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Mumbai compay seeks cancer drug licence

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MUMBAI: Natco Pharma’s success in getting the country’s first compulsory licence approval on exorbitantly-priced cancer drug—Nexavar—has paved the way for another generic company to follow suit. Little-known BDR Pharma has now filed an application with the Mumbai Patent Office, seeking compulsory licence to market a crucial cancer drug, dasatinib, at nearly 90-95 % cheaper than the patented version sold in the country. This is the country’s second compulsory licence application and more could follow.

The drug, Sprycel (dasatinib ) used for chronic myeloid leukemia, is marketed under a patent by Bristol-Myers Squibb (BMS) and is priced around Rs 1.6 lakh for a month’s dose. Sprycel (dasatinib) is protected by a patent granted by Indian Patent Office, Mumbai in 2006.

In an application filed on March 4, Mumbai-based BDR Pharma has sought approval to manufacture and market its generic version of Sprycel, on grounds of non-availability and ‘high price’ of the product. In its application, BDR, set up in 2003, has offered to sell at Rs 8,100 for a month’s treatment.
Confirming this, BDR Pharma founder and CMD Dharmesh Shah told TOI; “We are waiting for the reply of the patent authorities on our application of compulsory license.” BMS did not respond to queries.

Under the World Trade Organization TRIPS Agreement, compulsory licences are legally-recognized means to overcome barriers in accessing affordable medicines, where a government allows a company to manufacture a patented drug, without the consent of the innovator company. Natco’s application seeking approval to manufacture generic Nexavar through the compulsory licence was cleared on similar grounds last year, bringing down its price by 97%.

Sources said BDR first sought a voluntary licence from Bristol-Myers Squibb on the drug in February last year. The drug MNC raised certain queries which were not “valid” , after which, the company decided to apply for a compulsory licence from the patent office.

Incidentally, dasatinib is one of the three cancer drugs on which the government plans to issue a compulsory license. A committee established by the health ministry has recommended that the government consider issuing compulsory licences on three other cancer drugs — trastuzumab, ixabepilone and dasatinib. The three drugs are patented in India and cost approximately Rs 70,000 ($1,290) per vial, Rs 60,000 ($1,110) per vial and Rs 2,700 ($50) per tablet, respectively. The department of industrial policy and promotion has been examining the proposal for some time now.

Says Shah of BDR: “We are as of now working on identifying products similar to dasatinib , which are not available as well as not affordable for patients in India. The company which calls itself a “software pharmaceutical” company, is also in the news as it is planning to launch the generic version of sunitinib in the country at an affordable price. The drug is marketed by Pfizer as Sutent at Rs 61,000 for 50 mg tablets (seven tablets) and Rs 31,500 for 25 mg tablets (seven tablets).

Zydus Cadila to launch molecule for diabetes

Pharma major Cadila Healthcare may soon become one of a handful of Indian companies to launch an indigenously developed molecule. The company has been working on a new molecule for diabetes dyslipidemia, which is expected to be called ‘Saroglitizar’ . The name is believed to have been derived from the Gujarati word ‘saro’ , meaning good. Cadila Healthcare, part of the Zydus Cadila group, has been working on the project since 2004.

When contacted by TOI, a company spokesperson said: “We have several molecules in our research pipeline which we hope to bring to the market. At this juncture we are unable to provide any further details.”

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