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BioSante Pharmaceuticals Comments on Procter & Gamble's Decision to Withdraw and Resubmit NDA for Testosterone Patch

Posted on: Thursday, 23 December 2004, 09:00 CST

BioSante Pharmaceuticals, Inc. (Amex:BPA) today offered comment on the decision by Procter & Gamble to withdraw and resubmit, with guidance from the U.S. Food and Drug Administration (FDA), the New Drug Application (NDA) for its testosterone patch for female sexual dysfunction (FSD).

"BioSante, like Procter & Gamble, remains committed to the development of testosterone products for FSD, and it appears that the FDA is working responsibly to bring these products forward," said Stephen M. Simes, president and chief executive officer of BioSante. "We plan to meet with the FDA in the first quarter of 2005 and integrate any new recommendations into our protocols for LibiGel(TM), in order to initiate Phase III clinical development."

About LibiGel(TM) and Female Sexual Dysfunction (FSD)

LibiGel is a once-daily transdermal testosterone gel in late-stage clinical development for the treatment of FSD. LibiGel's formulation of bioidentical testosterone is quickly absorbed through the skin after application on the arms, shoulders or abdomen, delivering testosterone to the bloodstream evenly over time in a non-invasive, painless manner.

Approximately 43 percent of American women suffer from FSD, according to a study published in the Journal of the American Medical Association. FSD is often defined as a lack of sexual desire, arousal or pleasure. The majority of women with FSD are postmenopausal, experiencing symptoms due to hormonal changes that occur with aging, or with natural or surgical menopause.

About BioSante Pharmaceuticals, Inc.

BioSante is developing a pipeline of hormone therapy products to treat both men and women. In addition to LibiGel, the Company's hormone therapy products are gel formulations for transdermal administration, including Bio-E-Gel(TM) (bioidentical estradiol gel) for treatment of women with menopausal symptoms and Bio-T-Gel(TM) (bioidentical testosterone gel) for treatment of men with testosterone deficiency. 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 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.

Source: Business Wire

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