July 24, 2014
MELBOURNE, Australia -- At the AIDS 2014 conference in Melbourne today, the Medicines Patent Pool (MPP) announced a new licensing agreement with Gilead Sciences for tenofovir alafenamide (TAF), a promising new medicine currently in Phase III studies. The licence will allow manufacturers in India and China to develop generic versions of TAF for 112 countries that are home to more than 92% of people living with HIV in the developing world.
"The Gilead-MPP agreement aims to fast-track the production of low-cost versions of TAF for low- and middle-income countries soon after its approval in the United States," said Greg Perry, Executive Director of the Medicines Patent Pool. "This continues MPP's novel approach of licensing promising new medicines in advanced stages of development or soon after registration to speed delivery to countries most affected by the HIV epidemic."
TAF has the potential to play a large role in the international community's efforts to scale-up treatment and improve medical options for millions of people living with HIV. Phase 1b dose-ranging studies identified a dose of TAF that is ten times lower than that of 300 milligram tenofovir disoproxil fumarate (TDF) -- a World Health Organization preferred HIV therapy -- which may expand its use to broader populations. The smaller milligram dose may also allow lower production costs as well as greater ease in developing new fixed-dose combinations and single tablet regimens. The medicine is currently being studied by Gilead Sciences in Phase III clinical trials for the treatment of HIV as part of a single tablet regimen and as a standalone treatment for chronic hepatitis B in adults.
"Rapid access to new lower-dose HIV medicines such as TAF is a high priority for communities of people living with HIV worldwide," said AFROCAB'S representative Kenly Sikwese. "If clinical trials confirm its potential, TAF could replace TDF formulations that are currently used by millions of people. Its likely low manufacturing costs could reduce treatment costs and thus help to increase HIV treatment coverage."
The new licence expands upon MPP's existing collaboration with Gilead Sciences for the production of TDF, emtricitabine (FTC), cobicistat (COBI), and elvitegravir (EVG), as well as a single tablet regimen of all four ARVs. Amendments to the 2011 agreement allow manufacturers in China to produce generic TAF, TDF, FTC and COBI. They also provide for technology transfer of TAF to sub-licensees in India.
"The MPP is an innovative mechanism for increasing access to both patented pipeline and existing medicines," said Gregg Alton, Executive Vice President, Corporate and Medical Affairs for Gilead Sciences. "Our three-year collaboration has been very successful thus far. Countries eligible for generic competition for TDF, for example, have increased dramatically to the ultimate benefit of many national treatment programmes in key resource-limited countries."
The 2011 MPP-Gilead agreement already has demonstrated impact for communities living with HIV. The price of TDF has dropped 45%-87% in the past two years and MPP's generic partners have distributed three million TDF treatments in the same time period.
The full MPP licensing agreement is available at www.medicinespatentpool.org.