Mylan, Gilead Sign Manufacturing and Distribution Pact for HIV Drug
Mylan Inc. reports that its subsidiary Mylan Laboratories Limited has entered into an agreement with Gilead Sciences, Inc. 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 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.
As part of the licensing agreement, on US Food and Drug Administration (FDA) approval, Mylan will receive a technology transfer from Gilead, enabling the company to manufacture low-cost versions of TAF, if approved as a single agent or in approved combinations containing TAF for developing markets.
Phase III trials by Gilead Sciences met their primary objective supporting the potential for TAF to provide a new treatment option for individuals living with HIV.