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Press release from Business Wire

European Medicines Agency Validates Gilead's Marketing Application for Elvitegravir for Treatment of HIV Infection

Monday, June 18, 2012

European Medicines Agency Validates Gilead's Marketing Application for Elvitegravir for Treatment of HIV Infection16:30 EDT Monday, June 18, 2012 FOSTER CITY, Calif. (Business Wire) -- Gilead Sciences, Inc. (Nasdaq:GILD) announced today that its Marketing Authorisation Application (MAA) for elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced patients, has been validated by the European Medicines Agency (EMA). Gilead submitted the MAA on May 22, 2012. Review of the MAA will be conducted under the centralized licensing procedure, which, when finalized, provides one marketing authorization in all 27 member states of the European Union (EU). The MAA for elvitegravir is supported by 96-week data from a pivotal Phase 3 study (Study 145) in which elvitegravir (150 mg or 85 mg) dosed once daily was non-inferior to the integrase inhibitor raltegravir (400 mg) dosed twice daily, each administered with a background regimen that included a ritonavir-boosted protease inhibitor and a second antiretroviral. Topline 96-week data from this study were announced in December 2011, and complete results will be presented at the XIX International AIDS Conference taking place July 22-27 in Washington, D.C. Gilead's marketing application for the Quad single tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate was validated by EMA on December 20, 2011. Additionally, an MAA for cobicistat, our phamacoenhancer or “boosting” agent that increases blood levels of certain commercially available protease inhibitors and has no antiviral activity, was validated by EMA on May 22, 2012. About Elvitegravir Elvitegravir is a member of the integrase inhibitor class of antiretroviral compounds. Unlike other classes, integrase inhibitors interfere with HIV replication by blocking the ability of the virus to integrate into the genetic material of human cells. Elvitegravir was licensed by Gilead from Japan Tobacco Inc. (JT) in March 2005. Under the terms of Gilead's agreement with JT, Gilead has exclusive rights to develop and commercialize elvitegravir in all countries of the world, excluding Japan, where JT retains rights. Elvitegravir, cobicistat 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. Forward-Looking Statement This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including the risk that EMA and other regulatory agencies may not approve elvitegravir, cobicistat or the Quad, and that any marketing approvals, if granted, may have significant limitations on their use. Further, even if approved, Gilead may not be able to successfully commercialize these products and may make a strategic decision to discontinue their development if, for example, the market for the products fails to materialize as expected. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2012, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements. For more information on Gilead Sciences, please visit the company's website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000. Gilead Sciences, Inc.Patrick O?Brien, 650-522-1936 (Investors)Cara Miller, 650-522-1616 (Media)Stephen Head, +44 (208) 587-2359 (Media - EU)