Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir for the Treatment of Hepatitis C

  Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir for the
  Treatment of Hepatitis C

Business Wire

FOSTER CITY, Calif. -- June 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 Pacific.

Forward-Looking Statement

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.

Contact:

Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Cara Miller, 650-522-1616 (Media)
 
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