– VEMLIDY is a Once-Daily
Treatment that Demonstrated Similar Efficacy with Improved Renal
and Bone Laboratory Safety Parameters Compared to VIREAD®
–
MISSISSAUGA, ON, June 19, 2017 /CNW/ - Gilead Sciences Canada,
Inc. (Gilead Canada) today announced
that Health Canada has granted a Notice of Compliance (NOC) for
VEMLIDY™ (tenofovir alafenamide, TAF) 25mg tablets, a once-daily
treatment for adults with chronic hepatitis B virus (HBV) infection
with compensated liver disease.
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 Gilead's VIREAD® (tenofovir disoproxil fumarate,
TDF) 300mg. Data show that because VEMLIDY has greater plasma
stability and more efficiently delivers tenofovir to hepatocytes
compared to VIREAD, it can be given at a lower dose, resulting in
less tenofovir in the bloodstream. As a result, VEMLIDY
improved renal and bone laboratory safety parameters compared to
VIREAD.
"Chronic hepatitis B is a life-threatening disease, requiring
prolonged and often lifelong antiviral therapy.
While there are a small number of antiviral
agents available for hepatitis B, long-term treatment can
be associated with side effects in some patients," said Dr.
Scott Fung, Hepatologist at Toronto
General Hospital and Assistant Professor of Medicine at
the University of Toronto.
"Clinical trials have demonstrated that VEMLIDY is
highly effective in terms of viral suppression
with normalization of liver enzymes and has
shown improved renal and bone safety compared to VIREAD,
representing a significant advance in treatment for many
patients living with this chronic liver disease."
The approval of VEMLIDY 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
chronic HBV infection. Study 108 randomized and treated 425
HBeAg-negative patients with either VEMLIDY or VIREAD, and Study
110 randomized and treated 873 HBeAg-positive patients with either
VEMLIDY or VIREAD. Both studies met their primary endpoint of
non-inferiority to VIREAD 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 certain bone and renal
laboratory parameters compared to those treated with VIREAD.
Patients in the VEMLIDY arm also experienced numerically
higher rates of normalization of blood serum alanine
aminotransferase (ALT) levels.
"Chronic hepatitis B can be effectively controlled through
medication but patients must take it for life. This type of
prolonged treatment, while protecting the liver, can lead to other
health complications," said Dr. Morris
Sherman, Chairperson, Canadian Liver Foundation and
Hepatologist at Toronto General Hospital. "The more options
physicians have to customize treatment and lower doses with
improved safety to meet their patients' needs, the better the
outcomes will be over the long term."
"Gilead Canada continues its
commitment to improve and simplify care for people living with
chronic hepatitis B, as we have in hepatitis C and HIV/AIDS,"
said Kennet Brysting, General Manager, Gilead Canada.
"VEMLIDY is the first medication approved to treat chronic
HBV infection in nearly a decade, and we are excited to offer this
new, effective option to help advance long-term care for
patients. Gilead Canada will
also launch a new patient support program for those who are treated
with VEMLIDY or VIREAD to access medicine and provide optimal
care."
Important Safety Information
VEMLIDY has serious
warnings in its product label regarding the risks of lactic
acidosis/severe hepatomegaly with steatosis and post-treatment
severe acute exacerbation of hepatitis B. For important
safety information for VEMLIDY, including contraindications and
additional warnings and precautions, please see the Canadian
Product Monograph at www.gilead.ca.
About Gilead
Gilead Sciences, Inc. (Gilead) 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. Gilead Sciences Canada, Inc. is
the Canadian affiliate of Gilead Sciences, Inc. and was established
in Mississauga, Ontario, in
2005.
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 physicians
and patients may not see the advantages of VEMLIDY over other
therapies and may therefore be reluctant to prescribe the
product. These risks, uncertainties and other factors could
cause actual results to differ materially from those referred to in
the 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, 2017, 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.
Canadian Product Monograph for VEMLIDY™ is
available at www.gilead.ca.
VEMLIDY™ and VIREAD® are trademarks of Gilead
Sciences, Inc., or its related companies.
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.