Pharma Spectrum

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

International IPR

P&G Wins Patent Infringement Lawsuit against Teva Pharma May 15, Pharmabiz, Cincinnati, USA http://www.pharmabiz.com/article/detnews.asp?articleid =49730

Judge Fends Off Generic Pulmicort, for Now http://www.fiercepharma.com/story/judge-fendsgeneric-pulmicort-now/2009-05-21?utm_medium=nl&

May 21, 2009, Fierce Pharma

Apotex is out of luck. AstraZeneca has won an injunction against the generics maker's launch of copycat Pulmicort Respules, at least until the federal court can hear a patent-infringement trial. As you know, Apotex already has FDA approval for its version of the asthma drug, but AstraZeneca says it's patent-protected through at least 2018.

United States Court of Appeals for the Federal Circuit ruled in favour of the Procter & Gamble Company (P&G) in the patent infringement lawsuit filed by P&G against Teva Pharmaceuticals USA, Inc. The positive ruling protects P&G's rights in the US to exclusively market the osteoporosis therapy Actonel (risedronate sodium) tablets. Actonel is commercialised through a collaboration between Procter & Gamble Pharmaceuticals and sanofiaventis.

Blair Hains, a spokesman for AstraZeneca, told Bloomberg that the company is pleased with the decision. "We continue to have full confidence in the strength of the intellectual property rights protecting Pulmicort Respules," he said. A date for the trial has not yet been set.

On August 13, 2004, P&G filed a patent infringement lawsuit against Teva to enforce P&G's US composition of matter patent for risedronate, the active ingredient in Actonel. Teva sought to market a generic version of Actonel in the United States under the assertion that the Actonel patent was not valid due to obviousness of the invention. On February 28, 2008, the Court ruled in favor of P&G, expressly rejecting Teva's validity challenge. Shortly afterwards, Teva filed an appeal of the decision. Oral arguments for the appeal were heard in December, 2008.

Genzyme Sues Lupin for its ANDA Filing for Phosphate Binder Product, Renvela

Wyeth Sues Sun and its US Subsidiary over Protonix Drug

May 19, 2009, Pharmabiz The US-based Genzyme Corporation has filed a patent infringement suit against the Mumbai-based Lupin Ltd and its US subsidiary against the latters' Abbreviated New Drug Application (ANDA) filing for manufacturing and marketing of generic version of Genzyme's Renvela (sevelamer carbonate) used for the control of serum phosphorus in chronic kidney patients on dialysis. In a petition filed in the District Court of Maryland, US, on May 14, 2009, Genzyme alleges that by attempting to manufacture and market the generic form of the product, Lupin has tried to infringe six patent claims of the company. Genzyme holds US Patent Nos. 5,496,545 (`545), 5,667,775 (`775), 7,014,846 (`846) and 7,459,151 (`151) for phosphate-binding polymers for oral administration issued on 1996, 1997, 2006 and 2008 respectively. Another two patents, Patent Nos 6,509,013 (`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.

May 7, 2009, Mint http://www.livemint.com/2009/05/07220031/Wyethsues-Sun-and-its-US-subs.html?h=B US-based Wyeth Pharmaceuticals has sued Mumbai-based Sun Pharmaceutical Industries Ltd. and its US subsidiary Caraco Pharmaceutical Laboratories Ltd. for claiming that their heartburn drug was a generic version of its Protonix drug. The complaint, filed on 5 May in the US district court for the Eastern District of Michigan, claims false advertising by Sun and Caraco under the Lanham Act, according to two law journals—Law 360 and Justia. “Wyeth is seeking its damages caused by Sun and Caraco’s false advertising,” said Gwen Fisher, a Wyeth spokesperson. “We are not making any statement on this,” said a Sun spokesperson. The Lanham Act prohibits a number of activities, including trademark infringement, trademark dilution and false advertising.

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Pharma Spectrum Abbott Sues J&J over New Humira Rival May 5, 2009, Fierce Pharma http://www.fiercepharma.com/story/abbott-sues-j-jover-new-humira-rival/2009-0505?utm_medium=nl&utm_source=internal Get ready for a battle in the rheumatoid arthritis segment. Johnson & Johnson's Centocor unit is prepping for a launch of its new Humira competitor Simponi, and 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 intellectual property, right? Yes and no. Abbott's suit follows up a set of reverse accusations: Last year, Centocor and NYU sued Abbott, saying that they were entitled to patent royalties on Humira. And that case is still pending.

Wockhardt Settles Patent Dispute with Orion April 29, 2009, Business Standard http://www.businessstandard.com/india/news/wockhardt-settles-patentdisputeorion/59835/on Drug maker Wockhardt today said it has settled a patent dispute with European pharmaceutical firm Orion regarding the generic versions of the latter's two products used in the treatment of Parkinson's disease. The company has executed a settlement and licence agreement with Orion Corporation regarding Wockhardt's application before the US drug regulator for the generic version of European firm's Comtan and Stalevo products, the Mumbai-based drug major informed stock exchanges. Under the terms of settlement agreement, Wockhardt would be able to launch generic versions of the both drugs "on September 30, 2012, or possibly even earlier," the company further said.

Judge Gives Lilly a Generic Reprieve April 24, 2009, Fierce Pharma http://www.fiercepharma.com/story/judge-gives-lillygeneric-reprieve/2009-0424?utm_medium=nl&utm_source=internal Eli Lilly execs are high-fiving now that a district judge has blocked Teva Pharmaceutical's launch of an Evista copycat. True, the block is only temporary, until the companies' patent fight is resolved in court, probably later this year. But Judge Sarah Evans Barker, who gave Lilly the reprieve, will also decide the patent case. And in her ruling, analysts say, Barker left some clues that could make Lilly very happy.

In explaining her decision to prevent generic Evista's launch, Barker rejected some important building blocks in Teva's case for selling the drug ahead of its official patent expirations (which start in 2012). For one, Barker didn't agree that Evista's invention was just an obvious extension of previously known work, saying that the company is likely to "prevail in demonstrating the non obviousness" of the patent.

Regulatory Bayer's Nexavar gets Japanese Nod for Advanced Liver Cancer Treatment May 22, 2009, Pharmabiz, Berlin In Japan Bayer received approval for Nexavar (sorafenib) tablets for the treatment of unresectable hepatocellular carcinoma (HCC) from the Ministry of Health, Labour and Welfare (MHLW). Nexavar, an oral anti-cancer drug, jointly developed by Bayer HealthCare AG and Onyx Pharmaceuticals Inc, is the only drug therapy shown to significantly improve overall survival in patients with the disease. The product is already marketed in Japan as a therapy for unresectable or metastatic renal cell carcinoma (RCC). "Liver cancer is one of the leading causes of cancerrelated deaths in Japan, and the incidence is continuing to rise," said Gunnar Riemann, member of the executive committee of Bayer HealthCare. "We expect that this approval will provide patients a new option for improved treatment and we are pleased that with our MRI liver contrast agent Primovist we contribute to early diagnosis of HCC. We will make further efforts to contribute to patients and medical experts both in fields of diagnosis and treatment of HCC in Japan and worldwide."

Janssen Gets FDA Nod to Use Risperidone as Monotherapy, Adjunctive Therapy in Bipolar I Disorder May 20, 2009, Pharmabiz, Titusville, New Jersey Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals Inc has received US Food and Drug Administration (FDA) approval for Supplemental New Drug Applications (sNDAs) for the use of Risperdal Consta (risperidone) Long-Acting Treatment as both monotherapy and adjunctive therapy to lithium or valproate in the maintenance treatment of Bipolar I Disorder. Bipolar Disorder is a brain disorder that causes unusual 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

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Pharma Spectrum I Bipolar Disorder is characterized based on the occurrence of at least one manic episode, with or without the occurrence of a major depressive episode, and affects approximately one per cent of the American adult population in any given year.

UCB gets FDA Nod for Cimzia to Treat Rheumatoid Arthritis May 18, Pharmabiz, Brussels UCB announced that the US Food and Drug Administration (FDA) approved Cimzia, the only PEGylated anti-TNF (Tumour Necrosis Factor), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). Cimzia can be dosed at 400 mg initially and at weeks two and four, followed by 200 mg every other week; for maintenance dosing, 400 mg every four weeks can be considered. In clinical trials with Cimzia, together with methotrexate (MTX), patients experienced a significant reduction in the signs and symptoms of RA at week 24 with some showing clinical responses within one to two weeks, compared with MTX alone. Additionally, radiographic data showed Cimzia, together with MTX, inhibited progression of joint damage, with a significantly smaller change from baseline in modified Total Sharp Score (TSS) at 24 and 52 weeks of treatment, compared with MTX alone (p<0.001).

Novartis Bags Prevacid 24HR

FDA

Nod

to

Market

Pervasis Therapeutics Inc, a biotechnology company pioneering biologically active cellular therapies to treat vascular and other serious diseases, has received orphan drug designation for Vascugel, a novel allergenic cell therapy product that may restore natural repair and regeneration pathways in the vasculature, from the US Food and Drug Administration (FDA). The orphan drug designation is granted for the prevention of arteriovenous fistula or arteriovenous graft failure in patients with end-stage renal disease (ESRD) receiving haemodialysis or preparing for haemodialysis.

Roche's Avastin Gets US Accelerated Nod for Brain Cancer May 7, 2009, Pharmabiz, Basel

Roche has received accelerated approval for Avastin (bevacizumab) from the US Food and Drug Administration (FDA) for people with glioblastoma with progressive disease following prior therapy. The new indication for Avastin was granted under the FDA's accelerated approval programme that allows provisional approval of medicines for cancer or other lifethreatening diseases. It follows the unanimous vote by the FDA Oncologic Drugs Advisory Committee (ODAC) on March 31.

Jubilant Gets USFDA Nod to Market Cardiac Drug

May 15, 2009, Pharmabiz, Basel, Switzerland

May 4, 2009, Business Standard

http://www.pharmabiz.com/article/detnews.asp?articleid =49729§ionid=43

http://www.businessstandard.com/india/news/jubilant%5Cs-us-arm-getsusfda-nod-to-market-sestamibi/60376/on

Novartis announced that Prevacid 24HR (lansoprazole delayed-release capsules 15 mg) has been approved by the US Food and Drug Administration (FDA) as the first overthe-counter (OTC) Proton Pump Inhibitor (PPI) for the treatment of frequent heartburn since 2003. Prevacid 24HR is expected to be available over-the-counter in 2009. Once-daily Prevacid 24HR is the first OTC PPI approved in its original prescription formulation. It is the only PPI containing the active ingredient lansoprazole to be approved for OTC treatment of frequent heartburn, which is defined as heartburn that occurs two or more days per week. In three clinical studies, Prevacid 24HR demonstrated significantly better efficacy in treating frequent heartburn than placebo.

US FDA Grants Orphan Drug Status for Pervasis' Vascugel May 12, 2009, Massachusetts

Pharmabiz,

Cambridge,

FDA

Pharmaceutical firm Jubilant Organosys today said its American arm has got a nod from the USFDA to market the generic drug Sestamibi in the US.DRAXIMAGE LLC, the US subsidiary of BSE-listed Jubilant, received approval from the US Food and Drug Administration (FDA) for it's Abbreviated New Drug Application (ANDA) for DRAXIMAGEs generic Sestamibi, Jubilant said in a press release. Sestamibi is used in Myocardial Perfusion Imaging (MPI), which evaluates the flow of blood to the heart. The MPI market size is currently estimated at $400 million.

US FDA Asks OTC Drug Makers to Revise Labelling to Include Warning on Pain & Fever Drugs May 2, 2009, Pharmabiz, Maryland The Food and Drug Administration issued a final rule that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labelling to

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Pharma Spectrum include warnings about potential safety risks, such as internal bleeding and liver damage, associated with the use of these popular drugs. Products covered by the FDA action include acetaminophen, and a class of drugs known as the nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs include aspirin, ibuprofen, naproxen, and ketoprofen. Acetaminophen is in a class by itself. The revised labelling applies to all OTC pain relievers and fever reducers, including those that contain one of these ingredients in combination with other ingredients, such as in cold medicines containing pain relievers or fever reducers.

inclduign Clozaril.

Bial, Eisai Get European Marketing Nod for Once Daily Anti-Epileptic Zebinix

May 1, 2009, SCRIP

May 2, 2009, Pharmabiz, London http://www.pharmabiz.com/article/detnews.asp?articleid =49510§ionid=43 Bial-Portela & CA, SA, and Eisai Europe Limited, the European subsidiary of Eisai Co, Ltd, announced that the novel once daily anti-epileptic Zebinix (eslicarbazepine acetate) received marketing authorisation from the European Commission as adjunctive therapy in adults with partial-onset seizures, with or without secondary generalisation. Epilepsy is one of the most common neurological diseases, affecting approximately one in 100 people. Treatment of partial-onset seizures, the most common type of epilepsy, remains a constant challenge and up to 40 per cent of patients with partial seizures do not achieve seizure control with current anti-epileptics.

Strattera Approved For Paediatric ADHD in Japan May 1, 2009, SCRIP Lilly’s Strattera (atomoxetine) has been approved in Japan for attention-deficit hyperactivity disorder (ADHD) in paediatric patients aged six to 18 years. The formal clearance from the Ministry of Health, Labour and Welfare endorses a positive recommendation from anadvisory committee earlier this year (scripenews.com, February 5th, 2009). Strattera has been on the US market since early 2003 but was not submitted until mid-2007 in Japan, where it received a priority review.

