UPDATE 1-Optimer shares rise after report names Glaxo, Cubist as potential buyers

buyers@

* Co aims to get as much as $1 bln - report

* Optimer could get $15-$16/shr - analyst

* Shares up 18 pct

(Adds comments from an analyst, details)

April 2 (Reuters) - Shares of Optimer Pharmaceuticals Inc rose as much as 24 percent after a Bloomberg report said GlaxoSmithKline Plc and Cubist Pharmaceuticals Inc were among those interested in buying the antibiotic maker.

Optimer, the maker of diarrhea drug Dificid, aims to get as much as $1 billion in a possible auction, the report said, quoting two unnamed sources. (http://link.reuters.com/cys96t)

The report also named AstraZeneca PLC and Japan's Astellas Pharma Inc as potential buyers.

Robert W. Baird & Co analyst Brian Skorney said the $1 billion target implied a price of about $18 per share, which, he felt, would be difficult to achieve.

"I think we can see a $15 to $16 (per share) deal get done," Slorney said, calling the jump in Optimer's stock price a probable overreaction.

Tuesday's gains in the stock price eclipsed the 13 percent jump it had seen on Feb. 27, when the company first said it would explore a sale after replacing its CEO.

The shares were up 18 percent at $13.84 in afternoon trade on the Nasdaq, well above their closing price of $12.13 on Feb. 27.

"I think bankers are probably leaking some information to try drum up some more enthusiasm to get a higher deal value than what is already on the table," Skorney said.

Analysts have previously identified Pfizer Inc, Viropharma Inc and Cubist as potential suitors for Optimer.

"Anyone who has commercial infrastructure selling hospital-based antibiotics could be a bidder here," Skorney said.

"Astellas is already partnered with Optimer and since they already own most of the worldwide rights, it makes sense to consolidate everything."

Similarly, he said, Pfizer Inc had a number of antibiotics that would go generic over the next couple of years, so bidding for Optimer would make sense for it too.

Skorney said the cost, and the benefit, of the acquisition would be trivial for companies like Glaxo and Johnson & Johnson , but Forest Laboratories and Cubist would have to pay over 10 percent of their current valuation for Optimer.

Optimer spokesman David Walsey was unavailable for comment.

Cubist spokeswoman Julie DiCarlo said the company did not comment on speculation or rumors related to mergers and acquisitions. GSK declined to comment.

Dificid, which treats adult patients who contract infectious diarrhea in hospitals, accounted for $62.4 million in sales in 2012. The company is expected to generate sales of $310 million from the drug by 2017, according Thomson Reuters data.

Optimer is also testing to see if the drug can prevent diarrhea in patients under 18 years and whether it can treat it in patients undergoing bone marrow transplants.

(Editing by Sreejiraj Eluvangal)

View the original article here

UPDATE 4-Novartis loses landmark India cancer drug patent case

* Court verdict seen setting precedent in drug patent cases

* Novartis India shares fall before recovering; Natco, Cipla gain

* India intellectual property system "not very encouraging"- exec

* Activists see verdict as win for patients in poor countries

MUMBAI/NEW DELHI, April 1 (Reuters) - India's top court dismissed Swiss drugmaker Novartis AG's attempt to win patent protection for its cancer drug Glivec, a blow to Western pharmaceutical firms targeting India to drive sales and a victory for local makers of cheap generics.

The decision sets a benchmark for intellectual property cases in India, where many patented drugs are unaffordable for most of its 1.2 billion people, and does not bode well for foreign firms engaged in ongoing disputes in India, including Pfizer Inc and Roche Holding AG, analysts said.

It cements the role of local companies as big suppliers of inexpensive generics to India's rapidly growing $13 billion-a-year drugs market and also across the developing world.

Among the chief beneficiaries of Monday's Supreme Court ruling will be India's Cipla Ltd and Natco Pharma Ltd , which already sell generic Glivec in India at around one-tenth of the price of the branded drug.

"The multinational companies will have to find new ways of doing business in India," said Deepak Malik, healthcare analyst at brokerage Emkay Global, suggesting they may consider licensing agreements with local firms to offer cheap versions of branded drugs like Glivec.

Ranjit Shahani, managing director of Novartis India Ltd , the firm's locally listed unit, said it will be cautious about investing in India, especially over introducing new drugs, and seek patent protection before launching any new products. It will continue to refrain from research and development activities there.

"The intellectual property ecosystem in India is not very encouraging," Shahani told reporters in Mumbai after the ruling.

Healthcare activists have called on the government to make medicines cheaper in a country where many patented drugs are too costly for most people, 40 percent of whom earn less than $1.25 a day, and where patented drugs account for under 10 percent of total drug sales.

"This appears to be the best outcome for patients in developing countries as fewer patents will be granted on existing medicines," said Leena Menghaney, Medecins Sans Frontieres' Access Campaign manager for India.

Over 16,000 patients in India use Glivec and the vast majority of those get it free of charge, Novartis says. By contrast, generic Glivec is used by more than 300,000 patients, according to industry reports.

The Supreme Court's decision comes after a legal battle that began when Novartis was denied a patent for Glivec in 2006.

EXTRA WORK

Novartis had argued it was entitled to a patent for the amended version of Glivec because the original patented compound was never suitable for making into a pill. Developing the final chemically stable form took years of extra work and it was this effort that marked the real breakthrough in developing Glivec as a life-saving cancer medicine, the Swiss company said.

Glivec is used to treat certain forms of leukaemia and gastrointestinal cancer, as well as some other rare tumours.

Shares in Novartis' Indian unit ended 1.8 percent lower after falling as much as 6.8 percent after the verdict. Natco Pharma stock ended 5.4 percent higher after earlier gaining nearly 11 percent and Cipla gained 1.3 percent, beating the benchmark index which ticked up 0.15 percent.

India's domestic drugs market is the 14th-largest globally, but with annual growth of 13-14 percent and the world's second-biggest population, international pharmaceutical firms say India has massive potential at a time when traditional developed markets have slowed down.

The ruling may dampen enthusiasm from foreign pharmaceutical firms in the short term, said S. Majumdar, head of law firm S. Majumdar & Co based in the eastern city of Kolkata.

"They will have to get used to it and learn to live with the law," he said.

NOT SO EVERGREEN

Pfizer's cancer drug Sutent and Roche's hepatitis C treatment Pegasys lost their patented status in India last year, decisions the companies are fighting to have reversed. The Supreme Court's latest ruling will make it tougher for them to win back patent protection.

"Henceforth, multinational pharma companies are likely to want that their patents are first recognised in India before launch of a patented product," said Ameet Hariani, managing partner at Mumbai-based law firm Hariani & Co.

