BioSante Pharmaceuticals Comments on NIH Conference Panel Statement on Estrogen Therapy for Menopausal Women
LINCOLNSHIRE, Illinois (March 30, 2005) – BioSante Pharmaceuticals, Inc. (Amex: BPA) today offered comment on a statement released by a panel convened by the National Institutes of Health (NIH) supporting the use of estrogen therapy for the management of moderate-to-severe menopausal symptoms in women. The independent panel of health professionals met during the NIH’s State-of-the-Science Conference on the Management of Menopause-Related Symptoms, held March 21-23, 2005 in Bethesda, Maryland.
“The panel opinion stated that estrogen therapy is the most consistently effective treatment for hot flashes, which affect up to 85 percent of menopausal women,” said Stephen M. Simes, president and chief executive officer of BioSante. “With our Phase III trial of Bio-E-Gel nearing completion, BioSante is pleased that this hormone has received further validation as a therapy for the management of menopausal symptoms.”
BioSante’s randomized, 12-week, double-blind, placebo-controlled Phase III trial of Bio-E-Gel® (bioidentical estradiol transdermal gel) is being conducted in the United States and Canada. Current U.S. Food and Drug Administration (FDA) requirements for approval of new estradiol (bioidentical human estrogen) products include one 12-week Phase III clinical trial. The study includes three doses of Bio-E-Gel to maximize the safety profile by identifying the lowest effective dose.
Upon completion of the trial, expected by the end of Q1 2005, BioSante anticipates filing a New Drug Application with the FDA in mid-2005.
For additional information on NIH State-of-the-Science Conferences, visit www.consensus.nih.gov.
Bio-E-Gel is a gel formulation of estradiol for the treatment of moderate-to-severe hot flashes in menopausal women. It is designed to be quickly absorbed through the skin after topical application on the arms and shoulders, delivering estradiol to the bloodstream evenly over time at minimal dosage and in a non-invasive, painless manner. Estrogen products today are approved for the treatment of menopausal symptoms, including hot flashes and vaginal atrophy. Estrogen products are not approved for and should not be used for the treatment or prevention of heart disease. The current market in the U.S. for estrogen products is approximately $2.0 billion.
About BioSante Pharmaceuticals, Inc.
BioSante is developing a pipeline of hormone therapy products to treat both men and women. In addition to Bio-E-Gel®, the Company’s transdermal gel formulations include LibiGel® (bioidentical testosterone gel) for treatment of female sexual dysfunction and Bio-T-Gelœ (bioidentical testosterone gel) for treatment of men with testosterone deficiency. 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. The current vaccine market is approximately $9 billion and is predicted to triple in size by 2012. Additional information is available online at biosantepharma.cdmail.biz.
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 18 to 25 of BioSante’s Form 10-KSB, which discussion also is incorporated herein by reference.
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Harris D. McKinney, Inc.