Biosante Pharma (AMEX:BPA)
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BioSante Pharmaceuticals, Inc. (Amex:BPA) today
announced that Stephen M. Simes, the company's president and chief
executive officer, will present a corporate overview including a
summary of Bio-E-Gel(R), BioSante's transdermal estradiol gel for the
treatment of menopausal symptoms in women, at Rodman & Renshaw's 3rd
Annual Global Healthcare Conference in Monte Carlo, Monaco. The
presentation will take place on Monday, May 15, at 3:40 p.m. CEST
(9:40 a.m. EDT).
"Bio-E-Gel may offer greater comfort and convenience over a pill
or a patch, and we believe the lowest effective dose was identified in
clinical trials," commented Mr. Simes. "If and when approved,
Bio-E-Gel may become the lowest dose of estrogen available to treat
hot flashes, making it an attractive alternative in estrogen therapy.
We look forward to reviewing our positive Phase III data and
presenting our corporate overview at the Rodman & Renshaw Conference."
A live audio webcast of BioSante's presentation may be accessed at
http://wsw.com/webcast/rrshq8/bpa and a replay will be available at
the same link for 90 days. For additional information about the Rodman
& Renshaw Conference, please visit
http://www.rodmanandrenshaw.com/eu06conference.
About Bio-E-Gel(R)
Bio-E-Gel (transdermal estradiol gel) is a gel formulation of
bio-identical estradiol, the same estrogen produced naturally in
women. It is designed 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. The new drug application (NDA) for
Bio-E-Gel, submitted in February, has been accepted for filing and
review by the U.S. Food and Drug Administration (FDA).
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 significantly
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 (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.
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 approximately $250
million and growing.
About Estrogens
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(R) (transdermal estradiol gel) for the treatment of women
with menopausal symptoms, and LibiGel(R) (transdermal testosterone
gel) for the treatment of female sexual dysfunction (FSD). A Bio-E-Gel
New Drug Application (NDA) was submitted to the FDA in the first
quarter of 2006. 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 Inc. The company also is developing its
calcium phosphate nanotechnology (CaP) for novel vaccines, including
avian flu and 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.