BPA Biosante Pharmaceuticals

Data Suggest Estrogen-Alone Therapy May Decrease Incidence of Breast Cancer for Some Women BioSante Pharmaceuticals, Inc. (Amex:BPA) today offered comment on new data from the Women's Health Initiative (WHI) study, published in the April 12, 2006 issue of the Journal of the American Medical Association (JAMA), demonstrating that estrogen-alone therapy did not increase breast cancer incidence in postmenopausal women after an average of 7.1 years. The authors also suggest a possible protective effect of estrogen-alone therapy against breast cancer incidence among study participants in the following risk categories: women with a low five-year estimated risk of developing breast cancer as measured by the Gail Risk Score, women with no first-degree relatives with breast cancer, and women with no prior history of benign breast disease. Additionally, women in the study who adhered strictly to estrogen-alone dosing schedules had a statistically significant decrease in breast cancer risk (Hazard Ratio (HR) 0.67; 95% confidence interval (CI); 0.47-0.97; P=.03), compared to women taking placebo. When compared with data from an earlier WHI analysis, the new results also suggest that progestin, a hormone often used in combination with estrogen, may contribute to increased breast cancer risk. An additional article was published recently in the Archives of Internal Medicine, summarizing venous thrombosis (VT) data from the WHI estrogen-alone study (Archives of Internal Medicine. 2006; 166:772-780). This report of increased risk of VT is consistent with data from other studies and with information in the current product labeling for estrogen products. The findings of this study showed that women treated with estrogen-alone had a 30 percent increased chance of a VT compared to women who did not receive estrogen. This is well known, but in this same study it also was noted that women treated with estrogen plus progestin in combination had a rate of VT that was significantly higher than those treated with estrogen-alone (P = .03), even after adjusting for VT risk factors. "Although studies involving hormone use and breast cancer risk have produced varied results, these newly reported WHI data provide strong evidence that estrogen-alone does not increase the risk of breast cancer, and in fact may decrease the risk," said Stephen M. Simes, president and chief executive officer of BioSante. "In addition, the results from analyses of the VT data in WHI have shown again that treatment with estrogen-alone has less risk than estrogen plus progestin in combination." "With our New Drug Application for Bio-E-Gel(R) (transdermal estrogen gel) recently submitted to the U.S. Food and Drug Administration, we are pleased that these newly reported results, in addition to recent WHI data on cardiovascular disease, may further help women and their doctors assess how estrogen-alone therapy may provide a benefit for the treatment of menopausal symptoms in appropriate women." The full JAMA article is available at http://jama.ama-assn.org/cgi/content/full/295/14/1647 . About the Women's Health Initiative Sponsored by the National Institutes of Health, the Women's Health Initiative (WHI) was designed to evaluate hormone therapy, dietary modification, calcium and vitamin D as preventative therapies for post menopausal women. Between 1993 and 1998, the WHI enrolled approximated 27,000 women into two hormone therapy sub-studies designed to assess the long-term risks and benefits of estrogen-alone (conjugated equine estrogen (CEE)) and estrogen-plus-progestin (CEE / medroxyprogesterone combination). The estrogen-alone arm of WHI was a randomized, placebo-controlled evaluation of 10,738 women between the ages of 50 and 79 at baseline, all of whom had previously undergone a hysterectomy. All study participants received mammography screenings and clinical breast examinations at baseline and then annually for the trial's duration. Main outcome measures included breast cancer incidence, tumor characteristics and mammogram findings. To provide a measurement of breast cancer risk, the Gail Risk Score incorporates age, history of benign breast disease, age at menarche, age at first live birth, race/ethnicity, and number of sisters or a mother with breast cancer. The primary efficacy endpoint of the WHI study was the prevention of coronary heart disease, and the primary safety endpoint was the risk of breast cancer. Secondary endpoints included hip fracture, colorectal cancer, stroke, pulmonary embolism and death from other causes. The estrogen-plus-progestin arm concluded in July 2002; the estrogen-alone arm concluded in March 2004. For additional information on the Women's Health Initiative, visit http://www.nhlbi.nih.gov/whi/ . About Bio-E-Gel(R) Bio-E-Gel(R) is a transdermal gel formulation of estradiol (bioidentical human estrogen) 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 quick-drying, non-invasive, painless manner. 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 WHI study reported increased risks of stroke and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 6.8 years of treatment with oral conjugated equine estrogens (CEE 0.625 mg) alone per day, relative to placebo. The WHI study reported increased risk of myocardial infarction, stroke, invasive breast cancer, and pulmonary emboli in postmenopausal women during 5 years of treatment with CEE 0.635 mg combined with medroxyprogesterone acetate (MPA 2.5 mg) per day. 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 accept the Bio-E-Gel NDA for filing and that future studies may result in additional risk factors inherent in the use of estrogen products. 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.