Positive data from BioSante Pharmaceuticals' LibiGel Phase III clinical development program

BioSante Pharmaceuticals, Inc.Oct 20 2009

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), today announced positive safety data in its ongoing LibiGel Phase III clinical development program. For the first time, unblinded data have been reviewed by the independent DMC of the LibiGel Cardiovascular and Breast Cancer Safety Study. Based on this review of unblinded data, the DMC unanimously recommended continuation of the study as described in the study protocol, with no modifications.

BioSante reported that the DMC reviewed all unblinded adverse events in the safety study including all “serious adverse events” and all “adverse cardiovascular and breast cancer events” in 1,055 women with 883 women-years of exposure. To date, there have been no deaths, one myocardial infarction and only three breast cancers reported. Therefore, in view of the DMC recommendation, the BioSante LibiGel Phase III development program will continue as planned. BioSante targets submission to the FDA of a new drug application (NDA) by mid-2011.

“This review of unblinded LibiGel safety data by the DMC gives us even greater comfort about the safety of LibiGel,” said Michael Snabes, M.D., BioSante’s vice president of clinical development. “We have known, based on blinded data, that the rates of cardiovascular and breast cancer events in the study are lower than expected in women at the higher end of cardiovascular risk for the intended population. This recommendation by the DMC, after their confidential review of unblinded data, to continue the study without changes, is a validation of the safety to date of LibiGel in the treatment of female sexual dysfunction (FSD) in menopausal women, our target patient population. This outcome represents a significant advance for our LibiGel clinical development program,” Dr. Snabes continued.

“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).”