Gilead Licenses Tenofovir Alafenamide For HIV To Medicines Patent Pool

Gilead Sciences announced in a press release that it told attendees at the 20th International AIDS Conference in Melbourne, Australia about its new agreement with the Medicines Patent Pool (MPP). Contingent on Food and Drug Administration (FDA) regulatory approval of Gilead’s investigational drug tenofovir alafenamide (TAF), the arrangement allows the MPP to sub-license TAF to Chinese and Indian generic drug companies, who in turn can distribute it to 112 developing countries.

Gregg H. Alton, EVP for Corporate and Medical Affairs at Gilead Sciences, said, “The Medicines Patent Pool plays a critical role in efforts to expand access to HIV treatment in the developing world. By expanding our partnership to include TAF today, we hope to lay the groundwork for the rapid introduction of generic versions should it receive regulatory approval.”

Gilead and MPP Agreement

The new agreement is an expansion of Gilead’s previous agreement with MPP. Gilead was the first pharmaceutical company to join the medicine distribution alliance in 2011. Several Indian companies hold MPP and Gilead sub-licenses for HIV medicines. Greg Perry, executive director of the MPP, said, “We welcome this expansion of our partnership, and we look forward to working with our sub-licensees to provide access to low-cost, high-quality versions of TAF and other Gilead antiretroviral medicines.”

Gilead Licensing Agreements

Tenofovir alafenamide (TAF) is a nucleotide reverse transcriptase inhibitor (NtRTI) under investigation for the treatment of HIV and chronic hepatitis B. The agent is in Phase III trials for the treatment of chronic HBV infection. Gilead places a strong focus on licensing its therapies to partners in developing countries. Along with its arrangement with MPP, Gilead shares agreements with 11 generic manufacturers. The combined partnerships have delivered HIV medications to 5 million people in low and middle income countries. Almost all of the medications are produced by Gilead’s partners.

About MPP

The Medicines Patent Pool (MPP) states that requests from the international community spurred its formation in 2010. The MPP uses a business model that offers low-cost versions of existing medicines to people living with HIV in developing countries. It also offers new formulations, fixed dose combinations, and formulations for children. Endorsed by the World Health Organization (WHO), it accomplishes its mission through voluntary licensing of key HIV medicines patents, such as Gilead’s TAF.