Gilead Sciences has signed a license agreement with Tibotec Pharmaceuticals to develop and market a single-tablet regimen comprising Prezista (darunavir), Gilead's Emtriva (emtricitabine, GS7340) and a pharmacoenhancer cobicistat.
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As per the deal, Gilead will be responsible for the formulation, manufacturing, registration, distribution and commercialisation of the single-tablet regimen worldwide, while Tibotec will co-detail the single-tablet regimen in certain major markets.
Gilead Sciences chief scientific officer Norbert Bischofberger said for the first time they are developing a protease inhibitor-containing single-tablet regimen, due to the small milligram size of GS 7340.
GS 7340, Gilead’s investigational anti-HIV agent, is a novel prodrug of tenofovir, the active agent in the company’s HIV drug Viread (tenofovir disoproxil fumarate).
The company is likely to commence a Phase 2 study of GS 7340 in early 2012.