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Drugmakers in India and China will be able to develop generic or chemically similar versions of tenofovir alafenamide, a HIV drug in its last leg of human trials.
The development follows a new licensing agreement reached between the Medicines Patent Pool (MPP) and Gilead Sciences on tenofovir alafenamide (TAF), currently in Phase III studies.
The announcement was made today at the AIDS 2014 conference in Melbourne on Thursday.
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 per cent of people living with HIV in the developing world, a United Nations-backed MPP said.
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 US, Greg Perry, MPP Executive Director, said in a statement.
“This continues MPP’s novel approach of licensing promising new medicines in advanced stages of development or soon after registration to speed up delivery to countries most affected by the HIV epidemic,” he added.
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.
The new licence expands MPP’s existing collaboration with Gilead Sciences for the production of tenofovir disoproxil fumarate TDF, emtricitabine (FTC), cobicistat (COBI), and elvitegravir (EVG), as well as a single tablet regimen of all four anti-AIDS drugs.
Amendments to the 2011 agreement allow manufacturers in China to produce generic versions of these drugs. It also provides for technology transfer of TAF to sub-licensees in India, the note said.
The 2011 MPP-Gilead agreement has demonstrated the impact for communities living with HIV, the MPP note said. The price of TDF has dropped 45 to 87 per cent in the last two years and MPP’s generic partners have distributed three million TDF treatments in the same time.
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