Gilead Provides Update on Development of Fixed-Dose Regimen of Truvada® and Tibotec Pharmaceuticals’ TMC278
April 20 2010 - 8:51AM
Business Wire
Gilead Sciences, Inc. (Nasdaq:GILD) provided an update today on
the development of the fixed-dose combination of Truvada®
(emtricitabine and tenofovir disoproxil fumarate) and Tibotec
Pharmaceuticals’ investigational non-nucleoside reverse
transcriptase inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride,
25 mg). As part of its First Quarter 2010 earnings call, Johnson
& Johnson, which owns Tibotec Pharmaceuticals, announced today
that the two pivotal Phase III studies evaluating TMC278 as a
treatment for HIV in treatment-naïve patients met the primary
efficacy objective of non-inferiority as compared to efavirenz
based on the proportion of patients achieving HIV RNA levels of
less than 50 copies/mL at 48 weeks. Johnson & Johnson also
announced that full study results will be presented at a scientific
meeting later this year, and that the submission of
TMC278 for regulatory review is on track for the third quarter
of this year.
Gilead is working to identify a formulation of the fixed-dose
combination of Truvada and TMC278 that meets bioequivalence. A
bioequivalence study is required to demonstrate that a
co-formulated product results in the same levels of medication in
the blood as achieved when the individual products are dosed
simultaneously as separate pills.
In July 2009, Gilead announced that it had 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 Truvada and TMC278 for
treatment-naïve HIV-infected individuals. The companies are also
working toward an agreement to make the fixed-dose combination of
Truvada and TMC278 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 fixed-dose single-tablet combination of Truvada and TMC278
is an investigational product and the 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 Australia.
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 risks related to Gilead’s ability to identify a
formulation of the fixed-dose combination of Truvada and TMC278
that meets bioequivalence. In addition, safety and efficacy data
from additional clinical studies may not warrant further
development of this fixed-dose combination, regulatory agencies may
not approve the fixed-dose combination for the treatment of HIV,
and marketing approval, if granted, may have significant
limitations on its use. As a result, the fixed-dose combination may
never be successfully commercialized. Further, Gilead may make a
strategic decision to discontinue development of the fixed-dose
combination if, for example, we believe commercialization will be
difficult relative to other opportunities in its pipeline. 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. Gilead directs readers to its Annual
Report on Form 10-K for the year ended December 31, 2009. Gilead
claims the protection of the Safe Harbor contained in the Private
Securities Litigation Reform Act of 1995 for forward-looking
statements. All forward-looking statements are based on information
currently available to Gilead, and Gilead assumes no obligation to
update any such forward-looking statements.
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.
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