell bank has been accredited by National Accreditation
Board for Testing & Calibration Laboratories (NABL), against the meticulous
standard of ISO 15189: 2007 for the proficiency of its Labs. This recognition
makes LifeCell the first, and currently the only stem cell bank in the country
to receive this respected and recognized certification. NABL provides formal
third party recognition of competent laboratories, thus providing a ready
means for customers to find reliable testing and calibration services in order
to meet their demands. Read More…
Trivitron Healthcare invests in Kiran Medical Systems
Trivitron Healthcare, the largest medical technology of Indian origin, today
announced the completion of a strategic investment in Kiran Medical Systems
Ltd; making Trivitron the most comprehensive product and solution provider
in the country for medical imaging space. Kiran Medical, global leader in
image enhancement and radiation protection join hands with Trivitron
Healthcare. Kiran Medical manufactures products such as Cassettes, Screens,
Grids, Shields and Computer Radiography Systems, with a leadership
position in US, Europe, Japan and Latin America. The investment which
combines a cash component and a stock swap ensures wealth maximization
for the shareholders of both companies. The agreement between the two
companies also provides for Trivitron to increase its shareholding over the
next few years. This investment further strengthens Trivitron’s presence in
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South/ South East Asia, Middle East and Africa, which are its key export
markets and make an entry in to US, Europe, Japan & Latin America where
Kiran has a strong presence.
As a result of this strategic investment, the board of directors for Kiran
Medical will now have two members, Dr. G.S.K. Velu and Mr. Ramesh Verkot
for Trivitron Healthcare. Mr. Ramesh Modi, CEO, Kiran Medical will continue
to operate the business of Kiran as an independent entity, with complete
operational freedom. A core cross functional group with representation from
Kiran Medical and Trivitron Healthcare will evaluate synergies and implement
strategies that benefit both the entities. Kiran exports its products to over
160 countries across the world; USA, Europe, Japan and Latin America being
the primary markets. Both companies will benefit from cross contributions
coming from each product portfolio, sharing of network in export markets
and gaining from each other's innovation and manufacturing base and
knowledge.
Self care attitude of Indians may harm themselves: Dr. Kamal B
Kapur
Eyes are often referred as the mirror of the inner soul, are one of most
sensitive of all sensory organs and essential part of human body. Therefore
it’s most important that one should not neglect and discomfort related to the
eyes. Fortunately, many common eye disorders disappear without treatment
or can be managed by self-treatment. Various products from artificial tears
and ointments to steroid drops and ocular decongestants are available over
the counter (OTC). While these products can help with minor eye problems, a
word of caution: In some instances, what may seem like a minor eye
problem may lead to a severe, potentially blinding conditions due to
unsupervised self medications by using these over the counter eye
medicines.
Redness, itching, watering, pain or discharge is the common symptoms of
many eye problems and hence we generally tend to ignore or confuse then
with daily infections. Often, one tends to rush to the nearest chemist for
expert advice and medication and accept an unqualified medical
recommendation. Only once the problem becomes severe or irreversible do
we resort to specialist advice. According to Dr. Kamal B Kapur, Medical
Director- Sharp Sight Medfort group of hospitals, “As an Indian mindset we
don’t realize the importance of a specialist and try to cure the problem
ourselves. It is however important to remember that many medicines offered
by chemist for the eye can damage not only eyes but other organs of the
body too. This is especially relevant in India where even non-OTC drugs are
sold over at the counter by chemist without a prescription from the
ophthalmologist.”
New malaria vaccine trial throws up promising results
Millions of lives, especially that of kids in backward regions of the world,
could be saved from the deadly malaria after a clinical trial of a vaccine
produced promising results in Africa. The new vaccine could reduce the risk
of children contacting malaria by half, according to the results from a clinical
trial conducted by GlaxoSmithKline and partners. The trial cut the risk of
clinical malaria for young children by 56% and the risk of severe malaria by
47%, GlaxoSmithKline said. Severe malaria affects the brain, kidneys and
blood and can kill. Malaria kills about 800,000 people each year, most of
them young children in sub-Saharan Africa. Read More…
Natco Pharma to foray into bio-generics
NATCO Pharma Ltd. on Tuesday said that it has entered into an exclusive
agreement with Mabxience, the bio-similar division of Chemo Sa Lugano,
Switzerland, to purchase four ingredients that will be used in the
manufacture of finished drugs. Under the agreement, NATCO will purchase
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four mAb drug substances from Chemo and use the same for manufacturing
finished dosage pharmaceutical formulations. Three of these products viz.,
Trastuzumab, Bevacizumab, Rituximab belong to the oncology segment,
while Etanerceptis is for the treatment of auto-immune disease.
NATCO's obligations under the agreement will include manufacture of drug
products, undertaking local clinical trials, filing registration of dossiers,
applying for market authorizations and to commercialize the product in India
and a few other Asian countries. Oncology is the largest therapy area within
the mAb market, with eight marketed products. The mAb market is highly
innovative and a key trend has been the move from murine to humanized
and fully human antibodies, with insignificant generic presence. Worldwide,
the market for mAbs has grown rapidly and is currently at a revenue level of
around US$ 35bn. With the product combinations chosen by NATCO, the mAb
initiative is likely to be completed in a period of 24 to 36 months.
Sun Pharma offers to acquire remaining stake in Taro Pharma
Sun Pharmaceutical Industries Ltd has announced that on October 18, 2011,
the Company (together with its subsidiaries & affiliates, “Sun Pharma")
delivered a letter to Sun Pharrna’s Israeli subsidiary, Taro Pharmaceutical
Industries Ltd’s Board of Directors proposing acquisition by Sun Pharma, of
all of the outstanding shares of Taro not held by Sun Pharma for per share
consideration of US $ 24.50 in cash representing a 25.96% premium over the
most recent closing price of Taro common stock. This offer is subject to the
approval of Taro Board and such other authorities as may be required and
subject to completion of necessary cornpllances/formalities as may be
required.
Strides Arcolab receives US FDA approval for Bupivacaine
Hydrochloride Injections
Strides Arcolab Limited (Strides) today announced that it has received 2
ANDA approvals from US FDA for Bupivacaine Hydrochloride Injection, USP, a
general anaesthetic for the following strengths:
Bupivacaine Hydrochloride Injection, USP, 0.25%, 0.5% and 0.75%
packaged in 10 mL and 30 mL Single-dose Vials (Preservative Free).
Bupivacaine Hydrochloride Injection, USP, 0.25% (2.5 mg/ mL) and 0.5%
(5 mg/ mL) each packaged in 50 mL Multiple-dose Vials.
According to IIV15, the 2011 U.S. market for Injectable Bupivacaine
Hydrochloride approximates to USD 29 million. The product is expected to
be launched shortly. Bupivacaine is the thirteenth product approved under
the Sagent - Strides partnership. Strides is developing and supplying more
than 25 injectable products for the USA market which will be marketed by
Sagent.
Jain Hospital opens research centre for Spine Care
Osteoporosis, the disease of bones that is expected to impact over 36 million
patients in India by 2013, is the single largest cause of spinal fractures. 20%
of women and 10-15% of men aged above 50 suffer from Osteoporosis.
Despite 83% of all spinal fractures occurring due to Osteoporosis, the disease
significantly lacks the required awareness, diagnosis, preventive and
treatment measures.
‘Why bend to Osteoporosis!’
Commemorating World Osteoporosis Week, the All India Association of Spine
Surgeons (ASSI) made a call to action by reaching out to general public.
Objective of the campaign is to sensitize masses about symptoms and
significance of early diagnosis and right treatment of the disease that
enormously impairs quality of life of the patients. Millions of patients can
avoid severe consequences by adopting preventive measures and timely
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treatment. This campaign is supported by India Medtronic. The repercussions
of spinal fractures can be severe. Spinal fractures can result in stooped back
or change in spinal alignment, acute and chronic debilitating pain, loss of
height, immobility, depression, significant performance impairments in
physical, functional and psychosocial domains in older patients. It leads to
five fold increase in risk of future spinal fractures after the first fracture and
75 fold increase in risk after two or more spinal fractures. Patient experiences
reduced pulmonary function, increased dependence on family and even
premature death. These fractures
Birla Pacific Medspa launches State-of-art IVF Centre in Mumbai
Birla Pacific Medspa- part of the dynamic Rs. 30bn Yash Birla Group has
announced its foray into fertility clinics. The State – of the art centre will be
branded as ‘BIRLA IVF’. The first centre has been set up in Kandivali East.
The group known for its successful penetration in the sunrise sectors has set
its focus on the highly potential Indian infertility market. The IVF Centre
offers consultations, unrivalled expertise, standardized, transparent and
ethical fertility clinic services, quality processes and diagnostic services,
hand-holding at every step from pre-conception to post delivery and
treatment facilities.
At the launch, Mr. N. Venkat, Managing Director & CEO, Birla Wellness &
Healthcare Pvt Ltd said, “Birla IVF is a very promising investment of approx.
Rs.2 crores (approx.) made by Birla Pacific Medspa Ltd. We see substantial
growth potential and aim to help deliver a dream to aspiring parents by
offering the best quality standards and technology. With our current team of
experts we plan to expand to 10 centres in Metros and tier1 cities in the next
2 years. At Birla IVF it will be our constant effort to create consistent success
stories and capture a significant market capital. Medical tourism will also play
a major role in our domain.” With a higher success rate in helping infertile
couples building a family and advantages of highly-skilled manpower,
substantially lower cost of treatment are making India the 'mother
destination' for those seeking 'their own child'. At Birla IVF Centre, the issue
on infertility is addressed as a “couple problem”. Both the mother and fatherto-be are holistically evaluated to provide the most workable treatment
solutions,
in
line
with
the
latest
medical
advancements.
Announcing the launch of the Centre, Dr. Abhijit Desai, MD Birla Pacific
Medspa, said, “At Birla IVF our primary goal has always been to deliver the
highest quality to our patients. With the expertise of 8 renowned doctors in
the field of infertility treatments and the assurance of the best of practices
that comes associated with Yash Birla Group, we aim at providing a holistic
view to healthcare” The Birla IVF Centre is the fruition of efforts with the aim
providing the best of expertise and treatment options; very few can match up
to.
Wockhardt Foundation & Welspun launch Mobile Medical Unit in
Mumbai
Wockhardt
Foundation
has
entered into a strategic alliance
with Welspun to jointly launch
Mobile
Health
Reach,
a
healthcare
programme
in
Mumbai.
Flagging off the
mobile
healthcare
unit
launched the initiative in Lower
Parel, Mumbai. Dipali Goenka,
Director,
Welspun
India
Limited announced the official
launch of Mobile Medical Unit
during the flag-off ceremony;
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she was also accompanied by Ms. Mangala Tambe, DGM-CSR, Welspun India
Ltd and Vijay Batna-ED, CEO Welspun Max Steel India Ltd.
Wockhardt Foundation through its Mobile Health Reach aims to provide free
primary healthcare at the doorstep of the poor families in slum areas of
urban India through a pan-India network of mobile healthcare units. Through
its Mobile Health Reach healthcare outreach programme in Mumbai,
Wockhardt Foundation and Welspun aim to offer free primary healthcare aid
to nearly 22,500 patients annually in this area.
Advanced Gynecological Robotic Surgeries performed at KIMS
Traditionally, when medication and non-invasive procedures are unable to
relieve symptoms, Surgery is the only accepted and most effective treatment
for a range of gynecologic conditions in and out of developed world.
Traditional open gynecologic surgery, using a large cut to access the uterus
and surrounding anatomy has been the standard practice for many years.
This open surgery can bring significant amount of pain, trauma and a long
recovery process. There is sometimes even a threat to the surrounding
organs. Surgery causes lot of anxiety to the women.
Till recent times, laparoscopy was used by surgeons but it had its limitations.
The surgical locations in cases of Gynecology are narrow and maneuvering in
these areas with laparoscopic instruments is not easy. The very thought of
Gynaecological surgery brought up images of pain, discomfort, extended time
away from daily chores usually associated with traditional surgery. Now with
the advent of the Robotic surgery, patients can be back to their normal life
within a much shorter time compared to traditional surgery. Today, Robotic
Surgery in gynecology is one of the fastest growing fields of robotic surgery.
Read More…
Dr. Reddy’s and Teva launch generic Zyprexa in US
Teva Pharmaceutical Industries Ltd. and Dr. Reddy’s Laboratories announced
the commercial launch of Olanzapine Tablets, the generic version of Eli Lilly’s
Zyprexa. Annual sales of Zyprexa were approximately US$3.2bn in the
United States as of September 2011, based on IMS sales data. Teva’s
Olanzapine Tablets in 2.5 mg, 5 mg, 7.5 mg, 10 mg and 15 mg and Dr.
Reddy’s Olanzapine Tablets in 20 mg have each been awarded a 180-day
period of marketing exclusivity in the U.S. Dr. Reddy's is supplying the 20 mg
version of the product following an April 2011 commercialization,
manufacture and supply agreement with Teva. In addition, as per the terms
of the agreement, Dr. Reddy's will launch their 2.5 mg, 5 mg, 7.5 mg, 10 mg
,15 mg and 20 mg of Olanzapine tablets upon expiration of the 180-day
exclusivity period. Read More…
Wipro launches new version of Hospital IMS
Wipro Infotech, the India, Middle East and Africa, IT Business unit of Wipro
Ltd and a leading provider of IT and business transformation services
announced today the launch of a new version of its Hospital Information
Management System (HIMS) with enhanced business functionalities. The new
version of the HIMS has been developed by Healthcare IT services division of
Wipro and specially designed to cater to the future needs of large healthcare
providers, Hospital chains, Government hospitals, clinics, and diagnostic
centers in India, the Middle East and Africa. The comprehensive solution
automates the clinical, Electronic Medical Records (E), administrative and
inventory functions, thereby enabling increased operational effectiveness,
reduction in costs & medical errors, while raising the quality of patient care.
