Gilead, Bristol-Myers Squibb to develop and commercialize fixed-dose combination for HIV

Bristol-Myers Squibb Company (NYSE: BMY) and Gilead Sciences, Inc. (Nasdaq: GILD) today announced a licensing agreement for Bristol-Myers Squibb to develop and commercialize a fixed-dose combination containing Bristol-Myers Squibb's protease inhibitor REYATAZ® (atazanavir sulfate) and Gilead's cobicistat, a pharmacoenhancing or "boosting" agent that increases blood levels of certain HIV medicines to potentially allow for one pill once daily dosing. Gilead is currently studying atazanavir and cobicistat in Phase 2 and 3 studies in HIV-1 treatment-naïve patients.

REYATAZ is a prescription medicine used in combination with other medicines to treat people 6 years of age and older who are infected with the human immunodeficiency virus (HIV). REYATAZ should not be taken if patients are allergic to REYATAZ or to any of its ingredients.

Bristol-Myers Squibb will be responsible for the formulation, manufacturing, development, registration, distribution, and commercialization of the REYATAZ and cobicistat fixed-dose combination worldwide. Under the terms of the agreement, Bristol-Myers Squibb will pay Gilead an undisclosed royalty based on annual net sales of the product. Gilead retains sole rights for the manufacture, development and commercialization of cobicistat as a stand-alone product and for use in combination with other agents.

"This collaboration with Gilead builds on Bristol-Myers Squibb's longstanding commitment to develop medicines that have the potential to provide meaningful benefit to HIV patients, specifically aiming to enhance treatment options," said Elliott Sigal, M.D., Ph.D., Executive Vice President, Chief Scientific Officer & President, R&D, Bristol-Myers Squibb. "A REYATAZ and cobicistat fixed-dose combination has the potential not only to help simplify HIV therapy but also to address an unmet medical need in HIV for additional, innovative treatment options."

"Cobicistat provides us with the potential to co-formulate with a variety of commercially available HIV medicines that require boosting for optimal efficacy, such as the protease inhibitor atazanavir," said Norbert Bischofberger, Ph.D., Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "This agreement represents a shared commitment between Gilead and Bristol-Myers Squibb to develop multiple treatment options that can address individual patient needs."


Bristol-Myers Squibb Company


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