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Organisation Of Pharmaceutical Producers of India

Issue 12 , June 2009

INTERNATIONAL

1. IPR 1
2. Regulatory 2
3. New Products 5
4. R&D / Clinical Trials 6
5. Mergers & Acquisitions / Collaborations 8
6. Pricing 10
7. Trade & Others 10
8. Biotechnology 13
9. New Appointments 14

DOMESTIC

1. IPR 15
2. Regulatory 17
3. New Products 21
4. R&D / Clinical Trials 21
5. Mergers & Acquisitions / Collaborations 22
6. Pricing 23
7. Trade & Others 25
8. Biotechnology 26
9. New Appointments 27
10. OPPI Related News 28
11. OPPI Forthcoming Events 29
Pharma Spectrum

P&G Wins Patent Infringement Lawsuit


International against Teva Pharma
May 15, Pharmabiz, Cincinnati, USA

IPR http://www.pharmabiz.com/article/detnews.asp?articleid
=49730

United States Court of Appeals for the Federal Circuit


Judge Fends Off Generic Pulmicort, for ruled in favour of the Procter & Gamble Company (P&G) in
Now the patent infringement lawsuit filed by P&G against Teva
http://www.fiercepharma.com/story/judge-fends- Pharmaceuticals USA, Inc. The positive ruling protects
generic-pulmicort-now/2009-05-21?utm_medium=nl& P&G's rights in the US to exclusively market the
May 21, 2009, Fierce Pharma osteoporosis therapy Actonel (risedronate sodium) tablets.
Actonel is commercialised through a collaboration
Apotex is out of luck. AstraZeneca has won an injunction between Procter & Gamble Pharmaceuticals and sanofi-
against the generics maker's launch of copycat Pulmicort aventis.
Respules, at least until the federal court can hear a
patent-infringement trial. As you know, Apotex already On August 13, 2004, P&G filed a patent infringement
has FDA approval for its version of the asthma drug, but lawsuit against Teva to enforce P&G's US composition of
AstraZeneca says it's patent-protected through at least matter patent for risedronate, the active ingredient in
2018. Actonel. Teva sought to market a generic version of
Actonel in the United States under the assertion that the
Blair Hains, a spokesman for AstraZeneca, told Bloomberg Actonel patent was not valid due to obviousness of the
that the company is pleased with the decision. "We invention. On February 28, 2008, the Court ruled in favor
continue to have full confidence in the strength of the of P&G, expressly rejecting Teva's validity challenge.
intellectual property rights protecting Pulmicort Shortly afterwards, Teva filed an appeal of the decision.
Respules," he said. A date for the trial has not yet been Oral arguments for the appeal were heard in December,
set. 2008.

Genzyme Sues Lupin for its ANDA Filing Wyeth Sues Sun and its US Subsidiary
for Phosphate Binder Product, Renvela over Protonix Drug
May 19, 2009, Pharmabiz May 7, 2009, Mint
http://www.livemint.com/2009/05/07220031/Wyeth-
The US-based Genzyme Corporation has filed a patent sues-Sun-and-its-US-subs.html?h=B
infringement suit against the Mumbai-based Lupin Ltd and
its US subsidiary against the latters' Abbreviated New Drug US-based Wyeth Pharmaceuticals has sued Mumbai-based
Application (ANDA) filing for manufacturing and marketing Sun Pharmaceutical Industries Ltd. and its US subsidiary
of generic version of Genzyme's Renvela (sevelamer Caraco Pharmaceutical Laboratories Ltd. for claiming that
carbonate) used for the control of serum phosphorus in their heartburn drug was a generic version of its Protonix
chronic kidney patients on dialysis. drug. The complaint, filed on 5 May in the US district
court for the Eastern District of Michigan, claims false
In a petition filed in the District Court of Maryland, US, on advertising by Sun and Caraco under the Lanham Act,
May 14, 2009, Genzyme alleges that by attempting to according to two law journals—Law 360 and Justia.
manufacture and market the generic form of the product,
Lupin has tried to infringe six patent claims of the “Wyeth is seeking its damages caused by Sun and Caraco’s
company. Genzyme holds US Patent Nos. 5,496,545 false advertising,” said Gwen Fisher, a Wyeth
(`545), 5,667,775 (`775), 7,014,846 (`846) and 7,459,151 spokesperson. “We are not making any statement on this,”
(`151) for phosphate-binding polymers for oral said a Sun spokesperson. The Lanham Act prohibits a
administration issued on 1996, 1997, 2006 and 2008 number of activities, including trademark infringement,
respectively. Another two patents, Patent Nos 6,509,013 trademark dilution and false advertising.
(`013) and 6,858,203 (`203), for the method of making
phosphate-binding polymers for oral administration issued
on 2003 and 2009 respectively, were also questioned by
Lupin.

Organisation of Pharmaceutical Producers of India 1


Pharma Spectrum

Abbott Sues J&J over New Humira Rival In explaining her decision to prevent generic Evista's
launch, Barker rejected some important building blocks in
May 5, 2009, Fierce Pharma Teva's case for selling the drug ahead of its official patent
http://www.fiercepharma.com/story/abbott-sues-j-j- expirations (which start in 2012). For one, Barker didn't
over-new-humira-rival/2009-05- agree that Evista's invention was just an obvious extension
05?utm_medium=nl&utm_source=internal of previously known work, saying that the company is
likely to "prevail in demonstrating the non obviousness" of
Get ready for a battle in the rheumatoid arthritis the patent.
segment. Johnson & Johnson's Centocor unit is prepping
for a launch of its new Humira competitor Simponi, and

Regulatory
Abbott Laboratories is not amused. So unamused, in fact,
that Abbott slapped J&J with allegations of patent
infringement.

All in a day's work for the folks who defend Big Pharma Bayer's Nexavar gets Japanese Nod for
intellectual property, right? Yes and no. Abbott's suit Advanced Liver Cancer Treatment
follows up a set of reverse accusations: Last year,
Centocor and NYU sued Abbott, saying that they were
May 22, 2009, Pharmabiz, Berlin
entitled to patent royalties on Humira. And that case is
still pending. In Japan Bayer received approval for Nexavar (sorafenib)
tablets for the treatment of unresectable hepatocellular
carcinoma (HCC) from the Ministry of Health, Labour and
Wockhardt Settles Patent Dispute with Welfare (MHLW). Nexavar, an oral anti-cancer drug,
Orion jointly developed by Bayer HealthCare AG and Onyx
April 29, 2009, Business Standard Pharmaceuticals Inc, is the only drug therapy shown to
http://www.business- significantly improve overall survival in patients with the
standard.com/india/news/wockhardt-settles-patent- disease. The product is already marketed in Japan as a
disputeorion/59835/on therapy for unresectable or metastatic renal cell
carcinoma (RCC).
Drug maker Wockhardt today said it has settled a patent
dispute with European pharmaceutical firm Orion "Liver cancer is one of the leading causes of cancer-
regarding the generic versions of the latter's two products related deaths in Japan, and the incidence is continuing to
used in the treatment of Parkinson's disease. The company rise," said Gunnar Riemann, member of the executive
has executed a settlement and licence agreement with committee of Bayer HealthCare. "We expect that this
Orion Corporation regarding Wockhardt's application approval will provide patients a new option for improved
before the US drug regulator for the generic version of treatment and we are pleased that with our MRI liver
European firm's Comtan and Stalevo products, the contrast agent Primovist we contribute to early diagnosis
Mumbai-based drug major informed stock exchanges. of HCC. We will make further efforts to contribute to
patients and medical experts both in fields of diagnosis
Under the terms of settlement agreement, Wockhardt and treatment of HCC in Japan and worldwide."
would be able to launch generic versions of the both drugs
"on September 30, 2012, or possibly even earlier," the Janssen Gets FDA Nod to Use
company further said. Risperidone as Monotherapy, Adjunctive
Judge Gives Lilly a Generic Reprieve Therapy in Bipolar I Disorder
May 20, 2009, Pharmabiz, Titusville, New
April 24, 2009, Fierce Pharma
http://www.fiercepharma.com/story/judge-gives-lilly-
Jersey
generic-reprieve/2009-04-
24?utm_medium=nl&utm_source=internal Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals
Inc has received US Food and Drug Administration (FDA)
Eli Lilly execs are high-fiving now that a district judge has approval for Supplemental New Drug Applications (sNDAs)
blocked Teva Pharmaceutical's launch of an Evista for the use of Risperdal Consta (risperidone) Long-Acting
copycat. True, the block is only temporary, until the Treatment as both monotherapy and adjunctive therapy to
companies' patent fight is resolved in court, probably later lithium or valproate in the maintenance treatment of
this year. But Judge Sarah Evans Barker, who gave Lilly Bipolar I Disorder.
the reprieve, will also decide the patent case. And in her
ruling, analysts say, Barker left some clues that could Bipolar Disorder is a brain disorder that causes unusual
make Lilly very happy. shifts in a person's mood, energy and ability to function. It
is often characterized by debilitating mood swings from
extreme highs (mania) to extreme lows (depression). Type

Organisation of Pharmaceutical Producers of India 2


Pharma Spectrum

I Bipolar Disorder is characterized based on the Pervasis Therapeutics Inc, a biotechnology company
occurrence of at least one manic episode, with or without pioneering biologically active cellular therapies to treat
the occurrence of a major depressive episode, and affects vascular and other serious diseases, has received orphan
approximately one per cent of the American adult drug designation for Vascugel, a novel allergenic cell
population in any given year. therapy product that may restore natural repair and
regeneration pathways in the vasculature, from the US
UCB gets FDA Nod for Cimzia to Treat Food and Drug Administration (FDA).
Rheumatoid Arthritis The orphan drug designation is granted for the prevention
May 18, Pharmabiz, Brussels of arteriovenous fistula or arteriovenous graft failure in
patients with end-stage renal disease (ESRD) receiving
UCB announced that the US Food and Drug Administration haemodialysis or preparing for haemodialysis.
(FDA) approved Cimzia, the only PEGylated anti-TNF
(Tumour Necrosis Factor), for the treatment of adult Roche's Avastin Gets US FDA
patients with moderately to severely active rheumatoid
arthritis (RA). Cimzia can be dosed at 400 mg initially and Accelerated Nod for Brain Cancer
at weeks two and four, followed by 200 mg every other May 7, 2009, Pharmabiz, Basel
week; for maintenance dosing, 400 mg every four weeks
can be considered. Roche has received accelerated approval for Avastin
(bevacizumab) from the US Food and Drug Administration
In clinical trials with Cimzia, together with methotrexate (FDA) for people with glioblastoma with progressive
(MTX), patients experienced a significant reduction in the disease following prior therapy.
signs and symptoms of RA at week 24 with some showing
clinical responses within one to two weeks, compared with The new indication for Avastin was granted under the
MTX alone. Additionally, radiographic data showed Cimzia, FDA's accelerated approval programme that allows
together with MTX, inhibited progression of joint damage, provisional approval of medicines for cancer or other life-
with a significantly smaller change from baseline in threatening diseases. It follows the unanimous vote by the
modified Total Sharp Score (TSS) at 24 and 52 weeks of FDA Oncologic Drugs Advisory Committee (ODAC) on March
treatment, compared with MTX alone (p<0.001). 31.

Novartis Bags FDA Nod to Market Jubilant Gets USFDA Nod to Market
Prevacid 24HR Cardiac Drug
May 15, 2009, Pharmabiz, Basel, Switzerland May 4, 2009, Business Standard
http://www.pharmabiz.com/article/detnews.asp?articleid http://www.business-
=49729&sectionid=43 standard.com/india/news/jubilant%5Cs-us-arm-gets-
usfda-nod-to-market-sestamibi/60376/on
Novartis announced that Prevacid 24HR (lansoprazole
delayed-release capsules 15 mg) has been approved by the Pharmaceutical firm Jubilant Organosys today said its
US Food and Drug Administration (FDA) as the first over- American arm has got a nod from the USFDA to market the
the-counter (OTC) Proton Pump Inhibitor (PPI) for the generic drug Sestamibi in the US.DRAXIMAGE LLC, the US
treatment of frequent heartburn since 2003. Prevacid subsidiary of BSE-listed Jubilant, received approval from
24HR is expected to be available over-the-counter in 2009. the US Food and Drug Administration (FDA) for it's
Abbreviated New Drug Application (ANDA) for DRAXIMAGEs
Once-daily Prevacid 24HR is the first OTC PPI approved in generic Sestamibi, Jubilant said in a press release.
its original prescription formulation. It is the only PPI
containing the active ingredient lansoprazole to be Sestamibi is used in Myocardial Perfusion Imaging (MPI),
approved for OTC treatment of frequent heartburn, which which evaluates the flow of blood to the heart. The MPI
is defined as heartburn that occurs two or more days per market size is currently estimated at $400 million.
week. In three clinical studies, Prevacid 24HR
demonstrated significantly better efficacy in treating US FDA Asks OTC Drug Makers to Revise
frequent heartburn than placebo.
Labelling to Include Warning on Pain &
US FDA Grants Orphan Drug Status for Fever Drugs
Pervasis' Vascugel May 2, 2009, Pharmabiz, Maryland
May 12, 2009, Pharmabiz, Cambridge, The Food and Drug Administration issued a final rule that
Massachusetts requires manufacturers of over-the-counter (OTC) pain
relievers and fever reducers to revise their labelling to

Organisation of Pharmaceutical Producers of India 3


Pharma Spectrum

include warnings about potential safety risks, such as inclduign GalxoSmithKline’s Tykerb and Novartis’s
internal bleeding and liver damage, associated with the Clozaril.
use of these popular drugs.
Products covered by the FDA action include Tykerb (lapatinib) was given final regulatory clearance for
acetaminophen, and a class of drugs known as the use in combination with capecitabine (Chugai/Roche’s
nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs Xeloda) in patients with recurrent or non-operable
include aspirin, ibuprofen, naproxen, and ketoprofen. metastatic HER2-positive breast cancer who have received
Acetaminophen is in a class by itself. The revised labelling previous treatment containing Chuggai/Roche’s Herceptin
applies to all OTC pain relievers and fever reducers, (tratuzumab).
including those that contain one of these ingredients in
combination with other ingredients, such as in cold World Prepares for a Swine Influenza
medicines containing pain relievers or fever reducers.
Pandemic
Bial, Eisai Get European Marketing Nod May 1, 2009, SCRIP
for Once Daily Anti-Epileptic Zebinix As global authorities prepare for a possible swine influenza
May 2, 2009, Pharmabiz, London pandemic, the Pharma industry is poised to develop a
http://www.pharmabiz.com/article/detnews.asp?articleid vaccine.
=49510&sectionid=43
The World Health Organisation this week raised the level
Bial-Portela & CA, SA, and Eisai Europe Limited, the of influenza pandemic alert from phase three to phase
European subsidiary of Eisai Co, Ltd, announced that the five, just one step from a global pandemic. The move
novel once daily anti-epileptic Zebinix (eslicarbazepine comes after the WHO declared a “public emergency of
acetate) received marketing authorisation from the international concern” following a number of confirmed
European Commission as adjunctive therapy in adults with cases of swine influenza A (H1N1) in Mexico and the US.”
partial-onset seizures, with or without secondary All countries should immediately activate their pandemic
generalisation. preparedness plans, “said Dr. Margaret Chan, Director
General of WHO.
Epilepsy is one of the most common neurological diseases,
affecting approximately one in 100 people. Treatment of India Angry Over Drug Seizure Issue
partial-onset seizures, the most common type of epilepsy,
remains a constant challenge and up to 40 per cent of
April 30, 2009, Asian Age
patients with partial seizures do not achieve seizure
control with current anti-epileptics. India has complained the World Trade Organisation against
come of the European nations confiscating Indian generic
drugs being shipped to South America and Africa via
Strattera Approved For Paediatric ADHD Europe.
in Japan
May 1, 2009, SCRIP “We have taken it up in the WTO”, said the joint secretary
in the department of industrial policy and promotion N.N.
Lilly’s Strattera (atomoxetine) has been approved in Japan Prasad.
for attention-deficit hyperactivity disorder (ADHD) in
paediatric patients aged six to 18 years. Glenmark Receives US FDA Nod for
Ezetimibe
The formal clearance from the Ministry of Health, Labour
and Welfare endorses a positive recommendation from
April 28, 2009, Business Standard
anadvisory committee earlier this year (scripenews.com, http://www.business-
February 5th, 2009). Strattera has been on the US market standard.com/india/news/glenmark-receives-us-fda-nod-
since early 2003 but was not submitted until mid-2007 in for-ezetimibe/59483/on
Japan, where it received a priority review.
Drug firm Glenmark Generics Ltd today said it has
received tentative approval from the US Food and Drug
Tykerb and Clozaril among Formal Administration (FDA) for the generic version of cholesterol
Japanese Approvals lowering drug Ezetimibe, sold under the brand name
May 1, 2009, SCRIP 'Zetia' in 10 mg strength.