Read More…
Aanjaneya clarifies news on talk of Buying Formulation Co
Aanjaneya Lifecare Ltd has clarified about the earlier reported news
"Aanjaneya Hits Upper Circuit on Talk of Buying Formulation Co" as under :
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"The Company explores various strategic moves from time to time. However,
as a policy and in the interest of its shareholders, the Company does not
comment on any report relating to potential strategic initiatives unless they
have reached the definite stage. The Company has made it clear to the
journalist that it does not comment on market speculations and the same has
been mentioned by the newspaper article as well. We once again reiterate
that the news article is based on speculation and the Company had not
issued any press release or notification regarding the same. The Company's
policy is to inform the stock exchange(s) whenever it enters into any formal
agreement on such sensitive subjects."
GVK Biosciences extends license of its SAR Databases to Astellas
Pharma
GVK Biosciences (GVK BIO), Asia’s leading drug discovery research &
development organization, announced today that Astellas Pharma
Inc.extended and renewed its license to the GVK BIO SAR Databases
(GOSTAR). GOSTAR (GVK BIO Online Structure Activity Relationship (SAR)
Database) is an online scientific database product of GVK BIO. It integrates
information on compounds from discovery & development stages and
marketed drugs. Information provided includes SAR, ADME, toxicity,
preclinical, clinical and structural data for over 5.1 million compounds and
16.7 million SAR points. Sreeni Devidas, Vice President, Sales & Marketing,
Informatics, at GVK BIO said, “We are excited that Astellas has decided to
extend the license to the GOSTAR database. The GOSTAR database is
becoming an indispensible tool for scientists in drug discovery. Several
publications that have used the GOSTAR data validate the utility of this
product.”
Informatics at GVK BIO
The Informatics division is responsible for analyzing data to transform
chemical / biological patterns into knowledge. Informatics offers Custom
Curation, Cheminformatics and Bioinformatics services to global clients. It
also licenses and sells databases to Biotech and Pharma companies.
Carestream Health India unveils new CARESTREAM DRX-Ascend
System
Carestream Health India has recently unveiled the new CARESTREAM DRXAscend System, which is designed for small to mid-size hospital radiology
departments, imaging centers, clinics and specialists’ offices. The DR system
offers a versatile, floor-mounted tube stand and a wide and elevating floattop table with a patient weight capacity of 295 kilograms. In India, the first
CARESTREAM DRX-Ascend System has been recently installed at the stateof-the-art Siddhant Diagnostic Center, Varanasi, Uttar Pradesh. Speaking on
the uniqueness of the new DR system, Prabir Chatterjee, Managing Director,
Carestream Health India, says, “The CARESTREAM DRX-Ascend System is
well suited for smaller rooms, imaging centers and orthopedic applications.
This floor-mounted DR system delivers high-end features at an affordable
price.”Read More…
Breast Cancer Seminar held at Apollo Hospital
Breast cancer is curable when detected early. This message was effectively
spread through Apollo Hospital’s ‘Precious 5 Minutes’ campaign, which
culminated in a seminar, today. The resounding messages throughout the
campaign were that five minutes is all it takes to protect oneself from breast
cancer & that five minutes spent to do a breast self examination, once every
month, is the first step to early detection of this disease. Read More…
Apollo Hospital & Dr Santosh Hegde encourage Bangaloreans to
pledge to donate their eyes
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And they lived happily ever after...This familiar ending does not have to be
limited to fairytales alone. You can make this a reality in someone’s life – by
donating your eyes. As part of World Eyesight Day, Apollo Hospital conducted
an awareness program with former Lok Ayukta, Justice Dr. Santosh Hegde,
to spread the message that one can bequeath eyes by taking a pledge,
resolving to donate them after death.
Donated human eyes help preserve and restore sight through corneal
transplantation. Infants born with cloudy corneas gain sight from
transplantation. Donated eyes also aid supporting valuable research and
education purposes. Encouraging the nobel act of eye donation, Dr Umapathy
Panyala, COO, Apollo Hospital Bangalore, said, “Impairment of vision
threatens ones ability to be physically or financially self-sufficient. Read
More…
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International News - October 2011
Boehringer Ingelheim and Eli Lilly announce Expansion of Strategic
Diabetes Alliance
Boehringer Ingelheim India and Eli Lilly India (Lilly) announced that they are
entering into an agreement specific to India to co-promote a portfolio of
diabetes compounds currently either in late-stage development or on the
market. The collaboration includes Boehringer Ingelheim’s oral anti-diabetic
agent, Linagliptin, not yet approved for marketing in India and Lilly’s insulin
analogue, Humalog (Lispro), which is already on the Indian market.
Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor discovered by
Boehringer Ingelheim and developed as an oral once-daily single dose tablet
for the treatment of Type 2 diabetes. It is already approved in the United
States, the European Union and Japan, among other countries. The alliance
will leverage the collective scientific expertise and business capabilities of two
leading research-driven pharmaceutical companies to address patient needs
arising from the growing global diabetes epidemic. Read More…
Teva, Cephalon get European approval on merger
Teva Pharmaceutical Industries Ltd. has reportedly said that the company
has received approval from the European Commission to proceed with its
buyout of Cephalon. According to reports, as part of the process, Teva must
divest Cephalon's right to market generic modafinil in France. The deal is
expected to close Friday. The Israeli drugmaker also has to grant the
purchaser of the authorisation "certain additional rights with respect to the
entire European Economic Area, including a covenant not to sue effective as
of October 2012", added reports.
Roche sales off 13% in Swiss francs; confirms view
Roche Holding sales reportedly totalled 31.49 billion Swiss francs ($35.1
billion) in the first nine months of the year, which was flat on constant
exchange rates, but a 13% fall in Swiss francs and a 6% rise in U.S. dollars
against the year-ago period. According to reports, excluding Tamiflu, ninemonth sales rose to CH31.19 billion. "Roche's solid sales performance in the
third quarter is in line with our expectations. We're on track to achieve our
targets for 2011. Roche is targeting core earnings-per-share growth of
around 10% at constant exchange rates for 2011. It aims to grow the
dividend in line with core EPS growth and at least maintain last year's
dividend in Swiss francs, added reports.
Abbott to split into two companies
Abbott announced that it plans to separate into two publicly traded
companies, one in diversified medical products and the other in researchbased pharmaceuticals. The diversified medical products company will consist
of Abbott's existing diversified medical products portfolio, including its
branded generic pharmaceutical, devices, diagnostic and nutritional
businesses, and will retain the Abbott name. The research-based
pharmaceutical company will include Abbott's current portfolio of proprietary
pharmaceuticals and biologics and will be named later. Both companies will
be global leaders in their respective industries.
"Today's news is a significant event for Abbott, and reflects another dynamic
change in our company's 123-year history, strengthening our outlook for
strong and sustainable growth and shareholder returns," said Miles D. White,
chairman and chief executive officer, Abbott.
Abbott's proprietary pharmaceutical business has delivered market-leading
performance with a sustainable mix of products and built a strong pipeline of
proprietary medicines through internal discovery, in-licensing and
collaboration efforts. Abbott also has leadership positions in its diversified
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businesses, including established pharmaceuticals, nutritionals, diagnostics,
and vascular devices, where the company is now the global leader in
interventional cardiology. Read More…
Novartis to curb jobs: reports
Novartis reportedly launched a major job and cost cutting program as the
Swiss pharma giant reported a weaker-than-expected 7.9% rise in thirdquarter net profit, as last year's multi-billion dollar acquisition of eye care
company Alcon only partly offset the impact of the strong franc.
According to reports, the company said that the net profit for the three
months to the end of September rose to $2.46 billion from $2.28 billion a
year-earlier, missing market forecasts of $2.81 billion due to the franc's
strength and drug price cuts. Novartis said it is responding with a costcutting program that will see the loss of around 2,000 positions, mostly in
the U.S. and Switzerland, and the closure of two sites in Switzerland and one
in Italy.
The measures are scheduled to be occur over the next three to five years.
Novartis had around 120,000 full-time associates at the end of 2010, added
reports.
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Domestic News - November 2011
GlaxoSmithKline reaches agreement to resolve US probes
GlaxoSmithKline plc (GSK) has announced that it has reached an agreement
in principle with the US Government to conclude the Company’s most
significant ongoing Federal government investigations, specifically: the
investigation into GSK’s sales and marketing practices begun by the US
Attorney’s office of Colorado in 2004 and later taken over by the US
Attorney’s Office of Massachusetts;
the U.S. Department of Justice’s
investigation of possible inappropriate use of the nominal price exception
under the Medicaid Rebate Program;
and the Department of Justice’s
investigation of the development and marketing of Avandia.
The final settlement, which is expected to address civil and criminal liabilities,
remains subject to negotiation of specific terms and is expected to be
finalised in 2012.
The settlement of $3 billion is covered by existing
provisions and GSK expects to make payments under the final agreement in
2012. These payments will be funded through existing cash resources. Read
More…
Sun Pharma announces USFDA approval for generic Cardizem CD
Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its
subsidiary an approval for its Abbreviated New Drug Application (ANDA) to
market a generic version of Cardizem CD, Diltiazem HCl extended-release
capsules. These generic Diltiazem HCl extended-release capsules, are
equivalent to Valeant International’s, Cardizem CD, 120 mg, 180 mg, 240
mg, 300 mg and 360 mg. Annual sale in the US for these strengths is
approximately $ 300 million. Diltiazem HCl extended-release capsules are
indicated in the treatment of hypertension, for the management of chronic
stable angina and angina due to coronary artery spasm.
Fortis Healthcare to acquire Fortis Healthcare International for
US$665mn
Fortis Healthcare India Ltd. said on Tuesday that it would acquire Fortis
Healthcare International Pte. Limited, Singapore for US$665mn. Fortis
Healthcare International Pte. Limited has sales of ~US$500mn, according to
reports. The consolidated debt of Fortis Healthcare India would be US$1bn
post the acquisition of Fortis Healthcare International Pte. Limited. The Board
of Directors of the Company at its Meeting held on November 01, 2011, has
approved the valuation of US$ 665 Million, for consolidation of Fortis
Healthcare International Pte. Limited, Singapore with Fortis Healthcare
(India) Limited.
Lupin receives tentative FDA Approval for generic Combivir Tablets
Pharma Major, Lupin Limited announced today that its U.S. subsidiary, Lupin
Pharmaceuticals, Inc. (LPI) has received tentative approval for its Lamivudine
and Zidovudine Tablets, 150 mg/300 mg. from the United States Food and
Drugs Administration for the Company’s Abbreviated New Drug Application
(ANDA) to market a generic version of Combivir Tablets, 150 mg/300 mg of
ViiV Healthcare. Lupin’s Lamivudine and Zidovudine Tablets are the AB-rated
generic equivalent of Viiv Healthcare’s Combivir® Tablets, 150 mg/300 mg.
Lamivudine - Zidovudine is a combination of two nucleoside analogue reverse
transcriptase inhibitors and is indicated in combination with other
antiretroviral agents for the treatment of HIV-1 infection. Combivir Tablets,
150 mg/300 mg had annual U.S sales of approximately US$ 295 million for
the twelve months ending June 2011 (IMS Health sales data).
Parabolic Drugs gets Japanese nod for Cephalosporin Drugs
The Company has received an official accreditation from Japan's ministry of
Health, Labour and Welfare, enabling it to manufacture and supply
Cephalosponn non sterile drugs to the Japanese market. The 5-year
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accreditation has been awarded to PDL's manufacturing site at Derabassi in
Punjab and is in accordance with Article 13-3 of the Pharmaceutical Affairs
Act, which classifies Parabolic Drugs as a certified foreign drug manufacturer.
Japan, the second single largest drug market in the world is also a leading
nation in terms of pharma research, technology, machinery and medical
research and is valued at USD 107 billion in 2010. The Japanese certification
denotes the Company's technical capability in the non-sterile market and also
differentiates it from many of its competitors. Read More…
Aamby Valley City wins 7th Hospitality India International Award
It has certainly been a year of awards and recognition for Independent India’
first planned hill city “Aamby Valley”. Recognized for its finest of luxuries and
the rarest of pleasures that are exquisitely assembled for the delight and joy
of its patrons, Aamby Valley City has achieved another milestone by winning
the two most prestigious awards at the 7th Hospitality India International
Award. Vivek Kumar, CEO Aamby Valley City set a new benchmark by
achieving the Best Tourism Destination 2011 award for Aamby Valley City
and being honoured with Best CEO 2011 award.
The revered award has increased their drive to perform manifolds. With
these encouraging words from their leader and benevolent mentor to inspire
the team at Aamby Valley City, the city shall outshine all expectations and
have many more such laurels to its name.
GE Healthcare set to revolutionize imaging of live cells
Applied Precision Inc., a GE Healthcare company, today announced the
launch of DeltaVision OMX Blaze, a research microscopy system designed to
reach the next level in the evolution of super-resolution imaging by
employing a proprietary, ultra-fast, illumination module and the latest
advanced high-speed camera technologies. The new DeltaVision OMX Blaze
system’s speed of image acquisition enables researchers to follow tagged
proteins within the same living cell, over time, in three-dimensional space, at
near molecular resolution. This makes it possible to start answering new
kinds of research questions about how certain structures in cells behave,
what they interact with, and how long the events last. Paul Goodwin, Director
of Advanced Applications, API, said, “It’s a pretty extraordinary feeling, to
see moving images of live cells at a greater level of detail than anyone has
witnessed before. The implications of this advance in imaging technology are
hugely exciting for researchers. With the OMX Blaze we can start to answer
questions that we never could before.” Dr Amr Abid, General Manager of Cell
Technologies, GE Healthcare Life Sciences, said, “We are only at the
beginning of what this technology can do. The ability to follow cellular
interactions, over time at the molecular level will open up new frontiers in so
many areas of life science research. This is a hugely important step forward
for cellular imaging.”
Researchers at the UC Davis-based Center for Biophotonics Science and
Technology (CBST) collaborated early as beta testers for the technology. The
system is also being installed at a number of early adopter sites around the
world which are expected to go live in the next two months.
