BioSante Pharmaceuticals Comments On Boehringer Ingelheim Clinical Test Results In Treatment Of Female Sexual Dysfunction

Main Category: Sexual Health / STDs
Also Included In: Women's Health / Gynecology
Article Date: 18 Nov 2009 - 0:00 PST

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BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), a specialty pharmaceutical company developing products for female sexual health, including LibiGel® for the treatment of hypoactive sexual desire disorder (HSDD), applauds the efforts of Boehringer Ingelheim to develop a therapy to treat this unmet medical need. Boehringer today, at the European Society for Sexual Medicine annual meeting in Lyon, France, reported clinical test results of flibanserin, a drug candidate which treats HSDD by blocking the brain's release of serotonin, a chemical that regulates mood, appetite, sleep and memory and, in time, triggers the production of dopamine, a chemical associated with the stimulation of desire.

BioSante's product for this market is LibiGel, a transdermal testosterone gel targeting menopausal women. LibiGel currently is in late-stage Phase III clinical studies for the treatment of HSDD. BioSante President and CEO Stephen M. Simes, said, "The fact that one of the largest pharmaceutical companies in the world is targeting this condition is important and exciting medical news. For ten years, men have enjoyed the option of using drugs to treat erectile dysfunction but there is no pharmaceutical product approved by the FDA for the treatment of HSDD. BioSante is committed to bringing women an option in their decision-making about their own sexuality."

Boehringer has been studying flibanserin in pre-menopausal women. Data, pooled from three Phase III studies, presented today from trials in Europe and the U.S., show a statistically significant improvement in satisfying sexual events (SSEs) compared to placebo, with an average difference of 0.70 SSEs per four week period. The results reported by Boehringer for flibanserin are similar to data reported by Proctor & Gamble for their Intrinsa testosterone patch (now owned by Warner Chilcott).

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."

Source
BioSante Pharmaceuticals, Inc.