Lowest FDA-Approved Dosage of Estradiol to Significantly Reduce Hot Flashes Reported in Newly-Published Study
BioSante’s Elestrin™ Demonstrates Safe and Effective Menopausal Symptom Relief
LINCOLNSHIRE, Illinois (March 1, 2007) – BioSante Pharmaceuticals, Inc. (Amex: BPA) today announced that a pivotal study on the safety and efficacy of Elestrin™ (estradiol gel) in the treatment of menopausal symptoms has been published in the March issue of Obstetrics & Gynecology, the primary journal of the American College of Obstetricians and Gynecologists (ACOG). The paper titled “Low Dose of Transdermal Estradiol (E2) Gel for Treatment of Symptomatic Postmenopausal Women,” reports on a 12-week, double-blind, placebo-controlled Phase III study of 484 symptomatic menopausal women, which was designed to identify the lowest safe and effective dose of transdermal estradiol therapy. The lead investigator for the multicenter study was Dr. James A. Simon, Director of the Women’s Health Research Center in Washington, D.C.
BioSante received U.S. Food and Drug Administration (FDA) approval of Elestrin (0.87 grams per day and 1.7 grams per day) in December 2006. Elestrin 0.87 grams per day is the lowest approved dose of estradiol therapy in the United States for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) associated with menopause.
“When launched later this year, Elestrin should be of immediate clinical value to practicing physicians and their patients by offering the lowest daily dose of estradiol available for treating symptoms associated with menopause,” said Stephen M. Simes, President and CEO of BioSante. “We are very excited that the lowest dose of Elestrin has been approved. A significant potential advantage of this product is that it is 50 percent lower than the next lowest dose of estradiol currently on the market.”
More than 80 percent of women who used Elestrin reported “great” or “moderate” results, a highly significant improvement over placebo treatment (p<0.0001). In late 2006, BioSante signed a marketing agreement with Bradley Pharmaceuticals, Inc. (NYSE: BDY), which plans to market Elestrin in the U.S. in 2007 through its Kenwood Therapeutics Division.
“We believe that publication of Elestrin data in the top American gynecology journal speaks to the quality of the data and the importance of these clinical results in the treatment of menopausal hot flash symptoms with the lowest effective dose,” Simes said. “The recommendations set forth by ACOG, the FDA and other authoritative groups including the North American Menopause Society to use the lowest dose possible further validates the significance of these findings.”
Elestrin is BioSante’s fast-drying gel formulation of bio-identical estradiol, the same estrogen produced naturally in women. Elestrin is absorbed through the skin after topical application on the upper arm, and delivers estradiol to the bloodstream evenly over time in a non-irritating, painless manner. Elestrin is administered using a metered dose applicator that delivers 0.87 g of gel per actuation, thereby allowing for precise titration from dose to dose. The gel dries quickly in one to two minutes.
According to the North American Menopause Society, more than two-thirds of North American women have hot flashes during menopause. At present, oral conjugated estrogen is the primary treatment for this menopausal symptom. The U.S. estrogen therapy market is currently estimated at approximately $1.3 billion in annual sales, of which the transdermal segment, mostly patches, is about $250 million.
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, breast cancer or dementia. The Women’s Health Initiative (WHI) study reported increased risk of stroke and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 6.8 years of treatment with 0.625 mg of oral conjugated equine estrogens alone per day, relative to placebo.
The WHI study reported increased risk of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli and deep vein thrombosis in postmenopausal women during five years of daily treatment with 0.625 mg of oral conjugated equine estrogens combined with 2.5 mg of medroxyprogesterone acetate per day.
Although studies involving hormone use and breast cancer risk have produced varied results, newly reported estrogen-only data provide strong evidence that estrogen alone does not increase the risk of breast cancer, and in fact may decrease the risk and that transdermal estrogen may be safer than oral estrogen. The North American Menopause Society, the American College of Obstetricians and Gynecologists and the FDA all recommend women use the lowest effective dose of estrogen for the shortest period of time.
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 Elestrin™ (estradiol gel), developed through FDA approval by BioSante, indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, and LibiGel® (transdermal testosterone gel) in Phase III development 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 transdermal gel formulations used in the women’s gel products are licensed by BioSante from Antares Pharma. The company also is developing its calcium phosphate nanotechnology (CaP) for novel vaccines, including hepatitis B, avian flu and biodefense vaccines for toxins such as anthrax, as well as a system for delivering drugs via alternative routes of administration. 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 news release that are not historical in nature, particularly those that utilize terminology such as “may,” “will,” “should,” “likely,” “expects,” “anticipates,” “estimates,” “believes,” “plans,” “hopes,” 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, the success of clinical testing, 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 in BioSante’s most recent Forms 10-K and 10-Q, 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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