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Bristol-Myers Squibb and Gilead Will Develop Atazanavir/Cobicistat HIV Combination Pill

Bristol-Myers Squibb and Gilead announced this week that they will collaborate on the development of a new once-daily fixed-dose coformulation containing the widely used HIV protease inhibitor atazanavir (Reyataz) plus Gilead's novel pharmacoenhancer cobicistat. Currently atazanavir is typically boosted with a low dose of ritonavir (Norvir) taken as a separate pill.

Below is an edited excerpt from a joint company press release describing the new development plan.

Bristol-Myers Squibb and Gilead Sciences Announce Licensing Agreement for Development and Commercialization of New Fixed-Dose Combination Pill for People Living with HIV

Princeton, N.J. and Foster City, Calif. -- October 26, 2011 -- 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-naive 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, MD, PhD, Executive Vice President, Chief Scientific Officer and President, R and 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, PhD, 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."

Cobicistat is Gilead's proprietary potent mechanism-based inhibitor of cytochrome P450 3A (CYP3A), an enzyme that metabolizes drugs in the body. Cobicistat is an investigational product and has not yet been determined to be safe or efficacious in humans.

The full press release, including important safety information about Reyataz, is available online.

Please see Full Prescribing Information for Reyataz here.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.

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, please visit www.gilead.com.

10/28/11

Source

Bristol-Myers Squibb and Gilead Sciences. Bristol-Myers Squibb and Gilead Sciences Announce Licensing Agreement for Development and Commercialization of New Fixed-Dose Combination Pill for People Living with HIV. Press release. October 26, 2011.