Japan’s Ministry of Health, Labour and Welfare has Glenmark has got the tentative approval for the generic
formally approved a number of products given positive version of Schering Plough and MSP Singapore Company
recommendations by an advisory committee last month, LLC's anti-cholesterol compound Ezetimibe, which has

Organisation of Pharmaceutical Producers of India 4


Pharma Spectrum

received sales of 1.5 billion dollars in 2008, the company European countries will follow from autumn 2009 onwards,
said in a statement. a company press release said.

J&J, Schering Biologic Wins FDA Qlaira is the first in a new class of oral contraceptives to
deliver estradiol, the estrogen identical to the one
Approval produced by the female body. Over the past 50 years,
April 24, 2009, Fierce Biotech many new progestins have been developed for use in oral
http://www.fiercebiotech.com/story/breaking-news-j-j- contraceptives, but the estrogen component remained the
schering-biologic-wins-fda-approval/2009-04- same - ethinylestradiol. The introduction of Qlaira thus
24?utm_medium=nl&utm_source=internal offers women a new choice in oral contraception

Johnson & Johnson and Schering-Plough have won FDA Abbott Launches Two New Products for
approval for Simponi (golimumab), an injectable biologic
drug for the treatment of rheumatoid arthritis, psoriatic Peripheral Artery Disease Treatment
arthritis and ankylosing spondylitis. These chronic May 11, 2009, Pharmabiz, Abbott Park, Illinois
inflammatory diseases, which plague roughly 3 million http://www.pharmabiz.com/article/detnews.asp?articleid
Americans, result in pain and inflammation--and in some =49652&sectionid=43
cases, joint destruction and disability. The drug was also
approved in Canada earlier this week. Abbott launched two new products - FoxCross PTA
Catheter and HI-TORQUE Versacore .035 Guide Wire - for
Simponi is an update to the $5 billion-a-year blockbuster the treatment of peripheral artery disease (PAD), a
drug Remincade and will compete with Amgen;s Enbrel condition that occurs when the vessels supplying blood to
and Abbott Laboratories' Humira. Simponi's biggest the legs, arms, stomach or kidneys become narrowed or
advantage? It requires only injections rather than in-office blocked by plaque, restricting normal blood flow.
infusions, and is the first monthly subcutaneous anti-TNF-
alpha therapy. The FoxCross PTA Catheter is a next-generation .035
balloon dilatation catheter and is now available in the
New Products United States and Europe. The HI-TORQUE Versacore .035
Guide Wire is a peripheral guide wire for delivery of
catheters, balloons and stents and is now available in the
Generex Launches Oral Insulin in United States.
Lebanon
May 18, 2009, Pharmabiz, Worcester, Lundbeck Launches ATryn in US
Massachusetts May 8, 2009, Pharmabiz, Framingham,
Massachusetts
Generex Biotechnology Corporation, the leader in drug
delivery for metabolic diseases through the inner lining of ATryn (antithrombin [recombinant]) is now available
the mouth, together with Benta s.a.l., the company's commercially through Lundbeck Inc of Deerfield, Illinois, a
importation, marketing, distribution and sales sub- wholly owned subsidiary of H Lundbeck A/S in Denmark,
licensee in Lebanon, launched the commercial retail sales GTC Biotherapeutics, Inc's commercialization and
of Generex Oral-lyn in Lebanon. development partner in the United States. GTC is due to
receive a total of $1 million from Lundbeck for its initial
The launch was announced at a press conference in Beirut inventory of ATryn.
with Lebanese minister of Health H E Muhammad Jawad
Khalifah.The product has been approved for importation "We are delighted to have reached this important
and commercial marketing and sale in Lebanon by the milestone with the launch of ATryn in the US, which is the
Ministry of Public Health, and will be marketed and sold first transgenically produced therapeutic product to reach
for the treatment of patients with type-1 and type-2 the marketplace," stated Geoffrey F Cox, GTC's chief
diabetes in Lebanon. executive officer and chairman of the Board. "We look
forward to working with Lundbeck to deliver this
important new product."
Bayer Schering to launch Oral
Contraceptive Qlaira in Europe Watson Launches BPH Drug Rapaflo in
May 16, 2009, Pharmabiz, Berlin
the US
Bayer Schering Pharma AG, Germany, has launched its April 17, 2009, SCRIP
new oral contraceptive Qlaira (estradiol
valerate/dienogest) in Europe. Qlaira will be available in Watson Pharmaceuticals has launched its orally active
several European countries, including Germany. More alpha la-adrenoceptor selective antagonist Rapaflo

Organisation of Pharmaceutical Producers of India 5


Pharma Spectrum

(silodosin) in the US for the treatment of benign prostatic


hyperplasia (BPH) following an FDA approval last October. Europe Awards $331M to Accelerate
“We are confident that the proven rapid efficacy and Drug Research
safety of Rapaflo will provide BPH patients and their May 18, 2009, Fierce Biotech
physicians an important treatment option. We expect our http://www.fiercebiotech.com/story/europe-awards-
three-day sample packs to clearly demonstrate their rapid 331m-accelerate-drug-research/2009-05-
tolerability of Rapaflo,” said Paul Biasro, President and 18?utm_medium=nl&utm_source=internal
Chief Executive of Watson.
Europe’s Innovative Medicines Initiative has handed out
First Launch for Minodronic Acid in $331 million to back 15 cutting-edge research projects
designed to make the continent more competitive with
Japan the United States when it comes to drug development.
April 17, 2009, SCRIP
Academic groups and small companies alike competed for
Astellas and Ono have launched the oral bisphosphonate the support--a combination of €110 million in cash from
minodronic acid bydrate in Japan, its first market the European Union and €136 million in kind from the
worldwide, for the treatment of osteoporosis. The product continent's pharmaceutical industry. That money will go to
is being co-marketed by the two firms as Bonoteo and back "pre-competitive" work that will provide solutions to
Recallbon respectively. common problems in drug development.

Osteoporosis affects an estimated 10 million people in Regulus Therapeutics gets Initial


Japan, where a number of other bisphosphonates are
already on the market. Several of these, including Milestone from GSK Collaboration
Takeda/Ajinomoto’s Benet/Actonel (risedronate), are May 16, 2009, Pharmabiz, Carlsbad, California
available in once-weekly formulations.
Regulus Therapeutics Inc announced that it achieved the
initial milestone from GlaxoSmithKline (GSK) as part of
their ongoing worldwide strategic alliance established to
discover, develop and market novel microRNA-based
therapeutics to treat inflammatory diseases. The two
companies are working to identify drugs directed at four

R&D/Clinical Trials different microRNA targets related to inflammatory


disease.

Regulus has now reached an important discovery


Glaxo Forges $370M Pact with Oxford milestone, which triggered a payment, concurrent with
Biotherapeutics the first demonstration of a pharmacological effect in
May 18, 2009, Fierce Biotech immune cells by specific microRNA inhibition. Scientists
http://www.fiercebiotech.com/story/glaxo-forges-370m- successfully delivered specific microRNA inhibitors, known
development-pact-oxford-biotherapeutics/2009-05- as anti-miRs, to mice and clearly identified changes in
18?utm_medium=nl&utm_source=internal expression of the genes regulated by the microRNA in
immune cells.
GlaxoSmithKline has committed up to $370 million for a
new deal designed to bolster its presence in the cancer Lilly to Present Above 50 Studies at
market. The pharma giant announced a drug development ASCO 2009
pact with Oxford BioTherapeutics to discover, develop and
commercialize new therapeutic antibodies for the
May 15, 2009,Pharmabiz
treatment of primary, metastatic and recurring forms of http://www.pharmabiz.com/article/SectionWiseArchive
cancer. OBT gets an undisclosed upfront and the rest in News.asp?id=4
milestones.
Eli Lilly and Company will unveil data from more than 50
"We are extremely pleased to be collaborating with GSK studies at the 45th Annual Meeting of the American
given their proven commitment to innovation and their Society of Clinical Oncology (ASCO) in Orlando, Fla. from
expertise in the development and commercialization of May 29 to June 2, 2009. Majority of the presentations are
novel oncology medicines," said Christian Rohlff, CEO of learnt to support Lilly's leadership in thoracic cancer
OBT. research. The company will present the latest research
findings on Alimta (pemetrexed for injection), as well as
Gemzar (gemcitabine HCl for injection), and enzastaurin,
an investigational, oral, targeted therapy.
Organisation of Pharmaceutical Producers of India 6
Pharma Spectrum

Exelixis Inc and Boehringer Ingelheim, a global


This year's ASCO also marks the first time Lilly will pharmaceutical group of companies headquartered in
feature the newest molecules in its portfolio resulting Germany, have established an exclusive, worldwide
from Lilly's recent acquisition of ImClone Systems. collaboration with the aim to discover, develop and
commercialise autoimmune disease therapies. The
Roche Ties Up with Tekmira Pharma to collaboration is focused on the discovery of sphingosine-1-
phosphate type-1 receptor (S1P1) agonists. The S1P1
Advance RNAi Product Candidates receptor is a central mediator of multiple pathways
Thursday, May 14, 2009, Pharmabiz, implicated in a variety of autoimmune diseases.
Vancouver, BC
Under the terms of the agreement, Exelixis will receive a
Tekmira Pharmaceuticals Corporation has entered into a $15 million upfront payment. In addition, Exelixis will
product development agreement with global healthcare potentially receive up to $339 million in milestone
company Roche to advance Roche's first two RNA payments dependent on the successful achievement of
interference (RNAi) product candidates into human clinical development, regulatory and commercial programme
testing. Both of the product candidates will be based on goals and royalties on sales of potential products
Tekmira's stable nucleic acid-lipid particle (SNALP) commercialized under the collaboration.
technology.
Jubilant In R&D Deal with AstraZeneca
Under the terms of the product development agreement, May 6, 2009, Hindu Business Line
Roche will pay Tekmira up to US$ 18.4 million to support http://www.thehindubusinessline.com/2009/05/06/storie
the advancement of the product candidates to the filing of s/2009050650540200.htm
Investigational New Drug (IND) applications. Tekmira is
also eligible to receive up to US$ 32 million in milestones Jubilant Organosys Ltd announced that its Bangalore-
plus royalties on product sales as the first two products based subsidiary, Jubilant Biosys Ltd, has signed a
are advanced through development and commercialization research collaboration agreement with AstraZeneca,
based on Roche's access to Tekmira's intellectual property which is focused on developing new drugs to add to the
under previously announced agreements. international pharmaceutical company’s pre-clinical
pipeline.
Pfizer's Kindler Lays Out His Vision for
R&D Teams Jubilant Organosys is expected to earn $220 million in
research and milestone fees through this deal. Of this, it
May 12, 2009, Fierce Bioresearcher will get about $20 million as definite payment from
http://www.fiercebioresearcher.com/story/pfizers- AstraZeneca, with an annual payment of about $3 million
kindler-lays-out-his-vision-r-d-teams/2009-05- coming in during the first two years. It could also
12?utm_medium=nl&utm_source=internal potentially earn up to $200 million as and when it meets
certain targets in developing drugs under the deal. The
Takeda isn't the only big pharma company looking for ways two firms will work on neuroscience-related drugs.
to push scientists into a new, more productive groove.
Pfizer CEO Jeff Kindler has made R&D productivity a key
theme. And he sat down with the Wall Street Journal Oxford Biomedica, Sanofi-Aventis Enter
recently to review how R&D teams need to be Pact to Develop Gene-Based Medicines
structured in order to be successful.
for Ocular Diseases
First, he said, the teams have to be a manageable size. May 4, 2009, Pharmabiz, Oxford, UK
Say, no bigger than 100 to 150, so they can all fit into one http://www.pharmabiz.com/article/detnews.asp?articleid
cafeteria. Second, the team leaders, the CSOs, need to be =49540&sectionid=20
at the top of their field. And, third, they need to be left
alone to create a distinctive culture, being evaluated Oxford BioMedica announced that it has entered into a
based on their success demonstrating proof of concept. new collaboration with sanofi-aventis to develop novel
gene-based medicines, utilising the company's LentiVector
Exelixis, Boehringer Ingelheim gene delivery technology, for the treatment of ocular
Collaborate to Develop Autoimmune diseases.
Disease Therapies
Oxford BioMedica will receive an upfront payment of
May 11, 2009, Pharmabiz, South San US$26 million (£18 million) and committed funding of up
Francisco, California to a further US$24 million (£16 million) over three years.
http://www.pharmabiz.com/article/detnews.asp?articleid In addition, sanofi-aventis has an exclusive option for a
=49654&sectionid=20 worldwide licence to develop and commercialise four
ocular products. If successful, Oxford BioMedica will
Organisation of Pharmaceutical Producers of India 7
Pharma Spectrum

receive further undisclosed license fees, milestone multiple myeloma. Cougar will work with Ortho Biotech
payments and royalties on product sales, the terms of Oncology R&D, a unit of Centocor R&D.
which are consistent with other deals of this size and
scope. Cougar is conducting two Phase III trials for abiraterone
Pfizer, MMV Ink Pact to Fight against acetate for prostate cancer. The first
study involves patients with metastatic, castration-
Malaria resistant prostate cancer who have progressed after
April 25, 2009, Pharmabiz, New York docetaxel-based chemotherapy has failed. The second
http://www.pharmabiz.com/article/detnews.asp?articleid trial is testing patients who have not receive
=49413&sectionid=6 chemotherapy.

