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 lower than anticipated event rate of approximately 0.53 percent. In the same population of subjects, there have been 19 breast cancers reported, a rate of approximately 0.33 percent, which is in line with the ages of the subjects enrolled in the study.
Furthermore, study participants have been enrolled in this study for an average of more than 19 months. Over 2,500 participants have been enrolled for over a year and over 830 subjects have been involved for more than two.
Stephen M. Simes, CEO of Biosante from the press release:
BioSante's LibiGel Phase III safety study continues. We plan to meet with the FDA to determine the best path forward for the program, and will make a decision as to the conduct of the LibiGel safety study during the second quarter of this year. We have instituted appropriate cost savings in order to minimize the continuing cost of the safety study. Although LibiGel did not meet the co-primary or secondary endpoints in two Phase III efficacy studies, BioSante continues to investigate alternative strategies to utilize the continuing LibiGel cardiovascular event and breast cancer safety study.
Michael C. Snabes, M.D., Ph.D., and Sr. VP of Medical Affairs at BioSante from the same press release:
The DMC once again has recommended that the safety study continue as per the FDA-agreed protocol, without modification, as there were no general or specific safety issues based on their unblinded review of adverse events. We are pleased with the low number of CV events to date and we believe it is consistent with the safety of testosterone in this population.
None of the above necessarily means that LibiGel will see the fluorescent lights of a pharmacy ceiling, for any indication, anytime soon, but it shows that the company has no reason or desire to give up on the venture altogether. Meanwhile, word on Bio-T-Gel can be handed down by the FDA at any time now.
Shares of BioSante are up by more than 8% at the moment on above average volume.