Dr Frank Chuang, Associate Research Director, CBST, said, “We’re at the
point where we need to understand mechanisms of health and disease at the
molecular level. The OMX Blaze has tremendous potential as a research tool,
and we are very excited to apply this in our laboratory models to observe the
response of cancer cells to chemotherapy, the cell-to-cell transmission of HIV
and other viruses, and the dynamics of engineered nanoparticles.”
Strides Arcolab gets nod from US FDA for Doxorubicin Injection
Strides Arcolab Ltd's Onco Therapies Ltd. reportedly received approval from
the U.S. Food and Drug Administration for its doxorubicin chemotherapy
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injection. Strides Arcolab Ltd's Onco Therapies Ltd. reportedly received
approval from the U.S. Food and Drug Administration for its doxorubicin
chemotherapy injection. The shares of Strides Arcolab are trading at Rs. 402,
up by Rs. 6 or 1%, as against the previous close of Rs. 395. It had earlier
opened at the day's low of Rs. 394 and high of Rs. 404, stating the volume of
total traded quantity at 0.11 lakh shares on the BSE. as against the previous
close of Rs. 395. It had earlier opened at the day's low of Rs. 394 and high of
Rs. 404, stating the volume of total traded quantity at 0.11 lakh shares on
the BSE.
Uttam Air products launches only Oxygen Plant in Leh
Uttam Air Products, a leading gas manufacturer with an excellent record in
the manufacturing and distribution of medical and industrial gases for over
35 years, recently set up an Oxygen Plant at the Indian army base camp in
Leh, Ladakh. Uttam is the first ever gas manufacturing company in the
country to take up a project in association with DIPAS - a research
organization under the Defence Research & Development Organisation
(DRDO), Min. of Defense, Govt. of India for Ladakh.
At 10,500 feet above the seal level, the environmental conditions in Leh are
hostile with low concentrations of oxygen in air. This often results in hypoxic
situations where due to the lack of oxygen people (often non-natives),
experience loss of consciousness and other insidious and irreversible
consequences such as comatose state and paralysis.
Uttam Air Products is now working closely with Army Research Organization
and has undertaken a project for the Indian soldiers deployed at this height.
The company has set up a plant that offers ‘oxygen enrichment’ facilities. The
plant provides assured high percentage of oxygen under medical supervision
at such high altitudes. In the day to day operability of the plant, oxygen is
produced on site and its regulated transfer in certain pre-specified and
designed rooms or chambers is done. This is done under medical supervision
and with a lot of precision.
The oxygen plant tremendously benefits the Indian army personnel, posted
there, who face medical problems due to lack of natural oxygen. Availability
of such a facility so close to their posts greatly assists the medical staff in
treating them early. According to Mr. Karan Bhatia, Executive Director, Uttam
Air Products, “Uttam Air Products is proud to be the first gas manufacturing
company to establish and operate an oxygen plant at Leh. This is the highest
and one-of-a-kind plant in the world that is helping our India army soldiers at
such great altitudes.”
Strides Arcolab receives US FDA approval for Carboplatin Injection
(Strides) announced that it has received US FDA approval for Carboplatin
Injection 10 mg/ mL packaged in 50 mg/ mL, 150 mg/15 mL, 450 mg/ 45
mL and 600 mg/ 60 mL Multi-dose vials. According to IMS data June'll, the
US market for generic Carboplatin is approximately USD 35 Million.
Carboplatin is part of the Oncology portfolio licensed to Pfizer in January
2010 for the US market and expected to be launched shortly.
Ranbaxy and Daiichi Sankyo step up Community initiatives
Ranbaxy Laboratories Limited (Ranbaxy) and Daiichi Sankyo Company,
Limited (Daiichi Sankyo) today announced their joint community initiatives in
India with the Flag-off of two free Mobile Rural Healthcare Service Vans for
District Dewas in Madhya Pradesh. This is the first CSR programme being
undertaken jointly by the two companies as part of their commitment
towards global social contribution activities.
The Mobile Healthcare Vans were Flagged-off by Mr. Mukesh Chand Gupta,
District Collector, Dewas, in the presence of Guests of Honour, Mr. Anil
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Sharma, Superintendent of Police, Dewas, Dr. Amar Singh Vishnar, Chief
Medical & Health Officer, Dewas, Mr. Akira Toyama, Consul, Consulate
General of Japan, Mumbai and other distinguished guests. Read More…
Birla research and lifesciences launches Nutrinext- Nutraceutical
Range
Rebirth, the branded wellness stores of the Yash Birla Group (YBG) is
introducing the new Nutrinext Nutraceutical Range. These products are 100%
Natural and Vegetarian, hence they have no side-effects, the company
stated. The new range offers 4 distinctive products- Double Action Slimming
Stack, Healthy Heart, Natural Anti-Ageing and Longevity. Double Action
Slimming Stack- The two way action comes from the presence of 2
ingredients- GarciniaCambogia and Camellia Sinensis. GarciniaCambogia
helps increase your body metabolism so that it burns more calories in the
most natural way and Camellia Sinensis gives an anti-fat deposition action by
reducing the conversion of carbohydrates into fats. Read More…
Agada brings Joslin Diabetes Care to Chennai Pioneer in diabetes
care for over 100 years
Agada Hospitals, an upcoming world class Medical Centre promoted by Dr.
Mohan Thanikachalam today announced, that it has tied up with Joslin
Diabetes Centre, Boston, USA to provide the citizens of Chennai with world
class diabetes care and treatment. The Agada Health Care (AHC) is located in
the heart of the city on Dr. Nair road in T. Nagar and will be open to public
from 14th November 2011, which coincides with the World Diabetes Day.
The Joslin Diabetes Center, Boston, USA, is an affiliate of the Harvard Medical
School, Boston. Joslin Diabetes Center is the World’s First and most
respected diabetes care facility. Since its founding in 1898, Joslin Diabetes
Center has helped to revolutionize the diagnosis, treatment and prevention of
diabetes. It is well proven that Joslin’s clinical care and education program
improves the clinical outcomes, reduces hospital admission rates, and cuts
down health care cost. Read More…
Apollo Hospital launches MRI-HIFU for treatment of uterine fibroids
Apollo Hospitals Group today unveiled a breakthrough MRI-guided high
intensity focused ultrasound (HIFU) solution from Philips at its Hospital in
New Delhi. This was announced by Dr. Prathap C. Reddy, Chairman, Apollo
Hospitals Group and Mr. Krishna Kumar, President, Philips Healthcare, India,
here. MRI Guided HIFU offers a non-invasive alternative to the traditional
treatments for uterine fibroids in women. It combines magnetic resonance
(MR) imaging, with high-intensity focused ultrasound (HIFU). The benefits for
women include – no surgery, no radiation, no scar, no anesthesia, quicker
recovery, more precise image guided treatment and only little stress. The
technology has tremendous applications in the non-invasive treatment of
benign and malignant tumors.
Two-Day Symposium on Pediatric Epilepsies held in Hyderabad
Pediatric Epilepsy Society, Hyderabad and Department of Neurosciences,
Krishna Institute of Medical Sciences (KIMS) jointly organised a Two-Day
Symposium on Pediatric Epilepsies held in Hotel Taj Deccan on Saturday and
Sunday in city. The two day meet was attended by 230 International Faculty
from USA, Japan, England, Europe and Pediatricians and Neurosurgeons from
across India.
Pediatric epilepsy is epilepsy, a disorder characterized by recurrent seizures,
which occurs in a young patient. There are several potential causes of
seizures and epilepsy in children.
The objective of the meet according to Dr. Alladi Venkatesh, Founding
President of Pediatric Epilepsy Society, was to discuss epidemiology, genetics
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and classification of childhood epilepsies. Also to discuss the state-of-the-art
diagnostic and treatment approaches in epilepsy. Also to review medical,
surgical treatment strategies that affect epilepsy outcomes in children. The
symposium was an attempt to bring the latest in research and developments
in the specialised filed of Pediatric Epilepsy for common good. And to support
doctors and to treat and benefit patients using the latest edge of scientific
progress. The symposium helps doctors to keep abreast of the latest
developments in their area of specialisation.
The major focus of the symposium was to create awareness that if the
Pediatric Epilepsy cannot be cured by medicines, it can be cured by surgery.
Nearly 30% children do not respond to medicines. In such cases Epilepsy
Surgery offers best solution. India adds 5 lakh new Pediatric Epilepsy cases
every year. Nearly 10% of this number can be cured by the surgery,
informed Dr. Manas Panigrahi, Neurosurgeon at KIMS hospital. Not many are
aware of the Epilepsy Surgery. Only 500 kids are operated every year while
there is a need to operate 40 to 50,000 people in the country every year, he
said. Unfortunately there is no awareness. And also infrastructure required
for Epilepsy Surgery is also not available in many hospitals.
Lupin acquires I'rom Pharmaceuticals
Pharma Major Lupin Limited (Lupin) announced that its Japanese subsidiary,
Kyowa Pharmaceutical Industry Co., Ltd. (Kyowa), has entered into an
agreement with I’rom Holdings Co,, Ltd. (IH), an integrated Japanese
healthcare provider, to acquire up to 100% of the outstanding shares of its
subsidiary I'rom Pharmaceutical Co., Ltd (IP). Established in 1947, IP is a
specialty injectables company headquartered in Tokyo. For the fiscal year
ended March 2011, IP recorded sales revenues of JPY 5,361 Million. IP has a
significant presence in the DPC hospitals within Japan. Injectable products
enjoy a significant usage in the DPC Hospital segment, and generic injectable
penetration is slated to grow significantly in future. There are currently over
1,400 DPC hospitals in Japan, covering over 35% of all hospital beds
nationwide, and a market size of USD 11 Billion. Read More…
Indian Pharma bets high on US oral contraceptive market: reports
The pharmaceutical companies of India are reportedly betting high on the
American Oral Contraceptive (OC) market. Apart from Glenmark, Sun
Pharma and Lupin are set to tap part of the $4.5-billion US market for OCs,
through new generic versions. Nilesh Gupta, group president and executive
director, Lupin, was quoted as saying “Though the first of the OC products off
the block, the generic version of Nor-QD tablets, is a small one, with
estimated sales of $52 million for the year ended June 2011, Lupin has built
a 30-product OC pipeline for the US market. We could very well look at $100million in revenues over the next three years from our OC pipeline.” Lupin
had set up a dedicated OC facility in Indore, inspected and certified by the US
FDA as early as November 2009. Indian pharma companies with generic
products would do well to focus on high growth and value therapeutic
segments to be successful in the developed markets, added reports.
Glenmark Pharma forays into cosmeceutical segment
Glenmark Pharmaceuticals Ltd has announced its foray into the high-end
cosmeceutical segment in India with the launch of Canadian Company
Immanence-IDC'S scientific and sophisticated anti-ageing product line in
India. The company recently entered into a ten-year agreement with
Immanence-IDC to distribute the Canadian company high-end dermatology
products in 8 countries. Rajeev Sibal, Senior Vice President, Glenmark
Pharmaceuticals observed
“Our foray into cosmeceuticals will significantly
enhance Glenmark’s dermatology product offerings and will further
consolidate our leadership position in the segment. IDC products are based
on strong scientific foundation and we are proud to offer the advanced
cosmeceutical line to our wide network of cosmetologists and dermatologists
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across the country.” He added “Through the CosmoCare division, we aim to
be a leading player in the cosmeceutical space and one of the most
recommended brands by cosmetologists and dermatologists in India.” Read
More…
Fortis announces new hospitals in Hyderabad and Agra
Fortis Healthcare (India) Ltd. announced the launch of two hospitals, in
Hyderabad and Agra. Continuing its aggressive growth in India, Fortis
Healthcare has increased its India network to 68 hospitals. The superspeciality hospital in Hyderabad with a 150-bed capacity will be functional in
FY 2013 and is the second project from the company in the city, the first
being a tertiary care hospital with a 450-bed capacity, which is expected to
be operational end 2013. The hospital in Agra will initially function as a
Cardiac Care Centre, in a hub and spoke model, and expand eventually to
become a multi-speciality hospital. The 75-bed hospital will be operational by
the end FY2012. Speaking of expansion plans, Aditya Vij, Chief Executive
Officer, Fortis Healthcare (India) Ltd. said, “These two new projects are in
line with our commitment to increasing the network and making quality
healthcare accessible across the country. We are currently present in 17
Indian states and will continue to expand to newer geographies, while
strengthening our presence and increasing bed-capacity in existing cities and
states.”
…Fortis Healthcare CFO quits
Indian vaccine market reaches US$900mn
India has made a significant contribution to Vaccine development. Speaking
at the opening ceremony of International Vaccine Symposium here at
Surajkund, Dr Ashwani Kumar, Minister of State for Science and Technology,
and Earth Sciences said, India produces 60 percent of the world’s vaccines
and account for 60-80 percent of annual UN vaccine purchases. Several
Indian vaccine manufacturers are WHO pre-qualified.
The current Indian vaccine market is estimated at around $ 900 million and
targets $4.6 billion revenue by 2017. It is poised to grow 23% during 20112012. Vaccines are the most cost-effective public health products known to
us. And they are means to prevent or the potential to develop preventive
solutions. Every year, about eight million children globally never make it to
their fifth birthday that can be saved with vaccines. Read More…
Experts recommend banning of OTC sale of second line of TB drugs
Senior Government officials from the Central TB Control Division,
Government of India, today heard strong recommendations from pediatric
TB experts,on screening for TB to be done at the child health programme
level, for timely detection of children living with TB. Speaking at the function,
Ms. Rashmi Singh, IAS, Executive Director, National Mission On
Empowerment of Women, Ministry of Women and Child Development ,
Government of India , said that early diagnosis is critical and there is a lot of
apathy even among the community when it comes to timely treatment for
women and children. She also recommended a multi - pronged approach to
fighting pediatric TB pointing out that," Can any one strategy work in a
segmented manner. We need to work together,no one Ministry or NGO can
tackle the issue" . Ms. Singh also highlighted the role of personalised model
of communication and said that the Anganwadi workers and ANMs( Auxillary
Nurse Midwives) are being trained to look out for signs of Pediatric TB to
ensure early diagnosis of TB. Read More…
Protest at Dr Reddy's Srikakulam unit affects its production: reports
Dr Reddy's Laboratories production was reportedly hit at Srikakulam unit for
the past 3-4 days as some workers are on a strike. According to reports,
employees and workers in all the 13 production blocks are on strike, which
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has left the productions affected. The production is made based out of
orders.
