BioSante Pharmaceuticals Announces Positive Pill-Plus™ Data Presentation
Improvements reported in sexual desire, arousal, responsiveness and activity
LINCOLNSHIRE, Illinois (March 20, 2012) – 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.
About Pantarhei Bioscience B.V.
Pantarhei Bioscience B.V. is a bioscience company located in Zeist, the Netherlands. Its management has an extensive track record in the pharmaceutical industry. Pantarhei develops patent protected new medical uses of existing compounds (hormones, biologicals and approved drugs) in Women´s Health and Endocrine Cancer. Pantarhei operates by outsourcing all activities with the objective to obtain patent protection of concepts and demonstrate proof of concept (phase II) in the human. For development and commercialization into the final phase III, Pantarhei will generally seek partnerships with pharmaceutical companies.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante´s products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development. BioSante also is developing a portfolio of cancer vaccines, with 17 Phase I and Phase II clinical trials currently on-going. Four of these vaccines have been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA).
BioSante´s other products include a testosterone gel for male hypogonadism, for which a New Drug Application (NDA) was approved by the FDA on February 14, 2012, which is licensed to Teva Pharmaceuticals USA, Inc., and the Pill-Plus™, an oral contraceptive in Phase II clinical development by Pantarhei Bioscience B.V. BioSante´s first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Jazz Pharmaceuticals, BioSante´s licensee. Additional information is available online at: biosantepharma.cdmail.biz.
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante´s and Pantarhei´s plans, objectives, expectations and intentions with respect to its products and other statements identified by words such as “anticipates,” “will,” “continue,” “could,” “believe,” “intends,” “expects,” “plans,” “hopes,” “may,” “potential,” other words of similar meaning, derivations of such words and the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain.
Uncertainties and risks may cause BioSante´s actual results to be materially different than those expressed in or implied by BioSante´s forward-looking statements. For BioSante, particular uncertainties and risks include, among others, uncertainties regarding clinical testing, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing and other success of BioSante´s licensees or sublicensees and BioSante´s future revenues, if any, from its licensees and sublicensees; uncertainties relating to the future and costs of BioSante´s product development programs and BioSante´s need for and ability to obtain additional financing if needed.
More detailed information on these and additional factors that could affect BioSante´s actual results are described in BioSante´s filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K. All forward-looking statements in this news release speak only as of the date of this news release and are based on BioSante´s current beliefs and expectations. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
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