Gilead Sciences’ New Drug Applications for Cobicistat and Elvitegravir for HIV Therapy Accepted by U.S. FDA

  Gilead Sciences’ New Drug Applications for Cobicistat and Elvitegravir for
  HIV Therapy Accepted by U.S. FDA

        -- Final FDA Decisions Anticipated by October 3 and 4, 2014 --

Business Wire

FOSTER CITY, Calif. -- April 21, 2014

Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Food and
Drug Administration (FDA) has accepted the company’s refiling of two New Drug
Applications (NDA) for cobicistat, a pharmacoenhancing or “boosting” agent
that increases blood levels of the protease inhibitors atazanavir and
darunavir to enable once-daily dosing of these medicines in HIV therapy, and
elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in
treatment-experienced adults. The FDA has set target review dates under the
Prescription Drug User Fee Act (PDUFA) of October 3, 2014 for cobicistat and
October 4, 2014 for elvitegravir.

Gilead submitted NDAs for cobicistat and elvitegravir in June 2012. In April
2013, the company received Complete Response Letters from the FDA. In its
communications, the agency stated that it could not approve the cobicistat and
elvitegravir applications in their current forms, citing deficiencies in
documentation and validation of certain quality testing procedures and methods
that were observed during inspections. Gilead has worked with the FDA to
address the questions raised in the Complete Response Letters.

Cobicistat and elvitegravir are components of Gilead’s Stribild^®
(elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir
disoproxil fumarate 300 mg), a once-daily single tablet regimen for the
treatment of HIV-1 infection. Stribild was approved in the United States in
August 2012.

Cobicistat is approved under the tradename Tybost^® and elvitegravir is
approved under the tradename Vitekta^® in Europe, Canada and Australia.

About Cobicistat and Elvitegravir

Cobicistat is a cytochrome P450 3A (CYP3A) inhibitor. It boosts blood levels
of the HIV protease inhibitors atazanavir and darunavir by suppressing CYP3A,
an enzyme that metabolizes these drugs in the body. Cobicistat acts only as a
pharmacokinetic enhancer and has no antiviral activity.

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 as a single agent in all
countries of the world, excluding Japan, where JT retains rights.

Cobicistat and elvitegravir are investigational products in the United States
and their safety and efficacy have not yet been established.

AboutGilead Sciences

Gilead Sciencesis 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 inFoster City, California,
Gilead has operations inNorth and South America,EuropeandAsia 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 risks related to the fact
that the FDA may not approve elvitegravir or cobicistat in the currently
anticipated timelines or at all. In addition, any marketing approvals, if
granted, may have significant limitations on their use. Further, the FDA may
not be satisfied with the responses Gilead provided in connection with the
Complete Response Letters. 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 Annual Report on Form 10-K for the year ended December 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.

EU Summary of Product Characteristics for Tybost and Vitekta are available at
                          http://www.ema.europa.eu.

U.S. full prescribing information for Stribild is available at www.gilead.com.

  Tybost, Stribild and Vitekta are registered trademarks of Gilead Sciences,
                                     Inc.

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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