Venus Remedies receives Market Authorisation for Meropenem in UK
& New Zealand
Venus Remedies, a leading research based global pharmaceutical company
has received approval for Market Authorisation from MHRA (UK) via DCP
route (which covers Ireland, Poland, Slovenia, Netherlands, Finland, Austria,
Slovakia, Denmark, Germany, Sweden, France and Italy also) for its generic
broad spectrum injectable antibiotic carbapenem. The company is all set to
launch this drug soon within this fiscal year. Besides this, Venus has also got
Market Authorisation for the same product from New Zealand's Ministry of
Health. These grants have once again proved Venus Remedies’ R&D
capabilities and its expertise in developing world class products with
regulatory might. Read More…
Strides Arcolab receives US FDA approval for Carboplatin injection
(Strides) announced that it has received US FDA approval for Carboplatin
Injection 10 mg/ mL packaged in 50 mg/ mL, 150 mg/ 15 mL, 450 mg/ 45
mL and 600 mg/ 60 mL Multi-dose vials. According to IMS data June’11, the
US market for generic Carboplatin is approximately USD 35 Million.
Carboplatin is part of the Oncology portfolio licensed to Pfizer in January
2010 for the US market and expected to be launched shortly.
Suven Life Sciences presents pre-clinical data of their NCEs at SFN2011
Suven Life Sciences Is presenting several data presentations from their
portfolio of Investigations! neuroscience new chemical entitles (NlCEs) at SFN
2011 from 13 'Mo 16th of Nov held at Washington DC, USA. Neuroscience is
the annual meeting of the Society for Neuroscience (SFN) and more than 30
thousand Neuro- Scientists from all over the world covering all the major
Pharma, biotech and research institutes will be participating. Suven's nine (9)
data presentations covers the early-stage compounds from Histamine-3
receptor antagonist, Nicotinic acetylcholine alpha-4-beta-2 receptor agonist
and antagonist, Serotonin 5-HT4 receptor agonist in addition to 5HT6
antagonists to treat unmet medical needs of patients living with cognitive
dysfunction associated with Alzheimer's, Schizophrenia, ADHD; Depression &
Mood Disorders and Neuropathic Pain. These data presentation highlights
Suven's continued commitment to exploring new treatment options
addressing unmet medical need through novel mechanisms and targets and
address a market size of more than $30 billion. During SFN-2011 Suven lined
up several face to face meetings with major Pharma and Biotech companies
to explore integrated collaborative research programs (CRP) and also Drug
Discovery and Development Support Services (DDDSS) in addition to
continued discussions with global pharma majors regarding their clinical
candidate SUVN-502. Suven is committed to neuroscience research and for
development of new treatments for neurological disorders. Suven's discovery
research focuses on Central Nervous System (CNS) disorders through novel
mechanisms using small-molecule medicinal chemistry approaches. Suven's
CNS drug discovery scientists at Hyderabad, India are pursuing innovative
ways to develop treatments for a variety of CNS disorders like Alzheimer's,
Schizophrenia, Depression, Cognitive disorders, Sleep, Neurodegeneration
and Obesity through CNS targets.
Mughda Godse launches Aditya Birla Hospital’s new Cosmetology
department
A person attending the conference shared, "12 years back, my daughter due
to skin problem wasn't getting a boy for marriage. After seeing her, they use
to ask for dowry. It was a case of depression for my family and her. We went
to a cosmetologist, who treated her on concessional rate. We went for 500
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seating’s and the end result was excelled. As guaranteed by the doctor she
was married without a dowry within 6 months." He further added, "Making
this kind of advanced technology available in India, gives an opportunity to
all those girls who are not getting married for some skin, facial problem. The
Cosmetology Department is the most sophisticated liposuction unit located at
the Chinchwad unit of Aditya Birla Memorial Hospital. Dr. Hitesh Laad, an
expert known for his skills in cosmetology is the in-charge of the
Department. He is being supported by a team of efficient and highly trained
doctors for the facility. He shares, “At this department we provide the most
sophisticated service to people; we use the power assisted Liposuction
System which is as per U.S. standards. This advanced technology is used for
augmenting the body such as body contouring (removing fat from unwanted
parts of body and putting in the desired part). It has sectional co2 laser and
advanced diode laser which is used for facial rejuvenation – like wrinkles
around the eyes, acne scars hair removal from unwanted parts of body.
Pigmented lesions on the face can also be corrected.” He further added that,
“We have planned the most advanced and sophisticated department. There
are many people who are not satisfied with the services provided to them at
other places and are looking for good doctors. We give services in the most
scientific way to those who are looking for the best.”
IDMA to celebrate Golden Jubilee in January
Indian Drug Manufacturers’ Association (IDMA) will be celebrating the
completion of 50 Glorious Years in January 2012. Accordingly the 50th
Annual Day Golden Jubilee Year Celebrations will be held on 6th & 7th
January 2012 at Hotel Intercontinental – The Lalit, Sahar Airport Road,
Andheri (East), Mumbai. In its Golden Jubilee 50th year IDMA carried out
many activities in co-ordination with and support of all our State Boards and
Members. The activities included CSR initiatives such as free Healthcare and
Medical Camps in Mumbai where over 2000 needy people benefitted and
were provided the required medicines free of cost. We also organized an All
India Mega Blood Donation Drive on 14th June 2011 with over 75 camps all
over India to mark ‘World Blood Donation Day’, and over 6300 bottles of lifesaving blood were collected by the blood banks.
Other initiatives that have been undertaken on a Pan India basis are
supporting ‘No Tobacco Day’, ‘Save the Girl Child Campaign’, free Medicines
worth about Rs. 1.5 crores provided to BPL families in Himachal Pradesh,
‘CME programmes for Doctors’ etc. We have also conducted various
Seminars, Conferences, Workshops, Exhibitions, Table Top Exhibitions and
Training Programs to promote and support the Indian Pharmaceutical
Industry. This year at the 50th Golden Jubilee Annual Day Celebrations, we
have invited Eminent National and International personalities to address our
Members over two days. We will also be recognizing Top Achievers in the
Indian Pharmaceutical Industry, who have made India Proud and respected
world over as providers of affordable quality medicines. As part of the Annual
Celebrations, the winners of Best Patent Awards, Gold & Silver Quality
Excellence Awards, the IDMA J B Mody Awards and Indian Drugs Best Review
Article and Research Awards will be announced and the Awards would be
presented. Your Association has come a long way and many milestones have
been met in the last 50 years. We are sure you will be a part of the Golden
Jubilee Year celebrations.
Ranbaxy climbs on Lipitor settlement buzz
Ranbaxy shares gained amid reports that it may get approval from the US
Food and Drug Administration (USFDA) to sell copies of Pfizer's Lipitor as
early as next week. Ranbaxy and the American authorities are inching toward
a settlement over the Indian company's regulatory troubles in the world's
largest drug market, according to a business daily. Ranbaxy might shell out
US$350 to US$400mn as a penalty and settle its outstanding issues with the
USFDA. According to an agreement between Pfizer Inc. and Ranbaxy, the
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Indian company can launch its version of Lipitor on November 30, 2011. In
2008, the USFDA had banned Ranbaxy from selling 30 drugs and stopped
approving fresh products from its two Indian plants citing violation of US
manufacturing practices. Pfizer earns around US$6bn from Lipitor sales in the
US, and Ranbaxy is expected to garner US$500-600mn during the six-month
exclusivity period.
Dr Reddy's requests govt to denotify Medak SEZ: reports
Dr Reddy’s Laboratories (DRL) has reportedly urged the government to
denotify its Special Economic Zone (SEZ) at Medak in Andhra Pradesh.
Umang Vohra, chief financial officer, DRL was quoted as saying “We have
requested for denotification of entire SEZ (in Medak). We are locating both
our SEZs close together (at Visakhapatnam). Having an API unit at one place
and formulation unit at another place complicates the whole matter.” Reports
stated that DRL has given an undertaking to the commerce ministry for
refunding the duty benefits availed of in the name of SEZ and the
development commissioner of VSEZ has recommended the proposal. The
company is expected invest around $200mn in both the SEZs and the SEZ
land, after denotification, will be used for other expansion plans, added
reports.
…Strike at Dr. Reddy's Labs AP factory called off
Strides Arcolab gets 2 more USFDA approvals for Oncology products
(Strides) today announced that it has received approvals from USFDA for:
Carboplatin Injection 10 mg/ mL (Aqueous solution), packaged in 1000
mg/100 mL, Pharmacy Bulk Packages.
Oxaliplatin for Injection USP (Lyopholized) packaged in 50 mg and 100
mg single-use vials (Tentative approval)
The Company had earlier received approval for Carboplatin Injection 10 mg/
mL packaged in 50 mg/ 5 mL, 150 mg/ 15 mL, 450 mg/ 45 mL and 600 mg/
60 mL Multi-dose vials. According to IMS data, the US market for generic
Carboplatin is approximately USD 35 Million. Carboplatin is part of the
Oncology portfolio licensed to Pfizer in January 2010 for the US market and
expected to be launched shortly. The Company also received tentative
approval for additional strength of Oxaliplatin Injection.
According to IMS data, the US market for Oxaliplatin is approximately USD
1.4 Billion. The Company had earlier received tentative approval for
Oxaliplatin Injection, 5 mg / mL, packaged in 50 mg / 10 mL, 100 mg/ 20
mL, and 200 mg/ 40 mL single dose vials. While other generic Companies
approved for this product are expected to launch the product in August 2012,
Strides will issue further updates on this product in April 2012.
Transgene Biotek to sell technology for rh-EPO for US$5mn
Transgene Biotek Ltd, one of the fastest growing biotechnology companies in
India announced the sale of technology for recombinant human
Erythropoietin (rh-EPO) to TSS EXPORT GmbH FZE, one of the group
companies of the TSS Group for US$5.0 million. The technology transfer and
sale of this technology is expected to be completed during a period of
approximately 5-6 months.
Transgene Biotek Ltd has made headlines in recent years for having outlicensed two of its technologies - including a recombinant Hepatitis B Vaccine
to one of the largest vaccine producers in the world, and more recently
Orlistat to one of the biggest Indian pharma companies with a significant
presence on the global arena.
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Speaking to us about the transaction Dr. K.K.Rao, Managing Director,
Transgene Biotek Limited said “This transaction fulfills the pledge we made
earlier this year to focus on revenue generation whilst monetizing the sale of
underutilized Bio-generic drug assets; those developed by the company
during the last 7-8 years but which we now feel do not fit into our new
agenda for sustained growth” Read More…
UBM announces CPhI India 2011
UBM India, a part of UBM plc. a leading global business media company, will
host CPhI India, the largest and most comprehensive pharmaceutical event
in South Asia, from 30th November to 2nd December ‘11 at the Bombay
Exhibition Centre in Mumbai, India. Focused on pharmaceutical ingredients,
CPhI India will be joined by co-located events: P-MEC India for
pharmaceutical equipment, machinery and technology; ICSE India for
contract services, clinical trials; and CRO and the BioPh track for the
biopharma market.
Catering to all sectors in the pharma industry, both domestic and
international and with 825 exhibitors from 21 countries, this year’s CPhI and
its co-located events will offer attendees a dedicated platform to network
with key decision makers in the global and Indian pharmaceutical industry,
connect with existing partners and facilitate serious business deals.
“With the Indian pharmaceutical market growing at 13% annually, twice of
the world market growth rate, CPhI India and its co-located events have
been geared to deliver significant return on investment (ROI) for pharma
professionals who are currently working with or looking to establish
relationships with Indian pharmaceutical companies, commented Sanjeev
Khaira, MD, UBM India. Read More…
Global Hospitals & Health City to conduct Master Class in Liver
diseases
The stage is set for the major international conference at Chennai between
2nd – 4th Dec 2011. The World renowned liver transplantation surgeon Prof.
Mohamed Rela, Global Hospitals & Health city spearheads this international
liver conclave as course director with eminent international & national
faculties. MASTER CLASS IN LIVER DISEASES is first of its kind, 3days
scientific conference, incorporating Histopathology along with Clinical
aspects of Liver diseases & Transplantation, which will give the audience a
holistic and indepth understanding of liver diseases.
International Faculties include, Prof. Bernard C. Portmann, Dr. Alberto
Quaglio, Prof. Elwyn Elias, Prof. Diedre Kelly, Prof. S. Wali, Prof. Ashley
D’Cruz, Prof. Abid Suddle, Prof. Jack Lake, Prof. Julia Wendon, Prof. Nigel
Heaton and Prof. Anil Dhawan amongst many national faculties. Read More…
GVK Biosciences presents Frost & Sullivan Growth Leadership Award
GVK Biosciences , Asia’s leading drug discovery research and development
organization, announced that it was awarded the Frost & Sullivan 2011 Best
Practices Award for Growth Leadership in the Contract Research Services
Market. The Frost & Sullivan Award for Growth Leadership is presented to the
company that has demonstrated excellence in capturing an impressivegrowth
rate. GVK BIO is a notable growing Contract Research Organization; the
Growth Leadership Award is a prestigious recognition of GVK
BIO’saccomplishments in the Contract Research Service Market. With over
ten years of experience and with more than 2000 employees, GVK BIO offers
a spectrum of stand- alone and integrated services across the life Sciences
R&D value chain.
