European CHMP Adopts Positive Opinion for Gilead Sciences’ Sovaldi® for the
Treatment of Chronic Hepatitis C Infection
FOSTER CITY, Calif. -- November 22, 2013
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for
Medicinal Products for Human Use (CHMP), the scientific committee of the
European Medicines Agency (EMA), has adopted a positive opinion on the
company’s Marketing Authorisation Application (MAA) for Sovaldi^® (sofosbuvir
400 mg tablets), an investigational once-daily oral nucleotide analogue
polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV)
infection in adults. The CHMP opinion supports the approval of Sovaldi for the
treatment of HCV in combination with other agents. The CHMP’s recommendation
will now be reviewed by the European Commission, which has the authority to
approve medicines for use in the 28 countries of the European Union (EU).
Chronic HCV is a major cause of liver cancer and liver transplantation in
Europe and around the world. The current standard of care for HCV involves up
to 48 weeks of therapy with a pegylated interferon (peg-IFN)/ ribavirin
(RBV)-containing regimen. These regimens are not always effective and are
associated with significant side effects and contraindications with other
medicines. Many HCV patients in Europe are not considered appropriate
candidates for current treatment options.
The CHMP opinion was adopted following an accelerated review procedure, which
is reserved for medicinal products that are expected to be of major public
health interest. This assessment does not guarantee marketing authorisation by
the European Commission. However, if approved, Sovaldi could be available in
the EU in the first quarter of 2014.
The MAA for Sovaldi is supported primarily by data from four Phase 3 studies,
NEUTRINO, FISSION, POSITRON and FUSION in which 12 or 16 weeks of
Sovaldi-based therapy was found to be superior or non-inferior to currently
available treatment options or historical controls, based on the proportion of
patients who had a sustained virologic response (were HCV undetectable) 12
weeks after completing therapy (SVR12). Patients who achieve SVR12 are
considered cured of HCV. During the European review, data from two additional
Phase 3 studies, VALENCE and PHOTON-1 were filed to the MAA. In the
VALENCEstudy, patients with genotype 3 HCV infection were treated with
Sovaldi and RBV for 24 weeks. The PHOTON-1 study evaluated Sovaldi and RBV for
12 weeks in patients with genotype 2 HCV infection co-infected with HIV-1 and
for 24 weeks in patients with genotypes 1 or 3 HCV co-infected with HIV-1. In
all Phase 3 studies of Sovaldi, no viral resistance to the drug was detected
among patients who relapsed following completion of therapy.
To date, nearly 3,000 patients have received at least one dose of Sovaldi in
Phase 2 or 3 studies. Sovaldi was well tolerated in clinical studies. Adverse
events were generally mild and there were few treatment discontinuations due
to adverse events. The most common adverse events occurring in at least 10
percent of patients were consistent with the safety profiles of peg-IFN and
RBV and included fatigue, headache, nausea, insomnia, dizziness, pruritis
(severe itching) and anemia.
In the United States, an expert advisory committee of the U.S. Food and Drug
Administration (FDA) voted unanimously (15-0) on October 25, 2013 that the
available data support approval of sofosbuvir. A final decision from the FDA
is anticipated by December 8, 2013.
Sovaldi is an investigational product and its safety and efficacy have not
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.
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 of unfavorable
results from ongoing and subsequent clinical trials of Sovaldi for HCV. The
European Commission, FDA and other regulatory agencies may not approve Sovaldi
in the currently anticipated timelines or at all, and any marketing approvals,
if granted, may have significant limitations on their use. As a result,
Sovaldi may never be successfully commercialized. Further, Gilead may make a
strategic decision to discontinue development of Sovaldi 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 Quarterly Report on Form 10-Q for the quarter ended September 30,
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
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.
Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Cara Miller, 650-522-1616 (Media, U.S.)
Sonia Choi, 609-213-6015 (Media, Europe)
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