– Gilead’s Third TAF-based Filing, Submitted
with Priority Review Voucher –
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that it has
submitted a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for an investigational, once-daily single
tablet regimen that combines Gilead’s emtricitabine 200 mg and
tenofovir alafenamide (TAF) 25 mg with rilpivirine 25 mg (R/F/TAF)
from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical
Companies of Johnson & Johnson, for the treatment of HIV-1
infection in adult and pediatric patients 12 years of age and
older. The data submitted in the NDA support the use of R/F/TAF
among patients who are HIV treatment-naïve or who are virologically
suppressed and want to replace their current antiretroviral
treatment regimen.
A Priority Review voucher acquired from Knight Therapeutics in
November 2014 was submitted to the FDA along with the R/F/TAF NDA.
Under the Prescription Drug User Fee Act (PDUFA), the anticipated
target action date for the R/F/TAF NDA is six months after the
FDA’s acceptance of the filing.
“R/F/TAF is Gilead’s third TAF-based filing in less than a year,
and we are looking forward to the potential to offer people living
with HIV another effective treatment option with a favorable safety
profile,” said Norbert Bischofberger, PhD, Executive Vice
President, Research and Development and Chief Scientific Officer,
Gilead Sciences. “The R/F/TAF filing also represents Gilead’s next
collaboration with Janssen in our combined efforts to increase and
potentially improve HIV treatments for a range of patients.”
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 TAF-based HIV treatments are
also under FDA review. In November 2014, Gilead filed an NDA for an
investigational, once-daily single tablet regimen containing
elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and
TAF 10 mg (E/C/F/TAF). Gilead filed another NDA in April 2015 for
two doses of an investigational, fixed-dose combination of
emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg)
(F/TAF) for use in combination with other HIV antiretroviral
agents. Under the PDUFA, the FDA has set a target action date of
November 5, 2015, for E/C/F/TAF and April 7, 2016, for F/TAF.
Marketing Authorization Applications in the European Union were
fully validated on December 23, 2014, and May 28, 2015, for
E/C/F/TAF and F/TAF respectively. Gilead plans to submit a
regulatory application for R/F/TAF in the European Union in the
third quarter of 2015.
The current NDA is supported by a bioequivalence study
demonstrating that R/F/TAF achieved the same drug levels of
emtricitabine and TAF in the blood as E/C/F/TAF (10 mg TAF dosage)
and the same drug 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 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, including the United States. The original agreement
was established for the development and commercialization of
Complera®, marketed as Eviplera® in the European Union.
A fourth investigational TAF-based regimen containing Gilead’s
TAF, emtricitabine and cobicistat, and Janssen’s darunavir
(D/C/F/TAF) also is under development under another 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-based regimens are investigational products and have not
been determined to be safe or efficacious.
About Gilead Sciences
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 we may not file a marketing authorization
for R/F/TAF in the European Union in the currently anticipated
timelines. In addition, there is the possibility that the FDA and
other regulatory authorities may not approve F/TAF, E/C/F/TAF,
R/F/TAF, D/C/F/TAF or other F/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, F/TAF, E/C/F/TAF, R/F/TAF, D/C/F/TAF and other F/TAF-based
regimens may never be successfully commercialized. 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-Q for the quarter ended
March 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.
U.S. full prescribing information for Viread,
Complera and Stribild, including BOXED WARNING, is available
at www.gilead.com.
Edurant is a registered trademark of Johnson
& Johnson, or its related companies.
Viread, Complera, Stribild and Eviplera 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/20150701006447/en/
Gilead Sciences, Inc.Patrick O’Brien, 650-522-1936
(Investors)Ryan McKeel, 650-377-3548 (Media)
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