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BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced today that data from studies of the Pill-Plus “triple component” oral contraceptive were presented on March 10, 2012 by Pantarhei Bioscience at the World Congress of Gynecological Endocrinology in Florence, Italy. The title of the Pantarhei presentation was, “Clinical effects of normalizing testosterone levels during oral contraception.” The United States patents for oral use of the Pill-Plus are licensed by BioSante to Pantarhei Bioscience, a Netherlands-based pharmaceutical company, for development and marketing in the United States. BioSante retains rights to the Pill-Plus for transdermal development and marketing.
To date, six prospective, randomized controlled (placebo or active) Phase II clinical studies of the Pill-Plus have been completed in 355 subjects. In these studies, use of the Pill-Plus has been shown to increase frequency of sexual activity, arousal, responsiveness to partner, genital sensations and vaginal lubrication. In addition, improvements were seen in quality of life scores. No significant androgenic effects were noted.
“We are pleased with the results to date in the clinical work being carried out by Pantarhei Bioscience,” said Stephen M. Simes, BioSante’s president & CEO. Herjan J.T. Coelingh Bennink, Pantarhei’s president and CEO added, “With these positive clinical results in hand, Pantarhei’s current objective is to seek a development partner to move the Pill-Plus concept into Phase III clinical development.”
BioSante will receive royalty payments on sales of the Pill-Plus in the U.S., if and when introduced. If the product is sublicensed by Pantarhei to another company BioSante will receive a percentage of any and all payments received by Pantarhei for the sublicense from a third party. BioSante has retained all rights under the BioSante-licensed patents to the transdermal delivery of triple component contraceptives.
The Pill-Plus concept, also known as Androgen Restored Contraception (ARC), is to create an oral contraceptive that protects against androgen loss which occurs with current oral contraceptives, potentially causing reduced arousal, orgasms, pleasure and less frequent satisfying sexual activity in oral contraceptive users. The restoration of testosterone levels is achieved by adding the natural human adrenal steroid DHEA to current estrogen/progestogen combination oral contraceptives. DHEA restores testosterone levels by metabolic conversion to testosterone.