“GVK BIO has skilfully forward and upward integrated its service portfolio in
sync with the changing pharma & biotech environment. Their recent
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milestones in discovery validate GVK BIO's ability and leadership in discovery
programs.”
quoted Dr Ajaykumar Sharma, Frost & Sullivan's Industry
Manager - Pharma and Biotech. Read More…
Ranbaxy wins USFDA nod for generic Lipitor
Ranbaxy Laboratories Ltd. has finally received a green light from the US Food
and Drug Administration (USFDA) to launch its copy of Lipitor. Lipitor is
Pfizer’s cholesterol-lowering blockbuster medicine. Lipitor's US sales for the
12 months ended Sept. 30 were US$7.8bn, according to data provider IMS
Health. New York-based Pfizer recorded global sales of US$10.7bn for Lipitor
in 2010. The USFDA said in a statement late on Wednesday that Ranbaxy
would make generic Atorvastatin calcium in 10, 20, 40 and 80 milligram
tablets. The US regulator said that the generic drug would be manufactured
by Ohm Laboratories in New Brunswick, New Jersey.
Earlier, the USFDA withdrew a press statement on the approval, saying it had
been issued in error. Watson Pharmaceuticals Inc. launched an "authorized"
version of Lipitor. Watson said that it had begun shipping the pills, calling it
the largest generic product launch in US history. Arun Sawhney, CEO & MD,
Ranbaxy, said, "Atorvastatin helps millions of Americans manage healthy
cholesterol levels, and we are pleased to have received U.S. FDA approval to
manufacture and market a safe, effective, affordable and accessible
alternative to branded Lipitor. We are committed to continuing to expand our
portfolio of products offered in the U.S. market for the benefit of patients,
prescribers and the U.S. healthcare system." Pursuant to an agreement
between Ranbaxy and Teva Pharmaceuticals USA, Inc., a portion of the
profits from sales of Atorvastatin during Ranbaxy's 180-day first-to-file
exclusivity period will be paid to Teva. Terms of the agreement will not be
disclosed. Ranbaxy is expected to earn US$600-700mn if it manages to sell
the Lipitor generic, exclusively for six months, said some media reports.
Govt committed to provide quality medicines at affordable prices
The Government is committed to make available quality medicines at
affordable prices to the people+. In this context, Jan Aushadhi scheme for
providing generic medicine to maximum number people is important
significant initiative of the Ministry. This scheme needs proper sensitization
and marketing strategy. Inaugurating the 3rd India Pharma Summitt-2011
here today, Srikant Kumar Jena, Minister of State for Chemicals and
Fertilizers said that Indian Pharmaceutical sector has potential to grow in
global market and can play lead role in this sector. He further said that
research and development is important for new innovations in Pharma sector.
He said that the recommendations and deliberation of the Summit will help
stake holders to evolve new ideas and plans in this sector.
The focus of the Summit is to address the key issues, identify challenges and
opportunities in preparing a Roadmap for Global Leadership in Generic
Medicine. The objective of the summit is to offer insight into the challenges
and opportunities to become global leader in generics, address regulatory
challenges in global generics and foster global industry-institutional and
academia linkage in partnership mode for the benefit of all stake holders. On
the occasion, G. Balachandran, Chairman, National Pharmaceutical Pricing
Authority delivered the key note address. A power point presentation on
Pharma Sector was made by. Devendra Chaudhry, JS, Department of
Pharmaceuticals. Dr. Nata Menabde, WHO Representative to India was also
present. Senior officials from Government, representative of leading Pharma
industry and academia of this sector are taking part in this summit.
Draft pharma pricing policy circulated to stakeholders
Patented drugs are not defined in the drugs (Price Control) Order, 1995
(DPCO, 1995). Under the provisions of the DPCO, 1995, prices of 74
scheduled bulk drugs and the formulations containing any of these scheduled
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drugs are controlled. National Pharmaceutical Pricing Authority (NPPA) fixes
or revises prices of scheduled drugs / formulations as per the provisions of
the DPCO, 1995. Anti-cancer medicines are non-scheduled drugs, i.e. not
covered under DPCO, 1995. In respect of non-scheduled drugs,
manufacturers are at liberty to fix the prices by themselves without seeking
the approval of Government / NPPA. Department of Pharmaceuticals has
prepared a draft National Pharmaceutical Pricing Policy 2011 (NPPP-2011)
based on the criteria of essentiality and requirements as stipulated by the
Ministry of Health & Family Welfare. The draft Policy envisages bringing the
National List of Essential Medicines (NLEM) – 2011 and associated medicines
under price control. The draft NPPP-2011 has been circulated among the
concerned Ministries/Stake holders asking them for the feedbank.
CBI issues notices to Dr Reddy’s Laboratories: reports
The Central Bureau of Investigation (CBI) has issued a notice to Dr Reddy’s
Laboratories seeking details of the tax benefits it had availed during the reign
of N Chandrababu Naidu as chief minister in Andhra Pradesh, according to
reports. GV Prasad, vice-chairman and chief executive officer, Dr Reddy’s
Laboratories reportedly said that they have received a letter from the CBI
and have already responded to it. The report stated that CBI notice follows a
public interest litigation filed by YS Vijaya Lakshmi, former chief minister YS
Rajasekhara Reddy’s widow, in the Andhra Pradesh high court on the issue of
amassing of wealth by Naidu.
3 people injured in fire at Aurobindo Pharma unit
Aurobindo Pharma Ltd has announced that there was a fire incident in a
powder processing area at early hours on November 28, 2011 at Unit 11,
which is located at Pydibhimavaram, Srikakulam near Vizag, A.P. Three
persons were injured and they were taken to the hospital. The powder
processing area is isolated from the intermediate block. There was no impact
to the operations as well as to the assets.
Ind-Swift Labs clarifies MD's remarks on Lipitor
Ind-Swift Laboratories Ltd. said that the statement of its Managing Director
N.R. Munjal has been misinterpreted by a business daily. This is with
reference to a news item published in a financial newsaper dated November
30 titled "World’s Best Seller Drug goes off patent today". Replying to a
question, Munjal said that the company was not supplying any intermediate
to Ranbaxy for Atorvastatin drug. The said quote has been misinterpreted as
there was nothing left for Ranbaxy with regards to Lipitor now.
Ranbaxy gets USFDA nod for Mohali Plant: report
Ranbaxy Laboratories Ltd. has reportedly received an approval from the U.S.
Food and Drug Administration (USFDA) for it’s manufacturing plant in Mohali.
Ranbaxy shares declined amid concerns about its near-term business outlook
as the company has not been able to resolve outstanding regulatory issues
with the USFDA, delaying the launch of generic Lipitor in the US market. The
blockbuster drug, which is manufactured and sold by US drug major Pfizer is
going off patent in the world's biggest market. Ranbaxy still has to get final
clearance from the US drug regulator to launch its product in the US market.
Ranbaxy has 180-day exclusivity for launching its copy of Lipitor as it was the
first to challenge the Pfizer patents. As of now there are no clues as to when
Ranbaxy will be able to launch its version of Liptor in the US. The reported
USFDA approval for the Mohali plant might just help the company in its
endeavour. Meanwhile, Watson Pharma announced the launch of an
authorised generic version of Lipitor. Pfizer’s Lipitor generated revenue of
over US$10bn in 2010. The USFDA had blacklisted two of Ranbaxy’s plants in
India - Dewas and Paonta Sahib - in 2008. That led to the banning of 30
drugs while approvals for new ones manufactured at these plants were also
put on hold.
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Global Hospitals organises “Master Class in Liver Diseases”
Global Hospitals Group is organizing a 3 day international liver conclave,
‘Master Class in Liver Diseases’ in Chennai starting 2nd December to 4th
December 2011. This 3 day scientific conference will be spearheaded by the
world renowned Liver transplantation surgeon Prof. Mohamed Rela. Over 30
eminent doctors from USA & Europe and over 300 nationally renowned liver
specialists will be present to demonstrate the current concepts and trends on
liver transplantation across the globe.
MASTER CLASS IN LIVER DISEASES is the first of its kind, a 3 day scientific
conference, discussing various Clinical aspects of Liver diseases &
Transplantation, which will give the Indian audience a holistic and in depth
understanding of liver diseases. International Faculties participating in the
conclave include, Prof. Bernard C. Portmann, Dr. Alberto Quaglio, Prof. Elwyn
Elias, Prof. Diedre Kelly, Prof. S. Wali, Prof. Ashley D’Cruz, Prof. Abid Suddle,
Prof. Jack Lake, Prof. Julia Wendon, Prof. Nigel Heaton and Prof. Anil Dhawan
amongst many other national faculties.
Global Hospitals acknowledged as the world’s most comprehensive centre for
Liver, Pancreas diseases and transplantation offers the largest Liver
Transplant program in the country. The Global Liver Transplant program is
currently available in three centers across South India, Hyderabad, Chennai
& Bangalore and is soon expected to be operational in Mumbai. With all the
facilities and the technical knowhow, Global Hospitals has successfully set
new standards in the management of liver diseases.
The incidence of liver diseases in India is on a rise. Cases related to hepatitis,
liver cirrhosis, liver tumours are being frequently reported. A liver infection is
considered to be a serious medical condition thus it should not be taken
lightly
Honeywell unveils new film for pharma packaging
Honeywell introduced a new pharmaceutical packaging film that provides the
highest moisture barrier of any film of its type. Part of the Aclar family of
films, the new product, Aclar UltRx 6000, is effective at protecting moisturesensitive medicines in all climates, even the hottest and most humid
locations. This allows pharmaceutical companies to standardize their product
packaging with one solution that will work in all regions of the world.
Aclar films, including Aclar UltRx 6000, can also help reduce drug package
sizes by up to 55 percent compared with the alternative, cold-formed foil.
Aclar UltRx 6000 can be used in existing equipment, with only minor
adjustments, that pharmaceutical companies use to thermoform their
packages. Also, like all Aclar films, Aclar UltRx 6000 is clear, allowing
pharmaceutical companies to differentiate their brand by allowing the pill to
be seen through the packaging. “This Aclar film gives pharmaceutical
companies a clear, ultra-high barrier choice for their most moisture-sensitive
drugs sold in the most challenging regions,” said Jeff Czarnecki, global leader
of Honeywell’s health care and packaging business. “This new film will help
pharmaceutical companies around the world protect their medicines, simplify
their supply chains, and improve their branding.”
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International News - November 2011
Gilead Sciences announces New Drug Application to U.S. FDA
Gilead Sciences, Inc.announced today that it has submitted a New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA) for
marketing approval of the “Quad”, a complete single-tablet regimen of
elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate for
the treatment of HIV-1 infection in adults.If approved, the Quad would be
the only once-daily, single-tablet regimen containing an integrase inhibitor.
“We continue to dedicate our HIV research and development efforts to
advancing single-tablet regimens that address important patient needs,”
said Norbert Bischofberger, PhD, Executive Vice President, Research and
Development and Chief Scientific Officer, Gilead Sciences. “Based on data
from our pivotal studies, we believe that the Quad has the potential to be an
important new treatment option for people living with HIV, and we are
pleased to have reached this significant milestone less than six weeks after
the unblinding of the second pivotal Phase 3 study.” Read More…
P&G and Teva Pharma form OTC partnership
The Procter & Gamble Company and Teva Pharmaceutical Industries Ltd.
announced the creation of a new partnership and joint venture (JV) in
consumer health care. The JV, to be named PGT Healthcare, will be
headquartered in Geneva, Switzerland and will operate in essentially all
markets outside of North America. The partnership between P&G and Teva
will also develop new brands for the North American market.
PGT Healthcare, a new model in the industry, will focus on best-in-class
development and state-of-the-art commercialization of branded OTC
medicines. The JV will bring together each company’s complementary
capabilities and existing over-the-counter (OTC) medicines. As a result, PGT
Healthcare expects to accelerate growth for its parent companies and
compete for leadership in the fast-growing, $200 billion consumer health care
industry. The partnership will start from a solid base of approximately $1.3
billion in annual sales with the potential to grow to $4 billion in annual sales
towards the end of the decade. Read More…
Gilead announces positive 5-year data showing effect of Viread
Gilead Sciences, Inc. announced new five-year data from the open-label
phase of two pivotal Phase 3 clinical trials (Studies 102 and 103) evaluating
the efficacy of Viread (tenofovir disoproxil fumarate) for the treatment of
chronic hepatitis B virus (HBV) infection among primarily treatment-naïve
patients. Results show that Viread maintains long-term viral suppression of
HBV and is associated with a reduction in liver fibrosis and a reversal of
cirrhosis. Among patients in both studies, the majority (88%) experienced an
improvement in overall liver histology. Together, these two studies represent
one of the largest datasets evaluating the impact of an oral antiviral therapy
on histologic changes and showing a reduction in liver fibrosis. These findings
are being presented Monday, November 7 at the 62nd annual meeting of the
American Association for the Study of Liver Diseases (The Liver Meeting
2011) in San Francisco. Read More…
Bayer sales in region to grow to well over EUR 11bn by 2015
The Bayer Group plans to further expand its production, distribution network
and research activities in Asia and considerably increase its sales in the
region in the coming years. “We aim to achieve a more than 60 percent
increase in our sales in Asia by 2015,” Management Board Chairman Dr.
MarijnDekkers said on Wednesday at Bayer’s international press conference
“Perspective on Growth in Asia,” held in Shanghai, China. This would mean
annual sales of well over EUR 11 billion by 2015 at today’s exchange rates.
Dekkers officially inaugurated a new production facility for TDI – a raw
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material for the production of flexible foams – at the Bayer Integrated
SiteShanghai.
At the press conference, attended by more than 100 media representatives –
with journalists in India, Vietnam and Indonesia participating via live video
link – Dekkers explained the company’s perspectives in the emerging
countries of Asia. He said the Bayer Group already does a significant
proportion of its business in Asia. Twenty years ago, Asia accounted for only
about 10 percent of sales, equivalent to just over EUR 2 billion. Ten years
ago, the proportion had grown to about 15 percent, and last year the region
already accounted for some 20 percent of sales. In the Asian region, Bayer
achieved sales of EUR 6.9 billion in 2010, and anticipates further growth in
2011. “We have made capital expenditures of EUR 3.4 billion in Asia over the
past 10 years, creating a basis for outperforming market growth in this
region,” said Dekkers.
Bayer has laid a firm foundation for expansion. “Our country organizations
here have had local roots for many years, in fact we have been operating for
more than a century in India, Chinaand Japan,” said Dekkers. “We are
familiar with the markets, and we know how to tune our approaches to the
different conditions prevailing in different markets in order to further expand
our business.”
