BioSante Pharmaceuticals Comments on Women's Health Initiative Estrogen Study.

Business Editors/Health/Medical Writers

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LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--April 15, 2004

BioSante Pharmaceuticals, Inc. (Amex:BPA) today released comments on the newly published results of the Women's Health Initiative (WHI) study that links estrogen to reduced incidence of fracture and fewer cases of breast cancer. The results are published in the April 14, 2004 issue of the Journal of the American Medical Association (JAMA).

"We are very encouraged by the latest WHI findings and how they relate to estrogen therapy in general and the implications for our Bio-E-Gel(TM) (bioidentical estradiol gel) topical estrogen therapy in Phase III clinical trial for the treatment of menopausal symptoms," said Stephen M. Simes, president and chief executive officer of BioSante. "We are especially impressed with the reported decrease in breast cancer in estrogen treated women compared with those on placebo. We believe that women and health care providers will positively reevaluate their use of estrogen therapy and this will result in growth in the estrogen market."

Data from the estrogen-alone arm of the WHI study associate estrogen therapy with a reduction in fractures and fewer cases of breast cancer than placebo. The risk of stroke in the study is consistent with information in existing labeling for estrogen products.

Specifically, data from the WHI study showed that per 10,000 women per year, estrogen therapy was associated with 12 additional cases of stroke (39 percent higher), 56 fewer cases of osteoperotic bone fractures (30 percent lower) and seven fewer cases of breast cancer (23 percent lower) compared to placebo. There were 10,739 women enrolled in the study.

In preliminary subanalyses, it appears that the risks monitored in the WHI study were lower for women ages 50-59 and increased with age. This is important since the average age of women in the study was 63, while menopause typically begins between 50 and 52 and the average age of women at the time of hysterectomy is 42. Estrogen products should be used at the lowest dose and for the shortest duration in order to meet individual treatment goals by women experiencing menopausal symptoms and not by any women for the treatment of cardiovascular disease.

"As more becomes known about the benefits and risks of estrogen therapy, it is important that new treatment options become available so that therapy can be tailored to the preferences and risk factors of each individual patient, such as age, lifestyle and physical condition," Simes said. "We believe that Bio-E-Gel represents an important treatment option for women."

BioSante is developing a portfolio of gel-formulated hormone therapy products for both men and women, designed to be quickly absorbed through the skin after application on the arms, shoulders, abdomen or thighs, delivering the required hormone to the bloodstream evenly, at minimal dosage levels and in a non-invasive, painless manner. BioSante's hormone therapy products may pose fewer potential side effects than other delivery methods, and are far more comfortable and less conspicuous than wearing a patch.

BioSante's hormone therapy product pipeline includes Bio-E-Gel, a bioidentical estradiol transdermal gel for the treatment of postmenopausal symptoms; LibiGel(TM), a testosterone transdermal gel for female sexual dysfunction; and Bio-T-Gel(TM), a transdermal testosterone gel for the treatment of male testosterone deficiency.

Additionally, a combination hormone therapy gel product containing estradiol and progestin is being developed under a license with Solvay Pharmaceuticals, B.V., and an unnamed BioSante hormone therapy product is being developed by Teva Pharmaceuticals USA, Inc. under a license agreement. The estrogen and testosterone markets in the United States alone account for approximately $2.5 billion in annual sales.

About BioSante Pharmaceuticals, Inc.

BioSante is developing a pipeline of hormone therapy products to treat both men and women. The company also is developing its calcium phosphate nanotechnology (CAP) for novel vaccines, including biodefense vaccines 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 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 and especially of new vaccines, 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 18 to 25 of BioSante's Form 10-KSB, which discussion also is incorporated herein by reference. The information contained in this press release does not necessarily reflect the position or the policy of the U.S. Government and no official endorsement should be inferred.