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 Patients
FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 8, 2013-
Gilead Sciences, Inc. (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-na´ve patients with genotype 1, 4, 5 and 6 HCV
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 Pacific .
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, Inc.
Gilead Sciences, Inc.
Patrick O'Brien, 650-522-1936 (Investors)
Cara Miller, 650-522-1616 (Media)
"Reproduced with permission - Gilead"
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