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.

Source: Mylan