India has refused protection for Glivec on the grounds that it is not a new medicine, but an amended version of a known compound. By contrast, the newer form of Glivec has been patented in nearly 40 countries including the United States, Russia and China.

Indian law bans firms from extending patents on their products by making slight changes to a compound, a practice known as "evergreening". The Supreme Court said Glivec does not satisfy a patent's "novelty" requirement, Pravin Anand, lawyer for Novartis, told reporters.

Novartis can file a review petition within 90 days.

Indian Trade Minister Anand Sharma called the ruling "a historic judgment" that reaffirmed legal provisions mandating the need for substantial innovation before new patents are issued on medicines.

View the original article here

UPDATE 2-U.S. FDA approves Biogen's oral MS drug, Tecfidera

* Tecfidera expected to become dominant oral MS treatment

* Sales of Tecfidera expected to top $3 billion by 2017

* Tecfidera expected to be launched within days

* Stock rises 3.2 percent to $182.68

(Adds analyst comment, background, stock price)

By Toni Clarke

WASHINGTON, March 27 (Reuters) - U.S. regulators on Wednesday approved a new multiple sclerosis drug made by Biogen Idec Inc that is widely expected to become the No. 1 oral treatment for the disease, with annual sales topping $3 billion.

The drug, Tecfidera, activates a chemical pathway in the body known as Nrf2 that helps protect nerve cells from damage and inflammation. Following Wednesday's approval by the Food and Drug Administration, Biogen said it will launch the drug within the coming days.

Multiple sclerosis is a chronic condition that attacks the central nervous system and can lead to numbness, weakness, paralysis and blindness. It affects more than 2.1 million people worldwide, according to the National Multiple Sclerosis Society.

"We expect a solid launch of Tecfidera, and our sense is that there is a bolus of patients in the queue ready to transition to therapy," Geoff Meacham, an analyst at J.P. Morgan, said in a research note. "However, we believe that Street expectations likely already account for this and then some."

Shares of Weston, Massachusetts-based Biogen rose 3.2 percent to close at $182.68 on Wednesday. The shares have more than tripled over the past three years, mainly driven by high hopes for Tecfidera, known chemically as dimethyl fumarate.

Biogen already sells the MS drugs Avonex and Tysabri, which together account for about 30 percent of the market. Teva Pharmaceutical Industries Ltd's drug Copaxone is the current market leader, with a roughly 29 percent share and annual sales last year of more than $4 billion.

Unlike Copaxone, Avonex and Tysabri, which are injected or infused, Tecfidera comes in the more convenient form of a pill. As such, it will compete with Novartis AG's MS pill Gilenya, which, though first to market, has been dogged by heart safety concerns. Gilenya holds an 8.5 percent share of the market and generated worldwide sales of $1.2 billion last year.

Tecfidera will also compete with Sanofi's recently approved MS pill Aubagio. Aubagio's label carries a boxed warning -- the most serious kind of warning -- alerting physicians to a potentially heightened risk of liver problems.

Novartis said in a statement that it welcomed additional treatment options for people with MS, but warned that Tecfidera may not perform as well in the market as in clinical trials.

"As with any new medication, real-world experience is critical to gain an accurate understanding of a therapy's full clinical profile," the company said. "It will be important to see the clinical profile of dimethyl fumarate -- including efficacy, safety, tolerability and adherence with its twice-a-day dosing -- as it gains real-world experience."

Michael Yee, an analyst at RBC Capital Markets, said the overall profile of Tecfidera looks "significantly better than Gilenya."

Tecfidera's side effects appear relatively benign, consisting mainly of flushing, diarrhea and nausea. And its label contains no boxed warnings. The FDA recommended only that physicians monitor patients' infection-fighting white blood cell count once a year.

"That's an excellent label," said Yee. "I expect the drug to meet consensus of $300 million this year, and over five years it can achieve greater than $3 billion in sales based on its convenience and efficacy profile."

Tecfidera will be used to treat patients with relapsing-remitting MS, a form of the disease in which flare-ups are followed by periods of remission. About 85 percent of people with MS are initially diagnosed with this form of the disease.

Combined clinical trial data showed Tecfidera cut the average relapse rate by 49 percent after two years compared to patients taking a placebo. The drug is expected to generate sales of about $3 billion in 2017, according to data compiled by Thomson Reuters Cortellis.

Last week European regulators recommended approval for Tecfidera and Aubagio, but they declined to give Aubagio a "new active substance" designation because it is similar to an older drug. Without this designation, generic copies of the drug could be launched in Europe in as little as three years. That could hurt sales of most other MS drugs on the market.

Sanofi said it was disappointed by the decision and plans to request a re-examination of the case.

(Reporting By Toni Clarke in Washington; additional reporting by Bill Berkrot in New York; Editing by Tim Dobbyn, Bernard Orr and Leslie Adler)

((toni.clarke@thomsonreuters.com)(202-898-8340)(Reuters

Messaging: toni.clarke.thomsonreuters.com@reuters.net))

Keywords: BIOGEN TECFIDERA/

View the original article here

UPDATE 1-U.S. FDA approves Biogen's MS drug, Tecfidera

* Tecfidera expected to become dominant oral MS treatment

* Sales of Tecfidera expected to top $3 billion by 2017

* Tecfidera expected to be launched within days

March 27 (Reuters) - U.S. regulators have approved a new multiple sclerosis drug made by Biogen Idec Inc that is widely expected to become the No. 1 oral treatment for the disease, with annual sales of more than $3 billion.

The drug, Tecfidera, activates a chemical pathway in the body known as Nrf2 which helps protect nerve cells from damage and inflammation. It is expected to be launched within days.

Multiple sclerosis is a chronic condition which attacks the central nervous system and can lead to numbness, weakness, paralysis and blindness. It affects more than 2.1 million people worldwide, according to the National Multiple Sclerosis Society.

The U.S. Food and Drug Administration said on Wednesday that the drug may decrease a patient's white blood cell. White blood cells help protect the body from infection, and while no significant increase in infections was seen during clinical trials of the drug, the agency recommended patients have their white blood cell count assessed before treatment and once a year after that.

Biogen already sells the MS drugs Avonex and Tysabri, which together account for about 30 percent of the market. Teva Pharmaceutical Industries Ltd's drug Copaxone is the current market leader, with a roughly 29 percent share and annual sales last year of more than $4 billion.

Unlike Copaxone, Avonex and Tysabri, which are injected or infused, Tecfidera comes in the more convenient form of a pill. As such, it will compete with Novartis AG's MS pill Gilenya, which, though first to market, has been dogged by heart safety concerns. Gilenya holds an 8.5 percent share of the market and generated worldwide sales of $1.2 billion last year.

