Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the Committee
for Medicinal Products for Human Use (CHMP), the scientific committee of
the European Medicines Agency (EMA), has adopted a positive opinion on
the company’s Marketing Authorization Application (MAA) for Odefsey®
(emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg;
R/F/TAF), an investigational single tablet regimen for the treatment of
HIV-1 infection in adults and adolescents (ages 12 years and older with
body weight at least 35 kg) without known mutations associated with
resistance to the NNRTI class, tenofovir or emtricitabine, and with a
viral load less than 100,000 copies per mL. Odefsey combines Gilead’s
emtricitabine and tenofovir alafenamide with rilpivirine, owned by
Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies
of Johnson & Johnson, and marketed by Janssen Cilag International NV.
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 CHMP’s recommendation will now be reviewed by the European
Commission, which has the authority to approve medicines for use in the
28 countries of the European Union.
The MAA 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 supported
by clinical studies of rilpivirine-based therapy (administered as
R+F/TDF or Eviplera®; R/F/TDF) 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, non-nucleoside reverse-transcriptase
inhibitor-based regimens, or integrase strand transfer inhibitor-based
regimens, and virologically suppressed adults with mild-to-moderate
renal impairment.
The Odefsey CHMP opinion is part of an ongoing development and
commercialization agreement between Gilead and Janssen, first
established in 2009. Under this agreement, and pending the product’s
approval, Gilead will be responsible for the manufacturing,
registration, distribution and commercialization of the product in most
countries, while Janssen will distribute it in approximately 17 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.
In the European Union, Odefsey is an investigational product and its
efficacy and safety have yet not been established.
About Gilead
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.
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 Odefsey may not be approved by the European Commission or other
regulatory authorities, and marketing approvals, if granted, may have
significant limitations on its use. As a result, Gilead may not be able
to successfully commercialize 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 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 statements.
The European SmPCs for Eviplera®, Edurant®,
Genvoya® and Viread® and are
available from the EMA website at www.ema.europa.eu.
Odefsey, Genvoya, Viread, Complera and Eviplera are registered
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.
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