GalxoSmithKline’s

Tykerb

and

Novartis’s

Tykerb (lapatinib) was given final regulatory clearance for use in combination with capecitabine (Chugai/Roche’s Xeloda) in patients with recurrent or non-operable metastatic HER2-positive breast cancer who have received previous treatment containing Chuggai/Roche’s Herceptin (tratuzumab).

World Prepares for a Swine Influenza Pandemic As global authorities prepare for a possible swine influenza pandemic, the Pharma industry is poised to develop a vaccine. The World Health Organisation this week raised the level of influenza pandemic alert from phase three to phase five, just one step from a global pandemic. The move comes after the WHO declared a “public emergency of international concern” following a number of confirmed cases of swine influenza A (H1N1) in Mexico and the US.” All countries should immediately activate their pandemic preparedness plans, “said Dr. Margaret Chan, Director General of WHO.

India Angry Over Drug Seizure Issue April 30, 2009, Asian Age 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 Europe. “We have taken it up in the WTO”, said the joint secretary in the department of industrial policy and promotion N.N. Prasad.

Glenmark Receives US FDA Nod for Ezetimibe April 28, 2009, Business Standard http://www.businessstandard.com/india/news/glenmark-receives-us-fda-nodfor-ezetimibe/59483/on

Formal

May 1, 2009, SCRIP

Drug firm Glenmark Generics Ltd today said it has received tentative approval from the US Food and Drug Administration (FDA) for the generic version of cholesterol lowering drug Ezetimibe, sold under the brand name 'Zetia' in 10 mg strength.

Japan’s Ministry of Health, Labour and Welfare has formally approved a number of products given positive recommendations by an advisory committee last month,

Glenmark has got the tentative approval for the generic version of Schering Plough and MSP Singapore Company LLC's anti-cholesterol compound Ezetimibe, which has

Tykerb and Clozaril Japanese Approvals

among

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Pharma Spectrum received sales of 1.5 billion dollars in 2008, the company said in a statement.

European countries will follow from autumn 2009 onwards, a company press release said.

J&J, Schering Approval

Qlaira is the first in a new class of oral contraceptives to deliver estradiol, the estrogen identical to the one produced by the female body. Over the past 50 years, many new progestins have been developed for use in oral contraceptives, but the estrogen component remained the same - ethinylestradiol. The introduction of Qlaira thus offers women a new choice in oral contraception

Biologic

Wins

FDA

April 24, 2009, Fierce Biotech http://www.fiercebiotech.com/story/breaking-news-j-jschering-biologic-wins-fda-approval/2009-0424?utm_medium=nl&utm_source=internal Johnson & Johnson and Schering-Plough have won FDA approval for Simponi (golimumab), an injectable biologic drug for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. These chronic inflammatory diseases, which plague roughly 3 million Americans, result in pain and inflammation--and in some cases, joint destruction and disability. The drug was also approved in Canada earlier this week. Simponi is an update to the $5 billion-a-year blockbuster drug Remincade and will compete with Amgen;s Enbrel and Abbott Laboratories' Humira. Simponi's biggest advantage? It requires only injections rather than in-office infusions, and is the first monthly subcutaneous anti-TNFalpha therapy.

New Products Generex Lebanon

Launches

May 18, 2009, Massachusetts

Oral

Insulin

Pharmabiz,

in

Worcester,

Generex Biotechnology Corporation, the leader in drug delivery for metabolic diseases through the inner lining of the mouth, together with Benta s.a.l., the company's importation, marketing, distribution and sales sublicensee in Lebanon, launched the commercial retail sales of Generex Oral-lyn in Lebanon. The launch was announced at a press conference in Beirut with Lebanese minister of Health H E Muhammad Jawad Khalifah.The product has been approved for importation and commercial marketing and sale in Lebanon by the Ministry of Public Health, and will be marketed and sold for the treatment of patients with type-1 and type-2 diabetes in Lebanon.

Bayer Schering to launch Oral Contraceptive Qlaira in Europe May 16, 2009, Pharmabiz, Berlin Bayer Schering Pharma AG, Germany, has launched its new oral contraceptive Qlaira (estradiol valerate/dienogest) in Europe. Qlaira will be available in several European countries, including Germany. More

Abbott Launches Two New Products for Peripheral Artery Disease Treatment May 11, 2009, Pharmabiz, Abbott Park, Illinois http://www.pharmabiz.com/article/detnews.asp?articleid =49652§ionid=43 Abbott launched two new products - FoxCross PTA Catheter and HI-TORQUE Versacore .035 Guide Wire - for the treatment of peripheral artery disease (PAD), a condition that occurs when the vessels supplying blood to the legs, arms, stomach or kidneys become narrowed or blocked by plaque, restricting normal blood flow. The FoxCross PTA Catheter is a next-generation .035 balloon dilatation catheter and is now available in the 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 United States.

Lundbeck Launches ATryn in US May 8, 2009, Massachusetts

Pharmabiz,

Framingham,

ATryn (antithrombin [recombinant]) is now available commercially through Lundbeck Inc of Deerfield, Illinois, a wholly owned subsidiary of H Lundbeck A/S in Denmark, GTC Biotherapeutics, Inc's commercialization and development partner in the United States. GTC is due to receive a total of $1 million from Lundbeck for its initial inventory of ATryn. "We are delighted to have reached this important milestone with the launch of ATryn in the US, which is the first transgenically produced therapeutic product to reach the marketplace," stated Geoffrey F Cox, GTC's chief executive officer and chairman of the Board. "We look forward to working with Lundbeck to deliver this important new product."

Watson Launches BPH Drug Rapaflo in the US April 17, 2009, SCRIP Watson Pharmaceuticals has launched its orally active alpha la-adrenoceptor selective antagonist Rapaflo

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Pharma Spectrum (silodosin) in the US for the treatment of benign prostatic hyperplasia (BPH) following an FDA approval last October. “We are confident that the proven rapid efficacy and safety of Rapaflo will provide BPH patients and their physicians an important treatment option. We expect our three-day sample packs to clearly demonstrate their rapid tolerability of Rapaflo,” said Paul Biasro, President and Chief Executive of Watson.

First Launch for Minodronic Acid in Japan April 17, 2009, SCRIP Astellas and Ono have launched the oral bisphosphonate minodronic acid bydrate in Japan, its first market worldwide, for the treatment of osteoporosis. The product is being co-marketed by the two firms as Bonoteo and Recallbon respectively. Osteoporosis affects an estimated 10 million people in Japan, where a number of other bisphosphonates are already on the market. Several of these, including Takeda/Ajinomoto’s Benet/Actonel (risedronate), are available in once-weekly formulations.

R&D/Clinical Trials Glaxo Forges $370M Pact with Oxford Biotherapeutics May 18, 2009, Fierce Biotech http://www.fiercebiotech.com/story/glaxo-forges-370mdevelopment-pact-oxford-biotherapeutics/2009-0518?utm_medium=nl&utm_source=internal GlaxoSmithKline has committed up to $370 million for a new deal designed to bolster its presence in the cancer market. The pharma giant announced a drug development pact with Oxford BioTherapeutics to discover, develop and commercialize new therapeutic antibodies for the treatment of primary, metastatic and recurring forms of cancer. OBT gets an undisclosed upfront and the rest in milestones. "We are extremely pleased to be collaborating with GSK given their proven commitment to innovation and their expertise in the development and commercialization of novel oncology medicines," said Christian Rohlff, CEO of OBT.

Europe Awards $331M to Accelerate Drug Research May 18, 2009, Fierce Biotech http://www.fiercebiotech.com/story/europe-awards331m-accelerate-drug-research/2009-0518?utm_medium=nl&utm_source=internal Europe’s Innovative Medicines Initiative has handed out $331 million to back 15 cutting-edge research projects designed to make the continent more competitive with the United States when it comes to drug development. Academic groups and small companies alike competed for the support--a combination of €110 million in cash from the European Union and €136 million in kind from the continent's pharmaceutical industry. That money will go to back "pre-competitive" work that will provide solutions to common problems in drug development.

Regulus Therapeutics gets Initial Milestone from GSK Collaboration May 16, 2009, Pharmabiz, Carlsbad, California 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 different microRNA targets related to inflammatory disease. Regulus has now reached an important discovery milestone, which triggered a payment, concurrent with the first demonstration of a pharmacological effect in immune cells by specific microRNA inhibition. Scientists successfully delivered specific microRNA inhibitors, known as anti-miRs, to mice and clearly identified changes in expression of the genes regulated by the microRNA in immune cells.

Lilly to Present Above 50 Studies at ASCO 2009 May 15, 2009,Pharmabiz http://www.pharmabiz.com/article/SectionWiseArchive News.asp?id=4 Eli Lilly and Company will unveil data from more than 50 studies at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Fla. from May 29 to June 2, 2009. Majority of the presentations are learnt to support Lilly's leadership in thoracic cancer 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.

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Pharma Spectrum This year's ASCO also marks the first time Lilly will feature the newest molecules in its portfolio resulting from Lilly's recent acquisition of ImClone Systems.

Roche Ties Up with Tekmira Pharma to Advance RNAi Product Candidates Thursday, May Vancouver, BC

14,

2009,

Pharmabiz,

Tekmira Pharmaceuticals Corporation has entered into a product development agreement with global healthcare company Roche to advance Roche's first two RNA interference (RNAi) product candidates into human clinical testing. Both of the product candidates will be based on Tekmira's stable nucleic acid-lipid particle (SNALP) technology. Under the terms of the product development agreement, Roche will pay Tekmira up to US$ 18.4 million to support the advancement of the product candidates to the filing of Investigational New Drug (IND) applications. Tekmira is also eligible to receive up to US$ 32 million in milestones plus royalties on product sales as the first two products are advanced through development and commercialization based on Roche's access to Tekmira's intellectual property under previously announced agreements.

Pfizer's Kindler Lays Out His Vision for R&D Teams May 12, 2009, Fierce Bioresearcher http://www.fiercebioresearcher.com/story/pfizerskindler-lays-out-his-vision-r-d-teams/2009-0512?utm_medium=nl&utm_source=internal Takeda isn't the only big pharma company looking for ways 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 recently to review how R&D teams need to be structured in order to be successful.

Exelixis Inc and Boehringer Ingelheim, a global pharmaceutical group of companies headquartered in Germany, have established an exclusive, worldwide collaboration with the aim to discover, develop and commercialise autoimmune disease therapies. The collaboration is focused on the discovery of sphingosine-1phosphate type-1 receptor (S1P1) agonists. The S1P1 receptor is a central mediator of multiple pathways implicated in a variety of autoimmune diseases. Under the terms of the agreement, Exelixis will receive a $15 million upfront payment. In addition, Exelixis will potentially receive up to $339 million in milestone payments dependent on the successful achievement of development, regulatory and commercial programme goals and royalties on sales of potential products commercialized under the collaboration.

Jubilant In R&D Deal with AstraZeneca May 6, 2009, Hindu Business Line http://www.thehindubusinessline.com/2009/05/06/storie s/2009050650540200.htm Jubilant Organosys Ltd announced that its Bangalorebased subsidiary, Jubilant Biosys Ltd, has signed a research collaboration agreement with AstraZeneca, which is focused on developing new drugs to add to the international pharmaceutical company’s pre-clinical pipeline. Jubilant Organosys is expected to earn $220 million in research and milestone fees through this deal. Of this, it will get about $20 million as definite payment from AstraZeneca, with an annual payment of about $3 million coming in during the first two years. It could also potentially earn up to $200 million as and when it meets certain targets in developing drugs under the deal. The two firms will work on neuroscience-related drugs.

Oxford Biomedica, Sanofi-Aventis Enter Pact to Develop Gene-Based Medicines for Ocular Diseases

First, he said, the teams have to be a manageable size. Say, no bigger than 100 to 150, so they can all fit into one cafeteria. Second, the team leaders, the CSOs, need to be at the top of their field. And, third, they need to be left alone to create a distinctive culture, being evaluated based on their success demonstrating proof of concept.

May 4, 2009, Pharmabiz, Oxford, UK

May 11, 2009, Pharmabiz, South San Francisco, California

Oxford BioMedica will receive an upfront payment of US$26 million (£18 million) and committed funding of up to a further US$24 million (£16 million) over three years. In addition, sanofi-aventis has an exclusive option for a worldwide licence to develop and commercialise four ocular products. If successful, Oxford BioMedica will

Exelixis, Boehringer Ingelheim Collaborate to Develop Autoimmune Disease Therapies http://www.pharmabiz.com/article/detnews.asp?articleid =49654§ionid=20

http://www.pharmabiz.com/article/detnews.asp?articleid =49540§ionid=20 Oxford BioMedica announced that it has entered into a new collaboration with sanofi-aventis to develop novel gene-based medicines, utilising the company's LentiVector gene delivery technology, for the treatment of ocular diseases.

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Pharma Spectrum receive further undisclosed license fees, milestone payments and royalties on product sales, the terms of which are consistent with other deals of this size and scope.

