As previously announced by BioSante, treatment with LibiGel in a Phase II double-blind, placebo-controlled, clinical trial, conducted in the U.S., in surgically menopausal women distressed by their low sexual desire and activity, significantly increased satisfying sexual events in surgically menopausal women suffering from FSD. The Phase II trial results showed LibiGel significantly increased the number of satisfying sexual events by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05), an average difference of 3.4 SSEs per four week period. In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel.

Mr. Simes said Boehringer Ingelheim ™s commitment to HSDD validates the potential size of the market which could exceed $2 billion a year in U.S. sales. BioSante intends to submit a new drug application for LibiGel to the FDA in the first half of 2011 for potential approval by the end of that year. In addition, Phase II studies in pre-menopausal women are ongoing for a potential future indication.

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