Gilead Sciences to acquire Pharmasset, paying sizable premium in
$11bn deal
Gilead Sciences, Inc. and Pharmasset, Inc. announced today that the
companies have signed a definitive agreement under which Gilead will
acquire Pharmasset for $137 per share in cash. The transaction, which values
Pharmasset at approximately $11 billion, was unanimously approved by
Pharmasset's Board of Directors. Gilead plans to finance the transaction with
cash on hand, bank debt and senior unsecured notes. The company expects
the transaction, when completed, to be dilutive to Gilead's earnings through
2014 and accretive in 2015 and beyond. Further guidance will be provided
when the transaction closes, which is expected to be in the first quarter of
2012.
Pharmasset currently has three clinical-stage product candidates for the
treatment of chronic hepatitis C virus (HCV) advancing in trials in various
populations. The company's lead product candidate, PSI-7977, an
unpartnered uracil nucleotide analog, has recently been advanced into two
Phase 3 studies in genotype 2 and 3 patients. Both studies will utilize 12
weeks of treatment with PSI-7977 in combination with ribavirin. One study
will compare this all-oral regimen against 24 weeks of the standard-of-care
pegylated interferon/ribavirin in treatment-naÃ¯ve patients, and the second
study will compare the all-oral regimen to placebo in interferonintolerant/ineligible patients. A third Phase 3 study in genotype 1 patients will
be initiated in the second half of 2012, the design of which is dependent on
the outcome of Phase 2 studies which are evaluating PSI-7977 in various
combinations in genotype 1-infected patients. If successful, this strategy
could lead to an initial U.S. regulatory approval of PSI-7977 in 2014. PSI938, an unpartnered guanosine nucleotide analog, is being tested in a Phase
2b interferon-free trial as monotherapy and in combination with PSI-7977 in
subjects with HCV of all viral genotypes. Mericitabine (RG7128), a cytidine
nucleoside analog, is partnered with Roche and is being evaluated in three
Phase 2b trials. Roche is responsible for all aspects of the development of
mericitabine. Read More…
Pfizer to acquire Excaliard Pharmaceuticals
Pfizer Inc. and Excaliard Pharmaceuticals, Inc. announced today that they
have entered into a definitive agreement under which Pfizer will acquire
Excaliard, a privately owned biopharmaceutical company focused on
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developing novel drugs for the treatment of skin fibrosis, more commonly
referred to as skin scarring. The acquisition is expected to close before the
end of the year. Excaliard’s lead product, EXC 001, an antisense
oligonucleotide in phase 2, is designed to interrupt the process of fibrosis by
inhibiting expression of connective tissue growth factor (CTGF). CTGF is a
growth factor that can be over expressed in damaged skin or tissue following
surgery or traumatic injury and lead to disfiguring skin scarring. The phase 2
program for EXC 001 has thus far produced positive clinical results in
reducing scar severity. Upon completion of the acquisition, Pfizer plans to
continue development of EXC 001 to address unmet medical needs in patient
groups who suffer from excessive skin scarring. Currently, there are no FDAapproved products to reduce scar severity. “The acquisition of Excaliard is
part of our corporate research and development strategy to actively
complement our robust internal project pipeline with innovative and
differentiated drugs from biotech partners,” said Mikael Dolsten, president,
Worldwide Research and Development, Pfizer. Read More…
Merck to settle US Vioxx charge for US$950mn
Merck known as MSD outside the United States and Canada, announced it
has reached a resolution with federal and state authorities regarding a
previously disclosed investigation concerning Vioxx. Merck voluntarily
withdrew Vioxx from the market in September 2004. The company previously
recorded a charge of US$950mn in October 2010 in anticipation of today's
agreements. Under civil settlement agreements signed with the United States
and individually with 43 states and the District of Columbia, Merck will pay
approximately two-thirds of the reserved charge to resolve civil allegations
related to Vioxx. As a result, the United States and the participating states
have released Merck from civil liability related to the governments'
allegations regarding the sale and marketing of Vioxx in the United States.
Previously disclosed litigation with seven states remains outstanding. The
civil settlement does not constitute any admission by Merck of any liability or
wrongdoing. "We believe that Merck acted responsibly and in good faith in
connection with the conduct at issue in these civil settlement agreements,
including activities concerning the safety profile of Vioxx," said Bruce N.
Kuhlik, executive vice president and general counsel of Merck.
Merck sends Assistance to flood-ravaged Thailand
Merck KGaA and its Life Science division Merck Millipore have sent thousands
of state-of-the-art water test kits to Thailand in an effort to ensure the safety
of municipal drinking water following months of devastating flooding in that
region. In addition to the product shipment, the company has donated
€110,000 to assist flood victims. “Safe drinking water is a basic human
right,” said Robert Yates, Head of Merck Millipore. “When it became apparent
that public drinking water might be impacted by the floods, we did not
hesitate to send our test kits. It is our collective hope that in some small way
Merck can help the people of Thailand recover from these devastating
floods.”
The Merck Millipore division has shipped more than 10,000 test kit elements
that will be distributed to various Thai organizations, including the National
Metal and Materials Technology Center (MTEC), a member of National
Science and Technology Development Agency (NSTDA); the Ministry of
Science and Technology; and the Samsen office of the Metropolitan
Waterworks Authority. The test kits will be used to detect any evidence of
contamination in the drinking water. Read More…
Lilly provides additional funding to Infectious Disease Research
Institute
Eli Lilly and Company is providing more than $4 million in additional funding
to the Infectious Disease Research Institute. The funding will allow IDRI to
continue its early phase drug discovery efforts focused on identifying new
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and better therapies in the fight against tuberculosis, including multidrugresistant strains known as MDR-TB. In addition, Lilly will provide more than
$1 million in-kind for volunteer time from Lilly scientists and access to the
company's drug discovery expertise, chemical libraries, and research tools.
These additional commitments bring Lilly's total support of early stage TB
drug discovery efforts through IDRI to more than $20 million - and Lilly's
total funding of TB and MDR-TB efforts to more than $170 million.
IDRI is a member of the Lilly TB Drug Discovery Initiative, a not-for-profit
public-private partnership focused on accelerating early stage drug discovery
for potential new treatments for TB. TB and MDR-TB disproportionately affect
people in countries with developing economies. "While preventable and
treatable, nearly 1.5 million people die from TB and MDR-TB every year,"
said John C. Lechleiter, Ph.D., Eli Lilly and Company chairman, president and
chief executive officer. "Today's TB drugs are decades old and must be taken
for extended periods of time, which present challenges for patients and
health care providers. More effective medicines with fewer side effects are
desperately needed." Read More…
FDA Commissioner announces decision on Avastin for Metastatic
Breast Cancer
Roche announced that the FDA Commissioner is revoking the approval of
Avastin (bevacizumab) for the treatment of mBC in the United States. "We
are disappointed with the outcome. We remain committed to the many
women with this incurable disease and will continue to provide help through
our patient support programs to those who may be facing obstacles to
receiving their treatment in the United States," said Hal Barron, M.D., chief
medical officer and head, Global Product Development. "Despite today's
action, we will start a new Phase III study of Avastin in combination with
paclitaxel in previously untreated metastatic breast cancer and will evaluate
a potential biomarker that may help identify which people might derive a
more substantial benefit from Avastin."
Enbrel (etanercept) patent issued
Amgen announced the issuance of U.S. Patent No. 8,063,182 related to
Enbrel (etanercept). This patent is owned by Hoffman-La Roche Inc.
("Roche") and exclusively licensed to Amgen. Immunex Corporation
(acquired by Amgen in 2002) originally licensed this patent application from
Roche in 1999, and in 2004, Amgen paid Roche a one-time payment and
obtained an exclusive, fully paid-up license to the application which issued
today as the '182 patent. The patent describes and claims the fusion protein
that is etanercept, and by statute, the '182 patent has a term of 17 years
from today.
Pfizer completes acquisition Ferrosan Consumer Health's business:
reports
Pfizer Inc. has completed its previously announced acquisition of Ferrosan
Consumer Health's business, which includes dietary supplements and lifestyle
products, from Altor 2003 Fund GP Limited, according to reports. Paul
Sturman, President, Pfizer Consumer Healthcare reportedly said that
Ferrosan Consumer Health's innovative products and geographic footprint are
a strong fit for our business.
AstraZeneca commits an additional $100 million to venture
MedImmune Ventures
AstraZeneca has committed an additional $100 million to its venture capital
arm, MedImmune Ventures, increasing the total capital under management
to $400 million. MedImmune Ventures is an evergreen venture capital fund
that focuses on equity investments in private companies in the areas of
biopharmaceuticals, medical and healthcare technology. "With the additional
funding from AstraZeneca, we look forward to expanding our investment
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activities globally and across therapy areas. We believe that in the current
financial environment, there is a growing role for corporate venture capital
funds such as MedImmune Ventures," said Ron Laufer, Senior Managing
Director, MedImmune Ventures.
Simon Lowth, Chief Financial Officer, AstraZeneca said: "We continue to
support MedImmune Ventures strategy that combines commitment to
advance science and technology in the life science industry while generating
financial returns expected of venture capital funds." Additionally,
AstraZeneca also announced that MedImmune Ventures has co-led the
second round of financing for NeuProtect Pty Ltd, an Australian life science
company specialised in the reduction of cardiac remodelling post myocardial
infarction. Ron Laufer said: "We are delighted to co-lead with Starfish
Ventures a new round of financing for NeuProtect Pty Ltd, our first
investment in an Australian company."
Pradaxa awarded Prix Galien for most innovative product in Canada
Boehringer Ingelheim's breakthrough novel oral anticoagulant Pradaxa
(dabigatran etexilate) was awarded the prestigious Prix Galien in Canada. At
a Gala Ceremony during the Tenth Annual Canadian Health Research Awards
Ceremony in Ottawa, Pradaxa (Pradax in Canada) was recognised as the
most innovative Canadian product in 2011. Pradaxa has now received this
award for the second time, after winning the German Prix Galien in 2010, in
the Primary Care category.
The Prix Galien is awarded for new drugs representing a significant advance
in pharmaceutical research. "We are proud that Pradaxa® has been awarded
the Canadian Prix Galien," says Prof. Dr. Klaus Dugi, Corporate Senior Vice
President Medicine at Boehringer Ingelheim. "The decision by the jury
underlines the outstanding innovation Pradaxa brings for patients and
doctors, providing a much needed advance in stroke prevention in atrial
fibrillation, an area of high therapeutic need."
The approval of Pradaxa in prevention of stroke and systemic embolism in
adults with non-valvular atrial fibrillation (SPAF) was based on data from the
landmark RE-LY trial (Randomized Evaluation of Long term anticoagulant
therapY), a global, Phase III trial of 18,113 patients, enrolled in over 950
centres in 44 countries. 1 Compared to well-controlled warfarin (median time
in therapeutic range (TTR) 67.3%2), the following results were seen with
Pradaxa in the landmark RE-LY trial:(1,2,3)
Pradaxa 150mg bid significantly reduced the risk of stroke and systemic
embolism by 35%, providing clinically important stroke prevention in nonvalvular atrial fibrillation (AF). Read More…
Sanofi Confirms its Decades-Long Commitment to the Fight against
Malaria
Sanofi confirmed today its decades-long commitment to the fight against
malaria at the opening of 10th Edition of the Pan-African Conference against
Malaria. The 10th Edition of this conference gathers together the directors of
34 African National Malaria Control Programs (NMCPs), representatives of the
Global Fund To Fight Aids, Tuberculosis and Malaria, the World Health
Organization, the Roll Back Malaria partnership, and scientific experts.
During his opening ceremony speech, Christopher A. Viehbacher, Chief
Executive Officer of Sanofi declared: "Understanding that drugs are not
enough to win the fight against malaria, Sanofi has undertaken a decadelong strategy of partnership with African National Malaria Control Programs,
to propose solutions beyond existing treatments including prevention and
diagnosis to meet the challenges of the emergence of treatment-resistance
strains. Thanks to these major partnerships combining public and private
actors, as well as non-profit organizations, the elimination of malaria, which
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yesterday seemed utopian, has now become an achievable goal.” Read
More…
Watson Pharma launches generic Lipitor
Watson Pharmaceuticals, Inc. on Wednesday confirmed that Watson
Pharmaceuticals, Inc., has launched an authorized generic version of Lipitor
(atorvastatin calcium tablets) as part of an exclusive agreement with Pfizer
Inc. Watson began shipping the product. Lipitor is indicated as an adjunct to
diet to reduce elevated total cholesterol, LDL, triglycerides and to increase
HDL cholesterol. Under the terms of the exclusive supply and distribution
agreement, Pfizer manufactures and supplies Watson with all dosage
strengths of the authorized generic product. Watson markets and distributes
the product in the United States. Pfizer will receive a share of the net sales
from Watson's sales of the product. The agreement runs until November 30,
2016. Other terms of the agreement were not disclosed. For the most recent
twelve months ending September 30, 2011, Lipitor had sales of ~US$7.8bn,
according to IMS Health data.
Mylan gets nod for Generic version of Zinecard for Injection
Mylan Inc has announced that its business Mylan Institutional has received
final approval from the U.S. Food and Drug Administration (FDA) for its
Abbreviated New Drug Application (ANDA) for Dexrazoxane for Injection,
packaged in 250 mg and 500 mg Single-use Vials. This product is the
generic version of Pharmacia & Upjohn’s Zinecard® for Injection, a
chemoprotective agent. Dexrazoxane for Injection, when indicated for the
same use as Zinecard for Injection, had U.S. sales of approximately $3.4
million for the 12 months ending Sept. 30, 2011, according to IMS Health.
Mylan Institutional is shipping this product immediately.