Pfizer, MMV Ink Pact to Fight against Malaria April 25, 2009, Pharmabiz, New York http://www.pharmabiz.com/article/detnews.asp?articleid =49413§ionid=6

Pfizer Inc and Medicines for Malaria Venture (MMV) have signed an agreement that is designed to facilitate advancements in the battle against malaria, a disease that afflicts vulnerable populations in the developing world each year. Under the agreement, MMV will have access to the Pfizer library of novel chemical entities, in order to screen it for compounds that have the potential to be developed into new treatments for malaria. Malaria causes an estimated 881,000 deaths each year, of which over 90 per cent are in Africa and 85 per cent are children under five years of age.

Arzoxifene Shown to Increase Bone Mineral Density April 17, 2009, SCRIP A study of Lilly’s investigational selective oestrogen receptor modulator (SERM) arzoxifene showing it to increase lumbar spine and total hip bone minderal density (BMD) in postmenopausal women with normal or low bone mass, has been published in the Journal of Endocrinology & Metabolism. In addition, arzoxifene, dosed at 20mg/day, decreased the biochemical markets of bone turnover, and showed a neutral effect on the uterus and endometrium.

Mergers & Acquisitions/Collabo rations J&J Buys Cougar Biotech for $1B May 22, 2009, Fierce Biotech http://www.fiercebiotech.com/story/breaking-news-j-jbuys-cougar-biotech-1b/2009-0521?utm_medium=nl&utm_source=internal Johnson & Johnson has snagged a biotech with a latestage oncology drug in its pipeline. J&J will pay $1 billion cash for Los Angeles-based Cougar Biotechnology, which is developing drugs for prostate cancer, breast cancer and

multiple myeloma. Cougar will work with Ortho Biotech Oncology R&D, a unit of Centocor R&D. Cougar is conducting two Phase III trials for abiraterone acetate for prostate cancer. The first study involves patients with metastatic, castrationresistant prostate cancer who have progressed after docetaxel-based chemotherapy has failed. The second trial is testing patients who have not receive chemotherapy.

Aurobindo, Pfizer Expand Product Portfolio May 21, 2009, Pharmabiz Aurobindo Pharma has expanded its partnership with Pfizer Inc, a global leader in pharmaceuticals, by executing licensing and supply agreements for several solid dosage and sterile products for a number of emerging markets. Under the terms of the agreement, Pfizer has acquired rights to 55 solid oral dose products and five sterile injectable products for several countries throughout Asia, Latin America, Africa and the Middle East. These products fall under a broad range of some important therapeutic segments such as anti infectives, cardiovascular (CVS) and central nervous system disorders (CNS).

Claris Partners Pfizer to Strengthen Regulated Market Presence May 21, 2009, The Hindu Business Line http://www.thehindubusinessline.com/2009/05/21/storie s/2009052150490200.htm Pharmaceutical major Claris Lifesciences Ltd today 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, Europe, Australia and New Zealand. Pfizer, with a turnover of $10 billion in established products annually, had a similar licensing agreement with Aurobindo Pharma Ltd.

Sanofi-Aventis, DNDi Tie Up For Sleeping Sickness Drug Fexinidazole May 19, 2009, Pharmabiz, Paris http://www.pharmabiz.com/article/detnews.asp?articleid =49791§ionid=14 Sanofi-aventis and the non-profit Drugs for Neglected Diseases initiative (DNDi) have signed an agreement for the development, manufacturing and distribution of fexinidazole, a promising new drug for the treatment of human African trypanosomiasis, also known as sleeping

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Pharma Spectrum sickness, a fatal disease that threatens 60 million people in Sub-Saharan Africa. Fexinidazole will enter clinical development in the first half of 2009 and is the only new drug candidate in clinical development for sleeping sickness. Under the terms of the agreement, DNDi will be responsible for preclinical, clinical and pharmaceutical development. Sanofi-aventis will be responsible for the industrial development, registration, and production of the drug at its manufacturing sites. Considering their respective commitments to fight sleeping sickness, sanofi-aventis and DNDi have decided to combine their expertise to making fexinidazole available on a non-profit basis to all patients who need it.

Sanofi Inks $315M Inflammation Pact with Kyowa May 14, 2009, Fierce Biotech http://www.fiercebiotech.com/story/sanofi-inks-315minflammation-pact-kyowa/2009-0514?utm_medium=nl&utm_source=internal Now that Sanofi-Aventis has finished trimming some of its marginal drug development programs, the French pharma is reloading its pipeline with a licensing deal for a preclinical antibody advanced by Japan's Kyowa Hakko Kirin. Sanofi says that the inflammation deal will be worth up to $315 million in upfront fees and milestones for Kyowa. The companies didn't break that number down. Sanofi snared worldwide rights to the anti-light fully human monoclonal antibody, with a co-promotion pact in place for Japan and Asia. The program will initially test the antibody's effectiveness against ulcerative colitis and Crohn's disease and, depending on the data, could be further pursued into rheumatoid arthritis.

UCB to Acquire Schwarz Pharma Shares May 13, 2009, Pharmabiz, Brussels, Belgium http://www.google.co.in/search?hl=en&q=PharmabizUCB+ to+acquire+Schwarz+Pharma+shares&btnG=Search&meta= &aq=f&oq= 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 'squeezeout' procedure. In accordance with the legally stipulated procedure (under Sections 327a ff. of the German Stock Corporation Act [AktG]), the Schwarz Pharma shares held by minority shareholders are to be transferred to UCB and in return for an appropriate cash compensation, by way of a resolution still to be passed by the Annual General Meeting of Schwarz Pharma AG. UCB SP GmbH, Monheim, as the principal shareholder of Schwarz Pharma, informed the Executive Board of Schwarz Pharma AG in a letter that it had set the cash compensation for the transfer of the shares held by

minority shareholders in Schwarz Pharma to UCB SP GmbH, as the principal shareholder, to EUR 111.44 per share.

GSK Extends with Aspen

Strategic

Collaboration

May 13, 2009, Pharmabiz, London http://www.pharmabiz.com/article/detnews.asp?articleid =49696§ionid=14 GlaxoSmithKline plc (GSK) has agreed to extend its strategic relationship with Aspen Pharmacare Holdings Limited (Aspen) and to acquire a 16 per cent shareholding in the South African based pharmaceuticals company. This is part of a wide ranging agreement which includes combining commercial activities in sub-Saharan Africa and the divestment of several assets to Aspen. Abbas Hussain, president Emerging Markets, GlaxoSmithKline said, "Extending our strategic relationship with Aspen supports GSK's strategy to accelerate sales growth in emerging markets. The combination of our commercial activities in Sub-Saharan Africa is highly complementary and will mean that together we can provide more medicines of value to more patients in these countries. At the same time, GSK will also benefit from investing in one of Africa's leading healthcare companies with a formidable track record of delivery."

Merck Buys Clostridium Combination Rights

difficile

May 1, 2009, SCRIP Merck & Co. has acquired the worldwide rights to a biologic treatment for Clostridium difficile infection in a $ 225 million deal with Medarex and Massachusetts Biologic Laboratories (MBL) of the University Of Massachusetts Meidcal School. Merck will pay $ 60 million up front for the licence to develop and commercialise CDA – 1 and CDB-1, which was being developed by Medarex and MBL, and could pay a further $ 165 million in milestones, as well as double-digit royalties on sales.

BMS and Ensemble in $249 Million Drug Discovery Deal April 17, 2009, SCRIP Bristol-Myers Squibb and Ensemble Discovery are to discover and develop novel drug candidates in a deal worth up to $248.5 million. Ensemble is developing Ensemblins, a new class of oral drug molecules for targets that cannot be modulated effectively by traditional small-molecule pharmaceuticals. The deal will aim to develop Ensemblins for up to eight targets.

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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

01/04/2009

Clinical Data Inc (Cogenics division)

02/04/2009

Anhui Jingfang Pharmaceutical Co Ltd

Beckman Coulter Inc Tongjitang Chinese Medicines Company Charles River Laboratories International Inc

03/04/2009 07/04/2009

07/04/2009

09/04/2009 09/04/2009 16/04/2009

Piedmont Research Center LLC Gainbridge Investments (Cyprus) Limited Beleggingsmaatsch appij Lemore B.V (34.50% stake) Medley S/A Industria Farmaceutica Cipla Medpro South Africa Ltd Oktogon Investment ApS

16/04/2009

Pfizer Ltd

20/04/2009

Stiefel Laboratories, Inc.

Value (USD mn) 18

9

46

SSL International Plc

27

SSL International Plc

93

Sanofi-Aventis SA

658

Adcock Ingram Limited

266

Torfarm SA Pfizer Investments Netherlands BV GlaxoSmithKline Plc

14 27 3,300

Country

Type of Deal

USA

Acquisition, Cross border, Private

China

Acquisition, Domestic, Private

USA

Acquisition, Domestic, Private

Cyprus

Acquisition, Cross border, Private

Netherlands

Acquisition, Cross border, Private

Brazil

Acquisition, Cross border, Private

South Africa

Acquisition, Domestic, Public

Denmark

Acquisition, Cross border, Private

India

Acquisition, Cross border, Public

USA

Acquisition, Cross border, Private

USA

Acquisition, Domestic, Private

Israel

Acquisition, Cross border, Public

British Virgin Islands

Acquisition, Cross border, Private

USA

Acquisition, Buy & Build, Cross border, Private

Biotechnology 03/04/2009

Magen BioSciences Inc

PPD Inc

13/04/2009

Rosetta Genomics Ltd (16.43% stake)

Prometheus Laboratories Inc

17/04/2009

Genetel Biotech (BVI) Limited

HD Global Limited

36

21/04/2009

Endotec Inc.

Korea Bone Bank Co., Ltd.

20

For further information please contact Yes Bank Ltd.

15 8

Deal values approximated to nearest million.

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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 13 May 2009, SCRIP, Francesca Bruce "The Colombian government has set a maximum price for Abbott's Kaletra (lopinavir plus ritonavir), reducing the private sector price by around 55%. However, civil society is still pushing for the government to issue a compulsory licence.The national medicine pricing commission has set the maximum public sector price at $1,067 (down from $1,683) per patient per year, and $1,591 for the private sector (down from around $3,500). The move follows talks with Abbott after the government called for the firm to match the prices charged elsewhere in the region (scripnews.com, April 22nd, 2009). Local media reports suggest that Abbott refused to lower its prices, prompting the government to take action. The firm was unable to comment, but it stated earlier that it had already lowered its prices three times over the past two years.Nevertheless, the price ceiling still means that Kaletra is not subject to competition from generics. Many groups are therefore still arguing for the Colombian government to declare lopinavir plus ritonavir of public interest, which would allow it to issue a compulsory licence for the drug. The health ministry should make a decision on this at the end of the week.

Inaccurate: GSK Launches 50% Discount for Uninsured May 7, 2009, Fierce Pharma http://www.fiercepharma.com/story/glaxo-launches-50discount-uninsured/2009-0507?utm_medium=nl&utm_source=internal Andrew Witty puts charity to work again. The GlaxoSmithKline CEO, who's already pledged to slash prices for drugs sold in poor countries, now is offering a 50 percent discount on meds for U.S. patients who are uninsured. The discount-card program applies to anyone under 65 who doesn't have insurance, and patients will have access to it until they get employer-sponsored coverage or until health reform takes care of their insurance problems, whichever comes first. No income restrictions apply, either. Deirdre Connelly, Glaxo's U.S. pharma president, explains, "We feel this is simply the right thing to do, especially in this economy." Apparently, "the right thing to do" has been much on Witty's mind; as you know, he's has been on something of a good-boy binge. He's pledged to disclose payments to doctors and to limit them, too, and also promised to publish info on Glaxo's support for medical

Hetero Readies 'Swine Flu'

Drugs

for

Treating

May 13, 2009, Hindu Business Line http://www.thehindubusinessline.com/2009/05/13/storie s/2009051350710200.htm Hetero Drugs, the lead supplier of ‘Tamiflu’, which is considered the best bet to treat ‘swine flu’, has lined up supply of nine million capsules to the Centre, as part of the national preparedness to tackle a possible pandemic. “We have already supplied two million capsules, by end of May another three-four million would be sent and by June 10, 2009 will complete the entire supply,” Mr Srinivas Reddy, Director (Marketing) of the Hyderabad-based drug major, said. Immediately after reports of detection of swine flu cases in Mexico and other parts, the Centre had sounded Hetero Drugs for an immediate supply of 10 lakh doses of generic versions of Roche’s anti-influenza drug Tamiflu.

Trend: Hospitals Mounting Attack on Retail Clinic Business May 11, 2009, Fierce Healthcare http://www.fiercehealthcare.com/story/trend-hospitalsmounting-attack-retail-clinic-business/2009-0511?utm_medium=nl&utm_source=internal For a while, it was beginning to look like the retail clinic phenomenon was peaking or perhaps even petering out, with a handful of clinics even being forced out of business. But maybe the truth is that the battleground is shifting-from growth fueled by pharmacy chains and independent operators to a gradual encroachment by hospitals. While hospitals have been dabbling in the retail clinic market for years, a growing number are dipping their oar in. For example, the Cleveland Clinic has lent its impeccable brand and services to several CVS clinics in Ohio, and the Mayo Clinic is operating two clinics in Rochester, MN supermarkets.

