BioSante Pharmaceuticals to Present Bio-E-Gel(R) and Corporate Overview at Rodman & Renshaw Global Healthcare Conference
10 May 2006 - 10:00PM
Business Wire
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.
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