Quad Approved by US FDA; Patent Pool Licences Set to Speed Availability in Developing Countries

29 August 2012: The US Food and Drug Administration on Monday approved Gilead Science’s four-medicines-in-one “Quad” pill to treat HIV, also known as Stribild. The newly approved treatment is likely to reach developing country markets faster and more affordably thanks in part to the licence agreement signed between Gilead Sciences and the Medicines Patent Pool last year.  The Quad consists of two new medicines, elvitegravir and cobicistat, and two previously approved medicines, emtricitabine and tenofovir disoproxil fumarate, in a complete once-daily single tablet regimen.

New medicines in development often experience a delay of several years from the time that they are approved in developed countries to the time that they are made available in developing countries.

The licence agreement signed between the Pool and Gilead in July 2011 should significantly speed this process for the Quad. The agreement includes a technology transfer of the complete manufacturing process for the Quad, and grants the Gilead-Pool licensees the right to sell lower-cost generic versions in 100 developing countries. Four generic manufacturers have already signed up to do so through the Pool – Aurobindo Pharma, Emcure Pharmaceuticals, Hetero Labs and Medchem International.

Fixed-dose combinations such as the Quad, if recommended by the World Health Organization, can be particularly important in resource-limited settings, both to help keep people on medicines and to get medicines to more people who need them. The Medicines Patent Pool aims to facilitate the development of FDCs by negotiating public-health oriented voluntary licences with multiple patent holders, so that all of the relevant intellectual property needed to make an FDC is made available in one place.

 

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