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BioSante Pharmaceuticals Comments on New Data From Women's Health Initiative Study

Posted on: Tuesday, 21 February 2006, 09:00 CST

BioSante Pharmaceuticals, Inc. (Amex:BPA) today offered comment on new data from the Women's Health Initiative (WHI) study, published in the February volume of the Archives of Internal Medicine, demonstrating that estrogen-alone (conjugated equine estrogen (CEE) at a 0.625 mg once-daily dose) did not increase the risk of coronary heart disease (CHD) in postmenopausal women aged 50 to 79 after an average of 7.1 years of treatment. Additionally, data suggest that estrogen-alone therapy may lower the risk of coronary heart disease among women aged 50 to 59.

"We are pleased with these new data, which are especially timely for BioSante since just last week we submitted our new drug application (NDA) for Bio-E-Gel(TM), our transdermal estrogen gel, to the U.S. Food and Drug Administration," said Stephen M. Simes, president and chief executive officer of BioSante. "Most postmenopausal women who are treated for menopausal symptoms initiate estrogen therapy during their 50s, so these new data may make deciding to use estrogen to treat menopausal symptoms an easier decision for women and their health-care providers."

Initiated in 1993, the WHI study evaluated 10,738 women between the ages of 50 and 79 at baseline, all of whom had previously undergone a hysterectomy. Data demonstrated that estrogen-alone (CEE 0.625 mg) did not increase CHD risk in the overall population (RR 0.95; 95% CI 0.79-1.16). No increased CHD risk was observed in any study subpopulation. There was a statistically significant (34%) lower risk for the combined endpoint of myocardial infarction (heart attack), coronary death, coronary revascularization and confirmed angina among women who were between the ages of 50 and 59 at the start of the study (RR 0.66; 95% CI 0.45-0.96). These new data and other recent data from a January 2006 report published in the Journal of Women's Health, in which researchers from the Nurses Health Study (NHS), a large observational trial, reported a significant reduction in CHD among women who initiated hormone therapy early in menopause support the premise that timing of therapy may influence CHD risk and clearly show no increased risk of coronary heart disease with estrogen-alone therapy. These new data may help clarify the individual assessment of risk and benefit for women considering estrogen therapy for treatment of menopausal symptoms.

For additional information on the Women's Health Initiative, visit http://www.nhlbi.nih.gov/whi/.

About Bio-E-Gel(TM)

Bio-E-Gel is a transdermal gel formulation of estradiol (bioidentical human estrogen) designed to be quickly absorbed through the skin after topical application on the arms, shoulders, abdomen or thighs, delivering estradiol to the bloodstream evenly over time at minimal dosage and in a 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 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, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated equine estrogens (CEE 0.625 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(TM) (bioidentical estradiol gel) for the treatment of women with menopausal symptoms, and LibiGel(TM) (bioidentical testosterone gel) for the treatment of female sexual dysfunction (FSD). 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. BioSante 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. 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, 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 of BioSante's most recent Form 10-Q, which discussion also is incorporated herein by reference. 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.

Source: Business Wire

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