http://www.biocentury.com/dailynews/company/2014-12-12/bayer-fails-to-block-generic-nexavar-in-india
The Supreme Court of India dismissed an appeal by Bayer AG (Xetra:BAYN) and upheld a compulsory license issued to Natco Pharma Ltd. (BSE:NATCO; NSE:NATCOPHARM) to manufacture and market a generic version of cancer drug Nexavar sorafenib. Bayer had filed a Special Leave Petition seeking to overturn a Mumbai High Court decision that also left the license in place.
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The Supreme Court of India dismissed an appeal by Bayer AG (Xetra:BAYN) and upheld a compulsory license issued to Natco Pharma Ltd. (BSE:NATCO; NSE:NATCOPHARM) to manufacture and market a generic version of cancer drug Nexavar sorafenib. Bayer had filed a Special Leave Petition seeking to overturn a Mumbai High Court decision that also left the license in place.
The Indian Patent Office granted Natco India's first compulsory license in March 2012 after finding Bayer did not make Nexavar available to the public at a "reasonably affordable price" (see BioCentury Extra, March 12, 2012).
The license allows Natco to sell its drug in India prior to the 2021 expiration of Bayer's local patent. The Indian company is permitted to sell its version at a price not exceeding Rs8,800 ($141.68) for a month's supply of 120 tablets. Bayer markets Nexavar at Rs280,428 ($4,515).
A Bayer spokesperson said the company is "analyzing the order and will determine any future course of action afterwards."
Bayer and the Onyx Pharmaceuticals Inc. subsidiary of Amgen Inc. (NASDAQ:AMGN) have a worldwide co-development agreement for Nexavar outside of Japan, where Bayer owns rights. Nexavar, an inhibitor of
CRAF (RAF1) and multiple receptor tyrosine kinases, is approved in more than 100 countries to treat kidney, liver and thyroid cancers.
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