Gilead Submits New Drug Application to U.S. FDA for Once-Daily, Single-Tablet “Quad” HIV Regimen
October 27 2011 - 4:03PM
Business Wire
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that it has
submitted a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for marketing approval of the “Quad”, a
complete single-tablet regimen of elvitegravir, cobicistat,
emtricitabine and tenofovir disoproxil fumarate for the treatment
of HIV-1 infection in adults. If approved, the Quad would be the
only once-daily, single-tablet regimen containing an integrase
inhibitor.
“We continue to dedicate our HIV research and development
efforts to advancing single-tablet regimens that address important
patient needs,” said Norbert Bischofberger, PhD, Executive Vice
President, Research and Development and Chief Scientific Officer,
Gilead Sciences. “Based on data from our pivotal studies, we
believe that the Quad has the potential to be an important new
treatment option for people living with HIV, and we are pleased to
have reached this significant milestone less than six weeks after
the unblinding of the second pivotal Phase 3 study.”
The NDA is supported by 48-week data from two pivotal Phase 3
studies in which the Quad met its primary objective of
non-inferiority as compared to Atripla® (efavirenz 600
mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)
(Study 102) and to a regimen containing ritonavir-boosted
atazanavir (Study 103). Complete data from the Quad pivotal studies
will be presented at a scientific conference in 2012. The NDA is
also supported by Chemistry, Manufacturing and Controls (CMC)
information on the individual components of the Quad and the
co-formulated single-tablet regimen.
The first single-tablet regimen for HIV, Atripla, was approved
in 2006 and is marketed by Gilead and Bristol-Myers Squibb in the
United States. The company’s second single-tablet regimen,
Complera® (emtricitabine/rilpivirine/tenofovir disoproxil
fumarate), which combines Gilead’s Truvada®
(emtricitabine/tenofovir disoproxil fumarate) and Tibotec
Pharmaceuticals’ rilpivirine, was approved in the United States in
August 2011.
About the Quad
The Quad contains four Gilead compounds in a complete
once-daily, single-tablet regimen: elvitegravir, an integrase
inhibitor; cobicistat, a “boosting” agent that enables elvitegravir
once-daily dosing; and Truvada.
About Elvitegravir
Elvitegravir is an integrase inhibitor. Unlike other classes of
antiretroviral agents, integrase inhibitors interfere with HIV
replication by blocking the ability of the virus to integrate into
the genetic material of human cells. Elvitegravir was licensed by
Gilead from Japan Tobacco Inc. (JT) in March 2005. Under the terms
of Gilead’s agreement with JT, Gilead has exclusive rights to
develop and commercialize elvitegravir in all countries of the
world, excluding Japan, where JT retains rights.
About Cobicistat
Cobicistat is Gilead's proprietary potent mechanism-based
inhibitor of cytochrome P450 3A (CYP3A), an enzyme that metabolizes
drugs in the body. In addition to studying the agent as part of the
Quad, Gilead is also examining cobicistat's potential in boosting
commercially available HIV protease inhibitors, which are used in
many HIV treatment regimens.
The Quad, elvitegravir and cobicistat are investigational
products and their safety and efficacy have not yet been
established.
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 America, Europe and Asia Pacific.
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 the FDA and other regulatory agencies may
not approve the Quad, and that any marketing approval, if granted,
may have significant limitations on its use. Further, even if
approved, Gilead may not be able to successfully commercialize the
Quad and may make a strategic decision to discontinue development
of the Quad if, for example, the market for the product fails to
materialize as expected. 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, 2011, 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 Truvada
is available at www.Truvada.com
U.S. full prescribing information for Atripla
is available at www.Atripla.com.
U.S. full prescribing information for Complera
is available at www.Complera.com.
Truvada and Complera are registered trademarks
of Gilead Sciences, Inc. or its related companies.
Atripla is a registered trademark of
Bristol-Myers Squibb & Gilead Sciences, LLC.
For more information on Gilead Sciences, please
visit the company’s website at www.gilead.com or call Gilead Public
Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
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