View the original article here

UPDATE 1-U.S. FDA approves Biogen's MS drug, Tecfidera

* Tecfidera expected to become dominant oral MS treatment

* Sales of Tecfidera expected to top $3 billion by 2017

* Tecfidera expected to be launched within days

March 27 (Reuters) - U.S. regulators have approved a new multiple sclerosis drug made by Biogen Idec Inc that is widely expected to become the No. 1 oral treatment for the disease, with annual sales of more than $3 billion.

The drug, Tecfidera, activates a chemical pathway in the body known as Nrf2 which helps protect nerve cells from damage and inflammation. It is expected to be launched within days.

Multiple sclerosis is a chronic condition which attacks the central nervous system and can lead to numbness, weakness, paralysis and blindness. It affects more than 2.1 million people worldwide, according to the National Multiple Sclerosis Society.

The U.S. Food and Drug Administration said on Wednesday that the drug may decrease a patient's white blood cell. White blood cells help protect the body from infection, and while no significant increase in infections was seen during clinical trials of the drug, the agency recommended patients have their white blood cell count assessed before treatment and once a year after that.

Biogen already sells the MS drugs Avonex and Tysabri, which together account for about 30 percent of the market. Teva Pharmaceutical Industries Ltd's drug Copaxone is the current market leader, with a roughly 29 percent share and annual sales last year of more than $4 billion.

Unlike Copaxone, Avonex and Tysabri, which are injected or infused, Tecfidera comes in the more convenient form of a pill. As such, it will compete with Novartis AG's MS pill Gilenya, which, though first to market, has been dogged by heart safety concerns. Gilenya holds an 8.5 percent share of the market and generated worldwide sales of $1.2 billion last year.

View the original article here

UPDATE 2-U.S. FDA approves Biogen's oral MS drug, Tecfidera

* Tecfidera expected to become dominant oral MS treatment

* Sales of Tecfidera expected to top $3 billion by 2017

* Tecfidera expected to be launched within days

* Stock rises 3.2 percent to $182.68

(Adds analyst comment, background, stock price)

By Toni Clarke

WASHINGTON, March 27 (Reuters) - U.S. regulators on Wednesday approved a new multiple sclerosis drug made by Biogen Idec Inc that is widely expected to become the No. 1 oral treatment for the disease, with annual sales topping $3 billion.

The drug, Tecfidera, activates a chemical pathway in the body known as Nrf2 that helps protect nerve cells from damage and inflammation. Following Wednesday's approval by the Food and Drug Administration, Biogen said it will launch the drug within the coming days.

Multiple sclerosis is a chronic condition that attacks the central nervous system and can lead to numbness, weakness, paralysis and blindness. It affects more than 2.1 million people worldwide, according to the National Multiple Sclerosis Society.

"We expect a solid launch of Tecfidera, and our sense is that there is a bolus of patients in the queue ready to transition to therapy," Geoff Meacham, an analyst at J.P. Morgan, said in a research note. "However, we believe that Street expectations likely already account for this and then some."

Shares of Weston, Massachusetts-based Biogen rose 3.2 percent to close at $182.68 on Wednesday. The shares have more than tripled over the past three years, mainly driven by high hopes for Tecfidera, known chemically as dimethyl fumarate.

Biogen already sells the MS drugs Avonex and Tysabri, which together account for about 30 percent of the market. Teva Pharmaceutical Industries Ltd's drug Copaxone is the current market leader, with a roughly 29 percent share and annual sales last year of more than $4 billion.

Unlike Copaxone, Avonex and Tysabri, which are injected or infused, Tecfidera comes in the more convenient form of a pill. As such, it will compete with Novartis AG's MS pill Gilenya, which, though first to market, has been dogged by heart safety concerns. Gilenya holds an 8.5 percent share of the market and generated worldwide sales of $1.2 billion last year.

Tecfidera will also compete with Sanofi's recently approved MS pill Aubagio. Aubagio's label carries a boxed warning -- the most serious kind of warning -- alerting physicians to a potentially heightened risk of liver problems.

Novartis said in a statement that it welcomed additional treatment options for people with MS, but warned that Tecfidera may not perform as well in the market as in clinical trials.

"As with any new medication, real-world experience is critical to gain an accurate understanding of a therapy's full clinical profile," the company said. "It will be important to see the clinical profile of dimethyl fumarate -- including efficacy, safety, tolerability and adherence with its twice-a-day dosing -- as it gains real-world experience."

Michael Yee, an analyst at RBC Capital Markets, said the overall profile of Tecfidera looks "significantly better than Gilenya."

Tecfidera's side effects appear relatively benign, consisting mainly of flushing, diarrhea and nausea. And its label contains no boxed warnings. The FDA recommended only that physicians monitor patients' infection-fighting white blood cell count once a year.

"That's an excellent label," said Yee. "I expect the drug to meet consensus of $300 million this year, and over five years it can achieve greater than $3 billion in sales based on its convenience and efficacy profile."

Tecfidera will be used to treat patients with relapsing-remitting MS, a form of the disease in which flare-ups are followed by periods of remission. About 85 percent of people with MS are initially diagnosed with this form of the disease.

Combined clinical trial data showed Tecfidera cut the average relapse rate by 49 percent after two years compared to patients taking a placebo. The drug is expected to generate sales of about $3 billion in 2017, according to data compiled by Thomson Reuters Cortellis.

Last week European regulators recommended approval for Tecfidera and Aubagio, but they declined to give Aubagio a "new active substance" designation because it is similar to an older drug. Without this designation, generic copies of the drug could be launched in Europe in as little as three years. That could hurt sales of most other MS drugs on the market.

Sanofi said it was disappointed by the decision and plans to request a re-examination of the case.

(Reporting By Toni Clarke in Washington; additional reporting by Bill Berkrot in New York; Editing by Tim Dobbyn, Bernard Orr and Leslie Adler)

((toni.clarke@thomsonreuters.com)(202-898-8340)(Reuters

Messaging: toni.clarke.thomsonreuters.com@reuters.net))

Keywords: BIOGEN TECFIDERA/

View the original article here

UPDATE 2-Ziopharm cancer drug fails in trial; shares plunge 66 pct

* Company to halt drug development for soft tissue sarcoma

* Says will focus on synthetic biology drugs

(Adds CEO comment from conference call, analyst comment)

By Vrinda Manocha

March 26 (Reuters) - Ziopharm Oncology Inc will stop developing its drug to treat soft tissue sarcoma after it failed to improve patients' survival without the cancer worsening, wiping out nearly two-thirds of its market value.

The drug, palifosfamide, was being tested in a late-stage trial as a treatment for metastatic soft tissue sarcoma - a type of cancer of the bone, cartilage, fat or muscles.

"We know that based on progression-free survival, there is no way the drug will get approval anywhere in the world," Chief Executive Jonathan Lewis said.

