November 22, 2013
European CHMP Adopts Positive Opinion for Gilead Sciences’ Sovaldi® for the Treatment of Chronic Hepatitis C Infection
FOSTER CITY, Calif.--(BUSINESS WIRE)--Nov. 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
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 VALENCE study, 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 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 and South America, Europe and
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 statements.
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.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Miller, 650-522-1616 (Media, U.S.)
Sonia Choi, 609-213-6015 (Media,