FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb. 13, 2012--
Gilead Sciences, Inc. (Nasdaq:GILD) announced today that
the U.S. Food and Drug Administration (FDA) has accepted
the supplemental New Drug Application (sNDA) and granted a
six-month Priority Review for once-daily Truvada®
(emtricitabine/tenofovir disoproxil fumarate) for
pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1
infection among uninfected adults. Truvada was approved by
the FDA in 2004 for the treatment of HIV-1 infection and is
currently the most-prescribed antiretroviral treatment in
the United States.
The FDA grants priority review status to drug candidates
that provide major advances in treatment or provide a
treatment where no adequate therapy exists. Gilead
submitted the Truvada for PrEP sNDA on December 15, 2011.
The FDA has set a target review date for Truvada for PrEP
under the Prescription Drug User Fee Act (PDUFA) of June
15, 2012. The agency has also indicated that Truvada for
PrEP will be discussed at the FDA Antiviral Drugs Advisory
Committee meeting scheduled in May.
If the sNDA is approved, Truvada would be the first agent
indicated for uninfected individuals to reduce the risk of
acquiring HIV. The sNDA is based on the results of two
large placebo-controlled trials of Truvada as PrEP
sponsored by the U.S. National Institutes of Health and the
University of Washington. Several other clinical studies
support the use of Truvada for HIV risk reduction.
Truvada is not currently indicated to reduce the risk of
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 FDA may not approve Truvada for HIV-1 risk reduction,
and any approval, if granted, may have significant
limitations on its use. Additionally, even if approved,
physicians may be reluctant to prescribe the product for
HIV risk reduction, and payers may be reluctant to approve
or provide reimbursement for the product for HIV risk
reduction. As a result, there may not be significant use of
Truvada as a risk reduction tool. 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.
U.S. . 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 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)
Cara Miller, 650-522-1616 (Media)