BioSante Pharmaceuticals Announces Bio-E-Gel® (estradiol gel) Significantly Reduces Hot Flashes in Menopausal Women
Lincolnshire, Illinois (July 6, 2005) – BioSante Pharmaceuticals, Inc. (Amex: BPA) announced today significant Phase III safety and efficacy results of Bio-E-Gel® (bioidentical estradiol transdermal gel) for the treatment of moderate-to- severe hot flashes in menopausal women. A new drug application (NDA) will be filed as soon as possible after completion of the data analyses.
The Phase III trial was a 12-week, randomized, double-blind, placebo-controlled study of 484 symptomatic menopausal women. Following FDA recommendations, the Phase III trial tested three doses of Bio-E-Gel in order to establish the lowest effective dose and maximize the safety profile. The four co-primary endpoints, as defined by the FDA, are a significant decrease over placebo in both the number and severity of hot flashes at Week 4 and Week 12 of treatment.
Across the low, mid, and high Bio-E-Gel doses tested in the Phase III trial, there was a clear dose response in the reduction in the number and severity of hot flashes.
By Week 4 of treatment, the mid and high doses of Bio-E-Gel showed highly significant decreases in the number and severity of hot flashes versus placebo (p<0.0001), and this significant response was maintained from Week 4 to Week 12 of treatment (p<0.0001).
Beginning at Week 5, the low dose of Bio-E-Gel showed a highly significant decrease in the number (p<0.001) and severity (p<0.01) of hot flashes versus placebo, therefore suggesting identification of the lowest effective dose. This significant response for both number and severity of hot flashes was maintained through Week12 (p<0.0001).
There were no significant differences in the safety profile of any dose of Bio-E-Gel compared to placebo. A full report of the Phase III trial data is targeted for a medical meeting in the fall with publication in a peer-reviewed journal to follow.
“We are very pleased the Phase III trial results indicate the lowest effective dose of Bio-E-Gel thereby establishing the safest dose for women to begin treatment for reducing hot flashes. We look forward to completing the preparation and submission of the NDA as soon as possible,” said Dr. Leah M. Lehman, vice president of product development of BioSante. “We believe the low dose of Bio-E-Gel shown to be safe and effective in this trial will be an attractive alternative to currently marketed estrogen therapies.”
“This successful Phase III trial and the anticipated Bio-E-Gel NDA represent important milestones for BioSante,” said Stephen M. Simes, president and CEO of BioSante. “We believe Bio-E-Gel will be well positioned to compete in the U.S. estrogen therapy market, currently estimated to total approximately $1.4 billion in annual sales.”
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. Estrogen products are not approved for and should not be used for the treatment or prevention of heart disease.
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® (bioidentical estradiol gel) for the treatment of women with menopausal symptoms, and LibiGel® (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 company 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 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.
For more information please contact:
Harris D. McKinney, Inc.