April 08, 2013
Gilead Submits New Drug Application to U.S. FDA for Sofosbuvir for the Treatment of Hepatitis C
-- Sofosbuvir Would Form Basis of First All-Oral Regimen for HCV
Genotype 2 and 3 Patients, and Interferon-Sparing Regimen for Genotype 1
FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 8, 2013--
Gilead Sciences (Nasdaq: GILD) today announced that the company has
submitted a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for approval of sofosbuvir, a once-daily oral
nucleotide analogue for the treatment of chronic hepatitis C virus (HCV)
infection. The data submitted in this NDA 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 infection affects up to four million Americans, particularly
individuals born between 1946 and 1964. The disease is the leading cause
of liver cancer and liver transplantation in the United States.
Treatment for HCV currently includes 24-48 weeks of therapy with
peg-IFN, which has to be injected and is associated with significant
side effects, leaving some patients unable to complete therapy. If
approved, sofosbuvir would shorten HCV therapy to 12 to 16 weeks, and
depending on the genotype, would either eliminate or reduce the duration
of peg-IFN injections.
“Current therapies are not suitable for large numbers of patients with
HCV infection, and are challenging to take and tolerate,” said John C.
Martin, PhD, Chairman and Chief Executive Officer of Gilead Sciences.
“Sofosbuvir’s antiviral potency, safety profile and once-daily
administration have the potential to improve cure rates by simplifying
and shortening therapy for patients with this disease.”
The sofosbuvir NDA 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). Patients who
achieve SVR12 are considered cured of HCV.
Gilead plans to file for regulatory approval of sofosbuvir in other
geographies, including the European Union, in the second quarter of
2013. The European Medicines Agency (EMA) has accepted Gilead’s request
for accelerated assessment for sofosbuvir, a designation that is granted
to new medicines of major public health interest. Accelerated assessment
could shorten the EMA’s review time of sofosbuvir by two months.
Granting of accelerated assessment does not guarantee a positive opinion
from the CHMP or approval by the European Commission.
Sofosbuvir is a nucleotide analogue inhibitor of the HCV NS5B protein,
which plays an essential role in HCV replication. Unlike ribavirin and
pegylated interferon, sofosbuvir is a direct-acting agent, meaning that
it interferes directly with the HCV life cycle by suppressing viral
replication. Sofosbuvir is intended to become a cornerstone of
interferon-free, all-oral treatment regimens for HCV that achieve higher
cure rates more rapidly and with fewer side effects than current
therapeutic options. Sofosbuvir is an investigational product and its
safety and efficacy has 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
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 FDA, EMA and other regulatory agencies may not approve sofosbuvir,
and that any marketing approvals, if granted, may have significant
limitations on their use. In addition, additional studies of sofosbuvir,
including in combination with other products, may not produce favorable
results. Further, 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 Annual Report on Form 10-K for the
year ended December 31, 2012, 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
Patrick O’Brien, 650-522-1936 (Investors)
Kaiser, 650-522-1853 (Media)