LINCOLNSHIRE, Ill., Jun 30, 2010 (BUSINESS WIRE) -- BioSante Pharmaceuticals, Inc. announced today positive results in a Phase II study of the Pill-Plus “triple hormone” oral contraceptive (OC). Results showed an increase in the frequency of sexual activity (p< 0.05) and reduced frequency of rejection of initiation of sexual activity by partner (p< 0.05).
The study was a Phase II double-blind randomized clinical trial in 82 women comprising a cross-over design of two treatment periods of five months each. The study compared use of an OC alone to the same OC with the addition of an oral androgen (DHEA). The study was performed by Dr. Rik van Lunsen and Dr. Ellen Laan from the Department of Sexology of the Academic Medical Center in Amsterdam, The Netherlands in close collaboration with the Professor Herjan Coelingh Bennink and Dr. Yvette Zimmerman from Pantarhei Bioscience in The Netherlands. First results were reported on May 20, 2010 at the 11th Congress of the European Society of Contraception in The Hague, The Netherlands. Additional data will be reported upon full publication of the results of the study.
Paradoxically, many women who use OCs have reduced sexual desire, arousabilty and sexual activity due to the effects of estrogen and progestogen in normal OCs. The Pill-Plus is designed to restore testosterone levels that are significantly suppressed during OC use as documented in this Phase II study. A condition known as female sexual dysfunction (FSD) in oral contraceptive users, among other potential benefits, could be improved by adding an androgen, e.g., DHEA or testosterone to the OC regimen.
“We are pleased with the results to date in the clinical work being carried-out by Pantarhei Bioscience, our Pill-Plus licensee,” said Stephen M. Simes, BioSante’s president & CEO. “We look forward to additional clinical results in the Pill-Plus’ development program in the next 12 months. These efforts by Pantarhei in women taking OCs, in addition to our Phase III LibiGel clinical program in the treatment of FSD in menopausal women, highlight BioSante as a leader in women’s sexual health in the United States.”
The Pill-Plus United States patents for oral use 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.
In addition to this completed study, Pantarhei is engaged in several other Phase II/III clinical studies of the Pill-Plus. The objectives of the other studies are many, including investigating the effect of restoration of testosterone levels by oral DHEA on the pharmacokinetics of oral contraceptives and the effects of adding DHEA to oral contraceptive treatment on sexual function and other measures including mood, muscle mass and fat and bone parameters.
About Pantarhei Bioscience B.V.
Pantarhei Bioscience B.V. is a bioscience company located in Zeist, the Netherlands. It employs twelve persons with an extensive track record in the pharmaceutical industry. Pantarhei develops in the clinic, patent protected new medical uses of existing molecules (hormones, biologicals and approved drugs) in Women’s Health and Endocrine Cancer. Pantarhei operates in a close to virtual set-up with the objective to obtain patent protection of concepts and demonstrate proof of concept in the human. For development and commercialization into the next phases, Pantarhei will generally seek partnerships with pharmaceutical companies. Additional information is available online at: www.pantarheibio.com.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante’s lead products include LibiGel(R) (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment, and Elestrin(TM) (estradiol gel) for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, which is marketed in the U.S. by Azur Pharma, BioSante’s licensee. BioSante also is developing a portfolio of cancer vaccines (GVAX), three of which have been granted orphan drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel(TM), a testosterone gel for male hypogonadism, licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is developing its calcium phosphate technology (CaP) for aesthetic medicine (BioLook(TM)), as a vaccine adjuvant, including for an H1N1 (swine flu) vaccine, and drug delivery as well as seeking opportunities for its 2A/Furin and other technologies. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
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 plans, objectives, expectations and intentions with respect to future operations and products and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or 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, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante’s licensees or sublicensees; the success of clinical testing; and BioSante’s need for and ability to obtain additional financing. 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 and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
SOURCE: BioSante Pharmaceuticals, Inc.
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