Big Pharma Grows Online, Slowly May 11, 2009, Fierce Pharma http://www.fiercepharma.com/story/big-pharma-growsonline-slowly/2009-0511?utm_medium=nl&utm_source=internal Welcome to the revolution--the social media revolution, that is. Big Pharma is finally joining the party, AdAge reports, with a 36 percent increase in internet-media

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Pharma Spectrum spending in 2008. Though plenty of folks consider drugmakers' arrival to be too little, too late--even after that 36 percent hike, pharma still spent only $137 million online--the trade pub allows that FDA regulation makes it tough for them to be early adopters. Some of the mag's examples of pharma's forays online: Johnson & Johnson has a blog; AstraZeneca, Boehringer Ingelheim and Novartis send out company news via Twitter; Sanofi-Aventis and AstraZeneca have relatively new YouTube channels. We'd add that Pfizer and Roche both tweet news, too. You pharma-marketing experts know of more examples, few and far between though they are.

Dutch Body Lures IT, Pharma Companies May 9, 2009, Hindu Business Line http://www.thehindubusinessline.com/2009/05/09/storie s/2009050951021700.htm

http://www.financialexpress.com/news/us-trade-pactscould-harm-indian-pharma/454952/ Concerned over certain clauses in the free trade agreements (FTAs) of the US that could potentially curb Indian pharmaceuticals exports, New Delhi has decided to take up the matter with Washington soon. India’s concerns about the FTAs of the US — for instance the one which the US has with Morocco — stem from certain provisions in such trade pacts that aim at increasing the duration of drug patents. Usually, a patent is meant to last only for 20 years. However, these FTA clauses ensure the ‘patentability of new uses of discovered inventions’ (meaning even minor changes of an existing drug can be patented). The provisions are also aimed at increasing duration of the patent monopoly (a strategy called ‘ever-greening’ of patents) by taking into account the time taken to process patent claims.

Having assisted around 80 Indian companies establish offices in the Netherlands, the Netherlands Foreign Investment Agency (NFIA) in India is luring companies here to look at Europe. According to NFIA, in the last two years alone nearly 25 companies have established their presence in the Netherlands.

Glaxo, Roche Combat Antiviral Hoarding

“Opportunities exist during these recessionary times. An investment in Europe would be a profitable strategy for Indian companies in today’s economic context. When growth returns to the world economy, as it inevitably will, the companies that have established their presence in Europe will have the first-mover advantage,” says Mr Robert Schipper, Executive Director, NFIA-India.

GlaxoSmithKline and Roche have been reduced to playing flu-drug traffic cop. Because the worried well are snapping up drugs all over the world, prompting shortages in some places, the drugmakers are strategically allocating their stocks. Glaxo says it's sending its antiviral Relenza to areas of the U.S. and elsewhere in the world that need it most. Roche has actually cut off French pharmacies because of a run on its Tamiflu drug; it's only supplying Tamiflu to hospitals in France.

Ranbaxy to Sell Generics Medicines under AOK Agreement in Germany May 6, 2009, Pharmabiz http://www.pharmabiz.com/article/detnews.asp?articleid =49594§ionid=5 Ranbaxy Laboratories' German subsidiary Basics GmbH (Basics) has concluded new discount agreement with AOK Baden Wurttemberg, biggest health insurance group, for providing Cefaclor Basics and Tamsulosin Basics during the year 2009 and 2010. The agreement will come into effect from June 1, 2009. Cefaclor Basics product will be exclusive for all 15 AOK regional associations and five zones. Similarly, Tamsulosin Basics will be exclusive for 13 AOK regional associations and four zones.

US Trade Pacts Could Harm Indian Pharma May 6, 2009, Financial Express

May 4, 2009, Fierce Pharma http://www.fiercepharma.com/story/glaxo-rochecombat-antiviral-hoarding/2009-0504?utm_medium=nl&utm_source=internal

The number of daily prescriptions for antiflu drugs skyrocketed last week to nine times previous April levels, the New York Times reports. To help keep up with demand, Roche and Glaxo quickly jacked up production: Glaxo now has 6 million Relenza treatments in stock and plans to boost production to 5 million treatments per month.

Ranbaxy Forced to Recall Drug from US May 3, 2009, Business Standard http://www.business-standard.com/india/news/ranbaxyforced-to-recall-drugus-mkt/356916/ Withdrawal of nitrofurantoin capsules in coordination with 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 a generic urinary infection antibiotic drug. Ranbaxy Pharmaceuticals Inc (RPI), the US subsidiary of Ranbaxy, today said it was conducting a voluntary recall of

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Pharma Spectrum all lots of nitrofurantoin (monohydrate/macrocrystals) 100 mg capsules currently in the market in the US.

Novo Nordisk Among World's Most Ethical Companies: Ethisphere Study May 2, 2009, Pharmabiz Novo Nordisk, the world leader in diabetes care is recognized as one among the top ethical companies in the world according to Ethisphere study. The analysis is based on the sustainable and ethical leadership of the Denmark drug major. More than 10,000 of the world's leading companies were analyzed for a period of six months in six continents, across 35 industries before arriving at the final list. These companies were evaluated on seven key parameters which included corporate responsibility, governance, innovation leadership, integrity track record, internal systems programme before deciding on the final list.

Indian Pharma Emerges Big Plan in Japan May 2, 2009, Business Standard http://www.businessstandard.com/india/storypage.php?autono=356834 Leading Indian drug makers such as Ranbaxy, Lupin, Zydus Cadila and Dishman, which forayed into Japan in the past three years, have emerged as important players in the generic or copycat drug business of patented medicines in that market, the second largest in the world. The Japanese drug market, second after the US with a size of $74 billion, has a small generic segment, worth 5 percent of the total in value terms and 17 percent in volume terms.

Biocon Taps German Market through Axicorp April 30, 2009, Pharmabiz http://www.pharmabiz.com/article/detnews.asp?articleid =49535§ionid=50 The Bangalore-based leading biotech player Biocon's moves to tap growing business opportunities in Germany has achieved further momentum as its German subsidiary AxiCorp bagged a tender offer from AOK, Germany's largest health insurer, to supply Metformin, a key diabetic generic drug in Germany. The AOK tender is valued at Euro 13.5 million. The contract is planned to be awarded for the entire German territory over the next 2 years and is subject to review in accordance with the German tender regulations. The tender is expected to strengthen the market presence of AxiCorp in the booming generic business.

Docs Like E-Promos April 28, 2009, Fierce Pharma http://www.fiercepharma.com/story/news-flash-docs-epromos/2009-04-28?utm_medium=nl&utm_source=internal Look no further for more evidence that humanity is getting a little too, er, enamored with the internet. According to a study of pharma e-promotions, almost three-fourths of doctors said they'd just as soon talk with a computer than with a drug rep--and some even preferred the computer. If this study is to be believed, it's clear why e-promotion is on the move. More than two-thirds of physicians said they had a positive attitude toward this type of interaction with drugmakers. Perhaps that's because they could do so at their leisure. Almost 70 percent said they did their epromos in the evenings. Or perhaps it's just because they don't have to make conversation.

Institute of Medicine: Time to Nix Pharma Gifts April 28, 2009, Fierce Pharma http://www.fiercepharma.com/story/institute-medicinetime-nix-pharma-gifts/2009-0428?utm_medium=nl&utm_source=internal The government's top medical advisers are now putting their two cents into the conflict of interest debate. The Institute of Medicine says that collaborations between medical professionals and drugmakers can benefit society, but financial ties are getting in the way. In the 353-page report, IOM's Committee on Committee on Conflict of Interest in Medical Research, Education, and Practice warns that current industry practices are negatively influencing research and patient care. The Committee calls on medical professionals to cut or restrict many practices that have now become a common part of the pharma-doctor relationship, including the elimination of free meals, gifts and travel arrangements. Drug samples? Only for those who can't afford the meds. Meetings with sales reps? Restricted. Pharma-sponsored presentations and ghost-writing articles? Out. And researchers are being advised not to sign on for studies if they have a financial stake in the outcome.

Cipla Ready to Supply Generic Drug to West April 28, 2009, Financial Express http://www.financialexpress.com/news/cipla-ready-tosupply-generic-drug-to-west/451953/0

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Pharma Spectrum As worries about a possible swine flu outbreak in the West spread, pharma major Cipla Ltd on Monday said it is ready to supply 1.5 million doses of oseltamivir, the generic version of the bird flu drug, Tamiflu, which can be effective for swine flu. Cipla, which had challenged multinationals with its cheap versions of AIDS drugs for a Medecins Sans Frontieres programme in Africa years ago, said it can deliver the drug in a month. “Cipla has the capacity to supply the drug within 4-6 weeks,” Amar Lulla, joint managing director, Cipla, said on Monday.

$1b Drug Market in Africa at Stake April 26, 2009, Financial Chronicle http://www.mydigitalfc.com/news/1b-drug-marketafrica-stake-625 India has charged the European Union (EU) with working against its drug exports to Africa and South America. The Indian pharmaceutical industry’s exports to Africa are worth $1,065 million a year, a market that will be lost if the EU, prodded by multinational companies, succeeds in convincing African nations to not import Indian medicines. Kenya has already issued a notification saying that generic drugs – the Indian industry’s strong point -- patented elsewhere cannot be sold in that country. The law, in fact, classifies generic drugs as spurious.

Genentech Withdraws Raptiva in the US April 17, 2009, SCRIP Genentech is to withdraw its psoriasis therapy Raptiva (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. Three patients taking the monoclonal antibody therapy were diagnosed with cases of PML, two of which were fatal. A fourth patient developed progressive neurological symptoms and died of an unknown cause (scripnews.com; November 18th, 2008).

Merck & Co Taps Mylan for Japanese Promotion April 17, 2009, SCRIP Banyu, Merck & Co’s subsidiary in Japan, has tapped the generics company Mylan to promote two of its key cardiovascular products in the country. 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

Lipovas (simvastatin). Banyu will continue to produce, distribute and sell the products.

Global $225 Million Scheme Launched

Malaria

Drug

April 17, 2009, SCRIP A global scheme to subsidise newer medicines for malariaendemic countries has been finally launched, costing $225-233 million in the first two years. Most of the funding will come from UNITAID, an international drug purchasing facility (which has more than 25 donor nations), and the UK government. Other countries, including the Netherlands, are considering a financial contribution to the scheme.

Move to Publish “Secret” AntiCounterfeiting Treaty “Modest Step” April 17, 2009, SCRIP Following mounting pressure, the Office of the US Trade Representative (USTR) has published a six – page summary on the “secretive” anti-counterfeiting trade agreement (ACTA) that it is negotiating with major trading partners including the EU and Japan. Essential Action, which has being calling for its publication with more than 100 other public interest groups around the world, told Scrip that the move was a “modest step forward”. Its Director, Robert Weissman said he hoped the move signaled the beginnings of a new progressive policy on transparency at the USTR.

Biotechnology Sanofi-Aventis Builds $350m Dengue Fever Vaccine Plant May 13, 2009, Financial Chronicle Sanofi-Aventis began work on Tuesday on a €350 million ($477 million) plant that is to be devoted to production of the world’s first vaccine against dengue fever, a public health threat for some two-fifths of the world’s population. The company says its vaccine plant in this town north of Lyon is the largest single industrial investment it has ever made. By 2013 it is hoped the plant will begin turning out a dengue vaccine that the company is, at present, testing.

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Pharma Spectrum Pfizer, WARF Sign License Agreement for Human Embryonic Stem Cell Patents May 7, 2009, Pharmabiz, Madison, Wisconsin http://www.pharmabiz.com/article/detnews.asp?articleid =49602§ionid=3 Pfizer Inc, the world's premier biopharmaceutical company, and the Wisconsin Alumni Research Foundation (WARF), the private, non-profit patenting and licensing organisation for the University of Wisconsin-Madison, have signed a license for human embryonic stem (hES) cell patents for the development of new drug therapies. The WARF license provides Pfizer the rights to work with hES cells for drug research and discovery. Securing appropriate licenses, in an area as broad and rapidly moving as regenerative medicine, helps ensure rapid and efficient utilization of the many existing discoveries and inventions in this field and allows for the efficient transfer of information for development of future inventions

Big Pharma Swallows Billions in Biotechs May 5, 2009, Fierce Pharma

combination of two small molecules, formulated for oral use, which are believed to reduce the accumulation of DNA-damage, the underlying biochemical cause of Cockayne Syndrome. Cockayne Syndrome, the initial target of Prodarsan, is a rare genetic disease in which children suffer from accelerated (or premature) aging, while developing severe aging diseases. Progeria diseases are a group of genetic premature aging diseases which manifest in several forms that are genetically and clinically similar although not identical. Depending on the specific form of the disease, patients have a significantly reduced life expectancy and exhibit many aging-related symptoms early on in their lives. Quality of life for these patients is seriously impaired. Cockayne Syndrome is one of the more common forms of progeria and is characterized, among others, by growth failure, mental retardation, hearing and sight problems and a reduced life expectancy. Currently, no effective therapy for Cockayne Syndrome is available.

