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, Ill. -- BioSante Pharmaceuticals, Inc. (AMEX AMEX See: American Stock Exchange :BPA BPA British Paediatric Association. ) 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 Estrogens Hormones produced by the ovaries, the female sex glands. Mentioned in: Acne, Polycystic Ovary Syndrome estrogens (es´trōjenz), n. and progestins Progestins A female hormone, like progesterone, that acts on the inner lining of the uterus. Mentioned in: Anabolic Steroid Use, Endometrial Cancer with androgens, such as testosterone. This license, which covers all potential routes of administration, follows BioSante's existing license to triple hormone therapy Hormone therapy Treating cancers by changing the hormone balance of the body, instead of by using cell-killing drugs. Mentioned in: Breast Cancer, Thyroid Cancer 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 oral contraceptive n. A pill, typically containing estrogen or progesterone, that prevents conception or pregnancy. Also called birth control pill. 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 Oral Contraceptives Definition Oral contraceptives are medicines taken by mouth to help prevent pregnancy. They are also known as the Pill, OCs, or birth control pills. 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(TM), our transdermal testosterone gel for female sexual dysfunction sexual dysfunction Inability to experience arousal or achieve sexual satisfaction under ordinary circumstances, as a result of psychological or physiological problems. , 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(TM) (bioidentical estradiol gel) for reducing hot flashes. Also, BioSante plans to initiate Phase III testing of LibiGel(TM) (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 obstetrics and gynecology Medical and surgical specialty concerned with the management of pregnancy and childbirth and with the health of the female reproductive system. . Cedars-Sinai Medical Center Cedars-Sinai Medical Center is a world-renowned hospital located in Los Angeles, California. History Cedars-Sinai is the result of a merger in 1961 between two major Los Angeles hospitals, Cedars of Lebanon and Mount Sinai Home for the Incurables, with Steve Broidy as 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(TM) (bioidentical estradiol gel) for the treatment of women with menopausal symptoms, and LibiGel(TM) (bioidentical testosterone gel) for the treatment of female sexual dysfunction (FSD FSD Female Sexual Dysfunction FSD File System Driver FSD Family Support Division FSD Fire Services Department (Hong Kong) FSD Full Scale Development FSD Full Scale Deflection FSD Federal Systems Division ). 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 ricin /ri·cin/ (ri´sin) a phytotoxin in the seeds of the castor oil plant (Ricinus communis), used in the synthesis of immunotoxins. ri·cin n. , and drug delivery systems. Additional information is available online at www.biosantepharma.com. This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 19 to 31 of BioSante's Form 10-KSB, which discussion also is 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. |
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