The company will now evaluate all its palifosfamide programs and convert its late-stage study of the drug in small cell lung cancer to a mid-stage trial, he said.

Ziopharm said it would now focus on its synthetic biology program, which creates DNA-based drugs that enable controlled delivery of genes that produce proteins to treat cancer.

The palifosfamide sarcoma trial involved 447 patients with metastatic soft tissue sarcoma across 150 centers.

The patients received either palifosfamide along with doxirubicin - an approved cancer drug - or doxirubicin alone.

An independent committee recommended that the patients be followed to test the improvement in their overall survival, but the company said it does not expect to continue the follow-up.

Brinson Patrick Securities analyst Vernon Bernardino said the company's decision to stop the drug's development was "drastic" but noted that the company had "burned" a lot of money on the project.

"They obviously need to restructure expenses to meet the needs of what has the best chances of success and they believe more in the synthetic biologic program," Bernardino said.

Ziopharm is testing its lead drug in this program in two mid-stage trials for the treatment of melanoma and breast cancer.

However, Bernardino said he ascribed a very low value to the synthetic biology program and that it accounted for only 3 percent of his share-price target of $7.

The company's shares fell 66 percent to $1.76 in early trading -- their lowest in more than three years.

(Reporting by Esha Dey and Vrinda Manocha in Bangalore; Editing by Maju Samuel)

((esha.dey@thomsonreuters.com)(within U.S. +1 646 223 8780, outside U.S. +91 80 4135 5800)(Reuters Messaging: esha.dey.thomsonreuters.com@reuters.net))

Keywords: ZIOPHARM STUDY/CANCER

View the original article here

UPDATE 1-FDA rejects United Therapeutics' oral hypertension drug again

* Rejects resubmission filed in February

* Co likely to conduct fresh late-stage trial - analyst

* Shares down about 6 pct in early trade

(Adds analyst comment) By Vrinda Manocha

March 25 (Reuters) - Biotechnology company United Therapeutics Corp said its oral drug to treat hypertension was rejected for the second time by U.S. health regulators, sending its shares down about 6 percent in early trade on the Nasdaq.

The drugmaker did not say it would quit pursuing a marketing approval for the tablet.

"We remain confident that oral treprostinil will play an important role in treating pulmonary arterial hypertension," Chief Executive Martine Rothblatt said.

The drug, treprostinil diolamine, was first rejected by the U.S. Food and Drug Administration (FDA) in October after it had failed to show statistically significant results in patients taking a six-minute walk test during clinical studies.

The company would probably conduct another late-stage trial for the drug as it had originally planned, Wedbush analyst Liana Moussatos told Reuters.

"After the first rejection,the company thought they'd have to do another late-stage trial and it would take four years before they could resubmit the marketing approval application," she said.

"They did some additional analysis and brought in some historical data and thought they would give it another shot."

The drug will not be approved before 2017 if the trial and the review takes four years.

United Therapeutics already has a treprostinil injection named Remodulin and an orally inhaled version Tyvaso on the market to treat pulmonary arterial hypertension, a disease characterized by abnormally high blood pressure in the pulmonary artery that carries blood from the heart to the lungs.

Moussatos said United Therapeutics did not need oral treprostinil to maintain its growth. She had earlier projected $399 million in peak annual sales for the drug, but had not included the oral variant in her model.

Remodulin, the company's lead product, accounted for $458 million in revenue last year, about half of United Therapeutics's net revenue. The company also sells Adcirca, an oral tablet to treat PAH.

Oral versions of drugs are usually preferred over other forms due to their ease of administration.

(Reporting By Vrinda Manocha in Bangalore; Editing by Sreejiraj Eluvangal)

((Vrinda.Manocha@thomsonreuters.com)(within U.S. +1 646 223 8780, outside U.S. +91 80 4135 5800)(Reuters Messaging: vrinda.manocha.thomsonreuters.com@reuters.net))

Keywords: UNITEDTHERAPEUTICS FDA/HYPERTENSIONDRUG

View the original article here

UPDATE 1-U.S. FDA delays approval of GSK bird flu vaccine

* GSK says U.S. delay not related to narcolepsy controversy

* Similar vaccine linked to sleeping disorder in Europe

(Adds comment from GSK spokesman, background)

LONDON, March 25 (Reuters) - U.S. regulators have delayed approval of an H5N1 bird flu vaccine from GlaxoSmithKline , designed to be used in a pandemic.

A spokesman for Britain's biggest drugmaker said the delay was not related to recent controversy over links between a similar flu vaccine made by the company and narcolepsy.

Rather, the U.S. Food and Drug Administration (FDA) decided it needed more time to assess the product "due to an administrative matter that has recently been rectified", GSK said in a statement on Monday.

"GSK and the FDA are actively working together to complete the review in a timely manner," it added.

There is growing evidence of a link between GSK's earlier H1N1 flu vaccine, Pandemrix, and an increase in narcolepsy cases among children who received it in Europe - a fact which has raised questions as to whether the FDA should approve the similar H5N1 product.

Both vaccines contain AS03, a new adjuvant, or booster, that turbo-charges the body's immune response to a vaccine.

A 14-member panel of advisers to the FDA voted unanimously in November to recommend the H5N1 vaccine to protect against bird flu. The panel considered early studies from Europe showing an increase in the number of narcolepsy cases but concluded that the potential benefit of the vaccine outweighed the risk.

Since then, however, new data, including study results from Britain, suggest the scale and strength of the narcolepsy link to Pandemrix during the 2009-10 H1N1 swine flu pandemic could be greater than first thought.

Officials at the FDA were not immediately available to comment on the case.

(Reporting by Ben Hirschler; editing Keith Weir)

((ben.hirschler@thomsonreuters.com)(+44 20 7542 5082)(Reuters Messaging: ben.hirschler.thomsonreuters.com@reuters.net))

Keywords: GLAXOSMITHKLINE BIRDFLU/

View the original article here

UPDATE 2-FDA rejects United Therapeutics' oral hypertension drug again

* Rejects resubmission filed in February

* Co likely to conduct fresh late-stage trial - analyst

* Shares down 2 pct

(Adds company comment, details)

By Vrinda Manocha

March 25 (Reuters) - Biotechnology company United Therapeutics Corp said the oral version of its drug to treat hypertension was rejected for the second time by U.S. health regulators, sending its shares down as much as 7 percent in morning trade on the Nasdaq.

The drugmaker had resubmitted its marketing approval application last month, and an analyst said the fresh rejection was likely to necessitate new trials and a delay of about four years before the company tried again.

The drug, treprostinil diolamine, was first rejected by the U.S. Food and Drug Administration (FDA) in October after it had failed to show statistically significant results in patients taking a six-minute walk test during clinical studies.

