Mylan, Gilead Ink Deal for TAF-based HIV Drugs

Mylan Inc. and Gilead Sciences, Inc. have entered into an agreement under which Mylan has licensed the non-exclusive rights to manufacture and distribute tenofovir alafenamide (TAF) as both a single agent product and in combination with other drugs. TAF is an antiretroviral candidate for the treatment of HIV-1 infection.

As per terms of the licensing agreement, if the FDA approves the candidate, Mylan will receive a technology transfer from Gilead, enabling the company to manufacture low-cost versions of TAF. The license being granted to Mylan extends to 112 countries, accounting for 84% (more than 30 million patients) suffering from HIV infection worldwide.

Last week, Mylan announced that it has been sued by Baxter International, Inc. for filing an Abbreviated New Drug Application (ANDA) with the FDA for the generic version of the latter’s Brevibloc injection. Mylan believes that it is the first company to file a substantially complete ANDA containing a Paragraph IV certification for the generic version of Brevibloc, making it eligible for 180 days of marketing exclusivity for its generic version on approval (read more: Mylan Sued By Baxter for Generic Filing of Brevibloc).

As per Mylan’s press release on Nov 25, 2014, the company has 287 ANDAs filed with the FDA pending decisions, out of which 44 are potential first-to-file opportunities. According to IMS Health, these 287 ANDAs represent $111.6 billion in annual sales while the 44 first-to-file opportunities represent $29.5 billion in annual brand sales for the 12 months ending Jun 30, 2014.