– ODEFSEY is the Second Single Tablet
Regimen Containing the Descovy™ Backbone and the
Third Product in Gilead's New TAF Portfolio to Receive Approval in
Canada –
MISSISSAUGA, ON, Feb. 16, 2017 /CNW/ - Gilead Sciences
Canada, Inc. (Gilead Canada) today
announced that Health Canada has granted a Notice of Compliance
(NOC) for ODEFSEY™ (emtricitabine 200 mg/rilpivirine 25
mg/tenofovir alafenamide 25 mg) tablets as a complete regimen for
the treatment of adults with HIV-1 infection. ODEFSEY is the most
recent product approved from Gilead
Canada's range of tenofovir alafenamide (TAF)-based regimens
that include GENVOYA® and DESCOVY™.
ODEFSEY is indicated in Canada
as a complete regimen for the treatment of adults infected with
HIV-1 with no known mutations associated with resistance to the
non-nucleoside reverse transcriptase inhibitor (NNRTI) class,
tenofovir or emtricitabine, and who have HIV-1 RNA levels less than
or equal to 100,000 copies per mL.
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). TAF has also demonstrated improvement in surrogate
laboratory markers of renal and bone safety as compared to TDF in
clinical trials in combination with other antiretroviral agents.
Data show that because TAF loads cells, including HIV-infected
cells, more efficiently than TDF, it can be given at a much lower
dose resulting in >90 per cent lower concentrations of tenofovir
in plasma.
"People living with HIV today are increasingly likely to be
receiving treatment for other conditions, such as heart, kidney and
liver disease, because they are living longer than ever before,
exposing them for longer periods of time to the virus and to the
antiviral medications used to treat it," said Dr. Stephen Shafran, Professor of Medicine, Division
of Infectious Diseases, University of
Alberta. "Therefore, we need new treatments that are not
only efficacious, but well tolerated and simple to dose.
"In clinical studies, TAF has shown improvements in multiple
bone and renal laboratory parameters compared to TDF (tenofovir
disoproxil fumarate)," added Dr. Shafran. "ODEFSEY offers a new
treatment option to support patients who are new to antiretroviral
treatment, or who may be needing a replacement for an older
antiretroviral regimen in those who are virologically suppressed.
Today, the goal of treatment is beyond achieving an undetectable
status, as we are now able to address longer-term side effects to
help patients live an improved quality of life."
"The approval of ODEFSEY underscores Gilead's ongoing commitment
to researching and developing new treatment options to help address
the evolving needs of a range of HIV patients, which for many
patients has now become a chronic condition," said Kennet
Brysting, General Manager, Gilead Canada. "As such, novel
simple and well tolerated treatments, such as TAF-based regimens,
are becoming the cornerstone of HIV therapy."
ODEFSEY does not cure, nor prevent, HIV infection or AIDS.
Important Safety Information
The ODEFSEY Product Monograph has serious warnings regarding the
risks of lactic acidosis, severe hepatomegaly with steatosis, and
post treatment exacerbation of hepatitis B. For important safety
information for ODEFSEY, including contraindications and additional
warnings and precautions, please see the Canadian Product
Monograph.
About Gilead Sciences
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 may not see the benefits of
prescribing ODEFSEY™. 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.
Canadian Product Monograph for
ODEFSEY™ is available at www.gilead.ca
COMPLERA®, DESCOVY™, GENVOYA®, ODEFSEY™
are trademarks of Gilead Sciences, Inc., or its related
companies.
EDURANT® is a registered trademark of Janssen
Sciences Ireland UC.
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.