The company would now probably conduct another late-stage trial for the drug as it had originally planned, Wedbush analyst Liana Moussatos told Reuters. After the first rejection, the company had said that it could take four years to conduct a new trial and make a new application, she said.

However, "they did some additional analysis and brought in some historical data and thought they would give it another shot," she added.

United Therapeutics already has a treprostinil injection named Remodulin and an orally inhaled version Tyvaso on the market to treat pulmonary arterial hypertension (PAH), a disease characterized by abnormally high blood pressure in the pulmonary artery that carries blood from the heart to the lungs.

The FDA's latest rejection letter did not contain any new issues, the company's vice president for business development, Martin Auster, told Reuters.

"Our infused and inhaled versions have only penetrated a fraction of the market," Auster said. "We believe an orally delivered offering would be preferred by patients and physicians."

Wedbush's Moussatos said United Therapeutics did not need oral treprostinil to maintain its growth. She had earlier projected $399 million in peak annual sales for the drug, but had not included the oral variant in her model.

Remodulin, the company's lead product, accounted for $458 million in revenue last year, about half of United Therapeutics's net revenue. The company also sells Adcirca, an oral tablet to treat PAH.

United Therapeutics' PAH drugs compete with Gilead Sciences Inc's Letairis, Pfizer's Revatio and Swiss biotechnology company Actelion Ltd's Tracleer and Veletri.

United Therapeutics shares, which have risen about 14 percent since the drug was first rejected last year, were down about 2 percent at $59.73 on the Nasdaq.

(Reporting By Vrinda Manocha in Bangalore; Editing by Sreejiraj Eluvangal)

((Vrinda.Manocha@thomsonreuters.com)(within U.S. +1 646 223 8780, outside U.S. +91 80 4135 5800)(Reuters Messaging: vrinda.manocha.thomsonreuters.com@reuters.net))

Keywords: UNITEDTHERAPEUTICS FDA/HYPERTENSIONDRUG

View the original article here

UPDATE 1-EU medicines agency to restrict use of Otsuka drug

(Adds detail on drug, manufacturer)

LONDON, March 22 (Reuters) - The European Medicines Agency said on Friday it was recommending restricting the use of medicines containing cilostazol, sold by Otsuka under the brand name Pletal, following concerns over side effects.

A review of evidence found the drug's modest benefit was only greater than its risk of damaging the heart or causing serious bleeding in a limited number of patients.

Cilostazol, also sold as Ekistol, is used for treatment of intermittent claudication, or limping, usually as a result of arterial disease.

The agency said cilostazol should only be used in patients whose symptoms had not improved despite lifestyle changes. It should also not be used in patients who have fast, abnormal heartbeats, or those with recent unstable angina, heart attack or bypass surgery, or who take two or more blood-thinning drugs.

(Reporting by Ben Hirschler; Editing by Helen Massy-Beresford)

((ben.hirschler@thomsonreuters.com)(+44 20 7542 5082)(Reuters Messaging: ben.hirschler.thomsonreuters.com@reuters.net))

Keywords: EMA OTSUKA/

View the original article here

UPDATE 1-Medical device maker Cytori loses approval fight

WASHINGTON, March 22 (Reuters) - A U.S. appeals court ruled on Friday that the Food and Drug Administration acted correctly when it denied fast-track approval of two stem cell-related medical devices made by Cytori Therapeutics Inc.

The FDA had reasonable evidence to find that the devices were not substantially equivalent to devices already on the market, according to the unanimous ruling from the U.S. Court of Appeals for the District of Columbia Circuit.

The FDA's decision meant that Cytori had to conduct extensive clinical research as part of premarket approval.

Tom Baker, Cytori's director of investor relations, said the court ruling does not change the status quo because the company has a clinical trial under way.

"That will continue to be our priority and primary path to market," Baker said in a phone interview on Friday.

The clinical trial started last year and the company plans to have initial data in the first half of 2014, he said.

Cytori is hoping to develop a treatment for heart failure in which regenerative stem cells from a patient's own fat tissue would be injected into heart muscle, all in one procedure.

The appeals court ruling relates to two medical devices designed to extract stem cells from fat tissue, the Celution 700 and the StemSource 900.

Cytori and the FDA disagreed over how similar the devices are to existing devices that extract stem cells from blood or bone marrow. Devices that are similar to already approved ones require less testing.

Judge Brett Kavanaugh wrote for a three-judge panel that the appeals court must be careful when questioning the scientific judgment of an agency such as the FDA.

"FDA concluded and explained that fat is not blood and that the difference matters. A court is ill-equipped to second-guess that kind of agency scientific judgment," Kavanaugh wrote.

An FDA spokeswoman declined to comment.

View the original article here

UPDATE 2-FDA reviewers say Titan drug dose may be insufficient

* Review comes ahead of advisory committee meeting on Thursday

* Probuphine is experimental drug to treat opioid addiction * Titan stock down 41 pct at $1.20 in over-the-counter trade

(Updates with background on existing products, drug figures)

By Toni Clarke

March 19 (Reuters) - Titan Pharmaceuticals Inc's experimental drug to treat opioid addiction was less effective in a clinical trial than might have been expected, suggesting the proposed dose could be too low, reviewers for the U.S. Food and Drug Administration said in documents published on Tuesday.

The commentary was published on the FDA's website ahead of an advisory panel meeting to be held on Thursday and sent the company's stock down 41 percent to $1.20 in over-the counter trading at midday on Tuesday.

The reviewers said they would ask the advisory panel whether Titan should explore dosing further before the drug, Probuphine, is approved.

Probuphine is a long-acting version of buprenorphine, a drug sold by Britain's Reckitt-Benckiser Group Plc under the brand names Subutex and Suboxone.

Unlike Subutex and Suboxone, which are dissolved daily under the tongue, Titan's drug is implanted under the skin of the upper arm during a 10-15-minute office procedure and delivers a continuous supply of buprenorphine for six months.

Clinical data shows Probuphine to be more effective than placebo in curbing addiction, but the results were still not particularly robust, the reviewers said.

Only 8 percent of patients provided opioid-negative urine samples for at least 80 percent of tests, while roughly a quarter of Probuphine-treated patients were unable to provide four opioid-negative samples over the course of six months, the reviewers said.

"While the placebo group had even more discouraging results, supporting the conclusion that Probuphine does have an effect on drug use, overall, the response was not what one might hope for given that the product ensures compliance with the medication for six months," the reviewers said. "It prompts speculation that the dose is simply not high enough."

Drug overdose death rates have more than tripled since 1990, according to federal data. In 2008, more than 36,000 people died from an overdose, mostly caused by opioid painkillers, which outpaced deaths from heroin and cocaine combined.

