Gilead Sciences Announces Agreement With Tibotec Pharmaceuticals to Develop & Commercialize a New Fixed-Dose Combination of C...
June 28 2011 - 8:30AM
Business Wire
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it has
entered into a license agreement with Tibotec Pharmaceuticals for
the development and commercialization of a new fixed-dose
antiretroviral combination product containing Gilead’s cobicistat
and Tibotec’s protease inhibitor Prezista® (darunavir). Cobicistat
is an investigational pharmacoenhancing or "boosting" agent that
increases blood levels of certain HIV medicines to allow for
once-daily dosing. Prezista is indicated in the United States for
the treatment of HIV-infected individuals and is co-administered
with ritonavir in combination with other antiretroviral agents.
“Cobicistat’s formulation and clinical profile provides us with
the flexibility to co-formulate and develop new combination
products, including the potential to co-formulate with protease
inhibitors such as Prezista,” said Norbert W. Bischofberger, PhD,
Gilead’s Executive Vice President, Research and Development and
Chief Scientific Officer. “This agreement represents another
important step forward in our commitment to developing simplified
treatment regimens that can help address the individual needs of
people living with HIV.”
Subject to regulatory approval, Tibotec will be responsible for
the formulation, manufacturing, registration, distribution
and commercialization of the cobicistat and Prezista
fixed-dose combination worldwide. Gilead retains sole rights for
the manufacture, development and commercialization of cobicistat as
a stand-alone product and for use in combination with other
agents.
In connection with this agreement, the companies are also
negotiating terms for the development and commercialization of a
future single-tablet regimen (STR) combining Prezista with Gilead’s
Emtriva® (emtricitabine), which is approved for the treatment of
HIV infection on a worldwide basis, and its investigational agents
GS 7340 and cobicistat. Gilead would be responsible for the
development and commercialization of the new STR on a worldwide
basis. The agreement to develop the fixed-dose combination of
cobicistat and Prezista is contingent upon the signing of the
agreement to develop the Emtriva, GS 7340, cobicistat and Prezista
STR.
About Cobicistat
Gilead is evaluating cobicistat in a pivotal Phase III program,
both as a stand-alone boosting agent for protease inhibitors, in
this case with once-daily atazanavir, as well as part of the all
Gilead investigational fixed-dose single-tablet "Quad" regimen of
elvitegravir, cobicistat and Truvada® (emtricitabine/tenofovir
disoproxil fumarate) for the treatment of HIV infection.
Cobicistat is Gilead's proprietary potent mechanism-based
inhibitor of cytochrome P450 3A (CYP3A), an enzyme that metabolizes
drugs in the body.
About GS 7340
GS 7340, Gilead's investigational anti-HIV agent in Phase Ib
studies, is a prodrug of tenofovir, the active agent in the
company's HIV drug Viread® (tenofovir disoproxil fumarate). A GS
7340/Emtriva tablet has been developed and entered a human
bioavailability study earlier this year.
Cobicistat and GS 7340 are investigational products and have not
yet been determined safe or efficacious in humans.
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.
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 risks related to whether ongoing clinical trials for
cobicistat will be successful and the ability to formulate
cobicistat with other agents, including darunavir. In addition,
safety and efficacy data from additional clinical trials may not
warrant further development of cobicistat or the combination
product, the FDA and other regulatory approvals may not approve
cobicistat as a stand-alone product or in any combination product,
and marketing approval, if granted, may have significant
limitations on its use. As a result, the combination product may
never be successfully commercialized. The parties may make a
strategic decision to discontinue development of the combination
product if, for example, Tibotec is unable to successfully
formulate the combination product or the market for the product
fails to materialize as expected. Further, Gilead and Tibotec may
never reach agreement on the terms for the development of a STR of
darunavir, Emtriva, GS 7340 and cobicistat, and the clinical trials
of GS 7340 may not be successful. As a result, the agreement to
develop the fixed-dose combination of cobicistat and darunavir may
terminate. These risks, uncertainties and other factors could cause
actual results to differ materially from those referred to in the
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, 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.
Emtriva, Truvada and Viread are registered
trademarks of Gilead Sciences, Inc.
Prezista is a registered trademark of Tibotec,
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.
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