Gilead Sciences, Inc. : European Medicines Agency Validates Gilead's Marketing Application for Elvitegravir for Treatment of HIV Infection
06/18/2012| 04:35pm US/Eastern
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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)
© Business Wire 2012
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