BioSante Pharmaceuticals Comments on Updated FDA Guidance for Testosterone Therapy
LINCOLNSHIRE, Illinois (November 2, 2005) – BioSante Pharmaceuticals (AMEX: BPA) today offered comment on updated U.S. Food and Drug Administration (FDA) safety and efficacy guidance for the development of testosterone products for the treatment of female hypoactive sexual desire disorder (HSDD). The new guidance was announced on Saturday, October 29 at the International Society for the Study of Women’s Sexual Health (ISSWSH) Annual Meeting in Las Vegas, during a presentation by Dr. Daniel Shames, Director of the FDA’s Division of Reproductive and Urologic Products.
Dr. Shames stated that the FDA acknowledges testosterone’s efficacy in treating HSDD and the need for testosterone products to be approved for women affected by this condition. As extended long-term, pre-marketing safety studies are often not economically feasible for companies, the FDA will now permit a complete safety profile to be submitted post-marketing, with efficacy and some safety data submitted pre-approval. The agency will assist companies in determining the best development plan for their testosterone products, consistent with the need for sufficient efficacy and safety requirements. The FDA is most interested in safety data addressing cardiovascular and breast cancer risk associated with testosterone therapy.
“We are pleased that the FDA has validated testosterone’s potential as an effective therapy for HSDD,” said Stephen M. Simes, president and chief executive officer of BioSante. “Based on the updated FDA guidance, we plan on filing our Phase III efficacy and safety protocols for studies of LibiGel®, our testosterone gel. The new guidance may allow for a more timely review process than previously projected by many. We look forward to working cooperatively with the FDA to finalize our LibiGel Phase III efficacy and safety protocols.”
Additionally, to build the safety profile of testosterone, the FDA will accept and review epidemiological and surrogate endpoint data. The co-primary endpoints for approval of testosterone in HSDD are successful and satisfying sexual events, and increased sexual desire.
About LibiGel® and Female Sexual Dysfunction (FSD)
LibiGel is a once-daily transdermal testosterone gel in late-stage clinical development for the treatment of FSD, specifically HSDD. LibiGel’s formulation of bioidentical testosterone is quickly absorbed through the skin after application on the arm or shoulder, delivering testosterone to the bloodstream evenly over time in a non-invasive, painless manner. In a Phase II clinical trial, LibiGel increased the number of successful and satisfying sexual events by 238 percent, which was statistically significant compared to baseline and placebo.
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. 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. 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 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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