Mylan Inc., Gilead Sciences, Inc. Ink Agreement Covering Non-Exclusive TAF Rights
December 1, 2014
By Riley McDermid, BioSpace.com Breaking News Editor
The treatment of patients living with HIV in the developing world took a massive step forward Monday, when Gilead Sciences said it will allow Mylan Inc to have nonexclusive rights to manufacture and distribute its HIV drug tenofovir alafenamide (TAF) in 112 countries, which together account for 84 percent of people infected worldwide.
Under the terms of the deal, Mylan Laboratories Limited has licensed the non-exclusive rights to manufacture and distribute an investigational antiretroviral drug TAF as both a single agent product and in combination with other drugs.
The U.S. Food and Drug Administration must now receive from Mylan a technology transfer from Gilead, allowing the firm to manufacture low-cost versions of TAF approved as a single agent or in approved combinations containing TAF for developing markets.
Phase III trials conducted by Foster City, Calif.-based Gilead showed TAF met primary endpoints as a new treatment option for people living with HIV. The company also manufactures other HIV therapies containing tenofovir under the trade names Viread and Truvada, with the latter approved by the FDA as an HIV pre-exposure prophylaxis.
The deal benefits both companies, said executives in a statement, because it allows highly effective drugs to reach the neediest patients around the world.
"Mylan's mission is to provide the world's 7 billion people access to high quality medicines and set new standards in health care,” said Mylan CEO Heather Bresch in a statement. “By working with partners like Gilead to help ensure access to innovative new products such as Tenofovir Alafenamide (TAF) in the countries hardest hit by this disease, we can help stem the tide of HIV/AIDS around the world."
Big pharma has been increasingly willing to improve drug access across the developing world by partnering with generic firms: Gilead already shares limited licenses with generic drug manufacturers in India and South Africa, while London-based ViiV Healthcare recently announced it would partner with Mylan on a pediatric HIV formula.
Mylan is a global pharmaceutical company with a portfolio of more than 1,300 generic pharmaceuticals and several brand medications. The company also produces a suite of antiretroviral therapies, upon which approximately 40 percent of HIV/AIDS patients in developing countries depend. Mylan currently markets products in 140 countries and territories and employs more than 20,000 people.