BioSante's Menopause Treatment Fails to Meet Primary Objectives

Shares of biotech firm BioSante Pharmaceuticals

are expected to open lower when they resume trading in the after-hours session on news the company's Phase III LibiGel menopause treatment did not meet the co-primary or secondary endpoints. LibiGel is in development for the treatment of female sexual dysfunction (

), specifically, hypoactive sexual desire disorder (HSDD) in postmenopausal women, for which there is no FDA-approved product, the company said in a release. The LibiGel Phase III cardiovascular and breast cancer safety studies are continuing as planned. ““We obviously are very disappointed by the Phase III LibiGel efficacy trial results. We have been committed to LibiGel for many years and we are committed to determining the future of LibiGel,” stated Stephen M. Simes, BioSante's president & CEO, in the release. “We will continue to analyze the efficacy trial data fully and determine plans for our next steps in the LibiGel development plan, and provide an update at a later time.” The stock plunged almost 16% today on volume that was more than triple the daily average, but the shares were up 52% year-to-date in anticipation of positive results for LibiGel.