Business Wire - February 13, 2012
FOSTER CITY, Calif. - 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(R)
(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 HIV
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. full prescribing information for Truvada is available at
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 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)