News Release   
 
Tibotec Announces Expanded Access Program for
TMC125



 


YARDLEY, Pennsylvania, September 25 - Tibotec Pharmaceuticals Ltd. announced 
today that the expanded access program (EAP) for TMC125, its investigational 
non-nucleoside reverse transcriptase (NNRTI), has opened in the U.S. and will open 
shortly in Canada and Europe, subject to the necessary approvals. The program will 
provide access for HIV-1 infected patients who need the compound to construct a 
viable treatment regimen. TMC125 is a next-generation NNRTI active against NNRTI-
resistant strains of HIV. The phase 3 clinical trials (DUET 1 and 2) in treatment-
experienced HIV-1 infected patients are ongoing and have recently completed 
enrollment. The safety and efficacy of TMC125 in combination with other antiretroviral 
agents have not been established.

For more about the program, visit http://www.clinicaltrials.gov. Healthcare
professionals and people living with HIV/AIDS in the US may obtain
information by calling 1-866-889-2074 or emailing TMC125EAP@i3research.com.
Currently, over 15 US siteshave initiated the expanded access program and are 
listed on http://www.clinicaltrials.gov.

The TMC125 EAP is available to HIV-1 infected adults, at least 18 years
old, who have limited treatment options either due to virological failure
or intolerance to multiple ARV regimens. Patients must be three-class
experienced, having received licensed treatment from each of the 3 major
oral classes of anti-HIV drugs (NRTIs, NNRTIs, and PIs), and must have
received at least two PI-based regimens.
The EAP is a large, international early access program being
coordinated by Tibotec Pharmaceuticals Ltd. The program will be
administered by clinical affairs of local operating entities, and in the
U.S.A. it will be supported by i3 Research. Pending regulatory approval,
the product will be commercialized by Tibotec Therapeutics in the U.S. and
Tibotec, a division of Janssen-Cilag, in Europe.

Tibotec presented 48-week findings on TMC125 at the 16th International
AIDS conference (IAC), in August 2006 in Toronto, Canada. The presented
data were the final analysis of study TMC125-C223, a phase 2b dose-finding,
randomized, partially-blinded study in HIV-1 infected adult patients
(n=199) with substantial treatment experience, documented evidence of NNRTI
resistance and 3 or more primary PI mutations.
Tibotec has received fast track designation for TMC125 from the United
States Food and Drug Administration. Under fast track designation in the
FDA Modernization Act of 1997, FDA may expedite the review of a drug if it
is intended for the treatment of a serious or life-threatening condition,
and demonstrates the potential to address an unmet medical need for such a
condition. Support of this fast track designation was based on findings
from Phase 2 data from clinical studies of TMC125 in treatment-experienced
HIV-1 infected patients as well as results from in vitro studies indicating
TMC125's antiviral activity against HIV-1 strains resistant to currently
marketed NNRTIs

 

 


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