Showing posts with label licence. Show all posts
Showing posts with label licence. Show all posts

Thursday, June 13, 2013

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


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Monday, June 10, 2013

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

Saturday, January 12, 2013

Italy's Philogen signs drug licence deal with Pfizer

MILAN, Jan 3 (Reuters) - Italian biopharmaceutical company Philogen has signed a worldwide licence agreement with drug firm Pfizer for the development of Dekavil, an experimental treatment for autoimmune diseases.

Under the deal, Pfizer will retain exclusive rights to market any products developed during the collaboration, Philogen said in a statement on Thursday.

Philogen will receive an upfront payment and will be eligible to receive milestone and royalty payments.

Further financial details were not disclosed.

"The licensing agreement with Pfizer accelerates our strong commitment to Philogen's unique approach to delivering therapeutic molecules specifically to their site of action," Philogen Chief Executive Duccio Neri said.

Currently in Phase 1 clinical testing, Dekavil is designed as an "armed antibody" which selectively targets inflammatory disease sites in the body instead of suppressing the immune system, Philogen said.

The Siena-based biotech group focuses on developing treatments for disorders related to angiogenesis, the growth of new blood vessels which can play a role in illnesses such as cancer.


View the original article here