New Appointments IFPMA New Appointment

http://www.fiercepharma.com/story/big-pharmaswallows-billions-biotechs/2009-0505?utm_medium=nl&utm_source=internal

April 29, 2009, IFPMA

Megamergers may have grabbed most of the headlines of late, but drug makers snapped up plenty of small firms last year, Ernst & Young points out. In 2008, pharma swallowed some $28.5 billion worth of U.S. biotech companies, just a few billion short of a $33 billion record in 2007. And if you back out AstraZeneca’s 2007 buyout of vaccine maker MedImmune--a whopping $15.6 billion deal-then 2008 totted up the highest biotech M&A total ever. The 2008 deal roster includes TakedTakeda’s $8.8 billion acquisition of Millennium Pharmaceuticals, which makes the multiple myeloma treatment Velcade, and Eli Lilly’s $6.5 billion deal for ImClone Systems, maker of cancerfighter 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

Ms. Alicia Greenidge, IFPMA’s Director General, is resigning her position in order to pursue other opportunities. Ms. Greenidge came to IFPMA in 2008 after a distinguished career in the United State Government. During the search for a successor, Laurent Renaud, Director of Administration and Finances, IFPMA will take on the day-to-day administrative operations of the organisation under the direction of Michael Boyd, Vice President of Public Affairs International for ScheringPlough Corporation, who will be serving as Acting Director General.

Pharming Group's Prodarsan Product Gets Orphan Drug Status from US FDA April 30, 2009, Netherlands

Pharmabiz,

Leiden,

The

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

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Pharma Spectrum 'Protection against unfair commercial use' as the Union ministry of health and the department of pharmaceuticals wanted stakeholders to get further engaged in a dialogue before final details are worked out.

Domestic IPR

22 Patent Transferred

Department

Officers

May 18, 2009, Mint http://www.livemint.com/2009/05/18001429/22-patentdepartment-officers.html The New Controller General of India’s patents, designs and trademarks office, Mr. P.H. Kurian, has transferred at least 22 officers in its four regional offices. It is the first time, in at least a decade that transfers have taken place on this scale. Kurian, the first Indian Administrative Service officer to head the patents office, said on Tuesday that the transfers were aimed at a more equitable distribution of skilled officers and group leaders at the right places.

India Needs its Hatch-Waxman Act for Healthcare May 15, 2009, DNA Money http://www.dnaindia.com/report.asp?newsid=1256132 The Hatch-Waxman Act, a legislation that transformed the American drug industry, completed 25 years last week. Over those years, the American healthcare system saved a whopping $734 billion due to increased use of generic pharmaceuticals. While the opening up of the American drug industry to generics did lead to the growth of generic giants like Teva, Sandoz, Mylan and Ranbaxy, large innovators like Pfizer, GSK and Merck have been forced to come out of their safety zones of unending patent protection of blockbuster drugs and see the world differently. Vulnerability grew and so the desire to take unprecedented steps for continuous innovations.

Govt Accepts Satwant Reddy Recommendation on Data Exclusivity May 13, 2009, Pharmabiz http://www.pharmabiz.com/article/detnews.asp?articleid =49689§ionid=44 After almost two years of discussions with various stakeholders, the Centre is learnt to have accepted the recommendations of Dr Satwant Reddy committee on data exclusivity and may offer 'protection against disclosure' to the pharma companies. However, the government may take some more time to announce its decision on

According to sources, the government has accepted the recommendations of Dr Satwant Reddy committee as far as 'protection against disclosure' is concerned and may announce the same soon. "Government should take adequate steps to ensure that specified undisclosed data submitted for seeking marketing approval for pharmaceutical products is not disclosed to any third party. Officials in the office of Drug Controller General of India should be under obligation to keep secret the undisclosed information submitted to Drug Regulator for approval of new drug," the Dr Reddy committee had recommended.

US Rakes up Counterfeit Drugs Issue again by Charging Indian IPR Protection as Weak May 12, 2009, Pharmabiz Even as the indirect attempts by the multinationals to equate Indian generics with counterfeit drugs failed at WHO, the United States has once again raised the issue by expressing concern on the 'weak intellectual property rights protection and enforcement' in India. The 'Special 301' Report by the Office of the United States Trade Representative (USTR), which placed India on the priority watch list, has called for better and effective system to check counterfeit drugs.

Lupin Settles Venlafaxine XR Capsules Litigation with Wyeth May 11, 2009 Pharmabiz http://www.pharmabiz.com/article/detnews.asp?articleid =49661§ionid=44 Lupin, the sixth largest Indian pharma company with net sales of over Rs 2,700 crore, has settled all ongoing HatchWaxman litigation relating to venlafaxine extended release capsules, a generic version of Wyeth's antidepressant 'Effexor XR' capsules. These capsules had US sales of $3.01 billion for the year 2008 (IMS) and accounted for 17 per cent of the Wyeth's net revenue in 2008. As per the terms of the settlement, Lupin will be licensed under the relevant patents and would be free to commercially launch its generic product on or after June 1, 2011, or earlier in certain limited circumstances, but in no event earlier than January 2011.

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Pharma Spectrum Dr Reddy's Files Post-Grant Opposition against Pfizer May 9, 2009, Financial Express http://in.biz.yahoo.com/090508/203/batjqw.html Pharmaceutical giant Pfizer is facing a post-grant opposition from Dr Reddy's Laboratories for its antismoking drug, Chantix (Champix in India). The latter has resisted against the Indian patent (the '091 patent) for the usage of the tartrate salt of varenicline, the active ingredient of Chantix. Last year in February, Pfizer launched the varenicline prescription drug in India under the brand name Champix (Chantix in US). Recently, the Delhi patent office had rejected a patent application for Caduet, a high cholesterol and blood pressure drug, filed by Pfizer while considering a pre-grant opposition by Torrent. Post-grant opposition allows a company to challenge the validity of the patent of a drug which has been already launched. A similar post-grant opposition filed by Wockhardt against Roche's hepatitis C drug, Pegasys, was rejected by Indian patent office recently.

Indian Patent Office Set for Total Revamp, Most Backlog Files to be Cleared by June End May 6, 2009, Pharmabiz http://www.pharmabiz.com/article/detnews.asp?articleid =49581§ionid=44 The Intellectual Property Office (IPO) of India is all set to revamp its entire operations in the country by clearing all the possible backlog files before July 1, 2009, by more efficient deployment of its available human resources. The IPO is in a process of rationalising the allotment of patent applications for examination by creating four groups based on subject expertise to handle the cases promptly. The groups, Chemistry and allied sciences, Biotechnology and microbiology, Mechanical and allied subjects, Electrical, electronics and related subjects, will be operational soon to handle the files more promptly with the available human resource, informed P H Kurian, controller general of patents, designs and trademarks and geographical indications (CGPDTM).

Pfizer Sues 3 Indian Cos for Patent Infringement of its Pain Drug, Lyrica May 5, 2009, Pharmabiz 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.

The law suit against Lupin pharma is on the allegation that the company has infringed US Patent No 6,001,876 for isobutylgaba and its derivatives for the treatment of pain issued in December 1999, Patent No 6,197,819 for gamma amino butyric acid analogs and optical isomers, issued in March 2001, and Patent No 5,563,175 GABA and L-glutamic acid analogs for anti-seizure treatment, issued in October 1996.

SC Dismisses Plea against Sun Pharma May 5, 2009, manoramaonline.com http://week.manoramaonline.com/cgibin/MMOnline.dll/portal/ep/contentView.do?contentId=54 34451&programId=1073754912&pageTypeId=1073754893&c on tentType=EDITORIAL&BV_ID=@@@ New Delhi: The Supreme Court has dismissed the Central Excise Department's plea alleging that pharma major Sun Pharmaceuticals Ltd was undervaluing its physician's samples and thus paying lesser duty. It alleged that the pharma major, which manufactured both commercial packs and the physician's sample packs, was clearing the latter at a lower assessable value than the pro-rata value of the sale packs of the same medicines.

Will Compulsory Licensing Hit Roche, Glaxo? April 30, 2009, Fierce Pharma http://www.fiercepharma.com/story/will-compulsorylicensing-hit-roche-glaxo/2009-04-300?utm_medium=nl&utm_source=internal The World Health Organization's hike in pandemic threat level triggers certain pharma-related events, particularly the release of antivirals from government stockpiles around the world. And with those stockpiles being deployed, naturally FDA et al are coordinating with Roche and GlaxoSmithKline to get replacement stocks of their flu meds Tamiflu and Relenza. Another less-appetizing prospect, for the two drugmakers anyway, is the fact that with a public health emergency underway, the World Trade Organization allows various countries to buy from low-cost suppliers, a.k.a. generics firms, despite the fact that both meds are still under patent. This "compulsory licensing" process allows poor nations to gain access to meds they can afford, in the event of an epidemic. Intellectual property protections can quickly be trampled by officials aiming to protect their citizenry--and by politicians looking to score some points in the process.

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Pharma Spectrum Govt to Create 1,380 Patent Examiners Posts

diarrhoea, fever, pain and hypertension, said a health ministry official.

April 27, 2009, Hindu Business Line

Known as fixed dose combination (FDC) drugs in pharmaceutical industry parlance, these will help reducing the number of pills in a single dosage, and consequently the expenses incurred. For instance, doctors usually prescribe three to four medicines to patients suffering from common cold or diarrhoea. With FDCs, this could be cut down to just one.

http://www.thehindubusinessline.com/2009/04/27/storie s/2009042750770300.htm The Centre plans to create 1,380 patent examiners posts during the 11th Plan period, of which 414 will be filled up this year alone.Stating this at a function organised by the Confederation of Indian Industry (CII) in partnership with the Department of Industrial Policy and Promotion (DIPP) here on Sunday, the Joint Secretary in the DIPP, Mr N.N. Prasad, said that the Centre has spent around Rs 500 crore in the last five-six years towards the development of hard and soft intellectual property (IP) rights infrastructure. Between 1999-200 and 2006-07, the number of patent applications filed in the country has increased from 4,824 to 28,882, with the number of patents granted rising from 1,881 to 7,359. The number of patent applications filed is projected to jump to about 72,000. The present level of manpower in the IP offices is said to be insufficient to handle the workload.

Delhi HC Scraps Roche's Plea April 25, 2009, The Times of India http://timesofindia.indiatimes.com/Business/HC-scrapsRoches-plea/articleshow/4445931.cms In a ruling that might spell relief for lakhs of lung cancer patients, the Delhi High Court on Friday allowed Cipla to manufacture and sell the generic version of lung cancer drug `Erlotinib' of Swiss pharma firm Hoffman La Roche Ltd. Vacating its previous stay order on the generic manufacturer, a division bench also removed all restraints on Cipla, while exporting the life saving drug to other countries in which La Roche has patent rights. The court dismissed the plea of the Swiss company and also imposed a cost of Rs 5 lakh on it.

Regulatory Over 44 Fixed-Dose Combination Drugs Clear DGCI Tests May 25, 2009, The Economic Times http://economictimes.indiatimes.com/News/News-ByIndustry/Healthcare--Biotech/Over-44-fixed-dosecombination-drugs-clear-DGCItests/articleshow/4573397.cms

DCGI Calls Second Meeting of Expert Panel on FDCs on June 4 May 25, 2009, Pharmabiz http://www.pharmabiz.com/article/detnews.asp?articleid =49878§ionid=19 The Drug Controller General of India (DCGI) has called the next meeting of the expert panel on fixed dose combination (FDC) on June 4. The meeting will decide the fate of another 28 FDC drugs. This is the second meeting of the panel which was formed last year to resolve the vexed FDC issue. The first meeting of the expert panel was held on January 23 and 24 this year in which a total of 48 FDC drugs were examined.

DCGI Asks State Drug Authorities to Disallow Cos Altering Compositions without Changing Brand Names May 25, 2009, Pharmabiz http://www.pharmabiz.com/article/detnews.asp?articleid =49880§ionid=19 The office of the Drug Controller General of India has directed the state drug authorities to keep a track of companies indulging in the practice of changing the compositions of products after getting the approval but retaining same brand names. Pharma companies have 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 learnt. State drug authorities usually do not verify such changes in the composition in the formulations once the product licenses are issued. Several medium and small pharma companies have been taking advantage of this lack of monitoring by the state drug authorities for some time now.

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

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Pharma Spectrum Investors at Risk as US FDA Gets Tough with Drug Cos

Drug Export Quality Certificate to be Issued Only by DCGI

May 25, 2009, The Economic Times

May 21, 2009, The Hindu Business Line

http://economictimes.indiatimes.com/News-byIndustry/Investors-at-risk-as-US-FDA-getstough/articleshow/4573303.cms The recent warning letters issued by the US Food and Drug Administration (FDA), to manufacturing units of Indian pharmaceutical companies have significantly raised investors risk. With the FDA getting more stringent with its quality inspections and upcoming approvals for companies put on hold, investors are the ones who could lose out in the long-run, said analysts. "Companies need to put things in place. Once the US FDA issues inspectional observations or '483' concerns and if it goes to the next level of warning letters, it will take a couple of quarters for things to get sorted out," said Abhishek Singhal, an analyst with Macquarie.

FDA-Approved Inspectors Plan ShortNotice Audit of Trials May 23, 2009, The Economic Times http://economictimes.indiatimes.com/Pharmaceuticals/F DA-approved-inspectors-plan-short-notice-audit-oftrials/articleshow/4567501.cms Drug Controller General of India (DCGI) is planning random audit of clinical trial sites across the country on a regular basis by this June and will suspend any human experiment if the research organisation is found violating the guidelines. The move comes in the wake of successful audits over the last few months that enabled the drug regulator to efficiently monitor the human trials, a health ministry official said. 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.

