BioSante to initiate two new LibiGel Phase III efficacy trials in FSD, HSDD

BioSante Pharmaceuticals, Inc.Jun 11 2012

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), announced today that the Company plans to initiate two new LibiGel Phase III efficacy trials. This decision is based on an extensive analysis of previous efficacy data, consultation with key opinion leaders (KOLs) in female sexual dysfunction, testosterone therapy and placebo effects, as well as a meeting with the U.S. Food and Drug Administration (FDA). BioSante also intends to continue the on-going LibiGel Phase III cardiovascular and breast cancer safety study as per protocol. LibiGel (testosterone gel) is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women.

The protocol for the two new efficacy trials is in development, and BioSante intends to provide additional trial design information and timing of trial initiation once finalized. BioSante also intends to apply for an FDA Special Protocol Assessment (SPA) agreement prior to initiating the efficacy trials. Currently, it is expected that the efficacy trials will include the same FDA-required efficacy endpoints as prior Phase III efficacy trials: an increase in the number of satisfying sexual events and sexual desire, and decreased distress associated with low desire.

"We continue to believe that HSDD is an important unmet medical need for women and that LibiGel can provide a meaningful treatment option," said Stephen M. Simes, BioSante's president & chief executive officer. "In addition, the ongoing LibiGel Phase III safety study, the largest testosterone trial of its kind, has accumulated over 6,500 women-years of data to support the safety of LibiGel. It is our intention to conduct the primary analysis of the safety study in the second half of 2012."

Phillip Donenberg, BioSante's senior vice president of finance and chief financial officer added, "Our cash balance of $49.5 million on March 31, 2012 puts us in a strong financial position to launch this new LibiGel strategy. We are committed to the continued development of LibiGel and to maximizing value for our stockholders."

As announced on December 14, 2011, the Company's previous LibiGel Phase III efficacy trials indicated that LibiGel increased satisfying sexual events and sexual desire and decreased distress. However, the placebo response in the two previous efficacy trials was greater than expected; therefore, LibiGel's results were not shown to be statistically different from placebo. BioSante is committed to ensuring that the design of the new Phase III efficacy trials addresses the higher than expected placebo response observed in the prior trials.