Gilead Announces Phase 2 Results for Two Investigational All-Oral Sofosbuvir-Based Regimens for the Treatment of Chronic

  Gilead Announces Phase 2 Results for Two Investigational All-Oral
  Sofosbuvir-Based Regimens for the Treatment of Chronic Hepatitis C

-- Data Support Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination with
Ribavirin in Genotype 3 HCV; Product Under Regulatory Review for Genotype 1 in
                               U.S., Europe --

  -- Combination of Sofosbuvir and GS-5816 Demonstrates Efficacy Against HCV
                               Genotypes 1-6 --

The International Liver Congress 2014

Business Wire

LONDON -- April 10, 2014

Gilead Sciences, Inc. (Nasdaq: GILD) today announced data from two Phase 2
studies evaluating investigational all-oral regimens containing the nucleotide
analog polymerase inhibitor sofosbuvir (SOF) for the treatment of chronic
hepatitis C virus (HCV) infection. These data are being presented this week at
the 49th Annual Meeting of the European Association for the Study of the Liver
(The International Liver Congress 2014) in London.

The first study, ELECTRON2 (Oral #6), is an ongoing, open-label Phase 2
clinical trial evaluating a once-daily fixed-dose combination of SOF 400 mg
and the NS5A inhibitor ledipasvir (LDV) 90 mg, with and without ribavirin
(RBV) twice-daily (1,000 or 1,200 mg/day), among HCV-infected patient
populations.

In this study, 100 percent (n=26/26) of treatment-naïve genotype 3 patients
receiving 12 weeks of LDV/SOF plus RBV and 64 percent (n=16/25) of
treatment-naïve genotype 3 patients receiving 12 weeks of LDV/SOF without RBV
achieved a sustained virologic response 12 weeks after completing therapy
(SVR12). Among genotype 1-infected patients who had failed prior treatment
with SOF plus RBV, 100 percent (19/19) achieved SVR12 following 12 weeks of
LDV/SOF plus RBV. Additionally, 65 percent (n=13/20) of genotype 1-infected
patients with decompensated or Child-Turcotte-Pugh Class B cirrhosis receiving
12 weeks of LDV/SOF without RBV achieved SVR12. LDV/SOF with and without RBV
was well-tolerated, including among patients with more advanced liver disease.

“The ELECTRON2 data suggest that an all-oral regimen of LDV/SOF plus RBV has
the potential to provide high cure rates for genotype 3 patients in just 12
weeks – half the duration of current all-oral treatment regimens,” said
Professor Edward Gane, MD, Deputy Director and Hepatologist, New Zealand Liver
Transplant Unit, Auckland City Hospital in New Zealand, and principal
investigator of the ELECTRON2 study. “These results also suggest that LDV/SOF
may be an effective treatment regimen for HCV genotype 1-infected patients who
have failed a previous sofosbuvir-based regimen and those with advanced liver
disease, including decompensated cirrhosis.”

A second study, Study GS-US-342-0102 (Oral #111), is an ongoing randomized
Phase 2 clinical trial in which treatment-naïve, non-cirrhotic patients with
genotypes 1-6 HCV infection received a 12-week course of SOF plus the
pan-genotypic NS5A inhibitor GS-5816. Patients received SOF 400 mg and either
GS-5816 25 mg (n=77) or GS-5816 100 mg (n=77). In this study, 94.8 percent
(n=73/77) of patients receiving the 25 mg dose of GS-5816 and 96.1 percent
(n=74/77) of patients receiving the 100 mg dose achieved SVR12.

“The results of this study of sofosbuvir with a new pan-genotype NS5A
inhibitor demonstrate the curative potential of this combination,” said
Gregory T. Everson, MD, Professor of Medicine and Director, Section of
Hepatology, University of Colorado, Denver, and principal investigator of
Study GS-US-342-0102. “The combination was not only effective across all
genotypes and patient subgroups, but also was well tolerated. These results
warrant additional study in future trials, with the hope of providing a
potent, pan-genotypic combination with few side effects and a high chance for
cure.”

The most common adverse events occurring in more than 10 percent of patients
were fatigue, headache and nausea. There were no treatment discontinuations
due to adverse events, and no evidence of treatment-related laboratory
abnormalities.

Additional information about ELECTRON2 and GS-US-342-102 can be found at
www.clinicaltrials.gov.

About SOF-Based Fixed-Dose Combinations

Full data from three Phase 3 clinical trials of the LDV/SOF fixed-dose
combination (ION-1, ION-2 and ION-3) are also being presented at The
International Liver Congress 2014. Gilead announced topline results from the
ION studies on December 18, 2013. On February 10, 2014, Gilead submitted a New
Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the
LDV/SOF fixed-dose combination tablet for the treatment of genotype 1 HCV
infection in adults. The FDA has assigned the product a Breakthrough Therapy
designation, which is granted to investigational medicines that may offer
major advances in treatment over existing options. On April 7, 2014, the
company announced that the FDA has granted the application a priority review,
setting a target action date under the Prescription Drug User Fee Act (PDUFA)
of October 10, 2014.

On March 27, 2014, the European Medicines Agency (EMA) accepted Gilead’s
request for accelerated assessment for LDV/SOF, a designation that is granted
to new medicines of major public health interest. Accelerated assessment could
shorten the EMA’s review time of LDV/SOF by two months, although it does not
guarantee a positive opinion from the Committee for Medicinal Products for
Human Use, or final approval by the European Commission.

Gilead has developed a once-daily fixed-dose combination tablet containing SOF
and GS-5816. A second Phase 2 clinical trial (Study GS-US-342-0109) evaluating
12 weeks of SOF plus GS-5816, with or without RBV, among treatment-experienced
cirrhotic and non-cirrhotic patients with genotypes 1 or 3 HCV infection is
ongoing. Pending full results from Studies GS-US-334-102 and GS-US-342-0109,
Gilead plans to initiate Phase 3 studies evaluating the efficacy and safety of
the SOF/GS-5816 fixed-dose combination.

LDV/SOF and SOF/GS-5816 are investigational products and their safety and
efficacy have not yet been established.

SOF as a single agent is approved as Sovaldi^® in the United States, European
Union, Canada, New Zealand and Switzerland.

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 and South 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 the FDA,
European Commission and other regulatory agencies may not approve the LDV/SOF
fixed-dose combination in the currently anticipated timelines or at all, and
that any marketing approvals, if granted, may have significant limitations on
its use. Further, additional clinical studies of LDV/SOF, including subsequent
results from ELECTRON2, may produce unfavorable results. As a result, Gilead
may not be able to successfully commercialize LDV/SOF, and may make a
strategic decision to discontinue its development if, for example, the market
for the product fails to materialize as expected. Additional risks include the
possibility of unfavorable results from additional studies of SOF/GS-5816 and
the possibility that Gilead may make a strategic decision to discontinue
development of the fixed-dose combination of SOF/GS-5816 if, for example,
Gilead believes commercialization will be difficult relative to other
opportunities in its pipeline. 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.

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

          Sovaldi is a registered trademark 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, +1 650-522-1936 (Investors)
Cara Miller, +1 650-522-1616 (Media (U.S.))
Arran Attridge, +44 208 587 2477 (Media (Europe))
 
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