Mylan has entered into an agreement with Gilead Sciences 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. Tenofovir Alafenamide (TAF) is an investigational antiretroviral drug for the treatment of HIV-1 infection.
The license being granted to Mylan extends to 112 countries, which together account for more than 30 million people living with HIV, representing 84% of those infected globally.1 Mylan CEO Heather Bresch said, “Mylan’s mission is to provide the world’s 7 billion people access to high quality medicines and set new standards in health care. 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.”
As part of the licensing agreement, on U.S. Food and Drug Administration (FDA) approval, Mylan will receive a technology transfer from Gilead, enabling the company to manufacture low-cost versions of Tenofovir Alafenamide (TAF), if approved as a single agent or in approved combinations containing Tenofovir Alafenamide (TAF) for developing markets.
Phase III trials by Gilead Sciences met their primary objective supporting the potential for Tenofovir Alafenamide (TAF) to provide a new treatment option for individuals living with HIV.