Gilead Sciences and Tibotec Pharmaceuticals have agreed to work together on the development and commercialization of a single-tablet regimen combining Tibotec’s Prezista® with Gilead’s Emtriva® and two investigational agents. These compounds include GS 7340, a novel prodrug of tenofovir, and cobicistat, a pharmacoenhancer.
Gilead will be responsible for the formulation, manufacturing, registration, distribution, and commercialization worldwide. Tibotec will have the right to co-detail the single-tablet regimen in certain major markets.
The solidifies an agreement entered into by the companies in June to develop a fixed-dose combination containing Prezista and cobicistat. Subject to regulatory approval, Tibotec will be responsible for the formulation, manufacturing, registration, distribution, and commercialization of the fixed-dose combination of Prezista and cobicistat worldwide.
Gilead and Tibotec have allied on HIV drug development since July 2009. That arrangement covered development and commercialization of a single-tablet regimen combining Gilead’s Truvada® (emtricitabine/tenofovir disoproxil fumarate) and Tibotec’s Edurant® (rilpivirine). The product was approved under the trade name Complera® in the U.S. this August.
“We are pleased to once again be partnering with Tibotec to advance and simplify HIV treatment for patients,” says Norbert Bischofberger, Ph.D., evp, R&D, and CSO, Gilead Sciences. “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 300 mg of tenofovir disoproxil fumarate contained in Viread and Truvada.”
Cobicistat is in three separate Phase III studies both as a stand-alone boosting agent for once-daily atazanavir as well as part of the all-Gilead fixed-dose single-tablet Quad regimen of elvitegravir, cobicistat, and Truvada for the treatment of HIV infection. GS 7340 is expected to enter a Phase II study early next year. Phase IIa dose-ranging studies have identified a dose that is 10 times lower than Viread and provides greater antiviral efficacy, the firm reports.