ADDITIONAL SAFETY CONCERN

While the safety of Probuphine appears largely in keeping with that of other buprenorphine products, it presents an additional safety concern, reviewers said. It must be implanted, potentially leading to surgery-related complications. They said the product is in some ways similar to Norplant, an implantable, progestin-releasing contraceptive which is no longer marketed in the United States.

Even though insertion and removal of Norplant was performed by trained healthcare providers, there were cases of implantation and removal-related complications, some with disabling consequences, the reviewers said. They will ask the advisory committee whether it believes the company has adequately addressed these concerns under its proposed risk mitigation plan and whether the drug's benefit is enough to outweigh the potential risks.

In December, Titan licensed the U.S. and Canadian rights to Probuphine to Braeburn Pharmaceuticals, a company owned by the venture capital firm Apple Tree Partners. Titan received an up-front payment of $15.75 million and will receive up to $50 million if Probuphine is approved.

Reviewers noted that the dose of buprenorphine delivered by four Probuphine implants is less than a third of the dose delivered buprenorphine tablets.

"Potentially, Probuphine could deliver just enough buprenorphine to allow patients to continue to use illicit opioids without experiencing withdrawal when they stop," the reviewers said.

RECKITT DOMINANCE

To date, the market for buprenorphine has been dominated by Reckitt, a consumer goods company whose products range from cleaning supplies to condoms. Subutex and Suboxone generated sales in 2012 of roughly $1.3 billion.

Suboxone and Subutex lost market exclusivity in 2009, and while generic competitors promptly introduced cheap copies of Subutex they were slow to develop alternatives to Suboxone. In the meantime, Reckitt persuaded many physicians to switch from Suboxone tablets to Suboxone Film, its newer, patent-protected wafer-like strip that patients dissolve under the tongue. At the end of 2012, according to Reckitt, Suboxone Film had captured 64 percent of the market.

Even as it switched patients to Suboxone Film, Reckitt aggressively fought to block generic competition to Suboxone tablets. In a move generic drug critics claimed was designed to thwart competition, Reckitt produced a report showing that children were eight times more likely to be accidentally exposed to Suboxone tablets than to Suboxone Film.

It petitioned the FDA to reject all generic versions of Suboxone tablets unless packaging safety standards were improved. The company said it could not ignore the danger posed by the tablets it had been selling for a decade, and in September said it would only sell Suboxone Film.

The FDA rejected Reckitt's petition, saying there was not enough evidence to support the need for stricter packaging rules. And it expressed skepticism over Reckitt's motives, saying the timing of its decision to stop marketing the tablet, "given its close alignment with the period in which generic competition for this product was expected to begin," could not be ignored.

Earlier this year the FDA approved generic versions of Suboxone tablets from Amneal Pharmaceuticals LLC and Actavis Inc .

(Reporting by Toni Clarke in Washington; editing by Gerald E. McCormick, Alden Bentley and Matthew Lewis)

((toni.clarke@thomsonreuters.com)(202-898-8340)(Reuters

Messaging: toni.clarke.thomsonreuters.com@reuters.net))

Keywords: FDA TITAN/

View the original article here

UPDATE 1-Amid revamp, U.S. FDA names acting head of generic drugs office

* Dr Kathleen Uhl to replace Dr Gregory Geba

* Geba abruptly resigned last week

* Generic drug trade group has concerns about revamp

(Adds details of generic drug office realignment)

By Toni Clarke

March 19 (Reuters) - The U.S. Food and Drug Administration has named Dr Kathleen Uhl acting director of its generic drugs division as it implements the biggest revamp of the department in more than a decade.

Uhl replaces Dr Gregory Geba, who resigned abruptly last week after just eight months on the job, saying the reorganization will change the scope and responsibilities of the office in a way that no longer made his position attractive.

Uhl was previously Geba's senior adviser, according to Dr Janet Woodcock, director of the FDA's drugs division, who announced the news in a memo to staff.

In his own farewell memo to staff, Geba said that over the past five months, since the agency began collecting fees from generic drugmakers to speed up drug reviews, the office approved nearly 200 applications and sent back 600 more, reducing the backlog of pending applications to 2,166 from 2,762.

The realignment, whose details are still being finalized, is designed to sharpen the agency's focus and "bolster our resources around pharmaceutical quality," according to a September note to staff from Woodcock.

Generic drugmakers are unsettled by the changes.

In a statement last week, the Generic Pharmaceutical Association (GPhA) said it was "disappointed" to learn of Geba's departure from the office of generic drugs (OGD).

"Today, 80 percent of prescriptions dispensed in America are generics," the organization said, adding that it and its members "rely on the strength and continuity of the OGD on critical matters such as regulations governing the entry to market of new, cost-saving generic versions of critical medicines."

Geba's departure is particularly jarring since it took the FDA two years to find a permanent replacement for the previous director of OGD, Gary Buehler, who left in late 2010 to become vice president for regulatory strategic operations at Teva Pharmaceutical Industries Ltd , the world's biggest generic drugmaker.

"These vacancies and changes hold the potential to distract from the critical mission of the OGD," GPhA said, "and slow the flow of information, guidance, and approvals."

Uhl, who obtained a medical degree from the Medical College of Pennsylvania, joined the FDA in 1998 in a clinical pharmacology division. She spent five years as assistant commissioner for women's health and as director of FDA's Office of Women's Health.

In 2010, Uhl became deputy director in the office of medical policy. Woodcock said in her memo to staff that Uhl provided "exemplary leadership" of that office as it underwent a major organizational change by becoming a "Super office," or one that houses subordinate offices.

Part of the current realignment of the generic drugs office involves it too becoming a "Super Office."

(Reporting by Toni Clarke in Washington; editing by Gerald E. McCormick and Matthew Lewis)

((toni.clarke@thomsonreuters.com)(202 898-8340)(Reuters Messaging: toni.clarke.thomsonreuters.com@reuters.net))

Keywords: FDA GENERICS/DIRECTOR

View the original article here

UPDATE 2-BDR Pharma seeks India licence for Bristol-Myers drug

* BDR Pharma seeks compulsory licence on cancer drug dasatinib

* Company offers to sell drug at 8,100 rupees/month

(Recasts, adds Bristol comment)

By Kaustubh Kulkarni

MUMBAI, March 18 (Reuters) - BDR Pharmaceuticals said on Monday it has applied to India's patent office for a compulsory licence to sell a generic version of Bristol-Myers Squibb Co's

cancer drug dasatinib, after unsuccessfully seeking a voluntary licence from Bristol-Myers.

Under a global Trade-Related Aspects of Intellectual Property Rights agreement, countries can issue compulsory licences for certain drugs that are deemed unaffordable to a large section of their populations.