Drug Regulator to expand Survey on Fake Medicines

The Drug Controller General of India (DCGI) has decided to withdraw the powers given to State-level regulators to issue export quality licence, technically called Certificate of Pharmaceutical Products (CoPP). The move is to centralize pharmaceutical sector regulating. Speaking to Business Line, Dr. Surinder Singh, DCGI, said, “The power to issue CoPP was given to the State regulators earlier outside the Concurrent List. Therefore, now we are going to take it back to bring uniformity in regulations. We will notify this in over the next month or so.”

Karnataka Drugs Control Dept Issues Over 3000 Show Cause Notices, Suspends 1,000 Licenses May 20, 2009, Pharmabiz, Bangalore http://www.pharmabiz.com/article/detnews.asp?articlei d=49802 Karnataka drugs control department has issued a total of 3,768 show cause notices, suspended 1,398 licenses and cancelled 921 licenses of both manufacturers and the pharmacy outlets during the period ending March 31, 2008-09. During the year a total of 88 prosecution cases were filed in the court. In addition, there were 69 cases disposed and 50 convictions carried out. Around 178 complaints received from the public are being investigated. In the government drug testing lab, a total of 3,311 samples were analyzed of which 240 were declared not-of-standard quality and investigations are being carried out.

Pharma Policy to be Delayed As New Minister May Take Fresh Look at Industry May 19, 2009, Pharmabiz

May 22, 2009, The Hindu Business Line

http://www.pharmabiz.com/article/detnews.asp?articleid =49787§ionid=19

The Drug Controller General of India plans to widen the survey to map the prevalence of counterfeit drugs in the country with larger number of samples. The regulator, which is examining 26,500 samples of 62 top-selling medicines, is planning to pick up one lakh samples for the next survey. The first report on counterfeit drugs is expected in June.

Though the same Manmohan Singh government is all set to continue in the office after its thumping victory, the much awaited national pharmaceutical policy which has been pending since 2002 will have to go through another full circle of process and all progress made so far will have little impact.

Speaking to Business Line, Mr. Surinder Singh, DCGI, said, “We want to put to rest all the speculation about the extent of fake drugs prevalent in the Indian market.

With Ram Vilas Paswan, who has been pressing for the policy for long, is most unlikely to stay as chemicals minister under the new dispensation, the note on policy should be prepared by the department again under the

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Pharma Spectrum new minister and be forwarded to the cabinet for consideration.

country. India has been facing unfair criticism in this regard from the European nations for some time.

US FDA Office in India May Not Speed Up Certifications, Approvals for Domestic Cos

As per the new notification issued by the directorate general of foreign trade (DGFT),every exporter of drugs and pharmaceuticals at the time of shipment shall submit, along with other required documents, a copy of Certificate of Analysis issued by the manufacturer for the subject product; or a copy of Certificate of Analysis issued 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 Act, 1940 and the rules made thereunder.

May 18, 2009, Pharmabiz http://www.pharmabiz.com/article/detnews.asp?articleid =49768 Although the US FDA office in India may start its 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 Delhi, will have local drug inspectors within three months from now and the country director will take charge in September 2009. However, the move may not help the Indian companies to get approvals of Abbreviated New Drug Applications (ANDAs) and good manufacturing practice (GMP) certificates faster than now as every decision will have to be cleared by the FDA office in Washington, informed a senior official with US FDA.

MNC Units Abroad to Come Under Drug Regulator Scanner May 17, 2009, Hindu Business Line The Drugs Controller General of India (DCGI) will soon start sending its officers to foreign countries to inspect the manufacturing facilities of multinational pharmaceutical companies importing drugs into India. The move is in line with the processes followed by the drug regulators of other countries. Speaking to Business Line, Dr. Surinder Singh, DGCI, said “Inspectors from other countries, from Nepal to the US, come to India to check manufacturing facilities of Indian drug companies. We also get drugs imported from many countries such as Taiwan and China for which we will start sending our inspectors to examine whether they are following good manufacturing practices.”

Commerce Ministry Tightens Procedures for Export of Drugs to Ward off EU Allegations May 15, 2009, Pharmabiz http://www.pharmabiz.com/article/detnews.asp?articleid =49727§ionid=11 The Union commerce ministry has asked the pharma exporters to comply with more stringent quality guidelines to ensure that no counterfeit drugs are exported from the

Dept. of Pharma asks Industry to Provide Detailed Data of Units Wanting to Avail of CLCSS May 12, 2009, Pharmabiz In view of the extremely poor response from the industry to the Credit Linked Capital Subsidy Scheme (CLCSS) during the last eight years, the pharmaceutical department has asked the industry to provide a 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 beneficial to the pharma units to upgrade their units as per the revised Scheduled M. According to sources, the pharmaceutical department is apprehensive about the response of the industry to the tweaked CLCSS as a mere 200 pharma units availed the scheme during the last eight years. As the government is working on a revamping the scheme, it wanted to ensure that the scheme has enough takers. So, the government has asked the industry to provide a list of the probable number of units who might avail of the facility.

Centre Plans Health Management Information System to Monitor Demand & Supply of Drugs May 11, 2009, Pharmabiz During the current XIth Plan period, the Centre will be giving emphasis to e-Health by using IT in healthcare segment and plans to set up a national grid to share information among the healthcare providers, trainers, beneficiaries and the society. The Centre is also planning to launch a Health Management Information System (HMIS) which will help eventually to track the demand and supply of drugs and to curb wastage of drugs due to date expiry. When fully developed, it will work as a demand-driven management system to track and monitor the drug situation across the country and channelise the supply as per the demand in particular places.

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Pharma Spectrum Health Ministry Redrafting ART Bill to Regulate Thousands of Infertility Clinics

booming domestic market rather than on exports during the initial phase of running a pharma SEZ.

May 11, 2009, Pharmabiz

Recommending special treatment to the pharma sector, the report of the 'task force on pharmaceuticals' said the year of commencement of the tax holiday period for pharma SEZs should be computed from the year of profits and not as per the existing SEZ norms that calculates the tax holiday period from the year of setting up an SEZ.

http://www.pharmabiz.com/article/detnews.asp?articleid =49649§ionid=13 The Union health ministry is re-drafting the Assisted Reproductive Technology (Regulation) Bill, 2008 (ART Bill) which will be introduced to regulate thousands of infertility clinics that have mushroomed over the years in the country. The Bill will define the establishment and functioning of these clinics.

DCGI Calls Govt-Industry Meet to Finalise Guidelines on Spurious Drugs Act

The ministry has received a large number of suggestions and comments from foreign countries, embassies, legal institutions, international institutions, experts and others on the draft bill. The government had late last year published the draft bill and had invited suggestions and comments from the public on the proposed bill. The Bill, drafted by an 11-member expert committee appointed by the health ministry, proposes to establish a National Advisory Board and state Boards to regulate and supervise the establishment and functioning of the infertility clinics in the country.

May 2, 2009, Pharmabiz

Pharma Port Office Opened in Bangalore

The Drugs and Cosmetics (Amendment) Act 2008, stipulating stringent penalties for manufacturing and marketing spurious drugs, was passed by Parliament last year and the President gave her assent in last December. The only formality left on the Bill is its notification which the ministry will be doing soon.

May 7, 2009, Hindu Business line http://www.thehindubusinessline.com/2009/05/07/storie s/2009050751191700.htm 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 and pharma research, will also have a sub-zonal office of the Ministry’s drug quality arm, the Central Drugs Standard Control Organisation, the Drugs ControllerGeneral of India, Dr Surinder Singh, said on Wednesday. The port facility is part of the ongoing exercise to build capacity and recruit more people at the CDSCO, Mr Debashish Panda, Joint Secretary, Union Department of Health & Family Welfare, said. Dedicated pharma zones equipped with cold rooms would come up at the Delhi and Mumbai airports by March 2010; the stakeholders and operators of the two airport were meeting in Mumbai on May 8.

Task Force Prescribes Policy Change to Help Pharma SEZs May 7, 2009, Financial Express http://in.biz.yahoo.com/090506/50/batjaa.html 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

http://www.pharmabiz.com/article/detnews.asp?articleid =49507§ionid=19 The Drugs Controller General of India (DCGI) Dr Surinder Singh has called an industry-government meeting on May 19 to finalise guidelines to safeguard the interests of genuine drug manufacturers from misuse of recently amended spurious drugs Act. The DCGI has asked the industry to come out with its own specific suggestion in this regard.

WHO Auditors Inspect Indian Regulatory Authority Again, Gives 100 Score April 28, 2009, Pharmabiz http://www.pharmabiz.com/article/detnews.asp?articleid =49447§ionid=19 WHO inspectors along with drug control officials from other countries, held a comprehensive audit of the national regulatory authority (NRA) in India and gave a high score of 100, reversing its earlier adverse observations about the bad plight of regulatory system in the country two years ago. "As many as 13 auditors from the WHO and other nations held a week-long audit in different aspects and carried out on-site inspections to assess the performance of the regulatory mechanism recently. We got a 100 score on all specific six indicators this time, whereas in the previous similar assessment held in late 2007, we had been given just around 40 score," DCGI Dr Surinder Singh told Pharmabiz.

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Pharma Spectrum Govt Nod Must for Drug Cos to Rejig Combination April 27, 2009, The Economic Times Drug makers changing the composition of existing formulations to escape price cap will now have to come to the centre for a fresh approval. In a move to keep a check on companies which replace price control, the centre has directed state drug regulators not to allow them to sell such medicines with their old brand names. Instead, such drugs will be treated as new ones and the companies will have to go through the Centre’s scrutiny before it gets a fresh approval, a government official said. The move is significant as companies are now likely to think twice before they make change in the existing composition and approach the centre for a fresh approval. This would also mean that companies will have to subscribe to a new brand name.

As part of company's sales strategy to provide costeffective novel therapies & oncology drugs, the company has launched new sales division Bridge to strengthen its new brands of drugs and focus on specific therapeutic areas. With growing product portfolio, new sales division will now focus on drugs that cater to non small cell lung cancer (NSCLC) and multiple myeloma.

Shantha’s Oral Cholera Vaccine Launch on April 26 April 25, 2009, DNA http://www.dnaindia.com/report.asp?newsid=1250444 Hyderabad-based Shantha Biotechnics Ltd is all set to launch an oral vaccine for preventing cholera. The first bivalent oral cholera vaccine, it will be called Shanchol. The company plans to officially launch the vaccine on April 26; it will be available through commercial channels from June. "It's almost 38 years the world has been waiting for a vaccine to prevent cholera. There was one vaccine before that. But, it was withdrawn due to efficacy issues," Shantha managing director Varaprasad Reddy said.

New Products Piramal Healthcare Launches Actipatch for Pain Therapy May 14, 2009, The Economic Times http://economictimes.indiatimes.com/News/News-ByIndustry/Healthcare--Biotech/Pharmaceuticals/PiramalHealthcare-launches-ActiPatch-for-paintherapy/articleshow/4531084.cms Piramal Healthcare on Thursday announced the launch of BioElectronic's ActiPatch, a product in pain management. "ActiPatch is a medical device that utilises pulsed electromagnetic frequency (PEMF) to accelerate healing of soft tissue injuries. Patients suffering from pain and swelling in conditions ... can benefit from this product," Piramal Healthcare Director Swati Piramal told reporters. Its unique delivery system using patented technology, provides a cost-effective patient-friendly method to reduce soft tissue pain and swelling, Piramal said.

Intas Bio Introduces Bortezomib in Indian Market to Treat Multiple Myeloma May 11, 2009, Pharmabiz http://www.pharmabiz.com/article/search.asp Intas Biopharmaceuticals Limited has launched bortezomib 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).

R&D/Clinical Trials NACO Ties Up with 26 Research Institutions for NIIHAR Network May 20, 2009, Pharmabiz The National Aids Control Organisation (NACO) has tied up with 26 research institutions across the country to undertake operational, epidemiological and bio-medical research in the field of HIV/AIDS. NACO had earlier constituted a consortium Network of Indian Institutions/Organizations for HIV/AIDS Research (NIIHAR) for the purpose. Sources in the NACO said that it has already roped in 26 research institutions under the network and more will be added as the NACO is screening the other institutions in the panel of institutions which have shown interest in joining the network. This consortium will pool resources and expertise to conduct high quality, collaborative, multi-centric research that will help evidence based decision making on policy, management and evaluation of interventions. This consortium will have linkages with universities, ICMR, CSIR, DST, ICSSR and others stakeholders including donor organizations.

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Pharma Spectrum Ban on Clinical Trials for Wyeth Vaccine Lifted

disease burden in these countries and strengthening international collaborations.

May 15. 2009, The Mint

Ranbaxy Close to Completing Trials for New Malaria Drug

http://www.livemint.com/2009/05/14233904/Ban-onclinical-trials-for-Wye.html The drug controller general of India (DCGI) earlier this week lifted a temporary ban on clinical trials for a vaccine by US drug maker Wyeth Inc., allowing the drug company and the Hyderbad-based clinical research organization GVK Biosciences Pvt. Ltd to go ahead with the trials. The ban had been imposed following the death of a baby that was less than a year old due to lapses in standard operating procedures while conducting clinical trials for the vaccine in St John’s Hospital, Bangalore, in November. However, the ban on trials has been removed only for 11 of the 12 hospitals where they were being carried out. It stays in St John’s, said Surinder Singh, drug controller general.

