October 26, 2005
For more about the program, healthcare professionals and people living with HIV/AIDS may obtain information by calling 1-866-889-2074, emailing TMC114-C226@i3research.com, visiting www.tibotec.com or www.clinicaltrials.gov.
"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 them with access to TMC114 as soon as possible through this program," said Paul Stoffels, M.D., Company Group Chairman of Tibotec.
The TMC114 EAP is available to HIV-1 infected adults, at least 18 years old, who have limited or no treatment options due to virological failure or intolerance to multiple ARV regimens. Patients must be three-class experienced with at least two PI-based regimens, and have a CD4 cell count of equal or less than 200 cells/mm3.
The U.S. EAP is part of a larger, international early access program being coordinated by Tibotec Pharmaceuticals Ltd. The program will be administered by clinical affairs of local operating entities within Johnson & Johnson, and will be supported by i3 Research in North America. Pending US regulatory approval, the product will be commercialized by Tibotec Therapeutics in the U.S.
The 24-week data from two controlled dose finding studies POWER 1 and POWER 2 will form the foundation of the New Drug Application for TMC114 which will be submitted to the Food and Drug Administration by early 2006. The POWER 1 data were presented at the International AIDS Society conference in Rio de Janeiro in July 2005; the POWER 2 data will be presented at the 45th Interscience Conference on Antimicrobial Agents and Chemotherapy in Washington D.C. in December 2005.