European Commission Grants Marketing Authorization for Gilead’s Single Tablet Regimen Odefsey® (Emtricitabine, Rilpivirine...
June 23 2016 - 7:53AM
Business Wire
– Odefsey is the Second Single Tablet
Regimen Containing the Descovy Backbone and the Third
Product in Gilead’s New TAF Portfolio to be Approved in Europe
–
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the
European Commission has granted marketing authorization for the
once-daily single tablet regimen (STR) Odefsey®
(emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg
or R/F/TAF) for the treatment of HIV-1 infection in certain
patients. Odefsey combines Gilead’s emtricitabine and tenofovir
alafenamide (marketed as Descovy®) with rilpivirine,
marketed by Janssen Sciences Ireland UC, one of the Janssen
Pharmaceutical Companies of Johnson & Johnson. Following the
approval of Genvoya in November 2015, Odefsey is Gilead’s second
STR based on the Descovy backbone to receive marketing
authorization in the European Union and is currently the smallest
pill of any STR for the treatment of HIV.
Odefsey is indicated in the European Union for the treatment of
adults and adolescents (ages 12 years and older with body weight at
least 35 kg) without known mutations associated with resistance to
the non-nucleoside reverse transcriptase inhibitor (NNRTI) class,
tenofovir or emtricitabine, and with a viral load less than 100,000
HIV-1 RNA copies/ml.
“People living with HIV today are increasingly likely to be
receiving treatment for other conditions – such as heart and liver
disease – because they are living longer than ever before, exposing
them for longer periods of time to the virus and to the medications
used to treat it. Therefore, we need new treatment options that are
not only efficacious but also tolerable, and with convenient
dosing,” said Andy Ustianowski, MD, North Manchester General
Hospital. “Odefsey combines the antiviral efficacy and safety
profile of the new Descovy backbone with the established
tolerability profile of rilpivirine as a third agent.”
Photos and multimedia gallery available at
www.GileadHIVEU.com.
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 enters cells, including HIV-infected
cells, more efficiently than TDF, it can be given at a much lower
dose and there is 90 percent less tenofovir in the bloodstream.
“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,” said Norbert W.
Bischofberger, PhD, Gilead’s Executive Vice President, Research and
Development and Chief Scientific Officer. “Through our new
portfolio of products based on the Descovy backbone, Gilead is
pleased to offer effective treatments and simple dosing options for
people living with HIV, which has now become a chronic condition
for most patients.”
The marketing authorization for Odefsey is supported by a
bioequivalence study demonstrating that Odefsey achieved similar
drug levels of emtricitabine and TAF in the blood as Genvoya®
(elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200
mg/tenofovir alafenamide 10 mg; E/C/F/TAF) and similar drug levels
of rilpivirine as Edurant® (rilpivirine 25 mg). The safety,
efficacy and tolerability of Odefsey are also supported by clinical
studies of rilpivirine-based therapy (administered as R+F/TDF or
Eviplera®; emtricitabine 200 mg/rilpivirine 25 mg/tenofovir
disoproxil fumarate 245 mg) and F/TAF-based therapy (administered
as Genvoya) in a range of patients with HIV-1 infection. These
patients include treatment-naïve adults and adolescents,
virologically suppressed adults who switched from protease
inhibitor-based regimens, NNRTI-based regimens, or integrase strand
transfer inhibitor-based regimens, and virologically suppressed
adults with mild-to-moderate renal impairment. As with all
rilpivirine-containing regimens, Odefsey should be taken with
food.
The Odefsey approval is part of an ongoing development and
commercialization agreement between Gilead and Janssen, first
established in 2009. Under this agreement, Gilead is responsible
for the manufacturing, registration, distribution and
commercialization of Odefsey in most countries, while Janssen will
distribute it in approximately 18 markets and have co-detailing
rights in several key markets, including the United States. The
original agreement was established for the development and
commercialization of Eviplera, marketed as Complera® in the United
States, and was expanded in 2014 to include Odefsey.
For important safety information for Odefsey including posology
and method of administration, special warnings, drug interactions
and adverse drug reactions, please see the European SmPC for
Odefsey available from the EMA website at www.ema.europa.eu.
About Gilead
Gilead Sciences is a biopharmaceutical company that discovers,
develops and commercialises 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.
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 March 31, 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.
The European SmPCs for Descovy, Edurant,
Eviplera, Genvoya, Odefsey and Viread and are available from the
EMA website at www.ema.europa.eu.
Descovy, Eviplera, Genvoya, Odefsey and Viread
are registered trademarks of Gilead Sciences, Inc., or its related
companies.
Complera and Edurant are registered trademarks
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.
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Gilead Sciences, Inc.InvestorsSung Lee, +1 650-524-7792orMedia
(U.S.)Ryan McKeel, +1 650-377-3548orMedia (EU)Stephen Head, +44
(0)7768 705945
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