– Gilead’s Third TAF-based Filing Under
Review by EMA –
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the
company’s Marketing Authorization Application (MAA) for an
investigational, once-daily single tablet regimen that combines
emtricitabine 200 mg, tenofovir alafenamide 25 mg and rilpivirine
25 mg (R/F/TAF) has been fully validated and is now under
evaluation by the European Medicines Agency (EMA). Emtricitabine
and tenofovir alafenamide are marketed by Gilead Sciences and
rilpivirine is marketed by Janssen Sciences Ireland UC, one of the
Janssen Pharmaceutical Companies of Johnson & Johnson.
The data included in the application support the use of R/F/TAF
for the treatment of HIV-1 infection in adults and pediatric
patients 12 years and older.
“With this validation, R/F/TAF is now the third TAF-based filing
under review by the EMA as we advance a portfolio of new treatment
options that may offer high efficacy and favorable safety
profiles,” said Norbert Bischofberger, PhD, Executive Vice
President, Research and Development and Chief Scientific Officer,
Gilead Sciences. “The R/F/TAF filing also represents the next step
in our collaboration with Janssen to develop HIV treatments that
potentially meet the diverse needs of people living with HIV.”
TAF is a novel investigational nucleotide reverse transcriptase
inhibitor (NRTI) that has demonstrated high antiviral efficacy at a
dose less than one-tenth that of Gilead’s Viread® (tenofovir
disoproxil fumarate, TDF), as well as improved renal and bone
laboratory parameters as compared to TDF in clinical trials in
combination with other antiretroviral agents.
In addition to R/F/TAF, two other MAAs for TAF-based regimens
are under review by the EMA. The MAA for an investigational,
once-daily single tablet regimen containing elvitegravir 150 mg,
cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide
10 mg (E/C/F/TAF) was fully validated on December 23, 2014. The MAA
for two doses of an investigational fixed-dose combination of
emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg)
(F/TAF) was fully validated on May 28, 2015. Gilead has submitted
New Drug Applications to the U.S. Food and Drug Administration for
E/C/F/TAF, F/TAF and R/F/TAF on November 5, 2014, April 7, 2015,
and July 1, 2015, respectively.
The current MAA is supported by a bioequivalence study
demonstrating that administration of R/F/TAF results in the same
blood levels of emtricitabine and TAF as those that are achieved
with E/C/F/TAF (10 mg TAF dosage) and the same levels of
rilpivirine as a 25 mg dose of rilpivirine (Edurant®) alone. The
safety and efficacy of TAF is supported by a number of clinical
studies in a range of patients with HIV, including treatment-naïve
adults and adolescents, virologically suppressed adults who
switched regimens and adults with mild-to-moderate renal
impairment. In studies, TAF-based treatment (administered as
E/C/F/TAF) resulted in non-inferior efficacy and improved renal and
bone laboratory parameters as compared to TDF-based therapy
(administered as E/C/F/TDF or Stribild®).
The R/F/TAF filing will be reviewed by the EMA under the
centralized procedure, which, when finalized, may lead to the
granting of marketing authorization by the European Commission,
which is valid in all 28 member states of the European Union.
The R/F/TAF filing is the latest step in an expanded 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 regimen in most countries, while Janssen will distribute it in
approximately 17 markets and have co-detailing rights in several
key markets. The original agreement was established for the
development and commercialization of Eviplera®, marketed as
Complera® in the United States.
A fourth investigational TAF-based regimen containing Gilead’s
TAF, emtricitabine and cobicistat, and Janssen’s darunavir
(D/C/F/TAF) is also under development under a separate licensing
agreement. Under the agreement, Gilead is transferring to Janssen
further development of the regimen and, subject to regulatory
approval, the manufacturing, registration, distribution and
commercialization of the product worldwide.
TAF and TAF-based regimens are investigational products and have
not been determined to be safe or efficacious.
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 possibility that the EMA may not adopt a positive
opinion in its evaluation and the European Commission may not grant
marketing authorization for R/F/TAF. Further, the FDA, the European
Commission and other regulatory authorities may not approve
R/F/TAF, F/TAF, E/C/F/TAF and other TAF-based regimens in the
currently anticipated timelines or at all, and marketing approvals,
if granted, may have significant limitations on their use. As a
result, R/F/TAF, F/TAF, E/C/F/TAF and other TAF-based regimens may
never be successfully commercialized. In addition, Gilead may be
unable to file for regulatory approval for D/C/F/TAF with
regulatory authorities in the currently anticipated timelines.
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 June 30, 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 Stribild, Eviplera, and
Viread are available from the EMA website at www.ema.europa.eu.
Edurant is a registered trademark of Johnson
& Johnson, or its related companies.
Stribild, Complera, Eviplera and Viread are
registered 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20150820006134/en/
Gilead Sciences, Inc.InvestorsPatrick O’Brien, +1
650-522-1936orMedia (U.S.)Ryan McKeel, +1 650-377-3548orMedia
(EU)Kristine Kelly, +44 (0)78 1086 8956
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