– Gilead’s Third TAF-based Filing, Submitted with Priority Review
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jul. 1, 2015--
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
“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
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.
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
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
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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Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
McKeel, 650-377-3548 (Media)