-- Product Would Represent Second Truvada-Based Complete Fixed-Dose Regimen --FOSTER CITY, Calif.--(BUSINESS WIRE)--Jul. 16, 2009--
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it has entered
into a license and collaboration agreement with Tibotec Pharmaceuticals
for the development and commercialization of a new once-daily fixed-dose
antiretroviral regimen containing Gilead’s Truvada®
(emtricitabine and tenofovir disoproxil fumarate) and Tibotec’s
investigational non-nucleoside reverse transcriptase inhibitor (NNRTI)
TMC278 (rilpivirine hydrochloride, 25 mg) for treatment-naïve
HIV-infected individuals. Fixed-dose combinations contain multiple
medicines formulated into one tablet and help to simplify HIV therapy.
“Gilead and Tibotec share a strong focus on bringing safe and effective
treatment options to people living with HIV/AIDS,” said John C. Martin,
PhD, Chairman and Chief Executive Officer, Gilead Sciences. “Fixed-dose
regimens have become the standard of care as HIV treatment has evolved
toward more simplified regimens for patients. We are very pleased to
collaborate with Tibotec and look forward to advancing this new
fixed-dose product.”
Subject to regulatory approval, Gilead will assume the lead role in the
manufacturing, registration, distribution and commercialization of the
fixed-dose combination of Truvada and rilpivirine worldwide, excluding
the developing world and Japan. Tibotec will be responsible for the
commercialization of rilpivirine as a stand-alone product and will hold
rights to co-promote the fixed-dose combination in these territories.
The companies will also work towards an agreement to make the fixed-dose
combination of Truvada and rilpivirine available in the developing world.
If approved, the new product would become the second complete
antiretroviral treatment regimen for HIV available in a single tablet
taken once daily. The first and only such therapy available today,
Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir
disoproxil fumarate 300 mg), was approved by the U.S. Food and Drug
Administration (FDA) in 2006. Both Atripla and the new fixed-dose
combination contain a nucleoside reverse transcriptase inhibitor (NRTI)
backbone of Truvada.
Current HIV treatment guidelines issued by the U.S. Department of Health
and Human Services list emtricitabine and tenofovir (the components of
Truvada) in combination with an NNRTI or a protease inhibitor as a
preferred regimen for patients initiating therapy. Tibotec is currently
studying the combination of Truvada and rilpivirine in Phase III
clinical trials.
About Rilpivirine
Rilpivirine is an investigational non-nucleoside reverse transcriptase
inhibitor being developed by Tibotec Pharmaceuticals. Two Phase III
trials for rilpivirine are currently being conducted in the United
States, Canada, Africa, Asia, Europe and South America. As an
investigational agent, the safety and efficacy of rilpivirine, in
combination with other antiretroviral agents, has not yet been
established 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 Australia.
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 rilpivirine will be
successful and whether rilpivirine will receive regulatory approval, our
ability to formulate the combination product or to perform clinical
trials and our ability to obtain FDA and other regulatory approvals. As
a result, the combination product may never be successfully
commercialized. Further, the parties may make a strategic decision to
discontinue development of the combination product if, for example, we
are unable to successfully formulate the fixed-dose combination or 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 March 31, 2009, 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.
Truvada is a registered trademark of Gilead Sciences, Inc.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.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.Susan Hubbard, 650-522-5715 (Investors)Erin
Rau, 650-522-5635 (Media)