Currently, Mylan
has 161 ANDAs pending FDA approval representing $97.7 billion in annual
sales, according to IMS Health. Forty-three of these pending ANDAs are
potential first-to-file opportunities, representing $26.9 billion in annual brand
sales, for the 12 months ending June 30, 2011, according to IMS Health
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Domestic News - December 2011
Dilip Shanghvi buys minority stake in Natco Pharma
Dilip Shanghvi has reportedly bought a minority stake in Natco Pharma for
183.4mn, triggering speculation it may lead to a larger alliance between the
two. According to reports, Shanghvi bought Rs. 7.25 lakh shares, or 2.6% of
Natco, from Orange Mauritius Investments at Rs. 253 apiece. Natco shares
surged 15% to 278.6, coinciding with the company's sale of shares to
institutional investors under the qualified institutional buyers' plan. It is not
clear how much it planned to raise through the share sale and whether it is
complete. Natco's promoters and the promoter group own 63% of the
company, according to the company's website, added reports.
…Natco Pharma announces closure of QIP issue
EU not to detain Indian generic drugs: Govt
India initiated dispute settlement consultations on 11 May 2010 at the World
Trade Organisation (“WTO”) with the European Union (EU) on the issue of
detention of Indian generic medicines while in transit through EU. The
detentions were made by invoking the EC’s Regulation 1383/2003 which
contains customs procedures for taking action against goods suspected of
infringing intellectual property rights (IPRs). India and Brazil jointly held two
rounds of consultations with the EU on 7-8 July, 2010 and 13-14 September
2010. During these consultations, EU acknowledged that some provisions of
the EC Regulation 1383 were misinterpreted by the customs authorities while
detaining the Indian generic drugs. EU showed willingness to resolve this
dispute without resorting to the WTO dispute panel. Read More…
Shionogi & Co procures injunction order against Lupin: reports
Shionogi & Co has reportedly procured an injunction order against Lupin,
barring it from further selling a generic version of Fortamet in the US.
According to reports, before the district court renders a decision in the on
going litigation, injunction prevents Lupin from further importing and selling
a generic version. Lupin is currently evaluating options and is seeking a
speedy resolution on the same matter. Reports said that the US court has
denied the motion of Shionogi for recall of Lupin's already distributed generic
Fortamet during the two weeks of at-risk launch in October 2011. The Court
also ordered Shionogi to deposit a security bond of $15 million for losses
likely to be suffered by Lupin in next one year, pending the outcome of the
case. Lupin had launched the generic Fortamet at-risk triggering its 180-days
exclusivity on September 30, 2011, added reports.
Fortis Healthcare to invest upto Rs. 300mn to set up dialysis centres:
reports
Fortis Healthcare has reportedly said that it plans to invest up to Rs. 300mn
to set up 50 standalone dialysis centres for treatment of patients suffering
from kidney failure in the next 2 years across the country. Aditya Vij, CEO,
Fortis Healthcare (India) was quoted as saying "Our target is 50 centres in
the next two years. Depending upon the varied locations across the country,
the investment per centre would be in the range of Rs. 50-60 lakh."
Fortis Healthcare launched Renkare, a chain of stand-alone dialysis centres.
These stand-alone centres will expand Fortis’ reach and help meet the rising
demand for quality dialysis. The company plans to set up 50 stand-alone
dialysis centres across the country over the next two years, in a phased
manner. In the first phase, six centres will come up across Delhi & NCR
covering the territory in the North, South, West and East. The company plans
to set up six centres across Delhi and the National Capital Region (NCR) in
the first phase, while the remainder would come up in other metros and TierII and III cities, added reports.
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…Fortis launches RENKARE
Ranbaxy announces consent decree with U.S FDA
Ranbaxy Laboratories Ltd. announced that it has signed a consent decree
with the U.S. Food and Drug Administration (“FDA”). Ranbaxy has
committed to further strengthen procedures and policies to ensure data
integrity and to comply with current good manufacturing practices. The
consent decree is subject to approval by the United States District Court for
the District of Maryland. Separately, Ranbaxy also announced that it intends
to make a provision of $500 million in connection with the investigation by
the U.S. Department of Justice, which the company believes will be sufficient
to resolve all potential civil and criminal liability.
“We are pleased to have resolved this legacy issue with the FDA as we begin
the next chapter in Ranbaxy’s history,” said Arun Sawhney, Ranbaxy CEO &
Managing Director. “While we were disappointed by the conduct that led to
the FDA’s investigation, we are proud of the systematic corrective steps we
have taken to upgrade and enhance the quality of our business and
manufacturing processes. Ranbaxy’s new management team, and its new
majority shareholder, Daiichi Sankyo, are committed to the utmost levels of
professionalism and integrity, and to ensuring that all Ranbaxy facilities meet
the high standards that patients, prescribers and the public expect from a
leading global generic pharmaceutical company. We look forward to
continuing to work cooperatively with the FDA to strengthen the public trust
in our company.”
Sawhney continued, “With greater clarity around the outlook for our business
in the U.S., we look forward to continuing to serve the U.S. market with safe,
effective and affordable products, including our recent launches of
Atorvastatin (*brand Lipitor) and Atorvastatin-Amlodipine besylate (** brand
Caduet). Importantly, these developments bring greater predictability to
Ranbaxy’s U.S. operations and allow us to focus all of our efforts on bringing
high quality products to market for the benefit of consumers.”
…Ranbaxy to market Daiichi Sankyo's innovative products in Malaysia
Indian pharma exports facing competition from China
As per available information, Indian Pharmaceutical exporters are facing
intense competition in international markets from China, particularly in Bulk
drugs sector. Competition in formulations is also increasing gradually from
China. Government has already prepared strategies to double the pharma
exports to USD 25bn by 2013-14, including ‘Increase in the share of India’s
Pharma exports to China’. As per extant FDI policy, FDI, up to 100% under
the automatic route, is permitted for Greenfield investments in the
pharmaceuticals sector, while FDI, up to 100%, is permitted for brown field
investments (i.e. investments in existing companies), in the pharmaceuticals
sector, under the Government approval route. This information was given by
Shri Jyotiraditya M. Scindia, Minister of State for Commerce and Industry in
written reply to a question in the Lok Sabha.
Dr Reddy’s to focus on new chemical entities: reports
Dr Reddy’s Laboratories Limited is reportedly exiting from cardiovascular
diseases (CVD) and diabetes and focusing on new segments, including
dermatology and pain management due to high costs involved for the
latter.GV Prasad, Vice Chairman and CEO, Dr Reddy's Laboratories was
quoted as saying "We have now selected areas, which are available for
innovation...we moved away from cardiovascular diseases (CVDs) and
diabetes towards pain and inflammation, dermatology and of course antiinfectives." According to reports, Dr Reddy's is looking at a product which will
directly address this segment of post surgical infections to improve its
performance in India and Europe. Biosimilars is one such major area
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company is seeking for its growth from 2016 to 2020. The company could
not afford for some of the trials like CVDs as it required at least 30,000
patients, added reports.
…Dr Reddy's Labs announces VRS for employees of Mexico subsidiary:
reports
Strides Arcolab gets continued US FDA approval status for Sterile
Products Division
Strides
Arcolab
today
announced
the
following
US
FDA
approvals:
The Sterile Products manufacturing facility (SPD 1) in Bangalore, the principal
sterile facility of Agila, which was recently inspected by the US FDA as part of
the routine GMP compliance audit and the facility has been classified as
acceptable. This facility manufactures lyophilized, liquid, dry powder
injectables and pre-filled syringes. The last inspection and approval of this
site was in March 2009. V.S.Iyer, Executive Director and CEO - Agila said
"this approval endorses our commitment to continued compliance with cGMP.
Fludarabine Phosphate Injection USP 25 mg/mi, packaged in 50 mg/2 mL
Single-dose vials. Approval for Onco Therapies Limited (a wholly owned
subsidiary of Strides). According to IMS data, the US market for Fludarabine
is approximately USD 15 Million. Fludarabine is part of the Oncology portfolio
licensed to Pfizer in January 2010 for the US market and expected to be
launched shortly.
Orchid Pharma ties up funds for FCCB redemption
Chennai-based Global Pharma major, Orchid Chemicals & Pharmaceuticals
has announced that it has received sanction for US$ 100 mn by way of ECBs
(External Commercial Borrowings) from the banking system to redeem the
outstanding FCCBs (Foreign Currency Convertible Bonds) of US$ 117 mn,
along with the yield-to-maturity when they fall due in February 2012. “We
are fully geared to redeem the maturing FCCBs. The ECB sanction that we
have received, coupled with our internal accruals will enable us to
comfortably redeem the outstanding FCCBs on the due date. With over 85%
of Orchid’s sales being exports billed in US$, the company has a natural
hedge against currency fluctuations”, said K Raghavendra Rao, Chairman &
Managing
Director,
Orchid
Chemicals
&
Pharmaceuticals
Ltd.
…Orchid-Merck
anti-infective
program
meets
preclinical
milestone
Cadila acquires 100% stake in Mumbai-based Biochem
Zydus Cadila has acquired 100% stake in Biochem, one of the top 40 pharma
companies in India. A privately-held company headquartered in Mumbai,
Biochem is a well-integrated pharma player with a presence in the
antibiotics, cardiovascular, anti-diabetic and oncological segments. Biochem
has reported sales of Rs. 264,5 crores for the year 2010-2011.
Established in 1959, Biochem has proven strengths in manufacturing and
marketing of antibiotics. The top 5 brands of the company are Ampilox,
Biotax, Monotax, Amicin and Zithrocin which together contribute to 40% of
the company's sales. Three of Biochem's brands fall in the top 300 pharma
brands of India. The acquisition strengthens Zydus' operations in the Indian
pharma market.
Speaking on the latest acquisition, Zydus Cadila's Chairman and Managing
Director. Mr. Pankaj RL Pate! said, "The Formulations Business in India has
always been the bulwark of our operations and we have looked at every
strategic opportunity to grow and contribute to this market, either by way of
novel initiatives, collaborations or acquisitions. Biochem represents the right
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fit as they have a significant presence in our core therapy areas and also add
value to our product offerings in the key growth segments."
Opto Circuits group firm launches cardiac science products
Advanced Micronic Devices Limited’s (AMDL) healthcare division – AMDL
Health, a leading provider of medical equipment and devices, today
announced the launch of Cardiac ScienceTM family of advanced cardiac
diagnostic products in India. The products are being showcased at the 63rd
Annual Conference CSI, Mumbai, 8th -11th December 2011. This marks
AMDL Health’s foray into the Indian cardiovascular market. The products to
be sold are under the brands of Cardiac Science, Quinton, Burdick, and
Powerheart.
“India is the second largest potential cardiovascular market in the world and
is expected to reach $589M by 2017,” said Arindam Sen, Chief Executive
Officer, AMDL. “We are committed to make technologically advanced devices
accessible to the Indian healthcare market.” AMDL Health plans to target Tier
1 and Tier 2 cities that are changing the landscape of Indian medical
equipment industry.
Powerheart automated external defibrillators (AEDs) are easy to use devices
that are utilized for emergency treatment of sudden cardiac arrest (SCA).
The proven Burdick and Quinton brands bring ECG, stress test systems,
Holter monitors and supplies to physicians’ offices and hospitals. Quinton
QStress and Burdick ECG products are renowned for their reliability and
accuracy.
Elder Pharmaceuticals set to enter Japanese pharma market
Elder Pharmaceuticals Limited, the Indian pharma major, which has already
received accreditation from Ministry of Health-Japan for its Active
Pharmaceutical Ingredients (API) plant at Patalganga, Maharashtra is all set
to enter in the US $ 70 billion Japanese pharma market during the current
Financial year. “The Japanese pharmaceutical market is actually valued at
about US$70 billion. The opportunity which we are targeting is about USD 1
billion. Our plan is to actually try to get about 1-2%. We have also filed for
new patents in these markets so hopefully we should get these during the
current financial year which would open up another USD 500 million market
for us,” said Mr Alok Saxena, Joint Managing Director, Elder Pharmaceuticals
Limited
“The free trade agreement signed between the two countries earlier this year
is also expected to boost the supply of ingredients to Japanese players. The
Japanese pharma market, the second largest market, is an untapped, high
value market with lot of opportunities for Indian pharma ingredients
companies, in terms of supplies of APIs and intermediates to generic
companies in Japan. Elder is also positioning itself to become a supplier of
APIs and advanced intermediates to tap the vital Japanese market for the
future growth of the company.” said Saxena. Read More…
SC allows export of Endosulfan insecticide
The Supreme Court reportedly allowed export of unused stock of endosulfan
insecticide, while retaining the complete ban imposed by it on its production,
sale and use in the country. A three-judge Bench headed by Chief Justice
S.H. Kapadia was quoted as saying that the “dilution, packaging and export”
of the agrochemical will be handled by public sector unit (PSU) Hindustan
Insecticide Ltd. Its previous order to propose mechanism for packaging and
export of the insecticide will be followed. The company manufacturing
endosulfan was allowed by the Bench to export nearly 1,100 tonnes of the
pesticide to meet their contractual obligations while maintaining the ban on
its
use
and
production
on
September
30,
added
reports.
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Roche loses case vs Intas in Madras HC
Madras High Court has reportedly dismissed suit filed by Hoffman La Roche
against Intas, regarding the former's lung-cancer drug erlotinib due to lack of
jurisdiction. Mohan, advocate at the Madras HC was quoted as saying that
Intas' application said that the Court should not have granted permission for
Roche's case to be registered in the first place. According to reports, to stop
the sale of erlotinib, Roche had filed a case against Intas on the basis of a
single sale from a retail chemist in Chennai. The single sale was from a
retailer not authorised by Intas and did not tantamount to a commercial sale.
Roche was already fighting a patent-infringement suit against Natco, on the
same drug, at the Delhi High Court, added reports.
Glenmark Pharma seeks arbitration against Napo Pharma
Glenmark Pharmaceuticals Ltd. said on Tuesday that it was seeking a
declaration from an arbitration panel that Napo Pharmaceuticals, Inc.'s claims
of breach are unfounded. Napo recently issued a press release in which it
claims to have terminated a July 2, 2005 Collaboration Agreement between it
and Glenmark Pharma. On December 9, Glenmark formally requested that
the arbitration panel issue an interim order directing Napo to comply with the
Collaboration Agreement during the pendency of the arbitration. On August
8, 2011, Glenmark filed a statement of claim with the American Arbitration
Association against Napo seeking, among other things, a declaration that
Glenmark's exclusive rights to develop, commercialise and distribute
Crofelemer in 140 countries for treatment of diarrhoeal diseases includes the
exclusive rights to distribute though relief agencies in these countries.
