FDA approves BioSante Pharmaceuticals testosterone gel

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced that the U.S. Food and Drug Administration (FDA) has approved Bio-T-Gel, which is licensed by BioSante to Teva Pharmaceuticals USA, Inc. Bio-T-Gel is a testosterone gel for the treatment of male hypogonadism or low testosterone levels. Male hypogonadism is generally characterized by impotence, a lack of sex drive, muscle weakness and osteoporosis.

Bio-T-Gel was initially developed by BioSante, and then it was licensed to Teva for late stage clinical development. Teva is responsible for all Bio-T-Gel regulatory and marketing activities. BioSante will receive royalties and may receive certain milestone payments upon commercialization of Bio-T-Gel. The current U.S. market for male testosterone products is estimated at over $1.6 billion.

“We are pleased that Bio-T-Gel will provide another treatment option to men suffering from low testosterone levels,” said Stephen M. Simes, BioSante’s president & CEO. “We are confident that Teva has the commercialization and marketing expertise to implement a successful launch, and we look forward to Bio-T-Gel reaching the market.”