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Intrinsa

Generic name: testosterone
Treatment for: Female Sexual Dysfunction

BioSante Pharmaceuticals Comments on FDA Advisory Committee's Decision Not to Recommend Approval of Testosterone Patch

LINCOLNSHIRE, Ill., December 03, 2004 -- BioSante Pharmaceuticals, Inc. (AMEX:BPA) today offered comment on the decision not to recommend Procter & Gamble's Intrinsa testosterone patch for female sexual dysfunction (FSD) in surgically menopausal women made Thursday, December 2 by the U.S. Food and Drug Administration (FDA) Advisory Committee for Reproductive Health Drugs.

"The advisory committee's decision against recommending approval of Intrinsa with a request for additional safety data was unexpected," said Stephen M. Simes, president and chief executive officer of BioSante. "However, we are gratified that the panel agreed that FSD is an indication worthy of treatment with testosterone, and BioSante looks forward to the FDA's advice on what additional safety data will be required." He added: "As we move forward in 2005 with our Phase III studies of LibiGel, our unique testosterone gel formulation for FSD, we look forward to factoring in the recommendations made by the FDA. Moreover, we remain confident that LibiGel will provide an effective, convenient treatment option for women with FSD."

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 in surgically menopausal women who have had both ovaries removed. 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. BioSante's hormone therapy products are gel formulations for transdermal administration that deliver bioidentical estradiol and testosterone. 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.

Posted: December 2004

Intrinsa (testosterone) FDA Approval History

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