BIOSANTE COMPLETES ENROLLMENT IN PIVOTAL PHASE III CLINICAL TRIAL FOR ESTROGEN GEL

BioSante Pharmaceuticals has reached its enrollment target of more than 450 women in the company's pivotal, Phase III clinical trial to evaluate the safety and efficacy of Bio-E-Gel for the treatment of moderate-to-severe hot flashes in menopausal women.

Hot flashes occur in up to 85 percent of menopausal women. BioSante's randomized, 12-week, double-blind, placebo-controlled Phase III trial of Bio-E-Gel (bioidentical estradiol transdermal gel) is being conducted in the U.S. and Canada.

Current FDA requirements for approval of new estradiol products include one 12-week Phase III clinical trial. The study is evaluating three doses of Bio-E-Gel to maximize the safety profile by identifying the lowest effective dose. The company expects to complete the trial by the end of the first quarter. Moreover, BioSante plans to file a new drug application with the FDA in mid-2005.