Gilead and Tibotec Agree on New Single-Tablet Regimen

Gilead Sciences announced on November 15 that it has entered into a license agreement with Tibotec Pharmaceuticals for the development and commercialization of a single-tablet regimen combining Prezista (darunavir) with Gilead's Emtriva (emtricitabine), its investigational agent GS 7340, and cobicistat, a "booster" drug.

"We are pleased to once again be partnering with Tibotec to advance and simplify HIV treatment for patients," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, 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."

Gilead will be responsible for the formulation, manufacturing, registration, and, subject to regulatory approval, distribution and commercialization of the single-tablet regimen worldwide.

This is the second time Gilead and Tibotec have entered into an agreement about a single-tablet regimen, the first resulting in the newest pill on the market, Complera, which contains Gilead's Truvada (emtricitabine/tenofovir DF) and Tibotec's Edurant (rilpivirine).