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.
Conference Call and Webcast Information
A conference call and webcast will be held today at 8:30 a.m. EDT to discuss the new LibiGel Phase III efficacy trials strategy. Interested parties may join the call from within the U.S. by dialing (877) 407-8031; outside the U.S., dial +1-201-689-8031. A live audio webcast will be available at http://www.investorcalendar.com/IC/CEPage.asp?ID=168814. For those who are unable to participate in the live broadcast, a replay of the webcast will be available on BioSante’s website ( http://www.biosantepharma.com/Webcasts.php) beginning about two hours thereafter.
About LibiGelLibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD). Two Phase III efficacy trials of LibiGel have been completed and a cardiovascular (CV) events and breast cancer study that has completed enrollment of 3,656 subjects is ongoing. The two completed efficacy trials were double-blind, placebo-controlled trials that enrolled over 500 surgically menopausal women each for six-months of therapy. In the two completed Phase III efficacy trials, LibiGel performed as predicted based on previous experience with testosterone products for FSD, including an increase in satisfying sexual activity and sexual desire and a decrease in distress. However, the placebo response in the two efficacy trials was greater than expected; and therefore, LibiGel’s results were not shown to be statistically different from placebo. The completed efficacy trials were conducted according to an FDA special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after applying a once-daily pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.
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