Piramal Life Gets Molecule Trials

Nod

for

Cancer

May 13, 2009, Financial Chronicle http://www.mydigitalfc.com/knowledge/piramal-lifegets-nod-cancer-molecule-trials-007 Mumbai-based Piramal Life Sciences on Wednesday said it had received regulatory approval for initiation of phase-I & II combination studies of its cancer molecule P276 for pancreatic, head and neck cancer.

May 5, 2009, Hindu Business Line http://www.thehindubusinessline.com/2009/05/05/storie s/2009050551830100.htm Ranbaxy Laboratories Ltd on Monday announced the commencement of the third phase clinical trials for its new anti-malaria combination drug in India, Bangladesh and Thailand. The drug, Arterolane maleate + Piperaquine phosphate, is targeted at patients in developing countries with the aim of significantly improving upon the conventional options available for the treatment of malaria. According to Dr Sudershan Arora, President-R&D (Generics, NDDS, Clinical & Drug Development), Ranbaxy, the company will strive to successfully complete the trial and apply for marketing authorisation by late 2010.

Mergers & Acquisitions / Collaborations

Having received the go-ahead from the Drug Controller General of India (DCGI), Piramal Life Sciences, which is part of the Piramal Group, will now initiate phase I and II clinical trials at various locations to assess and identify right doses of the molecule to be used in combination with chemotherapeutic drugs, a company statement said.

Malvinder Singh Steps Down, Sobti New Ranbaxy CEO

India, Norway to Collaborate in Promoting Human Vaccination Research Projects

Nearly a year after selling his family’s entire 35% stake in the country’s largest drug manufacturer, Ranbaxy Laboratories Ltd, to Japanese firm Daiichi Sankyo, Malvinder Singh on Sunday stepped down as the company’s chairman, CEO and managing director. Daiichi Sankyo director and Ranbaxy board member, Tsutomu Une, has been appointed as the executive chairman of the company while, Atul Sobti, the current COO has been appointed the new CEO. The changes were announced after the company’s board meeting on Sunday.

May 11, 2009 PHARMABIZ http://www.pharmabiz.com/article/search.asp The Department of Biotechnology (DBT) and the Research Council of Norway (RCN) will collaborate to promote research in the field of human vaccination through joint projects, spanning for three years, as part of the programme for global health and vaccination research. The programme, carrying a total fund of 10.5 million 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

May 25, 2009, Financial Express http://www.financialexpress.com/news/malvinder-singhsteps-down-sobti-new-ranbaxy-ceo/465223/

With this the Singh family’s association with the company, which his grandfather Bhai Mohan Singh founded in 1961, comes to an end. Singh had joined Ranbaxy in 1998 and became CEO in 2006.

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Pharma Spectrum Ranbaxy Acquires Skin Care, Lifestyle Range May 22, 2009, Business Standard Ranbaxy Laboratories, the second largest drug company in India in terms of market share after Cipla, has acquired the entire range of skin care and lifestyle products of Ochoa Laboratories, a small to medium sized manufacturer located on the outskirts of New Delhi. The Company did not disclose the terms of the transaction. Sources said Ranbaxy acquired about 80 products of Ochoa Laboratories and many are established brands in the domestic market.

Elder Health Care Looks at Buying Two Indian Brands April 25, 2009, The Economic Times http://economictimes.indiatimes.com/News/News-ByIndustry/Cons-Products/FMCG/Elder-Health-Care-looks-atbuying-two-Indian-brands/articleshow/4446127.cms Elder Health Care, the FMCG arm of the Rs 560-crore pharma major Elder Group, is evaluating two Indian brands for acquisition. The two potential targets are in the areas of oral care and body care, and will help Elder consolidate its presence in the personal care segment. Elder expects to close each of the deals at a valuation of Rs 5-10 crore. The company wants to complete the acquisitions soon as it wants to capitalise on the present moment, when valuations are low. “We are looking at acquisitions to consolidate our presence in the personal care segment. We soon plan to appoint a merchant banker for reviewing the deals,” Elder Health Care managing director Anuj Saxena told ET.

Pricing Pharma Control

Industry

to

Oppose

Price

May 24, 2009, Financial Chronicle http://www.mydigitalfc.com/economy/pharma-industryoppose-price-control-932 The pharmaceutical industry has upped the ante against the move to put 356 medicines under price control. The industry is also pushing for early passage of the proposed legislations on clinical trials and biotech. The pharma industry is hoping that the new government would rescind the proposal of earlier incumbent Ram Vilas Paswan to bring back pricing controls on the sector.

Paswan lost the Hajipur seat in Lok Sabha elections. The industry feels that the government needs to focus on bigger problems such as availability of drugs in remote areas rather than pressuring companies to cut down on margins. “There are more than 10,000 pharma firms in India and for every branded drug there are at least 80-100 cheaper alternatives available. Pricing is not an issue here as cheap drugs are available, so the government has to do away with these proposals,” AV Dangi, president and chief executive officer at Danssen Consulting (a consultancy firm specialising in pharmaceuticals, life sciences and healthcare) said.

Cancer Drugs May Come Under NPPA Lens May 20, 2009, The Economic Times http://www.immservices.net:80/view/view_clip.php?vid= 1480514&cnm=T3IxOTk1NjE2MzAw Cancer drugs may soon come under the purview of India’s drug price regulatory, as they have become too expensive for the common man to afford, according to Drug Controller General of India (DCGI), Mr. Surinder Singh. The move could hurt the margins of multinational companies, such as Sanofi-Aventis, Pfizer, Roche, GlaxoSmithKline and Eli Lilly, who enjoy a near monopoly in the category, also populated by Indian Drug makers Dr. Reddy’s, Natco and Dabur. Mr. Singh told ET on Tuesday that he has recommended that cancer drugs be brought under the National Pharmaceutical Pricing Authority (NPPA). “As the DCGI, I have outlined the technical inputs and rationale, behind the suggestion for the inclusion of new drugs. Cancer drugs, in particular, should be included, since they are expensive and beyond the means of the common man,” he said. A final decision on this will have to be taken by the 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 the next two to three years.

Anti-Asthma Drugs to be 90% Cheaper May 11, 2009, Financial Chronicle http://www.mydigitalfc.com/news/anti-asthma-drugs-be90-cheaper-748 ANTI-ASTHMA medicines are expected to cost less than a tenth of their prices now after the regulator, the National Pharmaceutical Pricing Authority (NPPA), brought the bulk drug, doxofylline, under price control. Ranbaxy and Dr Reddy’s Laboratories (DRL) are among over a dozen companies that produce these medicines. NPPA found that doxofylline is a derivative of theophylline, which was already under price control. Brands of medicines produced from the bulk drug include Synasma (Ranbaxy), Doxobid (Dr Reddy’s), Doxflo (Lupin),

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Pharma Spectrum Zordox (Cipla) and Doxolin (German Remedies). Prices of all these will drop sharply to just Rs 5.74 per strip of 10 tablets. This is just a fraction of the Rs 78 that Dr Reddy’s now charges for Doxobid (400 mg) and Rs 75 Ranbaxy charges for Synasma. An NPPA official told Financial Chronicle that there was no point controlling theophylline and not doxofylline.“The companies were making use of the loophole,” he said.

NPPA Fixes, Revises Prices of 296 Formulations May 6, 2009, Pharmabiz http://www.pharmabiz.com/article/detnews.asp?articleid =20815§ionid=19 The National Pharmaceutical Pricing Authority (NPPA) has fixed or revised prices of 296 formulations, including nine imported drugs from global majors like Pfizer, Aventis Pharma, Novartis and Novo Nordic. And many of these imported formulations went costlier, while a couple of them registering a hike of over 12 per cent. According to the notification issued by the NPPA, prices of mono-component insulin formulations -- Lantus 100 IU/ML catridge and Lantus 100IU/ML solostar -- imported by Aventis Pharma were revised with the former one going up by 12.83 per cent (up from Rs 481 to Rs 543.12 per 3ml catridge). Three formulations by Pfizer Products India, containing methyl prednisolone also became costlier. Among them, price of Solu Medrol AOV 125mg was revised from Rs 252.46 per 2ml vial to Rs 290.34, up by a whopping 15 per cent.

Working of NPPA-CIFG at Chennai Disappointing Even After 8 Months May 5, 2009, Pharmabiz http://www.pharmabiz.com/article/detnews.asp?articleid =49554§ionid=19 Working of the Centre for Information Facilitation and Grievances (CIFG) at Chennai is disappointing as it is not able to attract any major complaints on drug prices and quality of products. The centre was set up by National Pharmaceutical Pricing Authority with the help of a local NGO a few weeks ago. The NPPA has started a new initiative in six places across the country, including Chennai, to disseminate information on drug prices and their availability.

Cure Against Costly Drugs on Way May 5, 2009, The Economic Times The government is laying ground rules for negotiating drug prices with multinational companies to ensure that costly patented drugs are provided at 40-70% lower prices

through the public health system, compared with those prevailing in the private health care system. This will ensure that patented drug sold in India – through public as well as private health systems-will be at their lowest international prices, said a government official who asked not to be named.

NPPA Hikes Price of Rifampicin, Cut Prices of Two Other Bulk Drugs April 29, 2009, Pharmabiz http://www.pharmabiz.com/article/detnews.asp?articleid =49467§ionid=19 The National Pharmaceutical Pricing Authority (NPPA) has cut the prices of two bulk drugs including tolnaflate, which became cheaper by around 40 per cent, and increased the prices of two other bulk drugs. The price of topical antifungal agent tolnaflate came down from Rs 4121 to Rs 2500 per kg, as per a recent notification by NPPA. The price was earlier fixed on February 13, 2007. And the prices of a number of formulations used to treat fungus and skin infections will come down with the huge reduction in the bulk drug cost. The price of glipizide, used in the anti-diabetic therapeutic area, came down from Rs 29,244 to Rs 26,114 per kg. The price was revised almost after three years.

Drugs with Composition Change Need Fresh Okay April 27, 2009, The Economic Times http://www.pressdisplay.com/pressdisplay/viewer.aspx# DRUGMAKERS changing the composition of existing formulations to escape price caps will now have to come to the Centre for fresh approvals. In a move aimed at keeping a check on companies, which replace pricecontrolled ingredients with ones outside price control, the Centre has directed state drug regulators not to allow them to sell such drugs with their old brand names. Instead, such drugs will be treated as new ones and the companies will have to go through the Centre’s scrutiny before it gets a fresh approval, a government official said. The move is significant as companies are now likely to think twice before they make any change in the existing composition and approach the Centre for a fresh approval. This would also mean that companies will have to subscribe to a new brand name. The decision comes in the wake of the National Pharmaceutical Pricing Authority (NPPA) seeking action from the Drug Controller General of India (DCGI) against companies that dodge price control by tweaking ingredients of medicines and then misguide consumers by retaining the original brand name. “We have been receiving cases from NPPA for some time now where companies have altered the composition and retained the brand names. This amounts to misleading consumers. We

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Pharma Spectrum have, therefore, asked all state drug regulators to treat such drugs as new drugs and not give approvals to sell under the same brand name,” DCGI Dr Surinder Singh told ET.

Trade & Others FAKE DRUGS May 25, 2009, Financial Express http://www.financialexpress.com/news/Fakedrugs/465221/ Much to the chagrin of the Indian pharmaceutical industry and patients alike, fake drugs are everywhere. Successful brands are being faked and sold on an unprecedented scale in India. So much so that fake allopathic as well as homeopathic medicines are estimated to occupy between 15 to 20% of the Rs 40,000 crore Indian pharmaceutical market. Originally, fake drugs were confined to lifestyle drugs such as Viagra or conventional medications for cold, cough and fever. Nowadays, they have made a smooth transition to lifesaving drugs as well. Their presence spans across a wide spectrum—AIDS/HIV therapy, antibiotics, insulin, cholesterol drugs, hormone replacement therapy, cancer drugs and many more.

Drug Inspector in Pondicherry Pulled Up for Not Clearing Drug License Applications for 2 Yrs May 23, 2009, Pharmabiz http://www.pharmabiz.com/article/detnews.asp?articleid =49863§ionid=19 Director of Medical Services in the Union Territory of Pondicherry has issued a show cause notice to a drug inspector at the General Hospital at Karaikal for not acting on several applications for drug licenses submitted to him by traders. The action was taken after receiving complaints from Chemists and Druggists of Karaikal in Pondicherry. In the complaint, chemists said that the official was keeping many applications for licenses in his custody for more than two years without recommending them to the Directorate of Drugs Control. The director has asked the drug inspector to explain the cause of this delinquency in ten days.

Jan Aushadhi Stores Make Progress, Average Weekly Sales at Rs 64,552 May 18, Pharmabiz

http://www.pharmabiz.com/article/detnews.asp?articleid =49766 The seven generic drug stores under the Jan Aushadhi Scheme, launched by the Department of Pharmaceuticals to ensure quality medicines at affordable prices, has 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 lately, takes an account on the performance of the Jan Aushadhi stores for 23 consecutive weeks from November 25, 2008 to May 3, 2009. According to the report, the first Jan Aushadhi store set up in Amritsar in November 25, 2008 has reported average weekly sales of Rs 38,859 in 23 weeks. The drug store at Gurgaon set up 11 weeks ago has sold Rs 7,449 worth drugs even as the 10-week-old Mohali and Panchkula stores dispensed Rs 7,180 and Rs 9,094 worth drugs, respectively, average in a week.

