December 23, 2011
U.S. FDA Accepts New Drug Application for Gilead’s Once-Daily, Single-Tablet Quad HIV Regimen
FOSTER CITY, Calif.--(BUSINESS WIRE)--Dec. 23, 2011--
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the U.S. Food
and Drug Administration (FDA) has accepted for review the New Drug
Application (NDA) for the Quad, a complete single-tablet HIV regimen
containing elvitegravir, cobicistat, emtricitabine and tenofovir
Gilead submitted the Quad NDA on October 27, 2011. The FDA has set a
target review date for the Quad under the Prescription Drug User Fee Act
(PDUFA) of August 27, 2012.
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®
(emtricitabine/tenofovir disoproxil fumarate).
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. In addition to studying the agent as part of the Quad, Gilead is
also examining cobicistat's potential in boosting commercially available
HIV protease inhibitors, which are used in many HIV treatment regimens.
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
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 FDA may not approve the Quad in the anticipated timelines
or at all, 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
U.S. full prescribing information for Truvada is available at www.Truvada.com.
Truvada is a trademark of Gilead Sciences, Inc.
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, 650-522-5715 (Investors)
Miller, 650-522-1616 (Media)