Pfizer Inc and Medicines for Malaria Venture (MMV) have Aurobindo, Pfizer Expand Product
signed an agreement that is designed to facilitate
advancements in the battle against malaria, a disease that Portfolio
afflicts vulnerable populations in the developing world May 21, 2009, Pharmabiz
each year. Under the agreement, MMV will have access to
the Pfizer library of novel chemical entities, in order to Aurobindo Pharma has expanded its partnership with
screen it for compounds that have the potential to be Pfizer Inc, a global leader in pharmaceuticals, by
developed into new treatments for malaria. executing licensing and supply agreements for several
solid dosage and sterile products for a number of emerging
Malaria causes an estimated 881,000 deaths each year, of markets.
which over 90 per cent are in Africa and 85 per cent are
children under five years of age. Under the terms of the agreement, Pfizer has acquired
rights to 55 solid oral dose products and five sterile
Arzoxifene Shown to Increase Bone injectable products for several countries throughout Asia,
Latin America, Africa and the Middle East. These products
Mineral Density fall under a broad range of some important therapeutic
April 17, 2009, SCRIP segments such as anti infectives, cardiovascular (CVS) and
central nervous system disorders (CNS).
A study of Lilly’s investigational selective oestrogen
receptor modulator (SERM) arzoxifene showing it to Claris Partners Pfizer to Strengthen
increase lumbar spine and total hip bone minderal density
(BMD) in postmenopausal women with normal or low bone Regulated Market Presence
mass, has been published in the Journal of Endocrinology May 21, 2009, The Hindu Business Line
& Metabolism. http://www.thehindubusinessline.com/2009/05/21/storie
s/2009052150490200.htm
In addition, arzoxifene, dosed at 20mg/day, decreased the
biochemical markets of bone turnover, and showed a Pharmaceutical major Claris Lifesciences Ltd today
neutral effect on the uterus and endometrium. announced a partnership with global giant Pfizer Inc. to
commercialise sterile injectable drugs that are off-patent
and have lost market exclusivity in the US, Canada,

Mergers & Europe, Australia and New Zealand.

Pfizer, with a turnover of $10 billion in established


Acquisitions/Collabo products annually, had a similar licensing agreement with
Aurobindo Pharma Ltd.

rations Sanofi-Aventis, DNDi Tie Up For


J&J Buys Cougar Biotech for $1B Sleeping Sickness Drug Fexinidazole
May 22, 2009, Fierce Biotech May 19, 2009, Pharmabiz, Paris
http://www.fiercebiotech.com/story/breaking-news-j-j- http://www.pharmabiz.com/article/detnews.asp?articleid
buys-cougar-biotech-1b/2009-05- =49791&sectionid=14
21?utm_medium=nl&utm_source=internal
Sanofi-aventis and the non-profit Drugs for Neglected
Johnson & Johnson has snagged a biotech with a late- Diseases initiative (DNDi) have signed an agreement for
stage oncology drug in its pipeline. J&J will pay $1 billion the development, manufacturing and distribution of
cash for Los Angeles-based Cougar Biotechnology, which is fexinidazole, a promising new drug for the treatment of
developing drugs for prostate cancer, breast cancer and human African trypanosomiasis, also known as sleeping

Organisation of Pharmaceutical Producers of India 8


Pharma Spectrum

sickness, a fatal disease that threatens 60 million people minority shareholders in Schwarz Pharma to UCB SP
in Sub-Saharan Africa. GmbH, as the principal shareholder, to EUR 111.44 per
share.
Fexinidazole will enter clinical development in the first GSK Extends Strategic Collaboration
half of 2009 and is the only new drug candidate in clinical
development for sleeping sickness. Under the terms of the with Aspen
agreement, DNDi will be responsible for preclinical, May 13, 2009, Pharmabiz, London
clinical and pharmaceutical development. Sanofi-aventis http://www.pharmabiz.com/article/detnews.asp?articleid
will be responsible for the industrial development, =49696&sectionid=14
registration, and production of the drug at its
manufacturing sites. Considering their respective GlaxoSmithKline plc (GSK) has agreed to extend its
commitments to fight sleeping sickness, sanofi-aventis and strategic relationship with Aspen Pharmacare Holdings
DNDi have decided to combine their expertise to making Limited (Aspen) and to acquire a 16 per cent shareholding
fexinidazole available on a non-profit basis to all patients in the South African based pharmaceuticals company. This
who need it. is part of a wide ranging agreement which includes
combining commercial activities in sub-Saharan Africa and
Sanofi Inks $315M Inflammation Pact the divestment of several assets to Aspen.
with Kyowa Abbas Hussain, president Emerging Markets,
May 14, 2009, Fierce Biotech GlaxoSmithKline said, "Extending our strategic relationship
http://www.fiercebiotech.com/story/sanofi-inks-315m- with Aspen supports GSK's strategy to accelerate sales
inflammation-pact-kyowa/2009-05- growth in emerging markets. The combination of our
14?utm_medium=nl&utm_source=internal commercial activities in Sub-Saharan Africa is highly
complementary and will mean that together we can
Now that Sanofi-Aventis has finished trimming some of its provide more medicines of value to more patients in these
marginal drug development programs, the French pharma countries. At the same time, GSK will also benefit from
is reloading its pipeline with a licensing deal for a investing in one of Africa's leading healthcare companies
preclinical antibody advanced by Japan's Kyowa Hakko with a formidable track record of delivery."
Kirin. Sanofi says that the inflammation deal will be worth
up to $315 million in upfront fees and milestones for Merck Buys Clostridium difficile
Kyowa. The companies didn't break that number down.
Sanofi snared worldwide rights to the anti-light fully Combination Rights
human monoclonal antibody, with a co-promotion pact in May 1, 2009, SCRIP
place for Japan and Asia. The program will initially test
the antibody's effectiveness against ulcerative colitis and Merck & Co. has acquired the worldwide rights to a
Crohn's disease and, depending on the data, could be biologic treatment for Clostridium difficile infection in
further pursued into rheumatoid arthritis. a $ 225 million deal with Medarex and Massachusetts
Biologic Laboratories (MBL) of the University Of
UCB to Acquire Schwarz Pharma Shares Massachusetts Meidcal School.
May 13, 2009, Pharmabiz, Brussels, Belgium Merck will pay $ 60 million up front for the licence to
http://www.google.co.in/search?hl=en&q=PharmabizUCB+ develop and commercialise CDA – 1 and CDB-1, which was
to+acquire+Schwarz+Pharma+shares&btnG=Search&meta= being developed by Medarex and MBL, and could pay a
&aq=f&oq= further $ 165 million in milestones, as well as double-digit
royalties on sales.
UCB is seeking to acquire the Schwarz Pharma shares held
by minority shareholders - representing approximately 0.4
per cent of stock capital - by way of a so-called 'squeeze- BMS and Ensemble in $249 Million Drug
out' procedure. In accordance with the legally stipulated Discovery Deal
procedure (under Sections 327a ff. of the German Stock April 17, 2009, SCRIP
Corporation Act [AktG]), the Schwarz Pharma shares held
by minority shareholders are to be transferred to UCB and Bristol-Myers Squibb and Ensemble Discovery are to
in return for an appropriate cash compensation, by way of discover and develop novel drug candidates in a deal
a resolution still to be passed by the Annual General worth up to $248.5 million.
Meeting of Schwarz Pharma AG.
Ensemble is developing Ensemblins, a new class of oral
UCB SP GmbH, Monheim, as the principal shareholder of drug molecules for targets that cannot be modulated
Schwarz Pharma, informed the Executive Board of Schwarz effectively by traditional small-molecule pharmaceuticals.
Pharma AG in a letter that it had set the cash The deal will aim to develop Ensemblins for up to eight
compensation for the transfer of the shares held by targets.
Organisation of Pharmaceutical Producers of India 9
Pharma Spectrum

INTERNATIONAL ACQUISITIONS - April ‘09


Listed below are some of the acquisitions that happened in the Pharmaceutical and Biotechnology domains in
the month of April, 2009. The list below mentioned the company acquired, and its country, bidder company
and value of the acquisition (where available).

Pharmaceutical
Date Target Company Bidder Value Country Type of Deal
(USD
mn)
Clinical Data Inc Beckman Acquisition, Cross border,
01/04/2009 USA
(Cogenics division) Coulter Inc 18 Private
Tongjitang
Anhui Jingfang
Chinese
02/04/2009 Pharmaceutical Co China Acquisition, Domestic, Private
Medicines 9
Ltd
Company
Piedmont Charles River
03/04/2009 Research Center Laboratories USA Acquisition, Domestic, Private
46
LLC International Inc
Gainbridge
SSL Acquisition, Cross border,
07/04/2009 Investments Cyprus
International Plc 27 Private
(Cyprus) Limited

Beleggingsmaatsch
SSL Acquisition, Cross border,
07/04/2009 appij Lemore B.V Netherlands
International Plc 93 Private
(34.50% stake)

Medley S/A
Sanofi-Aventis Acquisition, Cross border,
09/04/2009 Industria Brazil
SA 658 Private
Farmaceutica
Cipla Medpro Adcock Ingram
09/04/2009 South Africa Acquisition, Domestic, Public
South Africa Ltd Limited 266
Oktogon Acquisition, Cross border,
16/04/2009 Torfarm SA Denmark
Investment ApS 14 Private
Pfizer
16/04/2009 Pfizer Ltd Investments India Acquisition, Cross border, Public
27
Netherlands BV
Stiefel GlaxoSmithKline Acquisition, Cross border,
20/04/2009 USA
Laboratories, Inc. Plc 3,300 Private

Biotechnology
Magen BioSciences
03/04/2009 PPD Inc USA Acquisition, Domestic, Private
Inc 15
Rosetta Genomics Prometheus
13/04/2009 Israel Acquisition, Cross border, Public
Ltd (16.43% stake) Laboratories Inc 8
British
Genetel Biotech HD Global Acquisition, Cross border,
17/04/2009 Virgin
(BVI) Limited Limited 36 Private
Islands
Korea Bone Bank Acquisition, Buy & Build, Cross
21/04/2009 Endotec Inc. USA
Co., Ltd. 20 border, Private

For further information please contact Yes Bank Ltd. Deal values approximated to nearest million.

Organisation of Pharmaceutical Producers of India 9A


Pharma Spectrum

societies. Then there was the push for price cuts in poor
countries. And now this.

Pricing Trade & Others


Colombia Sets Kaletra Price Ceiling
Hetero Readies Drugs for Treating
13 May 2009, SCRIP, Francesca Bruce
'Swine Flu'
"The Colombian government has set a maximum price for May 13, 2009, Hindu Business Line
Abbott's Kaletra (lopinavir plus ritonavir), reducing the http://www.thehindubusinessline.com/2009/05/13/storie
private sector price by around 55%. However, civil society s/2009051350710200.htm
is still pushing for the government to issue a compulsory
licence.The national medicine pricing commission has set Hetero Drugs, the lead supplier of ‘Tamiflu’, which is
the maximum public sector price at $1,067 (down from considered the best bet to treat ‘swine flu’, has lined up
$1,683) per patient per year, and $1,591 for the private supply of nine million capsules to the Centre, as part of
sector (down from around $3,500). the national preparedness to tackle a possible pandemic.
“We have already supplied two million capsules, by end of
The move follows talks with Abbott after the government May another three-four million would be sent and by June
called for the firm to match the prices charged elsewhere 10, 2009 will complete the entire supply,” Mr Srinivas
in the region (scripnews.com, April 22nd, 2009). Local Reddy, Director (Marketing) of the Hyderabad-based drug
media reports suggest that Abbott refused to lower its major, said.
prices, prompting the government to take action. The firm
was unable to comment, but it stated earlier that it had Immediately after reports of detection of swine flu cases
already lowered its prices three times over the past two in Mexico and other parts, the Centre had sounded Hetero
years.Nevertheless, the price ceiling still means that Drugs for an immediate supply of 10 lakh doses of generic
Kaletra is not subject to competition from generics. Many versions of Roche’s anti-influenza drug Tamiflu.
groups are therefore still arguing for the Colombian
government to declare lopinavir plus ritonavir of public Trend: Hospitals Mounting Attack on
interest, which would allow it to issue a compulsory
licence for the drug. The health ministry should make a Retail Clinic Business
decision on this at the end of the week. May 11, 2009, Fierce Healthcare
http://www.fiercehealthcare.com/story/trend-hospitals-
Inaccurate: GSK Launches 50% Discount mounting-attack-retail-clinic-business/2009-05-
11?utm_medium=nl&utm_source=internal
for Uninsured
May 7, 2009, Fierce Pharma For a while, it was beginning to look like the retail clinic
http://www.fiercepharma.com/story/glaxo-launches-50- phenomenon was peaking or perhaps even petering out,
discount-uninsured/2009-05- with a handful of clinics even being forced out of business.
07?utm_medium=nl&utm_source=internal But maybe the truth is that the battleground is shifting--
from growth fueled by pharmacy chains and independent
Andrew Witty puts charity to work again. The operators to a gradual encroachment by hospitals.
GlaxoSmithKline CEO, who's already pledged to slash
prices for drugs sold in poor countries, now is offering a 50 While hospitals have been dabbling in the retail clinic
percent discount on meds for U.S. patients who are market for years, a growing number are dipping their oar
uninsured. The discount-card program applies to anyone in. For example, the Cleveland Clinic has lent its
under 65 who doesn't have insurance, and patients will impeccable brand and services to several CVS clinics in
have access to it until they get employer-sponsored Ohio, and the Mayo Clinic is operating two clinics in
coverage or until health reform takes care of their Rochester, MN supermarkets.
insurance problems, whichever comes first. No income
restrictions apply, either. Big Pharma Grows Online, Slowly
Deirdre Connelly, Glaxo's U.S. pharma president, explains,
May 11, 2009, Fierce Pharma
"We feel this is simply the right thing to do, especially in http://www.fiercepharma.com/story/big-pharma-grows-
this economy." Apparently, "the right thing to do" has been online-slowly/2009-05-
much on Witty's mind; as you know, he's has been on 11?utm_medium=nl&utm_source=internal
something of a good-boy binge. He's pledged to disclose
payments to doctors and to limit them, too, and also Welcome to the revolution--the social media revolution,
promised to publish info on Glaxo's support for medical that is. Big Pharma is finally joining the party, AdAge
reports, with a 36 percent increase in internet-media

