Paper in Journal of Sexual Medicine Cites Need for FDA-Approved Testosterone Treatment to Replace Growing Off-Label Use

Business Wire, June 25, 2009

Women Distressed by Lost Libido

LINCOLNSHIRE, Ill. -- A study to be published in the July 2009 issue of The Journal of Sexual Medicine reports that U.S. physicians wrote two million prescriptions a year for testosterone in 2006 and 2007, representing a significant increase since 2004. Importantly, 21% of the prescriptions written for male testosterone products were for women. Furthermore, the article notes that these statistics do not include the large number of prescriptions written for compounded testosterone formulations, a practice that has been criticized by the American Medical Association and the American College of Obstetrics and Gynecology, among others.

In their paper “Approved Hormonal Treatment for HSDD: An Unmet Medical Need,” Michael C. Snabes, M.D., Ph.D., vice president, clinical development and Stephen M. Simes, president and chief executive officer of BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) reveal independent survey results showing 80% of physicians believe there is a need or great need for an FDA-approved treatment for women with HSDD (Hypoactive Sexual Desire Disorder). In addition, 90% of these doctors would prescribe an approved product rather than currently available off-label therapies.

The high prevalence of these off-label prescriptions is related to an increase in the number of women seeking treatment for distress resulting from their decrease in sexual desire, a key indicator of HSDD. The authors suggest that low sexual desire is “nearly twice as high in naturally menopausal women as in pre-menopausal women (52.4% vs. 26.7%).” Further, this problem “appears to be greater in women who have undergone an oopherectomy. HSDD occurs nearly twice as frequently (26% vs. 14%) in surgically postmenopausal women as in premenopausal women matched for age.”

“The key message in these statistics is that low sexual desire in women is prevalent, and the number of women living their life being bothered with this condition is remarkably, but perhaps not surprisingly, high. To date, the U.S. Food and Drug Administration (FDA) has not approved any medication for treating HSDD, although the available information suggests that testosterone prescriptions are often written for U.S. women as an off-label indication.” This prescribing practice “runs counter to FDA’s renewed emphasis on drug safety and scrutiny of off-label use,” and raises concern “over appropriate dosing for women, particularly with respect to testosterone formulations produced through unregulated compounding,” the paper states.

Approval of testosterone to treat HSDD in postmenopausal women requires two Phase III six month 500 patient double-blind, placebo-controlled efficacy studies and a Phase III cardiovascular safety study. BioSante currently is conducting all three studies. The objective of the safety study is to show the relative safety of LibiGel® (testosterone gel) compared to placebo in the number of cardiovascular events. The incidence of breast cancer also will be tracked over the course of the study. The safety study has enrolled over 1,000 women with over 600 women-years of exposure and shows an exceptionally low number of adverse cardiovascular events. BioSante intends to submit a new drug application (NDA) to the U.S. FDA by mid-2011.

As previously announced by BioSante, treatment with LibiGel in a Phase II clinical trial significantly increased satisfying sexual events in surgically menopausal women suffering from FSD. The Phase II trial results showed LibiGel significantly increased the number of satisfying sexual events by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.

About BioSante Pharmaceuticals, Inc.

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism. BioSante's lead products include LibiGel® (transdermal testosterone gel) in Phase III clinical development by BioSante under a U.S. Food and Drug Administration (FDA) SPA (Special Protocol Assessment) for the treatment of female sexual dysfunction (FSD), and Elestrin™ (estradiol gel) developed through FDA approval by BioSante, indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, currently marketed in the U.S. Also in development are Bio-T-Gel™, a testosterone gel for male hypogonadism, and an oral contraceptive in Phase II clinical development using BioSante patented technology. The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion and for oral contraceptives approximately $3 billion. The company also is developing its calcium phosphate technology (CaP) for novel vaccines, drug delivery and aesthetic medicine (BioLook™). Additional information is available online at: www.biosantepharma.com.