BioSante Pharmaceuticals Announces Positive Oral Contraceptive Clinical Results
BioSante Pharmaceuticals, Inc. (BPAX) announced today positive results of clinical work on its Pill-PlusTM "triple hormone" therapy oral contraceptive. The Pill-Plus adds a third hormone, an androgen, to the normal two hormone (estrogen and progestogen) oral contraceptive to prevent androgen deficiency which often leads to a decrease in sexual desire, sexual activity and mood changes. The Pill-Plus for oral use is licensed 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 a completed Phase II double-blind randomized clinical trial, the addition of an oral androgen resulted in restoration of testosterone levels to the normal and physiological range for healthy women. Paradoxically, many women who use oral contraceptives have reduced sexual desire, arousabilty and activity due to the estrogen and progestogen in normal oral contraceptives. The Pill-Plus is designed to improve the condition known as female sexual dysfunction in oral contraceptive users, among other potential benefits.
"We are pleased with the results to date in the clinical work being carried-out by Pantarhei," said Stephen M. Simes, BioSante's president & CEO. "We look forward to additional clinical results in the Pill-Plus' development program in 2009."
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 oral androgen on the pharmacokinetics of oral contraceptives and the effects of adding an androgen to oral contraceptive treatment on sexual function and other measures.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism. BioSante's lead products include LibiGel® (transdermal testosterone gel) in Phase III clinical development by BioSante under a U.S. Food and Drug Administration (FDA) SPA (Special Protocol Assessment) for the treatment of female sexual dysfunction (FSD), and ElestrinTM (estradiol gel) developed through FDA approval by BioSante, indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, currently marketed in the U.S. Also in development are Bio-T-GelTM, a testosterone gel for male hypogonadism, and an oral contraceptive in Phase II/III clinical development using BioSante patented technology. The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion and for oral contraceptives approximately $3 billion. The company also is developing its calcium phosphate technology (CaP) for novel vaccines, drug delivery and aesthetic medicine (BioLookTM). Additional information is available online at: www.biosantepharma.com.
About Pantarhei Bioscience B.V.
Pantarhei Bioscience B.V. is a bioscience company located in Zeist, the Netherlands. It employs nine 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) for gender related diseases. 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
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The statements regarding BioSante contained in this news release that are not historical in nature, particularly those that utilize terminology such as "will," "potential", "could," "can,""intends," "continue,""plans," "expects" or comparable terminology, are forward-looking statements. Forward-looking statements are based on current expectations and assumptions, and entail various risks and uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements. Important factors known to BioSante that could cause actual results to differ materially from those expressed in such forward-looking statements include market conditions applicable to strategic alternatives, the availability of strategic alternatives to BioSante, timely and successful implementation by BioSante of one or more strategic alternatives, whether such strategic alternatives will result in increasing stockholder value, BioSante's eventual need for additional financing to implement its current business plan, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance, the success of clinical testing, and other factors identified and discussed from time to time in BioSante's filings with the Securities and Exchange Commission, including those factors discussed in BioSante's most recent annual report on Form 10-K and subsequent quarterly report on Form 10-Q, which discussions also are incorporated herein by reference. All forward-looking statements 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.