Organisation of Pharmaceutical Producers of India 10


Pharma Spectrum

spending in 2008. Though plenty of folks consider http://www.financialexpress.com/news/us-trade-pacts-


drugmakers' arrival to be too little, too late--even after could-harm-indian-pharma/454952/
that 36 percent hike, pharma still spent only $137 million
online--the trade pub allows that FDA regulation makes it Concerned over certain clauses in the free trade
tough for them to be early adopters. agreements (FTAs) of the US that could potentially curb
Indian pharmaceuticals exports, New Delhi has decided to
Some of the mag's examples of pharma's forays online: take up the matter with Washington soon. India’s concerns
Johnson & Johnson has a blog; AstraZeneca, Boehringer about the FTAs of the US — for instance the one which the
Ingelheim and Novartis send out company news via US has with Morocco — stem from certain provisions in
Twitter; Sanofi-Aventis and AstraZeneca have relatively such trade pacts that aim at increasing the duration of
new YouTube channels. We'd add that Pfizer and Roche drug patents.
both tweet news, too. You pharma-marketing experts
know of more examples, few and far between though they Usually, a patent is meant to last only for 20 years.
are. However, these FTA clauses ensure the ‘patentability of
new uses of discovered inventions’ (meaning even minor
Dutch Body Lures IT, Pharma Companies changes of an existing drug can be patented). The
provisions are also aimed at increasing duration of the
May 9, 2009, Hindu Business Line patent monopoly (a strategy called ‘ever-greening’ of
http://www.thehindubusinessline.com/2009/05/09/storie patents) by taking into account the time taken to process
s/2009050951021700.htm patent claims.
Having assisted around 80 Indian companies establish
offices in the Netherlands, the Netherlands Foreign Glaxo, Roche Combat Antiviral Hoarding
Investment Agency (NFIA) in India is luring companies here May 4, 2009, Fierce Pharma
to look at Europe. According to NFIA, in the last two years http://www.fiercepharma.com/story/glaxo-roche-
alone nearly 25 companies have established their presence combat-antiviral-hoarding/2009-05-
in the Netherlands. 04?utm_medium=nl&utm_source=internal

“Opportunities exist during these recessionary times. An GlaxoSmithKline and Roche have been reduced to playing
investment in Europe would be a profitable strategy for flu-drug traffic cop. Because the worried well are
Indian companies in today’s economic context. When snapping up drugs all over the world, prompting shortages
growth returns to the world economy, as it inevitably will, in some places, the drugmakers are strategically allocating
the companies that have established their presence in their stocks. Glaxo says it's sending its antiviral Relenza to
Europe will have the first-mover advantage,” says Mr areas of the U.S. and elsewhere in the world that need it
Robert Schipper, Executive Director, NFIA-India. most. Roche has actually cut off French pharmacies
because of a run on its Tamiflu drug; it's only supplying
Ranbaxy to Sell Generics Medicines Tamiflu to hospitals in France.
under AOK Agreement in Germany The number of daily prescriptions for antiflu drugs
May 6, 2009, Pharmabiz skyrocketed last week to nine times previous April levels,
http://www.pharmabiz.com/article/detnews.asp?articleid the New York Times reports. To help keep up with
=49594&sectionid=5 demand, Roche and Glaxo quickly jacked up production:
Glaxo now has 6 million Relenza treatments in stock and
Ranbaxy Laboratories' German subsidiary Basics GmbH plans to boost production to 5 million treatments per
(Basics) has concluded new discount agreement with AOK month.
Baden Wurttemberg, biggest health insurance group, for
providing Cefaclor Basics and Tamsulosin Basics during the Ranbaxy Forced to Recall Drug from US
year 2009 and 2010. The agreement will come into effect
from June 1, 2009.
May 3, 2009, Business Standard
http://www.business-standard.com/india/news/ranbaxy-
Cefaclor Basics product will be exclusive for all 15 AOK forced-to-recall-drugus-mkt/356916/
regional associations and five zones. Similarly, Tamsulosin
Basics will be exclusive for 13 AOK regional associations Withdrawal of nitrofurantoin capsules in coordination with
and four zones. the US FDA and will be at retail level. Ranbaxy
Laboratories is facing more trouble in the US. Quality
issues have forced the company to withdraw all batches of
US Trade Pacts Could Harm Indian a generic urinary infection antibiotic drug.
Pharma
May 6, 2009, Financial Express Ranbaxy Pharmaceuticals Inc (RPI), the US subsidiary of
Ranbaxy, today said it was conducting a voluntary recall of

Organisation of Pharmaceutical Producers of India 11


Pharma Spectrum

all lots of nitrofurantoin (monohydrate/macrocrystals) 100


mg capsules currently in the market in the US.

Novo Nordisk Among World's Most Docs Like E-Promos


April 28, 2009, Fierce Pharma
Ethical Companies: Ethisphere Study http://www.fiercepharma.com/story/news-flash-docs-e-
May 2, 2009, Pharmabiz promos/2009-04-28?utm_medium=nl&utm_source=internal

Novo Nordisk, the world leader in diabetes care is Look no further for more evidence that humanity is
recognized as one among the top ethical companies in the getting a little too, er, enamored with the internet.
world according to Ethisphere study. The analysis is based According to a study of pharma e-promotions, almost
on the sustainable and ethical leadership of the Denmark three-fourths of doctors said they'd just as soon talk with
drug major. a computer than with a drug rep--and some even
preferred the computer.
More than 10,000 of the world's leading companies were
analyzed for a period of six months in six continents, If this study is to be believed, it's clear why e-promotion is
across 35 industries before arriving at the final list. These on the move. More than two-thirds of physicians said they
companies were evaluated on seven key parameters which had a positive attitude toward this type of interaction
included corporate responsibility, governance, innovation with drugmakers. Perhaps that's because they could do so
leadership, integrity track record, internal systems at their leisure. Almost 70 percent said they did their e-
programme before deciding on the final list. promos in the evenings. Or perhaps it's just because they
don't have to make conversation.
Indian Pharma Emerges Big Plan in
Japan Institute of Medicine: Time to Nix
May 2, 2009, Business Standard Pharma Gifts
http://www.business- April 28, 2009, Fierce Pharma
standard.com/india/storypage.php?autono=356834 http://www.fiercepharma.com/story/institute-medicine-
time-nix-pharma-gifts/2009-04-
Leading Indian drug makers such as Ranbaxy, Lupin, Zydus 28?utm_medium=nl&utm_source=internal
Cadila and Dishman, which forayed into Japan in the past
three years, have emerged as important players in the The government's top medical advisers are now
generic or copycat drug business of patented medicines in putting their two cents into the conflict of
that market, the second largest in the world. interest debate. The Institute of Medicine says that
collaborations between medical professionals and
The Japanese drug market, second after the US with a size drugmakers can benefit society, but financial ties are
of $74 billion, has a small generic segment, worth 5 getting in the way. In the 353-page report, IOM's
percent of the total in value terms and 17 percent in Committee on Committee on Conflict of Interest in
volume terms. Medical Research, Education, and Practice warns that
current industry practices are negatively influencing
Biocon Taps German Market through research and patient care.
Axicorp The Committee calls on medical professionals to cut or
April 30, 2009, Pharmabiz restrict many practices that have now become a common
http://www.pharmabiz.com/article/detnews.asp?articleid part of the pharma-doctor relationship, including
=49535&sectionid=50 the elimination of free meals, gifts and travel
arrangements. Drug samples? Only for those who can't
The Bangalore-based leading biotech player Biocon's afford the meds. Meetings with sales reps? Restricted.
moves to tap growing business opportunities in Germany Pharma-sponsored presentations and ghost-writing
has achieved further momentum as its German subsidiary articles? Out. And researchers are being advised not to
AxiCorp bagged a tender offer from AOK, Germany's sign on for studies if they have a financial stake in the
largest health insurer, to supply Metformin, a key diabetic outcome.
generic drug in Germany. The AOK tender is valued at
Euro 13.5 million. Cipla Ready to Supply Generic Drug to
The contract is planned to be awarded for the entire West
German territory over the next 2 years and is subject to April 28, 2009, Financial Express
review in accordance with the German tender regulations. http://www.financialexpress.com/news/cipla-ready-to-
The tender is expected to strengthen the market presence supply-generic-drug-to-west/451953/0
of AxiCorp in the booming generic business.
Organisation of Pharmaceutical Producers of India 12
Pharma Spectrum

As worries about a possible swine flu outbreak in the West Lipovas (simvastatin). Banyu will continue to produce,
spread, pharma major Cipla Ltd on Monday said it is ready distribute and sell the products.
to supply 1.5 million doses of oseltamivir, the generic
version of the bird flu drug, Tamiflu, which can be Global $225 Million Malaria Drug
effective for swine flu.
Scheme Launched
Cipla, which had challenged multinationals with its cheap April 17, 2009, SCRIP
versions of AIDS drugs for a Medecins Sans Frontieres
programme in Africa years ago, said it can deliver the drug A global scheme to subsidise newer medicines for malaria-
in a month. “Cipla has the capacity to supply the drug endemic countries has been finally launched, costing
within 4-6 weeks,” Amar Lulla, joint managing director, $225-233 million in the first two years.
Cipla, said on Monday.
Most of the funding will come from UNITAID, an
$1b Drug Market in Africa at Stake international drug purchasing facility (which has more
than 25 donor nations), and the UK government. Other
April 26, 2009, Financial Chronicle countries, including the Netherlands, are considering a
http://www.mydigitalfc.com/news/1b-drug-market- financial contribution to the scheme.
africa-stake-625

India has charged the European Union (EU) with working Move to Publish “Secret” Anti-
against its drug exports to Africa and South America. The Counterfeiting Treaty “Modest Step”
Indian pharmaceutical industry’s exports to Africa are April 17, 2009, SCRIP
worth $1,065 million a year, a market that will be lost if
the EU, prodded by multinational companies, succeeds in Following mounting pressure, the Office of the US Trade
convincing African nations to not import Indian medicines. Representative (USTR) has published a six – page summary
on the “secretive” anti-counterfeiting trade agreement
Kenya has already issued a notification saying that generic (ACTA) that it is negotiating with major trading partners
drugs – the Indian industry’s strong point -- patented including the EU and Japan. Essential Action, which has
elsewhere cannot be sold in that country. The law, in being calling for its publication with more than 100 other
fact, classifies generic drugs as spurious. public interest groups around the world, told Scrip that
the move was a “modest step forward”.
Genentech Withdraws Raptiva in the US
April 17, 2009, SCRIP Its Director, Robert Weissman said he hoped the move
signaled the beginnings of a new progressive policy on
Genentech is to withdraw its psoriasis therapy Raptiva transparency at the USTR.
(efalizumab) in the US based on its association with an
increased risk of developing progressive multifocal
leucoencephalopathy (PML), a rare and potentially fatal
brain infection. Biotechnology
Three patients taking the monoclonal antibody therapy Sanofi-Aventis Builds $350m Dengue
were diagnosed with cases of PML, two of which were
fatal. A fourth patient developed progressive neurological Fever Vaccine Plant
symptoms and died of an unknown cause (scripnews.com; May 13, 2009, Financial Chronicle
November 18th, 2008).
Sanofi-Aventis began work on Tuesday on a €350 million
Merck & Co Taps Mylan for Japanese ($477 million) plant that is to be devoted to production of
the world’s first vaccine against dengue fever, a public
Promotion health threat for some two-fifths of the world’s
April 17, 2009, SCRIP population.

Banyu, Merck & Co’s subsidiary in Japan, has tapped the The company says its vaccine plant in this town north of
generics company Mylan to promote two of its key Lyon is the largest single industrial investment it has ever
cardiovascular products in the country. made. By 2013 it is hoped the plant will begin turning out
a dengue vaccine that the company is, at present, testing.
From May 1st, the US generics firm will begin providing
information to hospitals and other medical facilities for
the ACE-inhibitor Renivac (enalapril) and the hypolipaemic

Organisation of Pharmaceutical Producers of India 13


Pharma Spectrum

combination of two small molecules, formulated for oral


use, which are believed to reduce the accumulation of
Pfizer, WARF Sign License Agreement DNA-damage, the underlying biochemical cause of
for Human Embryonic Stem Cell Patents Cockayne Syndrome.
May 7, 2009, Pharmabiz, Madison, Wisconsin
http://www.pharmabiz.com/article/detnews.asp?articleid Cockayne Syndrome, the initial target of Prodarsan, is a
=49602&sectionid=3 rare genetic disease in which children suffer from
accelerated (or premature) aging, while developing severe
Pfizer Inc, the world's premier biopharmaceutical aging diseases. Progeria diseases are a group of genetic
company, and the Wisconsin Alumni Research Foundation premature aging diseases which manifest in several forms
(WARF), the private, non-profit patenting and licensing that are genetically and clinically similar although not
organisation for the University of Wisconsin-Madison, have identical. Depending on the specific form of the disease,
signed a license for human embryonic stem (hES) cell patients have a significantly reduced life expectancy and
patents for the development of new drug therapies. exhibit many aging-related symptoms early on in their
lives. Quality of life for these patients is seriously
The WARF license provides Pfizer the rights to work with impaired. Cockayne Syndrome is one of the more common
hES cells for drug research and discovery. Securing forms of progeria and is characterized, among others, by
appropriate licenses, in an area as broad and rapidly growth failure, mental retardation, hearing and sight
moving as regenerative medicine, helps ensure rapid and problems and a reduced life expectancy. Currently, no
efficient utilization of the many existing discoveries and effective therapy for Cockayne Syndrome is available.
inventions in this field and allows for the efficient transfer
of information for development of future inventions

Big Pharma Swallows Billions in Biotechs


New Appointments
May 5, 2009, Fierce Pharma
http://www.fiercepharma.com/story/big-pharma-
IFPMA New Appointment
swallows-billions-biotechs/2009-05- April 29, 2009, IFPMA
05?utm_medium=nl&utm_source=internal
Ms. Alicia Greenidge, IFPMA’s Director General, is
Megamergers may have grabbed most of the headlines of resigning her position in order to pursue other
late, but drug makers snapped up plenty of small firms opportunities. Ms. Greenidge came to IFPMA in 2008 after
last year, Ernst & Young points out. In 2008, pharma a distinguished career in the United State Government.
swallowed some $28.5 billion worth of U.S. biotech
companies, just a few billion short of a $33 billion record During the search for a successor, Laurent Renaud,
in 2007. And if you back out AstraZeneca’s 2007 buyout of Director of Administration and Finances, IFPMA will take
vaccine maker MedImmune--a whopping $15.6 billion deal- on the day-to-day administrative operations of the
-then 2008 totted up the highest biotech M&A total ever. organisation under the direction of Michael Boyd, Vice
President of Public Affairs International for Schering-
The 2008 deal roster includes TakedTakeda’s $8.8 billion Plough Corporation, who will be serving as Acting Director
acquisition of Millennium Pharmaceuticals, which makes General.
the multiple myeloma treatment Velcade, and Eli Lilly’s
$6.5 billion deal for ImClone Systems, maker of cancer-
fighter Erbitux. Meanwhile, pharma took some $5 billion in
European biotechs under its wing last year, including
Novartis’ purchase of the Swiss firm Speedel for $932
million

Pharming Group's Prodarsan Product


Gets Orphan Drug Status from US FDA
April 30, 2009, Pharmabiz, Leiden, The
Netherlands
Biotech company Pharming Group NV announced that its
wholly-owned subsidiary DNage BV has received a notice
from the US Food and Drug Administration that its product
Prodarsan has been awarded an orphan drug designation
for the treatment of Cockayne Syndrome. Prodarsan is a

Organisation of Pharmaceutical Producers of India 14


Pharma Spectrum

'Protection against unfair commercial use' as the Union

Domestic ministry of health and the department of pharmaceuticals


wanted stakeholders to get further engaged in a dialogue
before final details are worked out.

