[Ip-health] The Medicines Patent Pool (MPP) Broadens Collaboration with Gilead Sciences: Signs Licence for Phase III Medicine Tenofovir Alafenamide (TAF)

Jamie Love james.love at keionline.org
Fri Jul 25 03:50:54 PDT 2014

The new Gilead MPP license for patents on tenofovir alafenamide (TAF) is
very good news.  it is quite important that this license was extended to
China, and permits manufacturing in China, and China has also been added to
the older Gilead MPP license.  it is important that the new license
includes a promising pipeline product with potentially a long period of
exclusivity under post TRIPS patent laws, and that the new drug reportedly
will be far less expensive to manufacture, a very important factor for the
sustainability of treatments for HIV/AIDS.  In a week of lots of bad news,
this is welcome, and encouraging.

James Love, Knowledge Ecology International

On Fri, Jul 25, 2014 at 4:55 AM, Milena Marra <
mmarra at medicinespatentpool.org> wrote:

> The Medicines Patent Pool (MPP) Broadens Collaboration with Gilead
> Sciences: Signs Licence for Phase III Medicine Tenofovir Alafenamide (TAF)
> Announced at the 20th International AIDS Conference in Melbourne, the
> agreement seeks to increase access to a promising new HIV medicine in 112
> developing countries
> Melbourne, Australia, July 24, 2014 – 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
> - # # # -
> About the Medicines Patent Pool (MPP)
> The Medicines Patent Pool is a United Nations-backed organisation founded
> in 2010 by UNITAID to increase access to HIV treatment and spur new
> innovation worldwide. The MPP offers a new public health approach to
> negotiating patent licences for the production of low-cost versions of new
> and existing medicines and works with manufacturers to encourage the
> development of needed new technologies such as FDCs and formulations
> suitable for children. To date, MPP has signed licensing agreements for
> eight antiretrovirals and for one medicine for an HIV opportunistic
> infection. Ten generic manufacturers have now licensed from the
> organisation.
> Contact:
> Katherine Moore
> Head of Communications
> Medicines Patent Pool (MPP)
> Tel: +41 22 533 5054 | Mobile: +41 79 825 4786
> kmoore at medicinespatentpool.org<mailto:cnanzig at medicinespatentpool.org>
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James Love.  Knowledge Ecology International
http://www.keionline.org, KEI DC tel: +1.202.332.2670, US Mobile:
+1.202.361.3040, Geneva Mobile: +41.76.413.6584,   twitter.com/jamie_love

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