November 06, 2014
Gilead Submits New Drug Application to U.S. Food and Drug Administration for Tenofovir Alafenamide (TAF)-Based Single Tablet Regimen for HIV
– High Rates of Viral Suppression and Improved Renal and Bone
Safety Demonstrated in Phase 3 Studies –
– First of Several TAF-Based Single Tablet Regimens Being
Evaluated by Gilead –
FOSTER CITY, Calif.--(BUSINESS WIRE)--Nov. 6, 2014--
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 containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine
200 mg and tenofovir alafenamide (TAF) 10 mg (E/C/F/TAF) for the
treatment of HIV-1 infection in adults. The data submitted in the NDA
support the use of the regimen among adult and adolescent
treatment-naïve HIV individuals, virologically suppressed patients who
switch regimens and those with renal impairment. If approved, E/C/F/TAF
would be Gilead’s first single tablet regimen to contain TAF.
TAF is an investigational, novel prodrug of tenofovir, the active agent
in Gilead’s Viread® (tenofovir disoproxil fumarate). TAF is a
more targeted form of tenofovir than Viread that has demonstrated high
antiviral efficacy at a dose that is 10 times lower, as well as an
improved renal and bone safety profile.
“This TAF-based regimen has the potential to provide a range of HIV
patients with a highly effective and well-tolerated new treatment option
with a favorable safety profile,” said Norbert Bischofberger, PhD,
Executive Vice President, Research and Development and Chief Scientific
Officer, Gilead Sciences. “Gilead remains focused on advancing
next-generation therapies that have the potential to improve HIV
treatment over the long-term and TAF will be the cornerstone of future
Gilead single tablet regimens.”
The NDA for E/C/F/TAF is supported by 48-week data from two pivotal
Phase 3 studies (Studies 104 and 111) in which the regimen met its
primary objective of non-inferiority compared to Gilead’s Stribild®
(elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir
disoproxil fumarate 300 mg) among treatment-naïve patients. In the
studies, E/C/F/TAF demonstrated improved renal and bone safety compared
to Stribild. The NDA is also supported by data from additional Phase 3
studies evaluating the TAF-based regimen among virologically suppressed
patients who switched to E/C/F/TAF and among patients with renal
impairment. In addition, the filing is supported by Chemistry,
Manufacturing and Controls (CMC) information on the individual
components and the co-formulated single tablet regimen.
Gilead plans to submit a regulatory application for E/C/F/TAF in the
European Union by the end of 2014.
TAF and TAF-based regimens are investigational products and have not
been determined 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 worldwide. Headquartered in Foster City,
California, Gilead has operations in North and South America, Europe and
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 the FDA and other regulatory agencies may not approve E/C/F/TAF,
and that any marketing approvals, if granted, may have significant
limitations on its use. Further, even if approved, Gilead may not be
able to successfully commercialize E/C/F/TAF and may make a strategic
decision to discontinue its development if, for example, the market for
the product fails to materialize as expected. In addition, Gilead may be
unable to file for regulatory approval for E/C/F/TAF 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 September 30, 2014, 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 Stribild and Viread, including BOXED
WARNING for both products, is available at www.gilead.com.
Stribild and Viread are registered trademarks of Gilead Sciences, Inc.
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.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Patrick O’Brien, Investors, 650-522-1936
McKeel, Media, 650-377-3548