Huahai and HEC Pharm join other MPP licensees in helping speed availability of generic versions of Gilead Sciences’ medicines to low- and middle-income countries
Geneva, 9 June 2015 — The Medicines Patent Pool (MPP) announced today that Zhejiang Huahai Pharmaceutical, a large manufacturer of active pharmaceutical ingredients (API) and drug products with operations throughout China and the US, and HEC Pharm, a division of HEC Group, one of the top 50 Chinese private enterprises, have joined the MPP as sub-licensees.
The companies signed agreements to manufacture low-cost versions of Gilead Sciences’ antiretrovirals (ARVs) including tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF). TDF is a major ARV treating millions of people living with HIV currently, while TAF is a promising new antiretroviral now under US regulatory review. This brings the total number of MPP sub-licensees to 12 manufacturers with three based in China. Huahai and HEC Pharm join four other MPP licensees in developing TDF-based medicines, and six others for TAF, for 112 low- and middle-income countries.
“We are pleased to confirm two new sub-licensees from China have joined our network of generic manufacturers,” said Sandeep Juneja, Business Development Director, MPP, presenting at the 17th Annual Shanghai International Forum on Biotechnology (Bio-Forum 2015) in Shanghai today. “China has a strong manufacturing base and low production costs suggest they can more than adequately compete in the HIV medicines field.”
The MPP signed a licence with patent holder Gilead Sciences in July 2014 allowing manufacturers in India and China to develop TDF and TAF for use in developing countries. “The largest product in the ARV market today is tenofovir (TDF), lamivudine (3TC), efavirenz (EFV) with more than 50% of people living with HIV on this WHO first-line treatment,” stated Juneja. “Now, MPP Chinese sub-licensees can manufacture these combinations.”
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. TAF is a novel nucleotide reverse transcriptase inhibitor (NRTI) that has demonstrated high efficacy at a dose 10 times lower than the TDF dose. The smaller milligram dose may also reduce manufacturing costs as well as ease the development of new fixed-dose combinations and single-tablet regimens.
“This is good news for the MPP and for our ongoing efforts to distribute new antiretrovirals to countries with the highest HIV prevalence,” said Greg Perry, Executive Director of the MPP. “With eight manufacturers developing generic TAF, we can expect an interest in rapid production and registration efforts for this potentially very important new drug. Competition among multiple manufacturers will also contribute to low prices for TAF and TDF in the long run.”
The MPP expects to make additional sub-licensing announcements over the coming weeks for the development of other MPP licensed antiretrovirals in its portfolio.
About the Medicines Patent Pool (MPP)
The Medicines Patent Pool offers a public health-driven business model that aims to lower the prices of HIV medicines and facilitate the development of better-adapted HIV treatments such as fixed-dose combinations and special formulations for children. Founded by UNITAID in 2010, the MPP works with a range of stakeholders — communities of people living with HIV, governments, industry and international organisations. To date, MPP has signed agreements for twelve antiretrovirals (ARVs) for countries home to 87-93% of people living with HIV in the developing world and for one medicine for an HIV opportunistic infection.
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