TIBOTEC'S HIV DRUG GRANTED PRIORITY REVIEW

The FDA has granted a priority review to Tibotec Pharmaceuticals' new drug application (NDA) for its investigational HIV protease inhibitor, the company announced.

The firm's NDA is based on the efficacy and safety results from a 24-week analysis of two randomized, controlled studies and the supportive open-label safety data of a third study. Phase III trials of TMC114 boosted with low-dose ritonavir are ongoing in both treatment-experienced and treatment-naive HIV-1 infected patients.

TMC114 also is available through an expanded access program in the U.S. for people living with HIV who need the compound to construct a viable treatment regimen, and who are not eligible for other Tibotec clinical trials.

Pending FDA approval, Tibotec Therapeutics -- a division of Ortho Biotech Products -- will commercialize the product in the U.S. The trade name for the marketed product has not yet been determined.