BioSante Pharmaceuticals Honors World Menopause Day
LINCOLNSHIRE, Illinois (October 18, 2005) – BioSante Pharmaceuticals (Amex: BPA) announced its support of today’s World Menopause Day, established by the International Menopause Society to raise awareness of this important phase in a woman’s life.
“Millions of women are now experiencing menopause, yet many are unaware of the advances made in the understanding and alleviation of its undesirable effects,” said Stephen M. Simes, president and chief executive officer of BioSante. “As part of BioSante’s commitment to women’s health, BioSante supports World Menopause Day and is pleased to be developing important new treatment options to allow physicians to provide therapy in accordance with individual patient needs and preferences, and in the safest possible manner.”
At the recent annual meeting of the North American Menopause Society, researchers presented positive results of a Phase III clinical study with Bio-E-Gel® (bio-identical estradiol gel), being developed by BioSante for the treatment of moderate-to-severe hot flashes in menopausal women. The study 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 per day with a placebo (p<0.0001).
Bio-E-Gel produced markedly low estradiol blood levels and had a safety profile similar to that observed in the placebo group. Moreover, there was minimal application site irritation reported, a side effect commonly associated with transdermal patches.
“Almost two million women in the U.S. become menopausal every year as the populous baby boom generation reaches the susceptible age,” Simes said. “We are very pleased with the results of the Phase III trial and look forward to submitting Bio-E-Gel to the Food and Drug Administration for marketing approval.”
More than two-thirds of American women experience hot flashes during or after menopause, 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 that is not subject to first-pass liver metabolism, thereby avoiding known side effects associated with oral administration of conjugated estrogen.
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.
World Menopause Day is designated by the International Menopause Society to raise awareness of the changes a woman’s body goes through in this phase of life, as well as to challenge every woman age 45 or older to talk to her physician about her individual health history, her risks for diseases, the benefits and risks associated with hormone therapy, and steps she can take now to take charge of her health.
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 arm or shoulder, 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 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 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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