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European Medicines Agency Validates Gilead’s Marketing Application for Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for

  European Medicines Agency Validates Gilead’s Marketing Application for
  Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Chronic
  Hepatitis C Infection

 -- 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
                                      --

Business Wire

FOSTER CITY, Calif. -- March 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) 90mg and the nucleotide
analog polymerase inhibitor sofosbuvir (SOF) 400mg 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 24weeks. 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.

Contact:

For Gilead Sciences, Inc.
Patrick O’Brien, Investors
+1-650-522-1936
or
Cara Miller, Media (U.S.)
+1-650-522-1616
or
Arran Attridge, Media (Europe)
+44-208-587-2477
 
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