Gilead Finalizes Selection of Bioequivalent Formulation for the Fixed-Dose Regimen of Truvada® & Tibotec Pharmaceuticals’ ...
April 27 2010 - 8:30AM
Business Wire
Gilead Sciences, Inc. (Nasdaq:GILD) announced today it has
obtained data supporting bioequivalence of a formulation 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). 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.
Gilead anticipates submitting a New Drug Application (NDA) to the
U.S. Food and Drug Administration (FDA) for the fixed-dose
combination following validation of the TMC278 NDA.
Johnson & Johnson, which owns Tibotec Pharmaceuticals,
announced last week that the two pivotal Phase III studies
evaluating TMC278 as a treatment for HIV in treatment-naïve
patients met the primary efficacy objective. In addition, the
company announced plans to present the data in full at an upcoming
HIV conference, and that submission of TMC278 for regulatory
review is on track for the third quarter of this year.
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 file for regulatory
approval for the fixed-dose combination in the timelines currently
anticipated. 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. In addition,
future discussions with regulatory agencies may impact the amount
of data needed and timelines for review, which may differ
materially from Gilead's current projections. Further, safety and
efficacy data from additional clinical studies may not warrant
further development of this fixed-dose combination and as a result,
the fixed-dose combination may never be successfully
commercialized. 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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