Glenmark recognises the importance of relief agency distribution of
Crofelemer to populations in emerging countries with the most critical need
for the product. Glenmark believes that contractually it has exclusive rights
with respect to relief agency distribution in the countries and indications
licensed to Glenmark.
Lupin eyes US$300mn from Japan in 2 years: report
Lupin is reportedly looking to take a jump of over 80% in its revenues to
$300 million (about Rs. 1,5570mn) from the Japanese market in the next two
ears on the back of its enhanced presence in the country. According to
reports, the company has strengthened its presence with the acquisition of
I’rom Pharmaceuticals for an undisclosed amount. Japan is a priority market
for Lupin, and between the two companies in Japan (Kyowa and I’rom), Lupin
looks to clock in revenues of about $300 million over the next two years from
the present about $165 million. The company is also eyeing to enter other
markets, including Latin America and Europe, added reports.
Sun Pharma gets USFDA nod for generic Ultram ER Tablets
Sun Pharmaceutical Industries Ltd. announced that USFDA has granted Its
subsidiary sn approval for its Abbreviated New Drug Application (ANDA) to
market a generic version of Ultram ER, Tramadol hydrochloride extended
release tablets. These generic TramaUol hydrochloride extended release
tablets, 100 mg, 200 mg and 300 mg. are therapeutically equivalent to
Ultram ER tablets of Valeant. These tramadol HCL ER tablets have annual
sales of approximately USD 125 million in US. Tramadol HCL ER tablets are
indicated for management of moderate to moderately severe chronic pain in
adults who need around-the-clock treatment of their pain for an extended
period of time.
Strides's Onco Therapies get US FDA approval for 3 ANDAs of
Cytarabine Injection
(Strides) today announced that it has received approvals from USFDA for
Cytarabine Injection 20 mg/ mi, packaged in 500 mg/ 25 mL Multiple-dose
vials, 20 mg/ mi, packaged in 100 mg/5 mi Single-dose vial and 20 mg/mi,
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packaged in 1000 mg/ 50 mi Pharmacy Bulk Packages. According to IMS
data, the US market for Cytarabine is approximately USD 12.3 Million.
Cytarabine is part of the Oncology portfolio licensed to Pfizer in January 2010
for the US market and expected to be launched shortly.
Ranbaxy's generic Lipitor wins 2.5% market share in US
Ranbaxy Laboratories has reportedly managed to capture close to 2.5% of
the generic Lipitor's market share in the US within the first few days of the
launch. According to reports, government procurement agencies have so far
purchased over 29.18 lakh tonnes of paddy and delivered over 3.24 lakh
tonnes of custom milled rice to Food Corporation of India (FCI). Over 10.58
lakh tonnes of paddy have been purchased by the Food and Supplies
Department and over 10.10 lakh tonnes by HAFED. Karnal district led the
State in terms of paddy arrivals, with over 8.52 lakh tonnes making its way
to the mandis so far, followed by Kurukshetra district, where over 7.90 lakh
tonnes of paddy has arrived in the markets, added reports
113 of 118
International News - December 2011
Pfizer completes acquisition of Excaliard
Pfizer Inc. has completed its acquisition of Excaliard Pharmaceuticals, Inc., a
privately owned biopharmaceutical company focused on developing novel
drugs for the treatment of skin fibrosis, more commonly referred to as skin
scarring. "It is imperative at Pfizer that we continue to develop new and
innovative treatments to address unmet medical needs, and there is
currently no FDA-approved treatment for excessive skin scarring," said JoseCarlos Gutierrez-Ramos, senior vice president, Biotherapeutics, Worldwide
Research and Development, Pfizer.
"Acquiring Excaliard allows us to continue the development of its lead
compound EXC 001 to potentially fill a gap and bring a novel new treatment
to patients." Nicholas Dean, PhD., Founder and Chief Scientific Officer of
Excaliard: "We are excited that Pfizer will continue to develop EXC 001, which
has shown evidence of reducing scar severity in Phase 2 clinical trials." While
specific financial terms are confidential, Pfizer provided Excaliard's
shareholders, which include Isis Pharmaceuticals, Alta Partners, ProQuest
Investments and RiverVest Venture Partners, an upfront payment and will
make contingent payments if certain milestones are achieved in the future.
AstraZeneca to cut US sales forces
AstraZeneca announced that it will reduce its US sales force by
approximately 1,150 leadership positions and sales representatives as part of
the company's ongoing strategy to operate its business more efficiently to
best serve patients in the US. These changes, which were not included in
previously announced efficiencies to the US business, will account for roughly
24 per cent of the company's sales organisation in the US. The impact of the
changes will vary by geography and selling teams. "These are difficult
decisions that impact valued employees," said Rich Fante, President,
AstraZeneca US. "The changes we are making, however, will help us deliver
better results for our business and, most importantly, continue delivering on
our mission of patient health." Employees will have the option to self-identify
to potentially leave the company. All decisions will be finalised by early
February 2012. This change to the US sales force is incremental to the
ongoing second phase of the company's restructuring programme that was
announced in January 2010. As a result, a discrete restructuring cost
associated with today's announced changes, estimated at between $50
million to $100 million, will be charged in the fourth quarter of 2011.
Restructuring costs are excluded from the company's core financial
measures, so this initiative has no impact on guidance for core earnings per
share for 2011.
GlaxoSmithKline launches $50mn Life Sciences Innovation Fund in
Canada
GlaxoSmithKline Inc. (GSK) today announced the launch of the GSK Canada
Life Sciences Innovation Fund, a new national $50 million fund that will
significantly advance the commercialization of scientific innovation in Canada
by investing in early stage breakthrough research. The fund will identify
strategic investment opportunities within Canada’s life sciences industry
including academic and health institutions, translational research centres and
start-up companies. The announcement was made today in Toronto at an
event hosted by GSK in Canada President and CEO, Paul Lucas and Dr.
Moncef Slaoui, GSK’s Global Chairman of Research and Development. The
event was attended by federal and provincial government representatives
and leaders from Canada’s life sciences community. Read More…
Pfizer CEO Ian Read named new Chairman of Board
Pfizer Inc. announced that its Board of Directors has elected current
President and Chief Executive Officer, Ian Read, as Chairman of the Board
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and Chief Executive Officer, effective immediately. Read succeeds George
Lorch as Chairman of the Board. The independent members of the board
named Lorch as Lead Independent Director.
“Over the past year, Ian has clearly demonstrated the leadership and vision
necessary to drive Pfizer’s strategies and achieve the company’s objectives in
the continued challenging industry and macroeconomic environment,” stated
George Lorch. “His broad experience at Pfizer and his deep understanding of
the vital role that the pharmaceutical industry plays in advancing global
health and in the global economy make Ian the right person for the
chairmanship. We are fortunate to have someone of Ian Read’s caliber lead
Pfizer.”
“I am deeply honored to have been named chairman of Pfizer,” stated Ian
Read. “Working alongside Pfizer’s dedicated leaders and talented workforce, I
remain confident in the strength of our business and of our late-stage
pipeline. I believe in the future of this company and of our continued ability
to deliver value to shareholders and to improve the global health and wellbeing of people around the world.”
GE Healthcare and M+W Group form strategic alliance
GE Healthcare, the healthcare business of GE (NYSE: GE) and M+W Group, a
leading global engineering, construction and project management company,
have formed a strategic alliance aimed at overcoming the lack of key
biopharmaceuticals, especially in emerging nations. The alliance, which will
combine GE Healthcare's expertise in technologies for biopharmaceutical
manufacture with M+W Group's global capabilities in bio-engineering and
construction, will assist countries worldwide to become self-sufficient in the
manufacture of vital biopharmaceuticals such as vaccines, insulin and
biosimilars. Together, the companies will offer governments and
pharmaceutical companies an integrated, cost-competitive "turn-key"
approach for the construction of biopharmaceutical manufacturing plants, to
help meet the rapidly increasing worldwide demand for these potentially lifesaving treatments. The alliance between the two companies aligns with GE's
healthymagination initiative, which focuses on reducing cost, increasing
Read
More…
access
and
improving
quality
in
healthcare.
Simcere and Bristol-Myers Squibb enter innovative partnership
Bristol-Myers Squibb Company and Simcere Pharmaceutical Group, a leading
pharmaceutical company in China, have expanded the strategic partnership
formed last year to include a second collaboration in a different therapeutic
area. The companies agreed to co-develop BMS-795311, Bristol-Myers
Squibb's preclinical small molecule inhibitor of the Cholesteryl Ester Transfer
Protein (CETP). Inhibiting CETP could potentially raise HDL (good cholesterol)
levels and help prevent cardiovascular disease.
This collaboration is expected to accelerate the delivery of clinical Phase IIa
proof-of-concept by leveraging the complementary strengths of a premier
Chinese pharmaceutical company and a global biopharmaceutical company.
Under the terms of the agreement, Simcere will receive exclusive rights to
develop and commercialize BMS-795311 in China while Bristol-Myers Squibb
will retain exclusive rights in all other markets. The companies will together
determine the strategic development plan to explore the potential of BMS795311 to treat and prevent progression of cardiovascular disease. Simcere
will run and fund initial development work. Financial terms were not
disclosed. Read More…
Merck helps eliminate Schistosomiasis in Africa
Merck KGaA announced its intention to further boost its efforts in the fight
against the tropical disease schistosomiasis and to continue until the disease
has been officially eliminated in Africa. The company plans to double its
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annual donation of tablets containing the active ingredient praziquantel from
25 million to 50 million in the medium term. The company committed itself to
doing so at a meeting with the World Health Organization (WHO) in Geneva.
Having originally planned to end the project in 2017, Merck now intends to
continue its efforts to fight schistosomiasis indefinitely. Complementary to
this donation, Merck will financially support a WHO-led school-awareness
program in Africa. The objective is to educate children about the
consequences of schistosomiasis and ways to prevent the disease. In
addition, Merck intends to improve the tablet formulation and to step up its
schistosomiasis research efforts. Read More…
Mylan
receives
approval
for
3
antiretroviral
therapies
Mylan Inc. announced that its subsidiary Mylan Laboratories Limited
(formerly Matrix Laboratories Limited) has received approval for three
antiretroviral (ARV) therapies used to treat HIV/AIDS under the World Health
Organization’s (WHO) Prequalification of Medicines Programme. The products
include:
Atazanavir Capsule, 300 mg, Ritonavir Tablet, 100 mg (heat-stable), and
Tenofovir Disoproxil Fumarate and Lamivudine Tablet 300 mg/300 mg, or
“second-line-in-a-box”
Fixed-dose combination Atazanavir Sulfate and Ritonavir Tablets, 300
mg/100
mg
Fixed-dose combination Abacavir Sulfate, Lamivudine and Zidovudine
Tablets,
300
mg/150
mg/300
mg
Mylan President Heather Bresch said: “With these three approvals, Mylan will
further enhance our portfolio of more convenient, more affordable treatment
options for people in the developing world living with HIV/AIDS. In particular,
we are proud to deliver on a previous commitment that we made through an
announcement with President Bill Clinton on August 6, 2009[1], to lower the
price of second-line treatments for patients with drug-resistant HIV in
developing
countries.
Further, these product combinations and packaging solutions are an example
of our continued commitment to innovation in an effort to increase treatment
adherence and effectiveness. By bringing these medicines to market through
WHO’s Prequalified Medicines Programme, we are again delivering on our
promise to expand access to critical, life-saving ARV medicines for patients
Read
More…
who
need
them
in
the
developing
world.”
Pfizer initiates to prevent pneumococcal disease in infants and young
children
Pfizer Inc. has entered into a second supply agreement which will broaden
and extend the duration of the Company's commitment to help protect
millions of infants and young children in the developing world from
pneumococcal disease - the leading cause of vaccine-preventable death in
young children. Pfizer is now committed to supply up to a total of 480 million
doses of Prevenar 13 (Pneumococcal Polysaccharide Conjugate Vaccine [13valent, adsorbed]) through 2023 building on its original commitment
announced in March 2010 to supply up to 300 million doses of the vaccine
under the auspices of the Advance Market Commitment (AMC) for
pneumococcal vaccines. The AMC, an innovative program piloted by the GAVI
Alliance, is a public-private approach to health funding designed to create a
sustainable marketplace, ensure an affordable and stable supply of
pneumococcal vaccines at a steeply discounted price and stimulate the
development and expansion of manufacturing capacity for vaccines
specifically for the world's poorest countries. The agreements for supply of
pneumococcal vaccines have been financed by GAVI, five donor countries Italy, the United Kingdom, Canada, the Russian Federation, Norway - and the
Bill and Melinda Gates Foundation. Read More…
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AstraZeneca to take US$381.5mn charge on failed studies
AstraZeneca announced that its investigational compound olaparib will not
progress into Phase III development for the maintenance treatment of serous
ovarian cancer. In addition, AstraZeneca announced that the second
RENAISSANCE Phase III study of TC-5214 for patients with major depressive
disorder did not meet its primary end point. As a result, AstraZeneca will
take pre-tax impairment charges totalling $381.5 million to R&D expense in
the fourth quarter of 2011. The company confirms its expectation for full year
Core EPS in the range of $7.20 to $7.40, but with the inclusion of these
intangible impairments, Core EPS is likely to be in the lower half of this
range. The decision to discontinue olaparib’s development in serous ovarian
cancer was made following a review of an interim analysis of a Phase II study
(study 19) which indicated that the previously reported progression free
survival benefit is unlikely to translate into an overall survival benefit, the
definitive measure of patient benefit in ovarian cancer. In addition, attempts
to identify a suitable tablet dose for use in Phase III studies have not been
successful. No new safety concerns were identified for patients. Read More…
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Notes
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