The cardiovascular safety and breast cancer data indicate that LibiGel, to date, has been shown to be safe, said Stephen M. Simes, BioSante ™s president and CEO. A DMC can recommend continuing, changing or stopping a study and their main responsibility is to ensure that subjects recruited to the study are not exposed to unnecessary safety risks. Therefore, the DMC ™s recommendation to continue the LibiGel safety study unchanged is the best possible outcome of the DMC ™s unblinded review of all adverse events. This is very good news for BioSante and for women since LibiGel remains the only pharmaceutical product in the U.S. in active development for the treatment of hypoactive sexual desire disorder (HSDD) in surgically menopausal women. We continue to believe that LibiGel can be the first product approved by the FDA for this common and unmet medical need, also referred to as female sexual dysfunction (FSD).

SOURCE BioSante Pharmaceuticals, Inc.