IPR According to sources, the government has accepted the


recommendations of Dr Satwant Reddy committee as far
as 'protection against disclosure' is concerned and may
22 Patent Department Officers announce the same soon. "Government should take
Transferred adequate steps to ensure that specified undisclosed data
May 18, 2009, Mint submitted for seeking marketing approval for
http://www.livemint.com/2009/05/18001429/22-patent- pharmaceutical products is not disclosed to any third
department-officers.html party. Officials in the office of Drug Controller General of
India should be under obligation to keep secret the
The New Controller General of India’s patents, designs and undisclosed information submitted to Drug Regulator for
trademarks office, Mr. P.H. Kurian, has transferred at approval of new drug," the Dr Reddy committee had
least 22 officers in its four regional offices. It is the first recommended.
time, in at least a decade that transfers have taken place
on this scale. US Rakes up Counterfeit Drugs Issue
again by Charging Indian IPR Protection
Kurian, the first Indian Administrative Service officer to
head the patents office, said on Tuesday that the transfers as Weak
were aimed at a more equitable distribution of skilled May 12, 2009, Pharmabiz
officers and group leaders at the right places.
Even as the indirect attempts by the multinationals to
India Needs its Hatch-Waxman Act for equate Indian generics with counterfeit drugs failed at
WHO, the United States has once again raised the issue by
Healthcare expressing concern on the 'weak intellectual property
May 15, 2009, DNA Money rights protection and enforcement' in India.
http://www.dnaindia.com/report.asp?newsid=1256132
The 'Special 301' Report by the Office of the United States
The Hatch-Waxman Act, a legislation that transformed the Trade Representative (USTR), which placed India on the
American drug industry, completed 25 years last week. priority watch list, has called for better and effective
Over those years, the American healthcare system saved a system to check counterfeit drugs.
whopping $734 billion due to increased use of generic
pharmaceuticals. Lupin Settles Venlafaxine XR Capsules
While the opening up of the American drug industry to Litigation with Wyeth
generics did lead to the growth of generic giants like May 11, 2009 Pharmabiz
Teva, Sandoz, Mylan and Ranbaxy, large innovators like http://www.pharmabiz.com/article/detnews.asp?articleid
Pfizer, GSK and Merck have been forced to come out of =49661&sectionid=44
their safety zones of unending patent protection of
blockbuster drugs and see the world differently. Lupin, the sixth largest Indian pharma company with net
Vulnerability grew and so the desire to take sales of over Rs 2,700 crore, has settled all ongoing Hatch-
unprecedented steps for continuous innovations. Waxman litigation relating to venlafaxine extended
release capsules, a generic version of Wyeth's
Govt Accepts Satwant Reddy antidepressant 'Effexor XR' capsules. These capsules had
US sales of $3.01 billion for the year 2008 (IMS) and
Recommendation on Data Exclusivity accounted for 17 per cent of the Wyeth's net revenue in
May 13, 2009, Pharmabiz 2008.
http://www.pharmabiz.com/article/detnews.asp?articleid
=49689&sectionid=44 As per the terms of the settlement, Lupin will be licensed
under the relevant patents and would be free to
After almost two years of discussions with various commercially launch its generic product on or after June
stakeholders, the Centre is learnt to have accepted the 1, 2011, or earlier in certain limited circumstances, but in
recommendations of Dr Satwant Reddy committee on data no event earlier than January 2011.
exclusivity and may offer 'protection against disclosure' to
the pharma companies. However, the government may
take some more time to announce its decision on

Organisation of Pharmaceutical Producers of India 15


Pharma Spectrum

Dr Reddy's Files Post-Grant Opposition The law suit against Lupin pharma is on the allegation that
the company has infringed US Patent No 6,001,876 for
against Pfizer isobutylgaba and its derivatives for the treatment of pain
May 9, 2009, Financial Express issued in December 1999, Patent No 6,197,819 for gamma
http://in.biz.yahoo.com/090508/203/batjqw.html amino butyric acid analogs and optical isomers, issued in
March 2001, and Patent No 5,563,175 GABA and L-glutamic
Pharmaceutical giant Pfizer is facing a post-grant acid analogs for anti-seizure treatment, issued in October
opposition from Dr Reddy's Laboratories for its anti- 1996.
smoking drug, Chantix (Champix in India). The latter has
resisted against the Indian patent (the '091 patent) for the SC Dismisses Plea against Sun Pharma
usage of the tartrate salt of varenicline, the active
May 5, 2009, manoramaonline.com
ingredient of Chantix. Last year in February, Pfizer
http://week.manoramaonline.com/cgi-
launched the varenicline prescription drug in India under
bin/MMOnline.dll/portal/ep/contentView.do?contentId=54
the brand name Champix (Chantix in US).
34451&programId=1073754912&pageTypeId=1073754893&c
on tentType=EDITORIAL&BV_ID=@@@
Recently, the Delhi patent office had rejected a patent
application for Caduet, a high cholesterol and blood
New Delhi: The Supreme Court has dismissed the Central
pressure drug, filed by Pfizer while considering a pre-grant
Excise Department's plea alleging that pharma major Sun
opposition by Torrent. Post-grant opposition allows a
Pharmaceuticals Ltd was undervaluing its physician's
company to challenge the validity of the patent of a drug
samples and thus paying lesser duty.
which has been already launched. A similar post-grant
opposition filed by Wockhardt against Roche's hepatitis C
It alleged that the pharma major, which manufactured
drug, Pegasys, was rejected by Indian patent office
both commercial packs and the physician's sample packs,
recently.
was clearing the latter at a lower assessable value than
the pro-rata value of the sale packs of the same
Indian Patent Office Set for Total medicines.
Revamp, Most Backlog Files to be
Cleared by June End Will Compulsory Licensing Hit Roche,
May 6, 2009, Pharmabiz Glaxo?
http://www.pharmabiz.com/article/detnews.asp?articleid April 30, 2009, Fierce Pharma
=49581&sectionid=44 http://www.fiercepharma.com/story/will-compulsory-
licensing-hit-roche-glaxo/2009-04-30-
The Intellectual Property Office (IPO) of India is all set to 0?utm_medium=nl&utm_source=internal
revamp its entire operations in the country by clearing all
the possible backlog files before July 1, 2009, by more The World Health Organization's hike in pandemic threat
efficient deployment of its available human resources. level triggers certain pharma-related events, particularly
the release of antivirals from government stockpiles
The IPO is in a process of rationalising the allotment of around the world. And with those stockpiles being
patent applications for examination by creating four deployed, naturally FDA et al are coordinating with Roche
groups based on subject expertise to handle the cases and GlaxoSmithKline to get replacement stocks of their flu
promptly. The groups, Chemistry and allied sciences, meds Tamiflu and Relenza.
Biotechnology and microbiology, Mechanical and allied
subjects, Electrical, electronics and related subjects, will Another less-appetizing prospect, for the two drugmakers
be operational soon to handle the files more promptly anyway, is the fact that with a public health emergency
with the available human resource, informed P H Kurian, underway, the World Trade Organization allows various
controller general of patents, designs and trademarks and countries to buy from low-cost suppliers, a.k.a. generics
geographical indications (CGPDTM). firms, despite the fact that both meds are still under
patent. This "compulsory licensing" process allows poor
Pfizer Sues 3 Indian Cos for Patent nations to gain access to meds they can afford, in the
event of an epidemic. Intellectual property protections
Infringement of its Pain Drug, Lyrica can quickly be trampled by officials aiming to protect
May 5, 2009, Pharmabiz their citizenry--and by politicians looking to score some
points in the process.
Pfizer Inc has filed patent infringement suit against three
Indian companies, namely Sun Pharma, Wockhardt Ltd and
Lupin Ltd to block marketing generic equivalents to its
blockbuster neuropathic pain management drug, Lyrica, in
US.

Organisation of Pharmaceutical Producers of India 16


Pharma Spectrum

Govt to Create 1,380 Patent Examiners diarrhoea, fever, pain and hypertension, said a health
ministry official.
Posts
April 27, 2009, Hindu Business Line Known as fixed dose combination (FDC) drugs in
http://www.thehindubusinessline.com/2009/04/27/storie pharmaceutical industry parlance, these will help reducing
s/2009042750770300.htm the number of pills in a single dosage, and consequently
the expenses incurred. For instance, doctors usually
The Centre plans to create 1,380 patent examiners posts prescribe three to four medicines to patients suffering
during the 11th Plan period, of which 414 will be filled up from common cold or diarrhoea. With FDCs, this could be
this year alone.Stating this at a function organised by the cut down to just one.
Confederation of Indian Industry (CII) in partnership with
the Department of Industrial Policy and Promotion (DIPP) DCGI Calls Second Meeting of Expert
here on Sunday, the Joint Secretary in the DIPP, Mr N.N.
Prasad, said that the Centre has spent around Rs 500 crore Panel on FDCs on June 4
in the last five-six years towards the development of hard May 25, 2009, Pharmabiz
and soft intellectual property (IP) rights infrastructure. http://www.pharmabiz.com/article/detnews.asp?articleid
=49878&sectionid=19
Between 1999-200 and 2006-07, the number of patent
applications filed in the country has increased from 4,824 The Drug Controller General of India (DCGI) has called the
to 28,882, with the number of patents granted rising from next meeting of the expert panel on fixed dose
1,881 to 7,359. The number of patent applications filed is combination (FDC) on June 4. The meeting will decide the
projected to jump to about 72,000. The present level of fate of another 28 FDC drugs.
manpower in the IP offices is said to be insufficient to
handle the workload. This is the second meeting of the panel which was formed
last year to resolve the vexed FDC issue. The first meeting
Delhi HC Scraps Roche's Plea of the expert panel was held on January 23 and 24 this
year in which a total of 48 FDC drugs were examined.
April 25, 2009, The Times of India
http://timesofindia.indiatimes.com/Business/HC-scraps-
Roches-plea/articleshow/4445931.cms DCGI Asks State Drug Authorities to
Disallow Cos Altering Compositions
In a ruling that might spell relief for lakhs of lung cancer
patients, the Delhi High Court on Friday allowed Cipla to
without Changing Brand Names
manufacture and sell the generic version of lung cancer May 25, 2009, Pharmabiz
drug `Erlotinib' of Swiss pharma firm Hoffman La Roche http://www.pharmabiz.com/article/detnews.asp?articleid
Ltd. =49880&sectionid=19

Vacating its previous stay order on the generic The office of the Drug Controller General of India has
manufacturer, a division bench also removed all restraints directed the state drug authorities to keep a track of
on Cipla, while exporting the life saving drug to other companies indulging in the practice of changing the
countries in which La Roche has patent rights. The court compositions of products after getting the approval but
dismissed the plea of the Swiss company and also imposed retaining same brand names. Pharma companies have
a cost of Rs 5 lakh on it. been doing this to take advantage of the brand value of
the product and at the same time to escape price control
by substituting decontrolled drugs in the formulation, it is

Regulatory learnt.

State drug authorities usually do not verify such changes in


the composition in the formulations once the product
Over 44 Fixed-Dose Combination Drugs licenses are issued. Several medium and small pharma
Clear DGCI Tests companies have been taking advantage of this lack of
May 25, 2009, The Economic Times monitoring by the state drug authorities for some time
http://economictimes.indiatimes.com/News/News-By- now.
Industry/Healthcare--Biotech/Over-44-fixed-dose-
combination-drugs-clear-DGCI-
tests/articleshow/4573397.cms

The government may give permission to 44 more


combination drugs — a formulation of two or more active
ingredients combined in certain fixed doses - for treating

Organisation of Pharmaceutical Producers of India 17


Pharma Spectrum

Investors at Risk as US FDA Gets Tough Drug Export Quality Certificate to be


with Drug Cos Issued Only by DCGI
May 25, 2009, The Economic Times May 21, 2009, The Hindu Business Line
http://economictimes.indiatimes.com/News-by-
Industry/Investors-at-risk-as-US-FDA-gets- The Drug Controller General of India (DCGI) has decided to
tough/articleshow/4573303.cms withdraw the powers given to State-level regulators to
issue export quality licence, technically called Certificate
The recent warning letters issued by the US Food and Drug of Pharmaceutical Products (CoPP). The move is to
Administration (FDA), to manufacturing units of Indian centralize pharmaceutical sector regulating.
pharmaceutical companies have significantly raised
investors risk. With the FDA getting more stringent with its Speaking to Business Line, Dr. Surinder Singh, DCGI, said,
quality inspections and upcoming approvals for companies “The power to issue CoPP was given to the State
put on hold, investors are the ones who could lose out in regulators earlier outside the Concurrent List. Therefore,
the long-run, said analysts. now we are going to take it back to bring uniformity in
regulations. We will notify this in over the next month or
"Companies need to put things in place. Once the US FDA so.”
issues inspectional observations or '483' concerns and if it
goes to the next level of warning letters, it will take a Karnataka Drugs Control Dept Issues
couple of quarters for things to get sorted out," said
Abhishek Singhal, an analyst with Macquarie. Over 3000 Show Cause Notices,
Suspends 1,000 Licenses
FDA-Approved Inspectors Plan Short- May 20, 2009, Pharmabiz, Bangalore
Notice Audit of Trials http://www.pharmabiz.com/article/detnews.asp?articlei
d=49802
May 23, 2009, The Economic Times
http://economictimes.indiatimes.com/Pharmaceuticals/F Karnataka drugs control department has issued a total of
DA-approved-inspectors-plan-short-notice-audit-of- 3,768 show cause notices, suspended 1,398 licenses and
trials/articleshow/4567501.cms cancelled 921 licenses of both manufacturers and the
pharmacy outlets during the period ending March 31,
Drug Controller General of India (DCGI) is planning random 2008-09.
audit of clinical trial sites across the country on a regular
basis by this June and will suspend any human experiment During the year a total of 88 prosecution cases were filed
if the research organisation is found violating the in the court. In addition, there were 69 cases disposed and
guidelines. The move comes in the wake of successful 50 convictions carried out. Around 178 complaints
audits over the last few months that enabled the drug received from the public are being investigated. In the
regulator to efficiently monitor the human trials, a health government drug testing lab, a total of 3,311 samples
ministry official said. were analyzed of which 240 were declared not-of-standard
quality and investigations are being carried out.
Under the scheme, a team of drug inspectors will walk
into clinical trial centres at short notice and audit the
internal processes and the clinical trials data. Pharma Policy to be Delayed As New
Minister May Take Fresh Look at
Drug Regulator to expand Survey on Industry
Fake Medicines May 19, 2009, Pharmabiz
May 22, 2009, The Hindu Business Line http://www.pharmabiz.com/article/detnews.asp?articleid
=49787&sectionid=19
The Drug Controller General of India plans to widen the
survey to map the prevalence of counterfeit drugs in the Though the same Manmohan Singh government is all set to
country with larger number of samples. The regulator, continue in the office after its thumping victory, the much
which is examining 26,500 samples of 62 top-selling awaited national pharmaceutical policy which has been
medicines, is planning to pick up one lakh samples for the pending since 2002 will have to go through another full
next survey. The first report on counterfeit drugs is circle of process and all progress made so far will have
expected in June. little impact.

