US biotech firm Gilead Sciences (Nasdaq: GILD) has entered into a license agreement with Tibotec Pharmaceuticals, a subsidiary of health care giant Johnson & Johnson (NYSE: JNJ) for the development and commercialization of a single-tablet HIV/AIDS regimen combining Prezista (darunavir) with Gilead’s Emtriva (emtricitabine); its investigational agent GS 7340, a novel prodrug of tenofovir; and cobicistat, a pharmacoenhancer.
Norbert Bischofberger, executive vice president, R&D and chief scientific officer at Gilead, said: “This is the first time we are developing a protease inhibitor-containing single-tablet regimen, and we’re able to do that based on the small milligram size of GS 7340, which is less than one tenth of the amount of the 300mg of tenofovir disoproxil fumarate contained in Viread and Truvada.”
Gilead will be responsible for the formulation, manufacturing, registration and, subject to regulatory approval, distribution and commercialization of the single-tablet regimen worldwide. Tibotec will have the right to co-detail the single-tablet regimen in certain major markets. Financial terms of the accord were not revealed.
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