BioSante: LibiGel Lives On, FDA Word On Bio-T-Gel May Come At Any Time
By Kinetic Investments:
By Bert Wilkison
BioSante Pharmaceuticals, Inc. (BPAX) describes itself as a specialty pharmaceutical company focused on developing products for female sexual health and oncology. Its lead product candidate, Bio-T-Gel, a testosterone gel for male hypogonadism, is licensed to Teva Pharmaceutical (TEVA) and, somewhat befittingly, has PDUFA date scheduled for Valentine's Day (02/14/12).
The company made headlines again when it released news this morning that the independent Data Monitoring Committee [DMC] has completed another unblinded review of the LibiGel Phase III cardiovascular and breast cancer safety study. The DMC recommended that the LibiGel safety study should continue, and perhaps just as important, without modifications. LibiGel is often referred to as Viagra for women. The company disclosed that, with 3,656 women enrolled and over 5,800 women-years of exposure in its LibiGel Phase III cardiovascular and breast cancer safety study, there have been 31 adjudicated cardiovascular [CV] events, with a lowerComplete Story »