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news.The Medicines Patent Pool (MPP) announced an expansion of its current licensing agreement with Gilead Sciences for generic manufacture of tenofovir alafenamide (TAF), tenofovir disoproxil fumarate (TDF) and other Gilead medicines.
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The amendment enhances MPP’s current licence by allowing South African manufacturers to join Indian and Chinese companies in developing generics for low- and middle-income countries.
"We welcome the move by Gilead Sciences to broaden the manufacturing base of the current MPP licence," said Greg Perry, Executive Director of the MPP.
"The revision could contribute to local production of several important antiretrovirals in South Africa and increase supply to other sub-Saharan African countries with the world’s highest HIV burden."
The revision builds on MPP’s long-term 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.
In 2014, Gilead Sciences and the MPP amended the agreement to include the investigational medicine TAF and to expand the manufacturing of the licensed medicines TAF, TDF, FTC and COBI to Chinese companies.
With a licence for TAF, an investigational antiretroviral currently in US regulatory review, the MPP seeks to encourage the rapid introduction of new therapies in developing countries in line with their rollout in the US and Europe.
Eight MPP Indian and Chinese manufacturers are currently developing TAF, and thus the medicine could be registered in low- and middle-income countries shortly after it receives FDA approval. MPP announced on Tuesday that new generic partners, HEC Pharm and Huahai Pharmaceutical, based in China, have signed sub-licensing agreements to develop TAF as well.
Under the amended licence, Chinese and South African companies can now also manufacture EVG. As well, patents on the combination of TDF/FTC with efavirenz (EFV), the WHO-recommended first-line regimen for adults, have been added to the licence.
MPP’s first cooperative efforts with Gilead Sciences have demonstrated significant impact for communities living with HIV. The price of TDF has dropped 41%-90% since the MPP signed its first licence with the company. MPP’s generic partners have distributed approximately two billion TDF treatments in the same time period.