December 20, 2011
Gilead Files European Marketing Application for the Quad, a Once-Daily Single-Tablet Regimen for the Treatment of HIV Infection
FOSTER CITY, Calif.--(BUSINESS WIRE)--Dec. 20, 2011-- Gilead Sciences, Inc. (Nasdaq:GILD) announced today that the Marketing Authorisation Application (MAA) for the Quad single-tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate for the treatment of HIV-1 infection in adults, submitted on November 24, 2011, has been validated by the European Medicines Agency (EMA). 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).
“Based on the safety and efficacy data from the Phase 3 pivotal studies, we believe the Quad single-tablet regimen has the potential to be a convenient treatment option for patients new to HIV therapy,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “We look forward to working with European regulatory authorities to bring this new single-tablet regimen to physicians and patients as quickly as possible.”
The MAA for the Quad is supported by results from two Phase 3 studies (Study 102 and Study 103). The MAA is also supported by clinical data for the individual components of the Quad and Chemistry, Manufacturing and Controls (CMC) information on the individual components of the Quad and the co-formulated single-tablet regimen. Gilead submitted a U.S. regulatory application for the Quad in October 2011.
Gilead's first single-tablet regimen, Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), was approved in the EU in 2007 and is marketed in partnership with Bristol-Myers Squibb and Merck & Co. The company’s second single-tablet regimen, Eviplera® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate), which combines Gilead’s Truvada® (emtricitabine/tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals’ rilpivirine, was approved in the EU in November 2011.
About the Quad
The Quad contains four Gilead compounds in a complete once-daily, single-tablet regimen: elvitegravir; cobicistat, a “boosting” agent that enables elvitegravir once-daily dosing; and Truvada.
Elvitegravir is an integrase inhibitor. Unlike other classes of antiretroviral agents, 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.
Cobicistat is Gilead's proprietary potent mechanism-based inhibitor of cytochrome P450 3A (CYP3A), an enzyme that metabolizes drugs in the body.
The Quad, elvitegravir and cobicistat 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.
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 the EMA, the U.S. Food and Drug Administration and other regulatory agencies may not approve the Quad, and that any marketing approval, if granted, may have significant limitations on its use. Further, even if approved, Gilead may not be able to successfully commercialize the Quad and may make a strategic decision to discontinue development of the Quad if, for example, the market for the product 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 September 30, 2011, 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.
EU Summary of Product Characteristics for Atripla, Eviplera and Truvada are available at: www.ema.europa.eu.
U.S. full prescribing information for Truvada is available at www.Truvada.com.
U.S. full prescribing information for Atripla is available at www.Atripla.com.
Complera, Eviplera and Truvada are registered trademarks of Gilead Sciences, Inc. or its related companies.
Atripla is a registered trademark of Bristol-Myers Squibb & Gilead Sciences, LLC.
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.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Susan Hubbard, Investors
James Read, Media (Europe)
+44 208 587 2323
Cara Miller, Media (U.S.)