BIOSANTE ANNOUNCES FIRST TRANSDERMAL ESTRADIOL GEL WITH 3 DOSES THAT SIGNIFICANTLY DECREASE HOT FLASHES IN MENOPAUSAL WOMEN
BioSante’s Bio-E-Gel® Shows 88% Decrease in Hot Flashes and the Lowest Effective Dose is Established, According to Data at NAMS
LINCOLNSHIRE, Illinois (September 29, 2005) – BioSante Pharmaceuticals, Inc. (Amex: BPA) announced today the presentation of Phase III clinical study data on Bio-E-Gel® (bio-identical estradiol gel) at the North American Menopause Society (NAMS) annual meeting in San Diego. The study results showed three doses of Bio-E-Gel that significantly decrease the number of hot flashes in menopausal women and identified the lowest effective dose in order to implement estrogen therapy in the safest possible manner.
BioSante’s Phase III study assessed the safety and efficacy of Bio-E-Gel for the treatment of hot flashes in menopausal women. Results showed that the most effective Bio-E-Gel dose significantly decreased the number of hot flashes by 88 percent from 12.9 per day at baseline to 1.6 after treatment (p<0.0001). The decrease was also significant versus placebo, with a mean decrease of 11.3 hot flashes per day with Bio-E-Gel versus a decrease of 6.1 with placebo (p<0.0001). Bio-E-Gel produced low estradiol blood levels and had a safety profile similar to that observed in the placebo group. Notably, there was minimal application site irritation reported, a side effect known to be associated with transdermal patches.
More than two-thirds of North American women have hot flashes during perimenopause, according to The North American Menopause Society. Currently, the leading product for the treatment of menopausal symptoms is oral conjugated estrogen, which is derived from pregnant horses’ urine and is metabolized first-pass through the liver. Transdermal Bio-E-Gel offers an advantage over oral estrogen products by providing bio-identical estrogen which is not subject to first-pass liver metabolism, thereby avoiding known side effects associated with oral administration of conjugated estrogen.
“These study results demonstrate that Bio-E-Gel represents a significant improvement in low-dose estrogen therapy. Bio-E-Gel offers an important new treatment option for the reduction of hot flashes,” said lead study investigator Dr. James A. Simon, clinical professor of obstetrics and gynecology at George Washington Medical School, director of the Women’s Health Research Center and former president of NAMS. “Since non-oral hormone therapy may offer a potential safety benefit, Bio-E-Gel, having demonstrated efficacy at low doses, may fill an unmet medical need.”
“We are very pleased the Phase III trial results have successfully defined the safety and effectiveness of Bio-E-Gel, while establishing the lowest effective dose,” said Dr. Leah Lehman, vice president of product development at BioSante. “The Bio-E-Gel results compare very favorably to results reported in other estrogen therapy studies. In addition, BioEGel may be used at a lower dose than other estrogen products on the market, an important potential safety advantage.”
“This successful Phase III trial and the Bio-E-Gel New Drug Application submission, planned in the fourth quarter, represent important milestones for the company,” said Stephen M. Simes, president and chief executive officer 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. As a result, the company should be well positioned to compete in the U.S. estrogen therapy market, currently estimated to total approximately $1.4 billion in annual sales.”
The Phase III trial was a 12-week, randomized, double-blind, placebo-controlled study of 484 symptomatic menopausal women, using three dosage levels of Bio-E-Gel in order to establish the lowest effective dose and optimal safety profile. There was a clear dose and statistically significant response in the reduction in the number and severity of hot flashes across the low, mid and high Bio-E-Gel dosages tested.
Bio-E-Gel is a gel formulation of estradiol (bio-identical 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. 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 bio-identical estradiol and testosterone. BioSante’s lead products include Bio-E-Gel (bio-identical estradiol gel) for the treatment of women with menopausal symptoms, and LibiGel® (bio-identical testosterone gel) for the treatment of female sexual dysfunction (FSD). The transdermal gel formulations used in the women’s gel products are licensed by BioSante from Antares Pharma Inc. 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 19 to 31 of BioSante’s Form 10-KSB, 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.
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