Jan Aushadhi Stores Cause Credibility Crisis for Pharma Traders May 14, 2009, Pharmabiz http://www.google.co.in/search?hl=en&q=Jan+Aushadhi+s tores+cause+credibility+crisis+for+pharma+traders&btnG=S earch&meta=&aq=f&oq= Pharmaceutical traders are asking the government to fix trade margins for the generics-generic products in the country to ensure uniformity in prices in the market place. The demand has come in the wake of the government plan to sell unbranded generic products through Jan Aushadhi stores at lower prices than market rates. Traders fear that the government move will affect the credibility of the local chemists in the minds of consumers. Currently, the unbranded generic drugs which are not promoted ethically and sold by the chemist over the counter, does not have any fixed margin for the trader and are sold at different prices. Many of the products are sold at lower prices than the branded product of the same drug. The products, which are not having any promotional costs, are also priced high although their manufacturing costs are much low.

Banned From Chemists, Tamiflu Goes at Rs 2,000 for 10 Tablets May 6, 2009, Express Newsline http://www.expressindia.com/latest-news/banned-fromchemists-tamiflu-goes-at-rs-2-000-for-10-tablets/455009/ 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 running out of stock despite selling Tamiflu at Rs 2,000 for 10 tablets. The enterprising chemist who arranged the drug for Newsline, despite a ban on procurement and sale through

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Pharma Spectrum private channels, said with a touch of pride: “We have got scores of calls for Tamiflu since morning. We will ask for fresh stock tomorrow.”

with over 300 outlets spread over 17 states across India. It has been offering 10 per cent discount to its customers under the loyalty programme.

GSK Winds Up Actifed Range of Cough Drugs

Pharmaceutical Wholesalers Association (PWA) president Dilip Mehta said that the wholesale dealers are agitated over the unhealthy practice of offering 10 per cent discount on medicines by the Apollo Pharmacy chains in Mumbai. There are more than 100 Apollo pharmacy shops in Mumbai and retail traders in the surrounding vicinity of these Apollo Pharmacy shops are getting adversely affected by this unhealthy trade practice, he said.

May 2, 2009, The Economic Times GlaxoSmithKline Pharmaceuticals (GSK) India has stopped manufacturing its cold and cough drugs sold under the brand name Actifed and Actifed Plus after it was found that some people were illegally extracting pseudoephedrine, a narcotic chemical, from the medicines to sell overseas. In January, the Mumbai wing of India’s Food and Drugs Administration (FDA) busted a racket which included two GSK officials, who used to extract pseudoephedrine and sell it overseas. The FDA officials reportedly seized Actified and Actified Plus tablets worth Rs 67 lakh during the raid.

Local Drug Cos May Chip in to Treat Swine Flu April 28, 2009, The Economic Times http://economictimes.indiatimes.com/News/News-ByIndustry/Healthcare--Biotech/Pharmaceuticals/Localdrug-cos-may-chip-in-to-treat-swineflu/articleshow/4457204.cms The swine flu outbreak, classified by the World Health 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. “We have already received proposals from people on behalf of countries in Latin America, Mexico and Israel. We have the capability to supply 1.5 million dosages of the drug within 4-6 weeks,” said Amar Lulla, joint MD, Cipla.

Wholesalers Suspend Drug Supplies to Apollo Pharmacy for Unhealthy Trade Practice April 28, 2009, Pharmabiz http://www.pharmabiz.com/article/detnews.asp?articleid =49446§ionid=22 Pharmaceutical wholesalers have suspended medicine supplies to more than 100 Apollo Pharmacy shops in Mumbai and Thane in protest against the unhealthy trade practices indulged in by the Apollo stores. Apollo Pharmacy is the largest pharmacy chain in the country

Sales Promotion Staff of Organon, Fulford Protest against Unfair Labour Practices April 28, 2009, Pharmabiz http://www.pharmabiz.com/article/detnews.asp?articleid =49444§ionid=5 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' violation of certain provisions of Sales Promotion Employees Act, 1976. Both these companies are now under the control of Schering-Plough Corp of the US. Secretary of the Federation of Medical and Sales Representatives' Associations of India (FMRAI) Tamil Nadu branch said the field work of these two companies had paralyzed in India on that day. In Tamil Nadu these companies have 70 sales promotion employees. Their Union is affiliated to FMRAI.

Biotechnology Indian Pharma Biogenerics

Cos

Upbeat

on

May 8, 2009, Business Standard http://www.business-standard.com/india/news/indianpharma-cos-upbeatbiogenerics/357461/ Even as the substitutability of biogeneric or biosimilar medicines with their original patented counterparts continues to be a matter of debate world over, Indian drug companies, which have introduced biogeneric products or copies of biotechnology drugs in the country, are bullish over the marketing prospects of “biogenerics" after patents expire in developed markets. Companies such as Dr Reddy’s, Biocon, Reliance Life Sciences and Ranbaxy etc. are all in the process of strengthening their biogeneric portfolio to cater to future global demand. “The biogeneric market in India is pegged at Rs 600 crore, while the US and EU market for biosimilars is estimated to

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Pharma Spectrum reach $ 21 billion by 2015”, said KV Subramaniam, president and CEO, Reliance Life Sciences (RLS). RLS launched three biosimilars - ReliPoietin (Erythropoietin (EPO), ReliGrast (Granulocyte Colony Stimulating Factor (G-CSF), and ReliFeron (Interferon Alpha 2b) in the domestic market in 2008 and is working on a range of biosimilars, which are at different stages of development viz clinical trials, pre-clinical studies, process development and molecular biology.

INDUSTRIAL BIOTECHNOLOGY: Drug Making Made Easier April 30, 2009, Pharmabiz Industrial biotechnology (IB), the third wave of biotechnology, uses biological systems for the production of chemicals, materials and energy. This technology is mainly based on biocatalysis (the use of enzymes to catalyse chemical reactions) and fermentation technology (directed use of microorganisms), in combination with 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 generate industrial products.

Indian Pharma-Biotech R&D Consolidating & Downsizing to Maintain Productivity: Expert April 27, 2009, Pharmabiz The pharmaceutical and biotechnology industry is in the process of consolidating and down-sizing while trying to maintain R&D productivity. Small and medium-sized companies are trying to make the most of available opportunities in niche segments. While we see an extremely cautious approach to new R&D spending plans, the silver lining for Indian companies providing research services to big pharma is that the emphasis on controlling costs is leading to an increasing number of proposal requests, Dr Shoibal Mukherjee, senior vice president - Clinical Development, GVK Biosciences Private Limited told Pharmabiz in an email interaction.

New Appointments Mr. Om Prakash, New Member Secretary, NPPA

Currently, IB exhibits the maximum extent of penetration in the pharmaceutical sector (15 per cent). New technologies have proven to be a boon for the pharmaceutical industry in the use of better biological production methods. Since the pharmaceutical products are of high value, added inputs in research and development (R&D) can easily be recovered. The pharmaceutical sector is thus proving to be the model for the industrial development of biotechnology.

The Appointment Committee of the Cabinet has approved the proposal to appoint Mr. Om Prakash, CSS (77)as Member Secretary, in the National Pharmaceutical Pricing Authority (Joint Secretary level) under the Department of Pharmaceuticals. He has worked with the Ministries of Environment & Forests, Department of Industrial Policy & Promotion and Finance. Before his appointment as MS, NPPA, he was holding the post of Director, Department of Expenditure, Ministry of Finance.

ABLE to Address Issues of Bio-Similar Regulations, VC Funding: Dr. Vidyasagar

Ms Aparna Sharma, Has Been Given Additional Director, Department of Health, Ministry of Health & Family Welfare,

April 28, 2009, Pharmabiz http://www.pharmabiz.com/article/detnews.asp?articleid =49445§ionid=3 Association of Biotechnology Led Entrepreneurs (ABLE) is concerned about the regulatory environment existing for bio-similars in the country. Inadequate venture funding to this sector is yet another disincentive. The regulations governing bio-similars impose high barriers for Indian companies. "We need to make sure, by lobbying 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.

Ms Aparna Sharma, Director, Department of Health, Ministry of Health & Family Welfare, has been given additional charge of Food and Drugs, which was earlier handled by Mr. A M Prasad, Director, who has been promoted as Joint Secretary. She will continue holding this additional portfolio till the time a full time Director is appointed.

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Pharma Spectrum Mr. N N Prasad Appointed as Chief of Staff to WIPO DG May 6, 2009, Spicy IP http://spicyipindia.blogspot.com/2009/05/nn-prasadappointed-as-chief-of-staff.html In a momentous development for India, NN Prasad, Joint Secretary at the DIPP (Department of Industrial Policy and Promotion, Ministry of Commerce) has been selected as the Chef De Cabinet to the Director General of WIPO, Dr. Francis Gurry. This is a very high profile appointment, as the post of Chef De Cabinet is akin to the Principal Secretary to the Prime Minister of India. As many of you may be aware, NN Prasad has been instrumental in changing the face of Indian IP administration. And more importantly, in increasing the influence that India has on the international IP arena. Under his stewardship, India has carved out a nice for itself as a balancer of sorts at international negotiations involving the developed and the developing world. Illustratively, India hosted a development agenda meeting in 2006, where Prasad played a key role in getting the two sides to agree on common themes. Naturally, this is all very close to the middle path approach that this blog has been advocating for a while now.

Dr. Eswara Reddy Takes Charge as Deputy Drugs Controller (NZ) April 30, 2009, IDMA Bulletin

Is Protectionism a matter? ……… In both cases, the ruling was against the MNCs and in favour of generic companies. Both cases have been highprofile cases where landmark decision was given. Is this a show or protectionism on the part of Indian Judicial system towards generics? Expressing his views, Mr. Tapan Ray, Director General, OPPI, opines, “In its current form the patent laws appear to be somewhat protective in nature towards the domestic generic companies. Absence of data protection and less than adequate patent enforcement mechanism within the country will bear testimony to this fact. Probably because of all such reasons, in the Pharma space, India is attracting much lesser foreign direct investments than China, in the post IPR regime.” It seems that at present India needs a robust enough patent management systems and procedures within the country, for the countries own interest. Such world class patent management systems will be able to protect the long term interest of the innovators of India and not just for the acceptability by the West. Ray points out. Take on patent law in India……… Mr. Tapan Ray informs, “The patent management strategies in our country are evolving and may be for that reason, are not robust enough, as yet. When we compare India with China, it can be noticed that there is still some work needed to be done. For instance there is a big gap within the patent management system which undoubtedly shows the absence of regulatory data protection.

Dr. S. Eswara Reddy, M. Ph, Ph.D has taken charge as Deputy Drugs Controller, North Zone, and Ghaziabad. He was Drugs Inspector in West Zone, Mumbai for over 10 years. He has also been given some additional responsibilities at FDA Bhavan, New Delhi. Dr. Reddy has been awarded as the ‘Best Drugs Inspector’ in 2005 by All India Drugs Control Officers Confederation. He has been associated with IDMA and has actively participated in our Seminars and Conferences such as IDMA-APPA PAC. He has been involved in GMP, GLP and GCP inspections. He has published papers in journals including Indian Drugs.

Dept of Pharma to Organise International Meet on Pharma Industry in Mumbai in Nov.

OPPI Related News

A meeting, called by Pharma secretary Ashok Kumar 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 showcasing the strengths of the domestic industry. The meeting was attended by joint secretary Arun Jha, deputy secretary Paresh Johri, representatives from organisations like SPIC, IDMA, BDMA and OPPI, experts from UNIDO, Pharmexcil and CPhI organisers to chalk out the detailed plan for the event.

When we Think Of Pharmaceutical and Biotechnology Industry One Issue that Comes to Our Mind is Patent Protection. How Are Companies Coping with Evolving Patent Laws? Ms. Suja Nair Reports…….

May 16, 2009, Pharmabiz The Department of Pharmaceuticals, in association with FICCI and other pharma organisations, is organising an international conference on pharmaceuticals in Mumbai on November 30, ahead of the proposed CHI happening from next day, to showcase strength of Indian companies.

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Pharma Spectrum OPPI Calls Meeting of Pharma Bodies on May 12 to Evolve Code of Ethics for Marketing May 4, 2009, Pharmabiz http://www.pharmabiz.com/article/detnews.asp?articleid =49518§ionid=43 As desired by the Department of Pharmaceuticals, the Organisation of Pharmaceutical Producers of India (OPPI) will hold a brainstorming session in Mumbai on May 12 with other pharma associations to evolve a joint code of ethics for the industry in a bid to curb the growing unethical trade practices. The joint meeting is expected to be attended by different organisations representing small and large pharma sectors and it will work out a common code of ethics to be submitted to the department for final clearance and implementation with a view to reign on the sales promotions and increasing unethical practices like inducing doctors, sources said. Invitations have been sent to all the concerned associations.

OPPI Forthcoming Events OPPI Seminars: •

HRD Seminar on “HRx: Adopt, Align, Deliver” on 16th June, 2009, Mumbai

•

Technical Seminar on “Consumer Safety Through Anti-Counterfeiting Technologies on 3rd July, 2009

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Annual General Meeting on Saturday, 8th August, 2009, at ‘Ball Room’ The ITC Grand Central, Parel, Mumbai 400 012.

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§ionid=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.

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