If approved, a compulsory licence for dasatinib, a blood cancer drug, would be another setback for global drugmakers in India. German company Bayer AG lost an appeal earlier this month challenging the first such Indian license, which was granted to Natco Pharma for cancer drug Nexavar.

Dasatinib is sold as Sprycel by U.S.-based Bristol-Myers Squibb and costs about 165,000 rupees ($3,050) for a month's treatment in India.

BDR Pharma filed its application seeking a compulsory licence on March 4 and has offered to sell the drug at 8,100 rupees for a month's dose, Aravind Badiger, technical director at BDR, an Indian pharmaceuticals company, said.

"We expect the patent office to respond at the earliest," he said in an email response to a Reuters query.

BDR had unsuccessfully sought a voluntary licence from Bristol-Myers to sell a copycat version of the drug, Badiger said.

Bristol-Myers Squibb said in a statement that it does not comment on ongoing proceedings. The company said it "has and will continue to pursue all appropriate avenues to protect its intellectual property rights in India."

It said Sprycel is protected by a composition of matter patent from the Indian Patent Office.

Natco Pharma already sells a generic version of dasatinib in India, which is the subject of a legal battle with Bristol-Myers Squibb.

Generic drugs account for about 90 percent of India's $13 billion drug market. While India holds promise for global drugmakers facing slower growth in developed markets, big pharmaceutical companies have lost several rulings on intellectual property rights in recent years.

Among those setbacks, India revoked patents granted to Pfizer Inc's cancer drug Sutent, Roche Holding AG's

hepatitis C drug Pegasys, and Merck & Co's asthma treatment aerosol suspension formulation. ($1 = 54.17 Indian rupees)

(Additional reporting by Caroline Humer in New York; Editing by Tony Munroe, Charlotte Cooper and Leslie Adler)

((kaustubh.kulkarni@thomsonreuters.com)(+91 22 61807399)(Reuters Messaging: kaustubh.kulkarni.thomsonreuters.com@reuters.net))

Keywords: INDIA BDRPHARMA/DRUG

View the original article here

UPDATE 1-FDA reviewers say Titan drug dose may be insufficient

(Updates with additional FDA review comment, background)

March 19 (Reuters) - Titan Pharmaceuticals Inc's experimental drug to treat opioid addiction was shown to be more effective than placebo in a clinical trial, but patients' response suggested that the proposed dosage might be too low, reviewers for the U.S. Food and Drug Administration said in documents published on Tuesday.

The commentary was published on the FDA's website ahead of an advisory panel meeting to be held on Thursday and sent the company's stock down 42 percent to $1.19 in over-the counter trading.

The reviewers said they would ask the advisory panel whether Titan should explore dosing further before the product is approved.

The drug, Probuphine, is a long-acting version of buprenorphine, a drug sold by Britain's Reckitt-Benckiser Group Plc under the brand names Subutex and Suboxone.

Unlike Subutex and Suboxone, which are dissolved daily under the tongue, Titan's drug is implanted under the skin of the upper arm during a 10-15 minute office procedure and delivers a continuous supply of buprenorphine for six months.

"Overall, the response was not what one might hope for, given that the product ensures compliance with the medication for six months," the reviewers said. "It prompts speculation that the dose is simply not high enough."

While the safety of Probuphine appears largely in keeping that of other buprenorphine products it presents an additional safety concern, reviewers said. It must be implanted, potentially leading to surgery-related complications. The reviewers said the product is in some ways similar to Norplant, an implantable, progestin-releasing contraceptive which is no longer marketed in the United States.

Even though insertion and removal of Norplant was performed by trained health-care providers, there were cases of implantation and removal-related of complications, some with disabling consequences, the reviewers said. They will ask the advisory committee whether it believes the company has adequately addressed these concerns under its proposed risk mitigation plan and whether the drug's benefit is enough to outweigh the potential risks.

In December, Titan licensed the U.S. and Canadian rights to Probuphine to Braeburn Pharmaceuticals, a company owned by the venture capital firm Apple Tree Partners. Titan received an up-front payment of $15.75 million and will receive up to $50 million if Probuphine is approved.

(Reporting by Toni Clarke in Washington; Editing by Gerald E. McCormick and Alden Bentley)

((toni.clarke@thomsonreuters.com)(617-856-4340)(Reuters

Messaging: toni.clarke.reuters.com@reuters.net))

Keywords: FDA TITAN/

View the original article here

UPDATE 1-FDA staff does not recommend approval of Abbott's heart device

(Adds details, Abbott and analyst comments, stock movement)

March 18 (Reuters) - Staff reviewers for the U.S. Food and Drug Administration did not recommend the approval of Abbott Laboratories' implantable heart device MitraClip, citing a lack of "valid scientific evidence" of safety and effectiveness.

FDA reviewers said in briefing documents, posted on the regulator's website on Monday, that approval of the device would not be appropriate at the time as major questions of safety, efficacy and overall benefit-risk profile remained unanswered.

The device is being tested to treat mitral valve insufficiency - a disorder where a heart valve does not close properly when the heart pumps blood, causing blood to flow back into the heart - in patients considered high risk for open surgery.

The device is inserted into the blood stream using a catheter.

"The FDA staff is asking for more information. Abbott is conducting multiple trials on MitraClip, including the COAPT study, and the staff would want to look at that data," BMO Capital Markets analyst Joanne Wuensch said.

The COAPT trial is testing the device in high-risk inoperable and high-risk mitral valve patients. Abbott has also recently developed a European trial for the patient population.

Abbott had changed the proposed use for the device after the FDA expressed concerns that there was a lack of evidence to support its approval for a broader use in patients with significant mitral valve insufficiency, the reviewers said in the documents. ()

"FDA firmly believes that the currently enrolling COAPT and European trials are well-designed trials that will help to answer the many important questions posed by the very limited data analyses presented in this (approval application)," the reviewers said.

However, the reviewers recommended that MitraClip continue to remain available to high-risk patients as an investigational device so that Abbott can conduct its trials in an optimal manner.

"The MitraClip device represents a true advance for (high-risk) patients and we look forward to discussing the totality of the clinical evidence with the advisory committee members and hearing their recommendations on Wednesday," Abbott said in an emailed statement to Reuters.

An advisory panel of independent experts will discuss the data submitted by Abbott on the device and will vote on its safety, efficacy and risk profile.

BMO's Wuensch said her earnings estimate on Abbott did not include any expected revenue from MitraClip, adding that she believed the Street consensus also excluded any potential sales from the device.

Abbott shares were down 1.2 percent at $33.72 on the New York Stock Exchange on Monday.