Speaking to Business Line, Mr. Surinder Singh, DCGI, said, With Ram Vilas Paswan, who has been pressing for the
“We want to put to rest all the speculation about the policy for long, is most unlikely to stay as chemicals
extent of fake drugs prevalent in the Indian market. minister under the new dispensation, the note on policy
should be prepared by the department again under the

Organisation of Pharmaceutical Producers of India 18


Pharma Spectrum

new minister and be forwarded to the cabinet for country. India has been facing unfair criticism in this
consideration. regard from the European nations for some time.

US FDA Office in India May Not Speed Up As per the new notification issued by the directorate
general of foreign trade (DGFT),every exporter of drugs
Certifications, Approvals for Domestic and pharmaceuticals at the time of shipment shall submit,
Cos along with other required documents, a copy of
May 18, 2009, Pharmabiz Certificate of Analysis issued by the manufacturer for the
http://www.pharmabiz.com/article/detnews.asp?articleid subject product; or a copy of Certificate of Analysis issued
=49768 by approved laboratory of the importing country/US FDA:
or a copy of Certificate of Analysis issued by a laboratory
approved by Drugs Controller under Drugs and Cosmetics
Although the US FDA office in India may start its Act, 1940 and the rules made thereunder.
operations in the next few months, that is unlikely to
expedite the disposal of approvals of Indian companies as
expected, it is learnt. Indian office of US FDA at New Dept. of Pharma asks Industry to
Delhi, will have local drug inspectors within three months Provide Detailed Data of Units Wanting
from now and the country director will take charge in
September 2009.
to Avail of CLCSS
May 12, 2009, Pharmabiz
However, the move may not help the Indian companies to
get approvals of Abbreviated New Drug Applications In view of the extremely poor response from the
(ANDAs) and good manufacturing practice (GMP) industry to the Credit Linked Capital Subsidy Scheme
certificates faster than now as every decision will have to (CLCSS) during the last eight years, the pharmaceutical
be cleared by the FDA office in Washington, informed a department has asked the industry to provide a
senior official with US FDA. comprehensive data about the probable SSI units which
may avail the revamped scheme which is being tweaked
by the government to make it more attractive and
MNC Units Abroad to Come Under Drug beneficial to the pharma units to upgrade their units as
Regulator Scanner per the revised Scheduled M.
May 17, 2009, Hindu Business Line
According to sources, the pharmaceutical department is
The Drugs Controller General of India (DCGI) will soon apprehensive about the response of the industry to the
start sending its officers to foreign countries to inspect tweaked CLCSS as a mere 200 pharma units availed the
the manufacturing facilities of multinational scheme during the last eight years. As the government is
pharmaceutical companies importing drugs into India. The working on a revamping the scheme, it wanted to ensure
move is in line with the processes followed by the drug that the scheme has enough takers. So, the government
regulators of other countries. has asked the industry to provide a list of the probable
number of units who might avail of the facility.
Speaking to Business Line, Dr. Surinder Singh, DGCI, said
“Inspectors from other countries, from Nepal to the US, Centre Plans Health Management
come to India to check manufacturing facilities of Indian
drug companies. We also get drugs imported from many
Information System to Monitor Demand
countries such as Taiwan and China for which we will start & Supply of Drugs
sending our inspectors to examine whether they are May 11, 2009, Pharmabiz
following good manufacturing practices.”
During the current XIth Plan period, the Centre will be
giving emphasis to e-Health by using IT in healthcare
Commerce Ministry Tightens Procedures segment and plans to set up a national grid to share
for Export of Drugs to Ward off EU information among the healthcare providers, trainers,
Allegations beneficiaries and the society.
May 15, 2009, Pharmabiz The Centre is also planning to launch a Health
http://www.pharmabiz.com/article/detnews.asp?articleid Management Information System (HMIS) which will help
=49727&sectionid=11 eventually to track the demand and supply of drugs and to
curb wastage of drugs due to date expiry. When fully
The Union commerce ministry has asked the pharma developed, it will work as a demand-driven management
exporters to comply with more stringent quality guidelines system to track and monitor the drug situation across the
to ensure that no counterfeit drugs are exported from the country and channelise the supply as per the demand in
particular places.

Organisation of Pharmaceutical Producers of India 19


Pharma Spectrum

Health Ministry Redrafting ART Bill to booming domestic market rather than on exports during
the initial phase of running a pharma SEZ.
Regulate Thousands of Infertility Clinics
May 11, 2009, Pharmabiz Recommending special treatment to the pharma sector,
http://www.pharmabiz.com/article/detnews.asp?articleid the report of the 'task force on pharmaceuticals' said the
=49649&sectionid=13 year of commencement of the tax holiday period for
pharma SEZs should be computed from the year of profits
The Union health ministry is re-drafting the Assisted and not as per the existing SEZ norms that calculates the
Reproductive Technology (Regulation) Bill, 2008 (ART Bill) tax holiday period from the year of setting up an SEZ.
which will be introduced to regulate thousands of
infertility clinics that have mushroomed over the years in DCGI Calls Govt-Industry Meet to
the country. The Bill will define the establishment and
functioning of these clinics.
Finalise Guidelines on Spurious Drugs
Act
The ministry has received a large number of suggestions May 2, 2009, Pharmabiz
and comments from foreign countries, embassies, legal http://www.pharmabiz.com/article/detnews.asp?articleid
institutions, international institutions, experts and others =49507&sectionid=19
on the draft bill. The government had late last year
published the draft bill and had invited suggestions and The Drugs Controller General of India (DCGI) Dr Surinder
comments from the public on the proposed bill. The Bill, Singh has called an industry-government meeting on May
drafted by an 11-member expert committee appointed by 19 to finalise guidelines to safeguard the interests of
the health ministry, proposes to establish a National genuine drug manufacturers from misuse of recently
Advisory Board and state Boards to regulate and supervise amended spurious drugs Act. The DCGI has asked the
the establishment and functioning of the infertility clinics industry to come out with its own specific suggestion in
in the country. this regard.

Pharma Port Office Opened in Bangalore The Drugs and Cosmetics (Amendment) Act 2008,
stipulating stringent penalties for manufacturing and
May 7, 2009, Hindu Business line marketing spurious drugs, was passed by Parliament last
http://www.thehindubusinessline.com/2009/05/07/storie year and the President gave her assent in last December.
s/2009050751191700.htm The only formality left on the Bill is its notification which
the ministry will be doing soon.
The Health Ministry has opened a new port office for
pharma exports and imports at the Bengaluru International
Airport. Bangalore, a hub of biotechnology, clinical trials WHO Auditors Inspect Indian Regulatory
and pharma research, will also have a sub-zonal office of Authority Again, Gives 100 Score
the Ministry’s drug quality arm, the Central Drugs April 28, 2009, Pharmabiz
Standard Control Organisation, the Drugs Controller- http://www.pharmabiz.com/article/detnews.asp?articleid
General of India, Dr Surinder Singh, said on Wednesday. =49447&sectionid=19
The port facility is part of the ongoing exercise to build WHO inspectors along with drug control officials from
capacity and recruit more people at the CDSCO, Mr other countries, held a comprehensive audit of the
Debashish Panda, Joint Secretary, Union Department of national regulatory authority (NRA) in India and gave a
Health & Family Welfare, said. Dedicated pharma zones high score of 100, reversing its earlier adverse
equipped with cold rooms would come up at the Delhi and observations about the bad plight of regulatory system in
Mumbai airports by March 2010; the stakeholders and the country two years ago.
operators of the two airport were meeting in Mumbai on
May 8. "As many as 13 auditors from the WHO and other nations
held a week-long audit in different aspects and carried out
Task Force Prescribes Policy Change to on-site inspections to assess the performance of the
Help Pharma SEZs regulatory mechanism recently. We got a 100 score on all
specific six indicators this time, whereas in the previous
May 7, 2009, Financial Express similar assessment held in late 2007, we had been given
http://in.biz.yahoo.com/090506/50/batjaa.html just around 40 score," DCGI Dr Surinder Singh told
Pharmabiz.
In a booster dose to the growing Indian pharmaceutical
industry, an inter-ministerial task force has mooted
several changes in the Special Economic Zones (SEZ) policy
in favour of the sector allowing it to focus more on the

Organisation of Pharmaceutical Producers of India 20


Pharma Spectrum

Govt Nod Must for Drug Cos to Rejig As part of company's sales strategy to provide cost-
effective novel therapies & oncology drugs, the company
Combination has launched new sales division Bridge to strengthen its
April 27, 2009, The Economic Times new brands of drugs and focus on specific therapeutic
areas. With growing product portfolio, new sales division
Drug makers changing the composition of existing will now focus on drugs that cater to non small cell lung
formulations to escape price cap will now have to come to cancer (NSCLC) and multiple myeloma.
the centre for a fresh approval. In a move to keep a check
on companies which replace price control, the centre has Shantha’s Oral Cholera Vaccine Launch
directed state drug regulators not to allow them to sell
such medicines with their old brand names. Instead, such on April 26
drugs will be treated as new ones and the companies will April 25, 2009, DNA
have to go through the Centre’s scrutiny before it gets a http://www.dnaindia.com/report.asp?newsid=1250444
fresh approval, a government official said.
Hyderabad-based Shantha Biotechnics Ltd is all set to
The move is significant as companies are now likely to launch an oral vaccine for preventing cholera. The first
think twice before they make change in the existing bivalent oral cholera vaccine, it will be called Shanchol.
composition and approach the centre for a fresh approval. The company plans to officially launch the vaccine on
This would also mean that companies will have to April 26; it will be available through commercial channels
subscribe to a new brand name. from June.

"It's almost 38 years the world has been waiting for a

New Products vaccine to prevent cholera. There was one vaccine before
that. But, it was withdrawn due to efficacy issues,"
Shantha managing director Varaprasad Reddy said.
Piramal Healthcare Launches Actipatch
for Pain Therapy
May 14, 2009, The Economic Times R&D/Clinical Trials
http://economictimes.indiatimes.com/News/News-By-
Industry/Healthcare--Biotech/Pharmaceuticals/Piramal- NACO Ties Up with 26 Research
Healthcare-launches-ActiPatch-for-pain-
therapy/articleshow/4531084.cms Institutions for NIIHAR Network
May 20, 2009, Pharmabiz
Piramal Healthcare on Thursday announced the launch of
BioElectronic's ActiPatch, a product in pain management. The National Aids Control Organisation (NACO) has tied up
"ActiPatch is a medical device that utilises pulsed electro- with 26 research institutions across the country to
magnetic frequency (PEMF) to accelerate healing of soft undertake operational, epidemiological and bio-medical
tissue injuries. Patients suffering from pain and swelling in research in the field of HIV/AIDS. NACO had earlier
conditions ... can benefit from this product," Piramal constituted a consortium Network of Indian
Healthcare Director Swati Piramal told reporters. Institutions/Organizations for HIV/AIDS Research (NIIHAR)
for the purpose.
Its unique delivery system using patented technology,
provides a cost-effective patient-friendly method to Sources in the NACO said that it has already roped in 26
reduce soft tissue pain and swelling, Piramal said. research institutions under the network and more will be
added as the NACO is screening the other institutions in
Intas Bio Introduces Bortezomib in the panel of institutions which have shown interest in
joining the network. This consortium will pool resources
Indian Market to Treat Multiple and expertise to conduct high quality, collaborative,
Myeloma multi-centric research that will help evidence based
May 11, 2009, Pharmabiz decision making on policy, management and evaluation of
http://www.pharmabiz.com/article/search.asp interventions. This consortium will have linkages with
universities, ICMR, CSIR, DST, ICSSR and others
Intas Biopharmaceuticals Limited has launched bortezomib stakeholders including donor organizations.
injection, under the brand name Borviz, in the Indian
market. The new drug offers effective treatment for
'multiple myeloma', the second-most common cancer of
plasma cell (blood).

