September 25, 2006
Yardley, PA -- 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 www.clinicaltrials.gov. Health care professionals and people living with HIV/AIDS in the U.S. may obtain information by calling 1-866-889-2074 or emailing TMC125EAP@i3research.com.
"We know that many people living with HIV/AIDS have limited treatment options because of the increasingly significant issue of viral resistance, and we are working to provide eligible individuals with access to TMC125 as soon as possible through this program," said Roger Pomerantz, M.D., president of Tibotec Research and Development. Currently, over 15 U.S. sites have initiated the expanded access program and are listed on 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 three 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.
About Tibotec Pharmaceuticals Ltd.
Tibotec Pharmaceuticals Ltd., based in Cork, Ireland, is a pharmaceutical research and development company. The company's main research and development facilities are in Mechelen, Belgium, with offices in Yardley, PA. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.
Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., headquartered in Bridgewater, NJ, is dedicated to delivering innovative virology therapeutics that help health care professionals address serious unmet needs in people living with HIV.
Tibotec, a division of Janssen-Cilag, will bring innovative products for HIV/AIDS to patients in Europe, the Middle East and Africa. This new division was created within the Janssen-Cilag companies in October 2005 to focus on patients' and health care providers' specific needs in this disease domain. The company will also commercialize medicine against other viral diseases in the future.