-- High Rates of Viral Suppression and Improved Renal and Bone
Safety Parameters Compared to Viread in Phase 3 Studies --
FOSTER CITY, Calif.--(BUSINESS WIRE)--Mar. 31, 2016--
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it has
submitted a New Drug Application (NDA) to Japan’s Pharmaceutical and
Medical Devices Agency (PMDA) for tenofovir alafenamide (TAF) 25 mg, an
investigational once-daily treatment for adults with chronic hepatitis B
virus (HBV) infection.
TAF is a novel targeted prodrug of tenofovir that has demonstrated high
antiviral efficacy similar to and at a dose less than one-tenth that of
Gilead’s Viread® (tenofovir disoproxil fumarate, TDF), which
is marketed in Japan for the treatment of HBV as Tenozet® by
GlaxoSmithKline. TAF has also demonstrated improvements in surrogate
laboratory markers of renal and bone safety compared to TDF in clinical
trials.
“With more than one million people in Japan chronically infected with
hepatitis B, there is a significant need for effective new treatment
options that offer a favorable safety profile,” said Norbert
Bischofberger, PhD, Gilead’s Executive Vice President of Research and
Development and Chief Scientific Officer. “We are pleased with the
results of the Phase 3 studies, which suggest that TAF has the potential
to improve the care of chronic hepatitis B patients who require lifelong
treatment to manage their disease.”
The NDA for TAF is supported by 48-week data from two Phase 3 studies,
which met their primary objective of non-inferiority in efficacy (HBV
DNA compared to TDF among
treatment-naïve and treatment-experienced adults with HBeAg-negative and
HBeAg-positive chronic HBV infection. Both studies enrolled patients
from a number of clinical sites in Japan. Patients randomized to the TAF
arms showed a statistically significant increase in serum alanine
aminotransferase normalization relative to the TDF arms when using the
American Association for the Study of Liver Disease criteria. Changes in
renal and bone laboratory safety parameters favored the TAF treatment
arms. Overall, patients receiving TAF experienced a significantly
smaller percentage decrease from baseline in hip and spine bone mineral
density at Week 48 compared to patients receiving Viread. Additionally,
the overall change in serum creatinine from baseline to Week 48 favored
TAF. Rates of discontinuations due to adverse events and the most
commonly reported adverse events were similar in patients receiving TAF
or Viread.
TAF as a single agent treatment for HBV is an investigational product
and its safety and efficacy have not 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. Gilead has operations in more
than 30 countries worldwide, with headquarters in Foster City,
California.
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 Japan regulatory authorities may not approve TAF for the
treatment of chronic HBV and that any marketing approvals, if granted,
may have significant limitations on its use. As a result, Gilead may not
be able to successfully commercialize TAF 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 Annual Report on Form 10-K for the year ended
December 31, 2015, 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 statement.
Viread is a registered trademark of Gilead Sciences, Inc., or its
related companies.
Tenozet is a registered trademark of GlaxoSmithKline.
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/20160330006500/en/
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.Patrick O’Brien, 650-522-1936 (Investors)Cara
Miller, 650-522-1616 (Media)
