Healthcare Industry News: estradiol gel
News Release - April 19, 2006
BioSante Pharmaceuticals Announces FDA Filing and Review of NDA for Bio-E-Gel(R)LINCOLNSHIRE, Ill.--(HSMN NewsFeed)--April 19, 2006--BioSante Pharmaceuticals, Inc. (Amex:BPA ) announced today that its new drug application (NDA) for Bio-E-Gel (transdermal estradiol gel), an innovative low-dose topical therapy for moderate-to-severe hot flashes in menopausal women, has been accepted for filing and review by the U.S. Food and Drug Administration (FDA).
"This marks an important milestone for the company, and we are hopeful that Bio-E-Gel may become a significant advance in women's health," said Stephen Simes, president and chief executive officer of BioSante. "This bio-identical estrogen gel formulation may not only offer greater comfort and convenience over a pill or a patch, but we believe the lowest effective dose was identified in clinical trials at unusually low daily delivery of estrogen. Thus, if and when approved, Bio-E-Gel may become the lowest dose of estrogen available to treat hot flashes, making it an attractive alternative to currently marketed estrogen therapies."
Bio-E-Gel is a gel formulation of estradiol, the same estrogen produced naturally in women, developed to be quickly absorbed through the skin after topical application on the upper arm , delivering estradiol to the bloodstream evenly over time at minimal dosage and in a fast drying, non-invasive, painless manner.
A 12-week, double-blind, placebo-controlled Phase III study of 484 symptomatic menopausal women was designed to identify the lowest effective dose in order to implement estrogen therapy in the safest possible manner. The women in the study were randomly assigned to one of four treatment arms: low-dose, mid-dose or high-dose Bio-E-Gel, or matching placebo. The four co-primary endpoints, as defined by the FDA, were a significant decrease over placebo in both the number and severity of hot flashes at week 4 and week 12 of treatment.
There was a clear dose response in the reduction in the number and severity of hot flashes across the low, mid, and high doses tested in the Phase III trial. The most effective Bio-E-Gel dose decreased the number of hot flashes by 85 percent, from 12.9 per day at baseline to 1.6 per day after 12 weeks of treatment. 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 less than 0.0001).
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 less than 0.0001), and this significant response was maintained from week 4 to week 12 of treatment (p less than 0.0001).
Beginning at week 5, the low dose of Bio-E-Gel showed a highly significant decrease in the number (p less than 0.001) and severity (p less than 0.01) of hot flashes versus placebo, suggesting identification of the lowest effective dose. This significant response for both number and severity of hot flashes was maintained through week 12 (p less than 0.0001).
Importantly, more than 80 percent of women who used Bio-E-Gel reported "moderate" or "great" results (p less than 0.0001). The company in its NDA is seeking approval for all three doses.
The lowest dose of Bio-E-Gel produced low estradiol blood levels with a safety profile similar to that observed in the placebo group. There were no significant differences in the safety profile of any dose of Bio-E-Gel compared to placebo other than predictable estrogen effects such as breast tenderness.
"Bio-E-Gel offers an important additional advantage over oral estrogen products by providing bio-identical estrogen that is not subject to first-pass liver metabolism, thus avoiding further potential side effects associated with oral administration of conjugated estrogen," Simes noted. "It is also less conspicuous than wearing a patch, with less potential for irritation."
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 menopausal symptoms. The U.S. estrogen therapy market is currently estimated at approximately $1.3 billion in annual sales, of which the transdermal segment, mostly patches, already is about $250 million and growing.
The NDA includes data from the pivotal Phase III clinical trial of Bio-E-Gel and data from three additional clinical trials, including a transfer study, a sunscreen study and a pharmacokinetic study.
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 (50 to 79 years of age) 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.
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 (transdermal estradiol gel) for the treatment of women with menopausal symptoms, and LibiGelŪ (transdermal 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 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, 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 22 to 34 in BioSante's most recent Form 10-K, which discussion also is incorporated herein by reference. Additional risk factors include the risk that the FDA will not approve Bio-E-Gel for marketing or that if approved, Bio-E-Gel may not achieve commercial success. 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.
Source: BioSante Pharmaceuticals
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