June 27, 2012
Gilead Submits New Drug Application to U.S. FDA for HIV Integrase Inhibitor Elvitegravir for Treatment-Experienced Patients
Elvitegravir Also a Component of Quad Single Tablet Regimen,
Currently Under Regulatory Review for Patients New to Therapy
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun. 27, 2012--
Gilead Sciences, Inc. (Nasdaq:GILD) announced today it has submitted a
New Drug Application (NDA) to the U.S. Food and Drug Administration
(FDA) for marketing approval of elvitegravir, an integrase inhibitor for
the treatment of HIV-1 infection in treatment-experienced adults.
Elvitegravir is also a component of Gilead’s once-daily Quad single
tablet regimen, which is currently under U.S. and European regulatory
review for treatment-naïve adult patients.
The NDA 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 fully active ritonavir-boosted protease inhibitor and a
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.
About the Quad
The Quad contains four Gilead compounds in a complete once-daily, single
tablet regimen: elvitegravir 150 mg; cobicistat 150 mg, a “boosting”
agent that enables elvitegravir once-daily dosing; and Truvada® (emtricitabine
200 mg/tenofovir disoproxil fumarate 300 mg).
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
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 FDA 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.
U.S. full prescribing information for Truvada is available at www.Truvada.com.
Truvada is a registered trademark of Gilead Sciences, Inc.
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.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Rau, 650-522-5635 (Media)