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-- A Once-Daily Treatment that Demonstrated Comparable Efficacy
with Improved Renal and Bone Laboratory Safety Parameters Compared to
Tenofovir Disoproxil Fumarate (TDF) --
FOSTER CITY, Calif.--(BUSINESS WIRE)--Dec. 19, 2016--
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Japanese
Ministry of Health, Labour and Welfare (MHLW) has approved Vemlidy® (tenofovir
alafenamide) 25mg, a once-daily treatment for suppression of viral
replication in chronic hepatitis B patients with evidence of hepatitis B
virus replication and abnormal liver function.
Vemlidy is a novel targeted prodrug of tenofovir that has demonstrated
antiviral efficacy similar to and at a dose less than one-tenth that of
tenofovir disoproxil fumarate (TDF) 300mg. Data show that Vemlidy has
greater plasma stability and delivers tenofovir to hepatocytes more
efficiently compared to TDF. As a result, Vemlidy can be given at a
lower dose, reducing the concentration of tenofovir in the bloodstream.
Vemlidy has also shown improvements in renal and bone laboratory safety
parameters compared to TDF.
"It is very exciting that a new treatment with improvements in renal and
bone safety parameters is now approved for patients with chronic
hepatitis B. This is an important advancement, as these patients often
require lifelong therapy," said Namiki Izumi, MD, the President of
Musashino RedCross Hospital.
Vemlidy’s approval is supported by 48-week data from two international
Phase 3 studies (Studies 108 and 110) among 1,298 treatment-naïve and
treatment-experienced adult patients with HBeAg-negative and
HBeAg-positive chronic HBV infection. Study 108 randomized and treated
425 HBeAg-negative patients with either Vemlidy or TDF, and Study 110
randomized and treated 873 HBeAg-positive patients with either Vemlidy
or TDF. Study 108 enrolled 27 patients from 11 sites in Japan and Study
110 enrolled 46 patients from 16 sites in Japan. Both studies met their
primary endpoint of non-inferiority to TDF based on the percentage of
patients with chronic hepatitis B with plasma HBV DNA levels below 29
IU/mL at 48 weeks of therapy.
In an integrated analysis of both studies, patients receiving Vemlidy
demonstrated improvements in bone and renal laboratory parameters
compared to those treated with TDF. Patients in the Vemlidy arm also
experienced numerically higher rates of normalization of serum alanine
aminotransferase (ALT) levels.
Vemlidy and TDF were generally well-tolerated by patients in both
studies and discontinuations due to adverse events were 1% and 1.2%,
respectively. In both studies, the most commonly reported adverse events
included headache, abdominal pain, fatigue, cough, nausea and back pain
and occurred at similar rates in patients receiving either Vemlidy or
“There are currently more than one million people in Japan chronically
infected with hepatitis B, and we believe Vemlidy is an important option
for patients living with this disease,” said Norbert Bischofberger, PhD,
Gilead’s Executive Vice President, Research and Development, and Chief
Scientific Officer. “We have been pleased to partner with the medical
community here in Japan to demonstrate the efficacy and safety profile
of Vemlidy, and we look forward to making the medication available in
Gilead is now preparing to launch Vemlidy as quickly as possible.
In Japan, TDF is sold by GlaxoSmithKline K.K.
Important Safety Information and Indication for
Vemlidy in the U.S.
BOXED WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and
POST TREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B
Warnings and Precautions
Most common adverse reactions (incidence ≥5%; all grades) were headache,
abdominal pain, fatigue, cough, nausea and back pain.
Consult the full prescribing information for VEMLIDY for more
information on potentially significant drug interactions, including
Dosage and Administration
VEMLIDY is indicated for the treatment of chronic hepatitis B virus
(HBV) infection in adults with compensated liver disease.
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. Gilead has operations in more than 30
countries worldwide, with headquarters in Foster City, California.
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 physicians may not see the benefits of prescribing Vemlidy for the
treatment of chronic HBV. 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 September 30, 2016, 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.
U.S. full prescribing information for Vemlidy, including BOXED
WARNING, is available at www.gilead.com.
Vemlidy is a registered trademark of Gilead Sciences, Inc., or its
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
View source version on businesswire.com: http://www.businesswire.com/news/home/20161218005064/en/
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.InvestorsSung Lee, 650-524-7792Media
(Japan)Seiko Noma, 81-(3)-6837-0790Media (U.S.)Kelsey