BioSante Pharmaceuticals Licenses Contraceptive Technology From Wake Forest University
Triple Hormone Technology May Benefit Women Using Oral Contraceptives Who Suffer From Low Sexual Desire and Activity
LINCOLNSHIRE, Illinois (August 10, 2005) – BioSante Pharmaceuticals, Inc. (Amex: BPA) today announced that it has exercised an option for a license from Wake Forest University Health Sciences and Cedars Sinai Medical Center to three patents encompassing triple hormone contraception technology, a novel combination of estrogens and progestins with androgens, such as testosterone. This license, which covers all potential routes of administration, follows BioSante‰s existing license to triple hormone therapy for menopausal women.
Data indicate that a woman’s testosterone levels decrease by approximately 30 to 50 percent between her 20s and 40s. This natural decrease, combined with a decrease in testosterone levels due to oral contraceptive use, may result in lower sexual desire and activity in some women. The testosterone component of the triple hormone contraceptive formulation may help restore sexual desire and activity to women taking traditional oral contraceptives who have experienced this side effect.
“This license agreement with Wake Forest and Cedars Sinai is a very valuable addition to BioSante’s hormone therapy product pipeline,” said Stephen M. Simes, president and chief executive officer of BioSante. ‹We hope to enhance the value of hormone contraception for women and help alleviate the negative side effect of decreased libido associated with these drugs. Our plan is to study LibiGel®, our transdermal testosterone gel for female sexual dysfunction, as the androgen component of this technology, and ultimately combine these hormones in a single product that would aid therapy, compliance and cost. Currently, approximately ten million American women use oral contraceptives.”
“BioSante is a perfect fit to develop this technology, given its strong pipeline of hormone therapy products and successful product development experience,” said Dean Stell, associate director of Technology Asset Management for Wake Forest.
The financial terms of the exclusive, worldwide license include an upfront payment by BioSante and regulatory milestone payments, maintenance payments and royalty payments if a product incorporating the licensed technology is approved and subsequently marketed.
BioSante currently is preparing a New Drug Application for submission to the U.S. Food and Drug Administration for Bio-E-Gel® (bioidentical estradiol gel) for reducing hot flashes. Also, BioSante plans to initiate Phase III testing of LibiGel® (bioidentical testosterone gel) for the treatment of female sexual dysfunction in menopausal women by year-end 2005.
Triple hormone technology was developed through research conducted at the Comparative Medicine Clinical Research Center by two former Wake Forest faculty members, Dr. Manuel Jayo and Dr. Claude L. Hughes, Jr., who also was an associate professor of obstetrics and gynecology. Cedars-Sinai Medical Center in Los Angeles also participated in the developmental process.
About BioSante Pharmaceuticals, Inc.
BioSante is developing a pipeline of hormone therapy products to treat both men and women. These hormone therapy products are gel formulations for transdermal administration that deliver bioidentical estradiol and testosterone. BioSante‰s lead products include Bio-E-Gel® (bioidentical estradiol gel) for the treatment of women with menopausal symptoms, and LibiGel® (bioidentical testosterone gel) for the treatment of female sexual dysfunction (FSD). The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion. The transdermal gel formulations used in the women’s gel products are licensed by BioSante from Antares Pharma Inc. (Amex: AIS).
The company also is developing its calcium phosphate nanotechnology (CaP) for novel vaccines, including biodefense vaccines for toxins such as anthrax and ricin, and drug delivery systems. Additional information is available online at biosantepharma.cdmail.biz.
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 press release that are not historical in nature, particularly those that utilize terminology such as “may,” “will,” “should,” “likely,” “expects,” “anticipates,” “estimates,” “believes” or “plans,” 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 cause actual results to differ materially from those expressed in such forward-looking statements are the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance, and other factors identified and discussed from time to time in BioSante’s filings with the Securities and Exchange Commission, including those factors discussed on pages 18 to 25 of BioSante’s Form 10-KSB, which discussion also is incorporated herein by reference.
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