BioSante Pharmaceuticals Completes Pivotal Phase III Clinical Trial for Estrogen Gel
LINCOLNSHIRE, Illinois (April 4, 2005) – BioSante Pharmaceuticals, Inc. (Amex: BPA) today announced the completion of its12-week pivotal Phase III clinical trial to evaluate the safety and efficacy of Bio-E-Gel® (bioidentical estradiol transdermal gel) for the treatment of moderate-to-severe hot flashes in menopausal women. Hot flashes occur in up to 85 percent of menopausal women.
“The completion of our 483-patient Bio-E-Gel trial brings us closer to filing a new drug application (NDA) and reaching our goal of commercializing this important new therapy,” said Stephen M. Simes, president and chief executive officer of BioSante. “We are confident in Bio-E-Gel’s potential to help menopausal women better manage their symptoms, and look forward to analyzing and reporting data from this key study.”
BioSante’s multicenter, randomized, double-blind, placebo-controlled trial of Bio-E-Gel was conducted in the United States and Canada. Current U.S. Food and Drug Administration (FDA) requirements for approval of new estradiol products include one 12-week Phase III clinical trial. The study included three doses of Bio-E-Gel to maximize the safety profile by identifying the lowest effective dose.
Simes said this study was in line with FDA guidance, and the company plans to begin analysis of the data immediately. BioSante expects to announce topline results of the study by the end of the second quarter 2005.
BioSante also has completed three additional clinical studies required to be included in the NDA. These studies include a transfer/washing study, a sunscreen study and a pharmacokinetics study.
Bio-E-Gel is a gel formulation of estradiol (bioidentical human estrogen) 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 United States 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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