[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 04:04:48 PDT 2014

I would ask the MPP to clarify the access to TAF (and other Gilead MPP
licensed patents)  in China, in terms of patient access.

On Fri, Jul 25, 2014 at 6:50 AM, Jamie Love <james.love at keionline.org>

> 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

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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