June 07, 2013
Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir for the Treatment of Hepatitis C
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun. 7, 2013--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food
and Drug Administration (FDA) has granted priority review to the
company’s New Drug Application (NDA) for sofosbuvir, a once-daily oral
nucleotide analogue inhibitor for the treatment of chronic hepatitis C
virus (HCV) infection. The FDA grants priority review status to drug
candidates that may offer major advances in treatment over existing
options. Gilead filed the NDA for sofosbuvir on April 8, 2013, and FDA
has set a target review date under the Prescription Drug User Fee Act
(PDUFA) of December 8, 2013.
The data submitted in this NDA support the use of sofosbuvir and
ribavirin (RBV) as an all-oral therapy for patients with genotype 2 and
3 HCV infection, and for sofosbuvir in combination with RBV and
pegylated interferon (peg-IFN) for treatment-naïve patients with
genotype 1, 4, 5 and 6 HCV infection.
Sofosbuvir is an investigational product and its 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 sofosbuvir in the
anticipated timelines or at all, and that any marketing
approvals, if granted, may have significant limitations on its use.
Further, additional studies of sofosbuvir, including in combination with
other products, may produce unfavorable results. In addition, even if
approved, Gilead may not be able to successfully commercialize
sofosbuvir, and may make a strategic decision to discontinue its
development 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 March 31, 2013, 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.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Miller, 650-522-1616 (Media)