Gilead anticipates expansion of HBV, HIV drug into Medicines Patent Pool

Gilead Sciences has entered into an agreement with the Medicines Patent Pool allowing greater access to tenofovir alafenamide, an investigational drug for hepatitis B virus and HIV, according to an announcement at the International AIDS Conference in Melbourne, Australia.

Under the agreement, the Medicines Patent Pool (MPP) can sub-license tenofovir alafenamide (TAF), a nucleotide reverse transcriptase inhibitor, to generic drug companies in India and China if the drug gains US regulatory approval. If approved, the drug may be distributed in 112 developing countries.

“The Medicines Patent Pool plays a crucial role in efforts to expand access to HIV treatment in the developing world,” Gregg H. Alton, executive vice president of corporate and medical affairs at Gilead Sciences, said in a press release. “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.”

Formed in 2010, the MPP is backed by the United Nations and was created to increase access to quality, affordable medicines for people living with HIV in developing countries. Gilead became the first pharmaceutical company to join the MPP and established a licensing partnership in July 2011, according to the release.

“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,” Greg Perry, executive director of the MPP, said in the release.

Phase 3 clinical trials are under way to evaluate the efficacy and safety of TAF to treat hepatitis B virus, the release said.