(Reporting by Esha Dey in Bangalore; Editing by Maju Samuel and Roshni Menon)

((esha.dey@thomsonreuters.com; within U.S. +1 646 223 8780, outside U.S. +91 80 4135 5800; Reuters Messaging: esha.dey.thomsonreuters.com@reuters.net))

Keywords: ABBOTT FDA/MITRALVALVEDEVICE

View the original article here

UPDATE: Tea Party Senator Rand Paul Embraces Legal Status For Undocumented Immigrants

In the latest sign that comprehensive immigration reform has unprecedented popular and political support, Sen. Rand Paul (R-KY) endorsed on Tuesday a pathway to citizenship for 11 million undocumented immigrants.

The Tea Party favorite is presenting his own plan for reform, and departs from the Senate gang of eight’s plan by opposing the expansion of E-Verify — an error-prone system used by employers to check the legal status of workers. That would be “forcing businesses to become policemen,” Paul said.

His emphasis instead is on making citizenship contingent on meeting certain benchmarks for border security. Since 2007, the security on the border has greatly improved as border crossings are at a 40-year low and the vast majority of the border meets one of Homeland Security’s highest standards of security.

Paul’s plan creates an even longer road to citizenship, beyond the decade proposed by the Senate gang of eight. In year two, immigrants would receive temporary work visas, though Border Patrol, an inspector general and Congress would need to sign off on an improved border situation before other reforms move forward.

“If you wish to live and work in America, then we will find a place for you,” Paul said, according to the Associated Press.

Four months ago, Mitt Romney’s immigration policy was to suggest “self-deportation.” The conversation is at a different point now — Paul acknowledged “we aren’t going to deport” the millions here — showing how fringe the anti-immigrant Republican wing has become.

Rand Paul’s advisers claim the Associated Press report is false, and the senator does not back a path to citizenship. His office said in a statement, “He does not mention ‘path to citizenship’ in his speech at all.” An adviser told the Washington Post, “What his plan is extending to them is a quicker path to normalization, not citizenship, and being able to stay, work and pay taxes legally.”

The headline has been updated.

View the original article here

UPDATE 1-FDA reviewers say Titan drug dose may be insufficient

(Updates with additional FDA review comment, background)

March 19 (Reuters) - Titan Pharmaceuticals Inc's experimental drug to treat opioid addiction was shown to be more effective than placebo in a clinical trial, but patients' response suggested that the proposed dosage might be too low, reviewers for the U.S. Food and Drug Administration said in documents published on Tuesday.

The commentary was published on the FDA's website ahead of an advisory panel meeting to be held on Thursday and sent the company's stock down 42 percent to $1.19 in over-the counter trading.

The reviewers said they would ask the advisory panel whether Titan should explore dosing further before the product is approved.

The drug, Probuphine, is a long-acting version of buprenorphine, a drug sold by Britain's Reckitt-Benckiser Group Plc under the brand names Subutex and Suboxone.

Unlike Subutex and Suboxone, which are dissolved daily under the tongue, Titan's drug is implanted under the skin of the upper arm during a 10-15 minute office procedure and delivers a continuous supply of buprenorphine for six months.

"Overall, the response was not what one might hope for, given that the product ensures compliance with the medication for six months," the reviewers said. "It prompts speculation that the dose is simply not high enough."

While the safety of Probuphine appears largely in keeping that of other buprenorphine products it presents an additional safety concern, reviewers said. It must be implanted, potentially leading to surgery-related complications. The reviewers said the product is in some ways similar to Norplant, an implantable, progestin-releasing contraceptive which is no longer marketed in the United States.

Even though insertion and removal of Norplant was performed by trained health-care providers, there were cases of implantation and removal-related of complications, some with disabling consequences, the reviewers said. They will ask the advisory committee whether it believes the company has adequately addressed these concerns under its proposed risk mitigation plan and whether the drug's benefit is enough to outweigh the potential risks.

In December, Titan licensed the U.S. and Canadian rights to Probuphine to Braeburn Pharmaceuticals, a company owned by the venture capital firm Apple Tree Partners. Titan received an up-front payment of $15.75 million and will receive up to $50 million if Probuphine is approved.

(Reporting by Toni Clarke in Washington; Editing by Gerald E. McCormick and Alden Bentley)

((toni.clarke@thomsonreuters.com)(617-856-4340)(Reuters

Messaging: toni.clarke.reuters.com@reuters.net))

Keywords: FDA TITAN/

View the original article here

UPDATE 1-BDR Pharma seeks India licence for Bristol-Myers drug

* India's BDR Pharma seeks compulsory licence on cancer drug dasatinib

* BDR Pharma offers to sell generic dasatinib at 8,100 rupees/month

(Adds details, quote) By Kaustubh Kulkarni

MUMBAI, March 18 (Reuters) - BDR Pharmaceuticals has applied to India's patent office for a compulsory licence to sell a generic version of Bristol-Myers Squibb Co's cancer drug dasatinib, a BDR executive said on Monday.

Under a global Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, countries can issue compulsory licences for certain drugs that are deemed unaffordable to a large section of their populations.

If approved, the compulsory licence would be another setback for global drugmakers in India. German firm Bayer AG lost an appeal earlier this month challenging the first such Indian licence, which was granted to Natco Pharma on cancer drug Nexavar.

Dasatinib is a blood cancer drug sold as Sprycel by Bristol-Myers Squibb and costs about 165,000 rupees ($3,050) for a month's treatment in India.

India's BDR Pharmaceuticals had unsuccessfully sought a voluntary licence from Bristol-Myers Squibb to sell a copycat version, Aravind Badiger, technical director at the Indian firm,

said in an emailed response to a Reuters' query.

Officials at U.S.-based Bristol-Myers Squibb could not immediately be reached by Reuters for comment.

BDR Pharma filed its application seeking a compulsory licence on March 4 and has offered to sell the drug at 8,100 rupees for a month's dose, Badiger said.

"We expect the patent office to respond at the earliest," he said in the email.

Natco Pharma already sells a generic version of dasatinib in India, which is the subject of a legal battle with Bristol-Myers Squibb.

Generic drugs account for about 90 percent of India's $13 billion drug market. While India holds promise for global drugmakers facing slower growth in developed markets, big pharmaceutical firms have lost several rulings on intellectual property rights in recent years.

Among those setbacks, India revoked patents granted to Pfizer Inc's cancer drug Sutent, Roche Holding AG's

hepatitis C drug Pegasys and Merck & Co's asthma treatment aerosol suspension formulation. ($1 = 54.17 Indian rupees)

(Editing by Tony Munroe and Charlotte Cooper)

((kaustubh.kulkarni@thomsonreuters.com)(+91 22 61807399)(Reuters Messaging: kaustubh.kulkarni.thomsonreuters.com@reuters.net))

Keywords: INDIA BDRPHARMA/DRUG

View the original article here