May 21, 2013
European Medicines Agency Validates Gilead’s Marketing Application for Sofosbuvir for the Treatment of Hepatitis C
-- Once-Daily Sofosbuvir will Receive an Accelerated Assessment by
EMA;
Designation Granted to New Medicines of Major Public Health
Interest --
FOSTER CITY, Calif.--(BUSINESS WIRE)--May. 21, 2013--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company’s
Marketing Authorisation Application (MAA) for sofosbuvir, a once-daily
oral nucleotide analogue inhibitor for the treatment of chronic
hepatitis C virus (HCV) infection, which was submitted to the European
Medicines Agency (EMA) on April 17, 2013, has been fully validated and
is now under assessment. The data submitted in this MAA 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.
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 24-48 weeks of therapy with RBV and peg-IFN, which has to be
injected and is associated with significant side effects.
“The clinical and economic burden of untreated HCV is substantial and
growing rapidly. An estimated five million Europeans are living with
hepatitis C, the majority of whom have not yet been diagnosed or are not
in care. In addition, many are not suited to receive the current
treatment regimens,” said John C. Martin, PhD, Chairman and Chief
Executive Officer of Gilead Sciences. “If approved, sofosbuvir has the
potential to improve cure rates, while reducing the duration of HCV
therapy and reducing or eliminating the need for interferon injections.”
The MAA for sofosbuvir is supported primarily by data from four Phase 3
studies, NEUTRINO, FISSION, POSITRON and FUSION, in which 12 or 16 weeks
of sofosbuvir-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 (HCV
undetectable) 12 weeks after completing therapy (SVR12).
Review of the MAA will be conducted under the centralized licensing
procedure, which, when finalized, provides one marketing authorization
in all 27 member states of the European Union (EU). EMA has accepted
Gilead’s request for accelerated assessment for sofosbuvir, a
designation that is granted to new medicines of major public health
interest. Although accelerated assessment could shorten EMA’s review
time of sofosbuvir by approximately two months, it does not guarantee a
positive opinion from the EMA’s Committee for Medicinal Products for
Human Use (CHMP) or final approval by the European Commission. If
approved, sofosbuvir could be available for marketing in the EU in the
first half of 2014. Gilead submitted a U.S. regulatory application for
sofosbuvir in April 2013.
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 EMA, the U.S. Food and Drug Administration and other regulatory
agencies may not approve sofosbuvir, 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.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Cara
Miller, 650-522-1616 (Media)
