June 27, 2014
Gilead Submits New Drug Application to Japan’s Pharmaceutical and Medical Devices Agency for Sofosbuvir for Chronic Hepatitis C
-- If Approved, Sofosbuvir Would Be the First All-Oral Treatment
Regimen for Patients in Japan with Genotype 2 HCV --
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun. 27, 2014--
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company has
submitted a New Drug Application (NDA) to Japan’s Pharmaceutical and
Medical Devices Agency (PMDA) for approval of sofosbuvir, a once-daily
nucleotide analog polymerase inhibitor for the treatment of chronic
hepatitis C virus (HCV) infection. The data in the NDA support the use
of sofosbuvir with ribavirin (RBV) for 12 weeks in patients with
genotype 2 HCV infection. If approved, sofosbuvir would form the basis
of the first all-oral, interferon-free treatment regimen for genotype 2
patients in Japan.
Primarily due to HCV, Japan has one of the highest rates of liver cancer
of any industrialized country. Of the more than one million people
chronically infected with HCV, 20-30 percent have the genotype 2 strain
of the virus. Currently approved therapies in Japan for genotype 2 HCV
infection involve 24-48 weeks of injections with pegylated interferon,
which may not be suitable for certain patients.
“There is an urgent need in Japan for new HCV treatment options that are
more effective, well-tolerated and simpler for patients,” said Norbert
Bischofberger, PhD, Gilead’s Executive Vice President of Research and
Development and Chief Scientific Officer. “Based on Phase 3 studies, we
believe that sofosbuvir has the potential to provide high cure rates
among genotype 2 patients in just 12 weeks of interferon-free therapy.
We look forward to working with the PMDA as the agency reviews our
The NDA is based primarily on data from a Phase 3 clinical trial
conducted in Japan (Study GS-US-334-0118) among 153 treatment-naïve and
treatment-experienced genotype 2 patients. In the study, 97 percent
(n=148/153) of genotype 2 HCV-infected patients receiving 12 weeks of an
all-oral regimen of sofosbuvir plus RBV 600–1,000 mg/day achieved a
sustained virologic response 12 weeks after completing therapy (SVR12).
Patients who achieve SVR12 are considered cured of HCV infection. The
NDA is also supported by SVR12 results from four international Phase 3
studies (FISSION, FUSION, POSITRON and VALENCE), which included genotype
2 HCV patients.
Sofosbuvir represents Gilead’s first drug application in Japan, and if
approved, would be the first product to be launched and marketed by
Gilead in the country. The company established operations in Japan in
Gilead also has conducted a second Phase 3 clinical trial in Japan
(Study GS-US-337-0113) that is evaluating a once-daily fixed-dose
combination of sofosbuvir 400 mg and the NS5A inhibitor ledipasvir 90
mg, with and without RBV, for the treatment of genotype 1 HCV infected
patients. Genotype 1 is the most common strain of HCV in Japan. Gilead
announced SVR12 results from this study on June 15 and plans to file for
approval of the ledipasvir/sofosbuvir combination in Japan in the second
half of 2014.
Sofosbuvir is an investigational product in Japan and its safety and
efficacy has not yet been established. The compound has been approved by
regulatory authorities in the United States, European Union and Canada
and is commercialized under the tradename Sovaldi®. The
ledipasvir/sofosbuvir fixed-dose combination 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 and South America, Europe and
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
possibility that the PMDA may not approve sofosbuvir in Japan, and that
any marketing approval, if granted, may have significant limitations on
their use. In addition, Gilead may be unable to file for approval of the
ledipasvir/sofosbuvir combination in Japan in the currently anticipated
timelines. Further, the combination of ledipasvir/sofosbuvir may not be
approved by the PMDA or other regulatory authorities. 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, 2014, 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
U.S. full prescribing information for Sovaldi is available at www.Gilead.com.
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.
Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Flood, 650-522-5643 (Media)