-- If Approved, Once-Daily Tablet Would Simplify Therapy and
Eliminate Need for Interferon and Ribavirin for Genotype 1 Hepatitis C
Patients in Europe --
-- LDV/SOF Granted an Accelerated Assessment by the European
Medicines Agency --
FOSTER CITY, Calif.--(BUSINESS WIRE)--Mar. 27, 2014--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company’s
Marketing Authorisation Application (MAA) for a once-daily fixed-dose
combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and the
nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg for the
treatment of chronic hepatitis C virus (HCV) genotype 1 infection, has
been fully validated and is now under assessment by the European
Medicines Agency (EMA). The data included in the application, which was
submitted on February 27, 2014, support the use of LDV/SOF among adult
patients with genotype 1 HCV infection for eight or 12 weeks, depending
on prior treatment history and whether they have cirrhosis.
Genotype 1 is the most prevalent form of HCV in Europe, and accounts for
60 percent of infections worldwide. Current treatments for genotype 1
HCV include pegylated interferon and ribavirin (RBV), which may not be
suitable for certain patients.
“Based on the results of the Phase 3 ION studies, LDV/SOF has the
potential to transform HCV therapy for genotype 1 patients by
eliminating the need for interferon injections and ribavirin and
reducing the duration of treatment,” said Norbert Bischofberger, PhD,
Executive Vice President of Research and Development and Chief
Scientific Officer. “If approved, LDV/SOF would be the first all-oral
treatment option that has the potential to cure HCV in as little as
eight weeks.”
The MAA for LDV/SOF is supported by three Phase 3 studies, ION-1, ION-2
and ION-3, in which nearly 2,000 genotype 1 HCV patients were randomized
to receive the fixed-dose combination, with or without RBV, for
treatment durations of eight, 12 or 24 weeks. Trial participants
included patients who were treatment-naïve or who had failed previous
treatment, including protease inhibitor-based regimens, and patients
with compensated cirrhosis.
Review of the MAA will be conducted under the centralized licensing
procedure, which, when finalized, provides one marketing authorization
in all 28 member states of the European Union. The EMA has accepted
Gilead’s request for accelerated assessment of LDV/SOF, a designation
that is granted to new medicines of major public health interest.
LDV/SOF is an investigational product and its safety and efficacy has
not yet been established. Although accelerated assessment of this
investigational fixed-dose combination could shorten EMA’s review time
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, LDV/SOF could be
available for marketing in the EU by the end of 2014. Gilead has also
submitted regulatory applications for LDV/SOF in the United States and
Canada.
SOF as a single agent was granted marketing authorization in the
European Union on January 16, 2014 under the tradename Sovaldi®,
and is available in the United Kingdom, Ireland, Germany, France,
Austria, Sweden and Finland. Sovaldi is also approved in the United
States, 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 European Commission and other regulatory agencies, including in
the United States and Canada, may not approve the LDV/SOF fixed-dose
combination in the currently anticipated timelines or at all, and any
marketing approvals, if granted, may have significant limitations on its
use. Further, additional clinical studies of LDV/SOF, including results
from the 24-week arms of ION-1, 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.
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 full prescribing information for Sovaldi is available at www.ema.europa.eu.
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.
For Gilead Sciences, Inc.Patrick O’Brien, Investors+1-650-522-1936orCara
Miller, Media (U.S.)+1-650-522-1616orArran Attridge,
Media (Europe)+44-208-587-2477
