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HIV / AIDS

New Single-Tablet Regimen for HIV Treatment Under Development

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Gilead Sciences announced this week that it will collaborate with Tibotec/Janssen to develop a novel single-tablet antiretroviral therapy regimen. The combination pill will contain Tibotec's HIV protease inhibitor darunavir (Prezista), boosted with Gilead's new pharmacoenhancer cobicistat, plus emtricitabine (Emtriva) and GS 7340 (a pro-drug of tenofovir, or Viread).

Below is an edited excerpt from a Gilead press release describing the agreement.

Gilead Sciences Finalizes Agreement with Tibotec Pharmaceuticals to Develop and Commercialize a Single-Tablet Regimen of Prezista with Emtriva, GS 7340 and Cobicistat

Foster City, Calif. -- November 15, 2011 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced 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, a novel prodrug of tenofovir; and cobicistat, a pharmacoenhancer.

"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. Tibotec will have the right to co-detail the single-tablet regimen in certain major markets.

Gilead first entered into a collaboration with Tibotec in July 2009 for the 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 (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) in the United States in August 2011.

On June 28, 2011, Gilead announced a licensing agreement with Tibotec for the development of a fixed-dose combination containing Prezista and cobicistat, which was contingent upon the signing of the agreement to develop the Prezista, Emtriva, GS 7340 and cobicistat single-tablet regimen. Both agreements have now been finalized. Subject to regulatory approval, Tibotec will be responsible for the formulation, manufacturing, registration, distribution and commercialization of the Prezista and cobicistat fixed-dose combination worldwide.

About Cobicistat

Gilead is evaluating cobicistat in three separate pivotal Phase 3 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 Truvadafor the treatment of HIV infection.

About 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). Phase 2a dose-ranging studies have identified a dose that is ten times lower than Viread and provides greater antiviral efficacy. Gilead expects to initiate a Phase 2 study of GS 7340 early next year.

Cobicistat, GS 7340 and the Quad are investigational products and their safety and efficacy have not yet been established.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.

For more information on Gilead Sciences, please visit the company's website at www.gilead.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

11/18/11

Source

Gilead Sciences, Inc. Gilead Sciences Finalizes Agreement with Tibotec Pharmaceuticals to Develop and Commercialize a Single-Tablet Regimen of Prezista with Emtriva, GS 7340 and Cobicistat. Press release. November 15, 2011.