May 23, 2012
Gilead Files European Marketing Application for Boosting Agent Cobicistat
FOSTER CITY, Calif.--(BUSINESS WIRE)--May. 23, 2012--
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the Marketing
Authorisation Application (MAA) for cobicistat, submitted on April 26,
2012, has been validated by the European Medicines Agency (EMA).
Cobicistat is Gilead’s pharmacoenhancing or “boosting” agent that
increases blood levels of certain commercially available protease
inhibitors, including atazanavir and darunavir, in order to enable
once-daily dosing. Currently, ritonavir is the only agent used to boost
HIV therapy. Review of the MAA for cobicistat will be conducted under
the centralized licensing procedure, which, when finalized, provides one
marketing authorization in all 27 member states of the European Union
“With today’s EMA validation, we’re hopeful that we may soon be able to
offer an important new boosting option for patients who rely on protease
inhibitors as part of their HIV therapy,” said Norbert Bischofberger,
PhD, Executive Vice President, Research and Development and Chief
Scientific Officer, Gilead Sciences.
The MAA for cobicistat is supported by pharmacokinetic data
demonstrating that cobicistat boosts atazanavir and darunavir exposure
similar to ritonavir, and by 48-week data from a pivotal Phase 3 study
(Study 114) in which cobicistat met its primary objective of
non-inferiority to ritonavir, when both agents were administered with a
background regimen of atazanavir plus Truvada® (emtricitabine
and tenofovir disoproxil fumarate). Topline results from the study were
announced in December 2011, and complete data will be presented at an
upcoming medical meeting.
Gilead plans to submit an application for marketing approval of
cobicistat to the U.S. Food and Drug Administration (FDA) in the third
quarter of 2012. Cobicistat is a component of Gilead’s investigational
Quad single tablet regimen, which also contains elvitegravir,
emtricitabine and tenofovir disoproxil fumarate. Cobicistat enables
once-daily dosing of elvitegravir within the Quad.
In June 2011, Gilead announced an agreement with Janssen R&D Ireland for
the development of a fixed-dose combination of cobicistat and darunavir.
Subject to regulatory approval, Janssen will be responsible for the
formulation, manufacturing, registration, distribution and
commercialization of the cobicistat and darunavir fixed-dose combination
worldwide. Additionally, in October 2011, Gilead announced an agreement
with Bristol-Myers Squibb to develop a fixed-dose combination of
cobicistat and atazanavir. Bristol-Myers Squibb will be responsible for
the formulation, manufacturing, development, registration, distribution
and commercialization of the atazanavir and cobicistat fixed-dose
Cobicistat is Gilead’s proprietary mechanism-based inhibitor of
cytochrome P450 3A (CYP3A), an enzyme that metabolizes drugs in the
body. Unlike ritonavir, cobicistat acts only as a pharmacoenhancer and
has no antiviral activity.
Cobicistat, elvitegravir and the Quad 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
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 EMA and other regulatory agencies may not approve cobicistat,
any combination products containing cobicistat, elvitegravir or the
Quad, and that any marketing approvals, if granted, may have significant
limitations on their use. In addition, even if approved, Gilead may not
be able to successfully commercialize these products, and may make a
strategic decision to discontinue their development if, for example, the
market for the products fails to materialize as expected. Further,
Gilead may be unable to submit its New Drug Application for cobicistat
to FDA 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 March 31, 2012, 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
Truvada is a registered trademark of Gilead Sciences, Inc.
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.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Susan Hubbard, 650-522-5715 (Investors)
Rau, 650-522-5635 (Media)
Stephen Head, +44 (208) 587-2359 (Media -