BPA Biosante Pharmaceuticals

BioSante Pharmaceuticals, Inc. (Amex:BPA) today announced that Stephen M. Simes, the company's president and chief executive officer, will present a corporate overview including a summary of Bio-E-Gel(R), BioSante's transdermal estradiol gel for the treatment of menopausal symptoms in women, at Rodman & Renshaw's 3rd Annual Global Healthcare Conference in Monte Carlo, Monaco. The presentation will take place on Monday, May 15, at 3:40 p.m. CEST (9:40 a.m. EDT). "Bio-E-Gel may offer greater comfort and convenience over a pill or a patch, and we believe the lowest effective dose was identified in clinical trials," commented Mr. Simes. "If and when approved, Bio-E-Gel may become the lowest dose of estrogen available to treat hot flashes, making it an attractive alternative in estrogen therapy. We look forward to reviewing our positive Phase III data and presenting our corporate overview at the Rodman & Renshaw Conference." A live audio webcast of BioSante's presentation may be accessed at http://wsw.com/webcast/rrshq8/bpa and a replay will be available at the same link for 90 days. For additional information about the Rodman & Renshaw Conference, please visit http://www.rodmanandrenshaw.com/eu06conference. About Bio-E-Gel(R) Bio-E-Gel (transdermal estradiol gel) is a gel formulation of bio-identical estradiol, the same estrogen produced naturally in women. It is designed to be quickly absorbed through the skin after topical application on the upper arm, delivering estradiol to the bloodstream evenly over time at minimal dosage and in a fast drying, non-invasive, painless manner. The new drug application (NDA) for Bio-E-Gel, submitted in February, has been accepted for filing and review by the U.S. Food and Drug Administration (FDA). There was a clear dose response in the reduction in the number and severity of hot flashes across the low, mid, and high doses tested in the Phase III trial. The most effective Bio-E-Gel dose significantly decreased the number of hot flashes by 85 percent, from 12.9 per day at baseline to 1.6 per day after 12 weeks of treatment (p less than 0.0001). Importantly, more than 80 percent of women who used Bio-E-Gel reported "moderate" or "great" results (p less than 0.0001). The company in its NDA is seeking approval for all three doses. According to the North American Menopause Society, more than two-thirds of North American women have hot flashes during menopause. At present, oral conjugated estrogen is the primary treatment for menopausal symptoms. The U.S. estrogen therapy market is currently estimated at approximately $1.3 billion in annual sales, of which the transdermal segment, mostly patches, already is approximately $250 million and growing. About Estrogens Estrogen products today are approved for the treatment of menopausal symptoms, including hot flashes. Estrogen products are not approved for and should not be used for the treatment or prevention of heart disease, breast cancer or dementia. The Women's Health Initiative (WHI) study reported increased risk of stroke and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 6.8 years of treatment with 0.625 mg of oral conjugated equine estrogens alone per day, relative to placebo. The WHI study reported increased risk of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during five years of daily treatment with 0.625 mg of oral conjugated equine estrogens combined with 2.5 mg of medroxyprogesterone acetate per day. Although studies involving hormone use and breast cancer risk have produced varied results, newly reported estrogen-only data provide strong evidence that estrogen-alone does not increase the risk of breast cancer, and in fact may decrease the risk. 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(R) (transdermal estradiol gel) for the treatment of women with menopausal symptoms, and LibiGel(R) (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD). A Bio-E-Gel New Drug Application (NDA) was submitted to the FDA in the first quarter of 2006. 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 avian flu and biodefense vaccines for toxins such as anthrax and ricin, 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 of 1995. The statements regarding BioSante contained in this news release that are not historical in nature, particularly those that utilize terminology such as "may," "will," "should," "likely," "expects," "anticipates," "estimates," "believes," "plans," "hopes," 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 22 to 34 in BioSante's most recent Form 10-K, which discussion also is incorporated herein by reference. Additional risk factors include the risk that the FDA will not approve Bio-E-Gel for marketing or that if approved, Bio-E-Gel may not achieve commercial success. 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.