Organisation of Pharmaceutical Producers of India 21


Pharma Spectrum

Ban on Clinical Trials for Wyeth Vaccine disease burden in these countries and strengthening
international collaborations.
Lifted
May 15. 2009, The Mint Ranbaxy Close to Completing Trials for
http://www.livemint.com/2009/05/14233904/Ban-on-
clinical-trials-for-Wye.html New Malaria Drug
May 5, 2009, Hindu Business Line
The drug controller general of India (DCGI) earlier this http://www.thehindubusinessline.com/2009/05/05/storie
week lifted a temporary ban on clinical trials for a vaccine s/2009050551830100.htm
by US drug maker Wyeth Inc., allowing the drug company
and the Hyderbad-based clinical research organization Ranbaxy Laboratories Ltd on Monday announced the
GVK Biosciences Pvt. Ltd to go ahead with the trials. commencement of the third phase clinical trials for its
new anti-malaria combination drug in India, Bangladesh
The ban had been imposed following the death of a baby and Thailand. The drug, Arterolane maleate + Piperaquine
that was less than a year old due to lapses in standard phosphate, is targeted at patients in developing countries
operating procedures while conducting clinical trials for with the aim of significantly improving upon the
the vaccine in St John’s Hospital, Bangalore, in November. conventional options available for the treatment of
However, the ban on trials has been removed only for 11 malaria.
of the 12 hospitals where they were being carried out. It
stays in St John’s, said Surinder Singh, drug controller According to Dr Sudershan Arora, President-R&D
general. (Generics, NDDS, Clinical & Drug Development), Ranbaxy,
the company will strive to successfully complete the trial
Piramal Life Gets Nod for Cancer and apply for marketing authorisation by late 2010.
Molecule Trials
May 13, 2009, Financial Chronicle
http://www.mydigitalfc.com/knowledge/piramal-life-
gets-nod-cancer-molecule-trials-007
Mergers &
Mumbai-based Piramal Life Sciences on Wednesday said it Acquisitions /
had received regulatory approval for initiation of phase-I
& II combination studies of its cancer molecule P276 for
pancreatic, head and neck cancer.
Collaborations
Having received the go-ahead from the Drug Controller Malvinder Singh Steps Down, Sobti New
General of India (DCGI), Piramal Life Sciences, which is
part of the Piramal Group, will now initiate phase I and II
Ranbaxy CEO
clinical trials at various locations to assess and identify May 25, 2009, Financial Express
right doses of the molecule to be used in combination with http://www.financialexpress.com/news/malvinder-singh-
chemotherapeutic drugs, a company statement said. steps-down-sobti-new-ranbaxy-ceo/465223/

Nearly a year after selling his family’s entire 35% stake in


India, Norway to Collaborate in the country’s largest drug manufacturer, Ranbaxy
Promoting Human Vaccination Research Laboratories Ltd, to Japanese firm Daiichi Sankyo,
Projects Malvinder Singh on Sunday stepped down as the company’s
chairman, CEO and managing director. Daiichi Sankyo
May 11, 2009 PHARMABIZ director and Ranbaxy board member, Tsutomu Une, has
http://www.pharmabiz.com/article/search.asp been appointed as the executive chairman of the company
while, Atul Sobti, the current COO has been appointed the
The Department of Biotechnology (DBT) and the Research new CEO. The changes were announced after the
Council of Norway (RCN) will collaborate to promote company’s board meeting on Sunday.
research in the field of human vaccination through joint
projects, spanning for three years, as part of the With this the Singh family’s association with the company,
programme for global health and vaccination research. which his grandfather Bhai Mohan Singh founded in 1961,
comes to an end. Singh had joined Ranbaxy in 1998 and
The programme, carrying a total fund of 10.5 million became CEO in 2006.
dollars, will aim at strengthening and expanding research
that can contribute to sustainable improvements in health
in low and middle-income countries. This will include
development of knowledge and tools to combat the major

Organisation of Pharmaceutical Producers of India 22


Pharma Spectrum

Ranbaxy Acquires Skin Care, Lifestyle Paswan lost the Hajipur seat in Lok Sabha elections. The
industry feels that the government needs to focus on
Range bigger problems such as availability of drugs in remote
May 22, 2009, Business Standard areas rather than pressuring companies to cut down on
margins. “There are more than 10,000 pharma firms in
Ranbaxy Laboratories, the second largest drug company in India and for every branded drug there are at least 80-100
India in terms of market share after Cipla, has acquired cheaper alternatives available. Pricing is not an issue here
the entire range of skin care and lifestyle products of as cheap drugs are available, so the government has to do
Ochoa Laboratories, a small to medium sized away with these proposals,” AV Dangi, president and chief
manufacturer located on the outskirts of New Delhi. executive officer at Danssen Consulting (a consultancy
firm specialising in pharmaceuticals, life sciences and
The Company did not disclose the terms of the healthcare) said.
transaction. Sources said Ranbaxy acquired about 80
products of Ochoa Laboratories and many are established Cancer Drugs May Come Under NPPA
brands in the domestic market.
Lens
Elder Health Care Looks at Buying Two May 20, 2009, The Economic Times
http://www.immservices.net:80/view/view_clip.php?vid=
Indian Brands 1480514&cnm=T3IxOTk1NjE2MzAw
April 25, 2009, The Economic Times
http://economictimes.indiatimes.com/News/News-By- Cancer drugs may soon come under the purview of India’s
Industry/Cons-Products/FMCG/Elder-Health-Care-looks-at- drug price regulatory, as they have become too expensive
buying-two-Indian-brands/articleshow/4446127.cms for the common man to afford, according to Drug
Controller General of India (DCGI), Mr. Surinder Singh.
Elder Health Care, the FMCG arm of the Rs 560-crore The move could hurt the margins of multinational
pharma major Elder Group, is evaluating two Indian companies, such as Sanofi-Aventis, Pfizer, Roche,
brands for acquisition. The two potential targets are in GlaxoSmithKline and Eli Lilly, who enjoy a near monopoly
the areas of oral care and body care, and will help Elder in the category, also populated by Indian Drug makers Dr.
consolidate its presence in the personal care segment. Reddy’s, Natco and Dabur.
Elder expects to close each of the deals at a valuation of
Rs 5-10 crore. Mr. Singh told ET on Tuesday that he has recommended
that cancer drugs be brought under the National
The company wants to complete the acquisitions soon as it Pharmaceutical Pricing Authority (NPPA). “As the DCGI, I
wants to capitalise on the present moment, when have outlined the technical inputs and rationale, behind
valuations are low. “We are looking at acquisitions to the suggestion for the inclusion of new drugs. Cancer
consolidate our presence in the personal care segment. drugs, in particular, should be included, since they are
We soon plan to appoint a merchant banker for reviewing expensive and beyond the means of the common man,” he
the deals,” Elder Health Care managing director Anuj said. A final decision on this will have to be taken by the
Saxena told ET. department of pharmaceuticals. According to a Pharma
analyst, oncology is still a small segment for Indian firms,
but they have a number of products in the pipeline over

Pricing the next two to three years.

Anti-Asthma Drugs to be 90% Cheaper


Pharma Industry to Oppose Price May 11, 2009, Financial Chronicle
Control http://www.mydigitalfc.com/news/anti-asthma-drugs-be-
90-cheaper-748
May 24, 2009, Financial Chronicle
http://www.mydigitalfc.com/economy/pharma-industry- ANTI-ASTHMA medicines are expected to cost less than a
oppose-price-control-932 tenth of their prices now after the regulator, the National
Pharmaceutical Pricing Authority (NPPA), brought the bulk
The pharmaceutical industry has upped the ante against drug, doxofylline, under price control. Ranbaxy and Dr
the move to put 356 medicines under price control. The Reddy’s Laboratories (DRL) are among over a dozen
industry is also pushing for early passage of the proposed companies that produce these medicines. NPPA found that
legislations on clinical trials and biotech. doxofylline is a derivative of theophylline, which was
already under price control.
The pharma industry is hoping that the new government
would rescind the proposal of earlier incumbent Ram Vilas Brands of medicines produced from the bulk drug include
Paswan to bring back pricing controls on the sector. Synasma (Ranbaxy), Doxobid (Dr Reddy’s), Doxflo (Lupin),

Organisation of Pharmaceutical Producers of India 23


Pharma Spectrum

Zordox (Cipla) and Doxolin (German Remedies). Prices of through the public health system, compared with those
all these will drop sharply to just Rs 5.74 per strip of 10 prevailing in the private health care system.
tablets. This is just a fraction of the Rs 78 that Dr Reddy’s
now charges for Doxobid (400 mg) and Rs 75 Ranbaxy This will ensure that patented drug sold in India – through
charges for Synasma. An NPPA official told Financial public as well as private health systems-will be at their
Chronicle that there was no point controlling theophylline lowest international prices, said a government official who
and not doxofylline.“The companies were making use of asked not to be named.
the loophole,” he said.
NPPA Hikes Price of Rifampicin, Cut
NPPA Fixes, Revises Prices of 296 Prices of Two Other Bulk Drugs
Formulations April 29, 2009, Pharmabiz
May 6, 2009, Pharmabiz http://www.pharmabiz.com/article/detnews.asp?articleid
http://www.pharmabiz.com/article/detnews.asp?articleid =49467&sectionid=19
=20815&sectionid=19
The National Pharmaceutical Pricing Authority (NPPA) has
The National Pharmaceutical Pricing Authority (NPPA) has cut the prices of two bulk drugs including tolnaflate,
fixed or revised prices of 296 formulations, including nine which became cheaper by around 40 per cent, and
imported drugs from global majors like Pfizer, Aventis increased the prices of two other bulk drugs.
Pharma, Novartis and Novo Nordic. And many of these
imported formulations went costlier, while a couple of The price of topical antifungal agent tolnaflate came
them registering a hike of over 12 per cent. down from Rs 4121 to Rs 2500 per kg, as per a recent
notification by NPPA. The price was earlier fixed on
According to the notification issued by the NPPA, prices of February 13, 2007. And the prices of a number of
mono-component insulin formulations -- Lantus 100 IU/ML formulations used to treat fungus and skin infections will
catridge and Lantus 100IU/ML solostar -- imported by come down with the huge reduction in the bulk drug cost.
Aventis Pharma were revised with the former one going up The price of glipizide, used in the anti-diabetic
by 12.83 per cent (up from Rs 481 to Rs 543.12 per 3ml therapeutic area, came down from Rs 29,244 to Rs 26,114
catridge). Three formulations by Pfizer Products India, per kg. The price was revised almost after three years.
containing methyl prednisolone also became costlier.
Among them, price of Solu Medrol AOV 125mg was revised Drugs with Composition Change Need
from Rs 252.46 per 2ml vial to Rs 290.34, up by a
whopping 15 per cent. Fresh Okay
April 27, 2009, The Economic Times
Working of NPPA-CIFG at Chennai http://www.pressdisplay.com/pressdisplay/viewer.aspx#
Disappointing Even After 8 Months DRUGMAKERS changing the composition of existing
May 5, 2009, Pharmabiz formulations to escape price caps will now have to come
http://www.pharmabiz.com/article/detnews.asp?articleid to the Centre for fresh approvals. In a move aimed at
=49554&sectionid=19 keeping a check on companies, which replace price-
controlled ingredients with ones outside price control, the
Working of the Centre for Information Facilitation and Centre has directed state drug regulators not to allow
Grievances (CIFG) at Chennai is disappointing as it is not them to sell such drugs with their old brand names.
able to attract any major complaints on drug prices and Instead, such drugs will be treated as new ones and the
quality of products. The centre was set up by National companies will have to go through the Centre’s scrutiny
Pharmaceutical Pricing Authority with the help of a local before it gets a fresh approval, a government official said.
NGO a few weeks ago.
The move is significant as companies are now likely to
The NPPA has started a new initiative in six places across think twice before they make any change in the existing
the country, including Chennai, to disseminate composition and approach the Centre for a fresh approval.
information on drug prices and their availability. This would also mean that companies will have to
subscribe to a new brand name. The decision comes in the
Cure Against Costly Drugs on Way wake of the National Pharmaceutical Pricing Authority
(NPPA) seeking action from the Drug Controller General of
May 5, 2009, The Economic Times India (DCGI) against companies that dodge price control by
tweaking ingredients of medicines and then misguide
The government is laying ground rules for negotiating drug consumers by retaining the original brand name. “We have
prices with multinational companies to ensure that costly been receiving cases from NPPA for some time now where
patented drugs are provided at 40-70% lower prices companies have altered the composition and retained the
brand names. This amounts to misleading consumers. We
Organisation of Pharmaceutical Producers of India 24
Pharma Spectrum

have, therefore, asked all state drug regulators to treat http://www.pharmabiz.com/article/detnews.asp?articleid


such drugs as new drugs and not give approvals to sell =49766
under the same brand name,” DCGI Dr Surinder Singh told
ET. The seven generic drug stores under the Jan Aushadhi
Scheme, launched by the Department of Pharmaceuticals
to ensure quality medicines at affordable prices, has

Trade & Others reported an average weekly sales worth Rs 64,552 from
the time of their launch, according to the latest report.

The report, published by the Dept of Pharmaceuticals


FAKE DRUGS lately, takes an account on the performance of the Jan
May 25, 2009, Financial Express Aushadhi stores for 23 consecutive weeks from November
http://www.financialexpress.com/news/Fake- 25, 2008 to May 3, 2009. According to the report, the first
drugs/465221/ Jan Aushadhi store set up in Amritsar in November 25,
2008 has reported average weekly sales of Rs 38,859 in 23
Much to the chagrin of the Indian pharmaceutical industry weeks. The drug store at Gurgaon set up 11 weeks ago has
and patients alike, fake drugs are everywhere. Successful sold Rs 7,449 worth drugs even as the 10-week-old Mohali
brands are being faked and sold on an unprecedented and Panchkula stores dispensed Rs 7,180 and Rs 9,094
scale in India. So much so that fake allopathic as well as worth drugs, respectively, average in a week.
homeopathic medicines are estimated to occupy between
15 to 20% of the Rs 40,000 crore Indian pharmaceutical
market.
Jan Aushadhi Stores Cause Credibility
Crisis for Pharma Traders
Originally, fake drugs were confined to lifestyle drugs such May 14, 2009, Pharmabiz
as Viagra or conventional medications for cold, cough and http://www.google.co.in/search?hl=en&q=Jan+Aushadhi+s
fever. Nowadays, they have made a smooth transition to tores+cause+credibility+crisis+for+pharma+traders&btnG=S
lifesaving drugs as well. Their presence spans across a earch&meta=&aq=f&oq=
wide spectrum—AIDS/HIV therapy, antibiotics, insulin, Pharmaceutical traders are asking the government to fix
cholesterol drugs, hormone replacement therapy, cancer trade margins for the generics-generic products in the
drugs and many more. country to ensure uniformity in prices in the market place.
The demand has come in the wake of the government plan
Drug Inspector in Pondicherry Pulled Up to sell unbranded generic products through Jan Aushadhi
stores at lower prices than market rates. Traders fear that
for Not Clearing Drug License the government move will affect the credibility of the
Applications for 2 Yrs local chemists in the minds of consumers.
May 23, 2009, Pharmabiz
http://www.pharmabiz.com/article/detnews.asp?articleid Currently, the unbranded generic drugs which are not
=49863&sectionid=19 promoted ethically and sold by the chemist over the
counter, does not have any fixed margin for the trader
Director of Medical Services in the Union Territory of and are sold at different prices. Many of the products are
Pondicherry has issued a show cause notice to a drug sold at lower prices than the branded product of the same
inspector at the General Hospital at Karaikal for not acting drug. The products, which are not having any promotional
on several applications for drug licenses submitted to him costs, are also priced high although their manufacturing
by traders. costs are much low.

