Gilead Files European Marketing Application for the Quad, a Once-Daily Single-Tablet Regimen for the Treatment of HIV Infection
December 20 2011 - 4:30PM
Business Wire
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.
About Elvitegravir
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.
About Cobicistat
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.
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 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.
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