BioSante (BPAX) to Start Two New LibiGel Phase IIIs for Efficacy Evaluation

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BioSante Pharmaceuticals, Inc. (Nasdaq: BPAX), 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.

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