The action was taken after receiving complaints from Banned From Chemists, Tamiflu Goes at
Chemists and Druggists of Karaikal in Pondicherry. In the
complaint, chemists said that the official was keeping
Rs 2,000 for 10 Tablets
many applications for licenses in his custody for more than May 6, 2009, Express Newsline
two years without recommending them to the Directorate http://www.expressindia.com/latest-news/banned-from-
of Drugs Control. The director has asked the drug chemists-tamiflu-goes-at-rs-2-000-for-10-tablets/455009/
inspector to explain the cause of this delinquency in ten
days. The government may have banned the distribution of
Tamiflu and Relenza, two options available to battle the
H1N1 influenza (or swine flu), but chemists say they are
Jan Aushadhi Stores Make Progress, running out of stock despite selling Tamiflu at Rs 2,000 for
Average Weekly Sales at Rs 64,552 10 tablets.
May 18, Pharmabiz
The enterprising chemist who arranged the drug for
Newsline, despite a ban on procurement and sale through
Organisation of Pharmaceutical Producers of India 25
Pharma Spectrum

private channels, said with a touch of pride: “We have got with over 300 outlets spread over 17 states across India. It
scores of calls for Tamiflu since morning. We will ask for has been offering 10 per cent discount to its customers
fresh stock tomorrow.” under the loyalty programme.

GSK Winds Up Actifed Range of Cough Pharmaceutical Wholesalers Association (PWA) president
Dilip Mehta said that the wholesale dealers are agitated
Drugs over the unhealthy practice of offering 10 per cent
May 2, 2009, The Economic Times discount on medicines by the Apollo Pharmacy chains in
Mumbai. There are more than 100 Apollo pharmacy shops
GlaxoSmithKline Pharmaceuticals (GSK) India has stopped in Mumbai and retail traders in the surrounding vicinity of
manufacturing its cold and cough drugs sold under the these Apollo Pharmacy shops are getting adversely
brand name Actifed and Actifed Plus after it was found affected by this unhealthy trade practice, he said.
that some people were illegally extracting
pseudoephedrine, a narcotic chemical, from the medicines Sales Promotion Staff of Organon,
to sell overseas.
Fulford Protest against Unfair Labour
In January, the Mumbai wing of India’s Food and Drugs Practices
Administration (FDA) busted a racket which included two April 28, 2009, Pharmabiz
GSK officials, who used to extract pseudoephedrine and http://www.pharmabiz.com/article/detnews.asp?articleid
sell it overseas. The FDA officials reportedly seized =49444&sectionid=5
Actified and Actified Plus tablets worth Rs 67 lakh during
the raid. About 700 sales promotion employees of Organon India
Limited and Fulford India Limited struck work nationally in
the first week of April, in protest against the Companies'
Local Drug Cos May Chip in to Treat violation of certain provisions of Sales Promotion
Employees Act, 1976. Both these companies are now under
Swine Flu the control of Schering-Plough Corp of the US.
April 28, 2009, The Economic Times
http://economictimes.indiatimes.com/News/News-By- Secretary of the Federation of Medical and Sales
Industry/Healthcare--Biotech/Pharmaceuticals/Local- Representatives' Associations of India (FMRAI) Tamil Nadu
drug-cos-may-chip-in-to-treat-swine- branch said the field work of these two companies had
flu/articleshow/4457204.cms paralyzed in India on that day. In Tamil Nadu these
companies have 70 sales promotion employees. Their
The swine flu outbreak, classified by the World Health Union is affiliated to FMRAI.
Organisation as a “public health emergency of
international concern”, may see Indian drug makers
pitching in with the generic version of the antiviral
Tamiflu as the world looks for quick, affordable options to
counter the infection.
Biotechnology
“We have already received proposals from people on
Indian Pharma Cos Upbeat on
behalf of countries in Latin America, Mexico and Israel. Biogenerics
We have the capability to supply 1.5 million dosages of May 8, 2009, Business Standard
the drug within 4-6 weeks,” said Amar Lulla, joint MD, http://www.business-standard.com/india/news/indian-
Cipla. pharma-cos-upbeatbiogenerics/357461/

Wholesalers Suspend Drug Supplies to Even as the substitutability of biogeneric or biosimilar


medicines with their original patented counterparts
Apollo Pharmacy for Unhealthy Trade continues to be a matter of debate world over, Indian
Practice drug companies, which have introduced biogeneric
April 28, 2009, Pharmabiz products or copies of biotechnology drugs in the country,
http://www.pharmabiz.com/article/detnews.asp?articleid are bullish over the marketing prospects of “biogenerics"
=49446&sectionid=22 after patents expire in developed markets. Companies
such as Dr Reddy’s, Biocon, Reliance Life Sciences and
Pharmaceutical wholesalers have suspended medicine Ranbaxy etc. are all in the process of strengthening their
supplies to more than 100 Apollo Pharmacy shops in biogeneric portfolio to cater to future global demand.
Mumbai and Thane in protest against the unhealthy trade
practices indulged in by the Apollo stores. Apollo “The biogeneric market in India is pegged at Rs 600 crore,
Pharmacy is the largest pharmacy chain in the country while the US and EU market for biosimilars is estimated to

Organisation of Pharmaceutical Producers of India 26


Pharma Spectrum

reach $ 21 billion by 2015”, said KV Subramaniam, Indian Pharma-Biotech R&D


president and CEO, Reliance Life Sciences (RLS). RLS
launched three biosimilars - ReliPoietin (Erythropoietin Consolidating & Downsizing to Maintain
(EPO), ReliGrast (Granulocyte Colony Stimulating Factor Productivity: Expert
(G-CSF), and ReliFeron (Interferon Alpha 2b) in the April 27, 2009, Pharmabiz
domestic market in 2008 and is working on a range of
biosimilars, which are at different stages of development The pharmaceutical and biotechnology industry is in the
viz clinical trials, pre-clinical studies, process process of consolidating and down-sizing while trying to
development and molecular biology. maintain R&D productivity. Small and medium-sized
companies are trying to make the most of available
INDUSTRIAL BIOTECHNOLOGY: opportunities in niche segments.
Drug Making Made Easier
While we see an extremely cautious approach to new R&D
April 30, 2009, Pharmabiz spending plans, the silver lining for Indian companies
providing research services to big pharma is that the
Industrial biotechnology (IB), the third wave of emphasis on controlling costs is leading to an increasing
biotechnology, uses biological systems for the production number of proposal requests, Dr Shoibal Mukherjee, senior
of chemicals, materials and energy. This technology is vice president - Clinical Development, GVK Biosciences
mainly based on biocatalysis (the use of enzymes to Private Limited told Pharmabiz in an email interaction.
catalyse chemical reactions) and fermentation technology
(directed use of microorganisms), in combination with

New Appointments
molecular genetics, enzyme engineering and metabolic
engineering. It enables to bring down (reduce) material
and energy consumption, as well as pollution and waste
generation for the same level of industrial production.
Technologies include the use of plants and enzymes to Mr. Om Prakash, New Member
generate industrial products. Secretary, NPPA
Currently, IB exhibits the maximum extent of penetration The Appointment Committee of the Cabinet has approved
in the pharmaceutical sector (15 per cent). New the proposal to appoint Mr. Om Prakash, CSS (77)as
technologies have proven to be a boon for the Member Secretary, in the National Pharmaceutical Pricing
pharmaceutical industry in the use of better biological Authority (Joint Secretary level) under the Department of
production methods. Since the pharmaceutical products Pharmaceuticals. He has worked with the Ministries of
are of high value, added inputs in research and Environment & Forests, Department of Industrial Policy &
development (R&D) can easily be recovered. The Promotion and Finance. Before his appointment as MS,
pharmaceutical sector is thus proving to be the model for NPPA, he was holding the post of Director, Department of
the industrial development of biotechnology. Expenditure, Ministry of Finance.

ABLE to Address Issues of Bio-Similar Ms Aparna Sharma, Has Been Given


Regulations, VC Funding: Dr. Vidyasagar Additional Director, Department of
April 28, 2009, Pharmabiz
http://www.pharmabiz.com/article/detnews.asp?articleid
Health, Ministry of Health & Family
=49445&sectionid=3 Welfare,
Association of Biotechnology Led Entrepreneurs (ABLE) is Ms Aparna Sharma, Director, Department of Health,
concerned about the regulatory environment existing for Ministry of Health & Family Welfare, has been given
bio-similars in the country. Inadequate venture funding to additional charge of Food and Drugs, which was earlier
this sector is yet another disincentive. handled by Mr. A M Prasad, Director, who has been
promoted as Joint Secretary. She will continue holding this
The regulations governing bio-similars impose high barriers additional portfolio till the time a full time Director is
for Indian companies. "We need to make sure, by lobbying appointed.
both Indian and foreign governments to ensure that these
barriers are lowered", Dr. M Vidyasagar, president
Association of Biotechnology Led Entrepreneurs and
executive vice president, Tata Consultancy Services told
Pharmabiz in an email interaction.

Organisation of Pharmaceutical Producers of India 27


Pharma Spectrum

Mr. N N Prasad Appointed as Chief of Is Protectionism a matter? ………


In both cases, the ruling was against the MNCs and in
Staff to WIPO DG favour of generic companies. Both cases have been high-
May 6, 2009, Spicy IP profile cases where landmark decision was given. Is this a
http://spicyipindia.blogspot.com/2009/05/nn-prasad- show or protectionism on the part of Indian Judicial
appointed-as-chief-of-staff.html system towards generics?

In a momentous development for India, NN Prasad, Joint Expressing his views, Mr. Tapan Ray, Director General,
Secretary at the DIPP (Department of Industrial Policy and OPPI, opines, “In its current form the patent laws
Promotion, Ministry of Commerce) has been selected as appear to be somewhat protective in nature towards
the Chef De Cabinet to the Director General of WIPO, Dr. the domestic generic companies. Absence of data
Francis Gurry. This is a very high profile appointment, as protection and less than adequate patent enforcement
the post of Chef De Cabinet is akin to the Principal mechanism within the country will bear testimony to this
Secretary to the Prime Minister of India. fact. Probably because of all such reasons, in the Pharma
space, India is attracting much lesser foreign direct
As many of you may be aware, NN Prasad has been investments than China, in the post IPR regime.”
instrumental in changing the face of Indian IP
administration. And more importantly, in increasing the It seems that at present India needs a robust enough
influence that India has on the international IP arena. patent management systems and procedures within the
Under his stewardship, India has carved out a nice for country, for the countries own interest. Such world class
itself as a balancer of sorts at international negotiations patent management systems will be able to protect the
involving the developed and the developing world. long term interest of the innovators of India and not just
Illustratively, India hosted a development agenda meeting for the acceptability by the West. Ray points out.
in 2006, where Prasad played a key role in getting the two
sides to agree on common themes. Naturally, this is all Take on patent law in India………
very close to the middle path approach that this blog has Mr. Tapan Ray informs, “The patent management
been advocating for a while now. strategies in our country are evolving and may be for that
reason, are not robust enough, as yet. When we compare
Dr. Eswara Reddy Takes Charge as India with China, it can be noticed that there is still some
work needed to be done. For instance there is a big gap
Deputy Drugs Controller (NZ) within the patent management system which undoubtedly
April 30, 2009, IDMA Bulletin shows the absence of regulatory data protection.

Dr. S. Eswara Reddy, M. Ph, Ph.D has taken charge as Dept of Pharma to Organise
Deputy Drugs Controller, North Zone, and Ghaziabad. He
was Drugs Inspector in West Zone, Mumbai for over 10 International Meet on Pharma Industry
years. He has also been given some additional in Mumbai in Nov.
responsibilities at FDA Bhavan, New Delhi. Dr. Reddy has May 16, 2009, Pharmabiz
been awarded as the ‘Best Drugs Inspector’ in 2005 by All
India Drugs Control Officers Confederation. He has been The Department of Pharmaceuticals, in association with
associated with IDMA and has actively participated in our FICCI and other pharma organisations, is organising an
Seminars and Conferences such as IDMA-APPA PAC. He has international conference on pharmaceuticals in Mumbai on
been involved in GMP, GLP and GCP inspections. He has November 30, ahead of the proposed CHI happening from
published papers in journals including Indian Drugs. next day, to showcase strength of Indian companies.

A meeting, called by Pharma secretary Ashok Kumar


OPPI Related News recently, decided to organise the event in a bid to lure
the big traders from the developed countries and thereby
giving a fillip to the exports from the country by
When we Think Of Pharmaceutical and showcasing the strengths of the domestic industry. The
meeting was attended by joint secretary Arun Jha, deputy
Biotechnology Industry One Issue that secretary Paresh Johri, representatives from organisations
Comes to Our Mind is Patent Protection. like SPIC, IDMA, BDMA and OPPI, experts from UNIDO,
How Are Companies Coping with Pharmexcil and CPhI organisers to chalk out the detailed
plan for the event.
Evolving Patent Laws? Ms. Suja Nair
Reports…….
May 16, 2009, Express Pharma

Organisation of Pharmaceutical Producers of India 28


Pharma Spectrum

OPPI Calls Meeting of Pharma Bodies on


May 12 to Evolve Code of Ethics for OPPI Forthcoming
Marketing
May 4, 2009, Pharmabiz
http://www.pharmabiz.com/article/detnews.asp?articleid
Events
=49518&sectionid=43
OPPI Seminars:
As desired by the Department of Pharmaceuticals, the
Organisation of Pharmaceutical Producers of India (OPPI) • HRD Seminar on “HRx: Adopt, Align,
will hold a brainstorming session in Mumbai on May 12 with Deliver” on 16th June, 2009, Mumbai
other pharma associations to evolve a joint code of ethics
for the industry in a bid to curb the growing unethical • Technical Seminar on “Consumer Safety
trade practices. Through Anti-Counterfeiting Technologies
The joint meeting is expected to be attended by different on 3rd July, 2009
organisations representing small and large pharma sectors • Annual General Meeting on Saturday, 8th
and it will work out a common code of ethics to be
submitted to the department for final clearance and August, 2009, at ‘Ball Room’ The ITC
implementation with a view to reign on the sales Grand Central, Parel, Mumbai 400 012.
promotions and increasing unethical practices like
inducing doctors, sources said. Invitations have been sent
to all the concerned associations.

The department wanted the associations to bridle own


members and warned that the department would
intervene if the organisations failed to do so. Two
meetings were already held by pharma secretary Ashok
Kumar with the pharma associations and finally entrusted
the job of compiling the common code with OPPI which
was one of the pioneers to introduce guidelines to its
members

DCGI, Ranga Iyer, Anji Reddy Among 40


Most Powerful Pharma People
April 30, 2009, Pharmabiz
http://www.pharmabiz.com/article/detnews.asp?articleid
=49490&sectionid=17

DCGI Dr Surinder Singh, OPPI President Ranga Iyer, and


Reddy's Laboratories chairman Dr Anji Reddy have been
selected as among the 40 most influential personalities of
the global pharma industry by the World Pharmaceutical
Frontiers.

The annual list of 2009, judged by their contributions to


the pharma industry, is led by US president Barak Obama.
It also has some other well-known names like Bill and
Melinda Gates, former US president Bill Clinton, WHO
director general Margaret Chan among others including
the heads of a number of global pharma majors. But there
are only a very few from Asian region and all the three
Indians in the list have made it this time as new entrants,
while many of others were there in the previous list also.

Organisation of Pharmaceutical Producers of India 29