European CHMP Adopts Positive Opinion for Gilead’s TAF-Based Single Tablet Regimen Odefsey® (Emtricitabine, Rilpivirine, T...
April 29 2016 - 8:21AM
Business Wire
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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version on businesswire.com: http://www.businesswire.com/news/home/20160429005537/en/
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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