BioSante Pharmaceuticals Announces Bio-E-Gel(TM) (estradiol gel); Significantly Reduces Hot Flashes in Menopausal Women; Investo
06 July 2005 - 10:01PM
Business Wire
BioSante Pharmaceuticals, Inc. (Amex: BPA) announced today
significant Phase III safety and efficacy results of Bio-E-Gel(TM)
(bioidentical estradiol transdermal gel) for the treatment of
moderate-to-severe hot flashes in menopausal women. A new drug
application (NDA) will be filed as soon as possible after
completion of the data analyses. The Phase III trial was a 12-week,
randomized, double-blind, placebo-controlled study of 484
symptomatic menopausal women. Following FDA recommendations, the
Phase III trial tested three doses of Bio-E-Gel in order to
establish the lowest effective dose and maximize the safety
profile. The four co-primary endpoints, as defined by the FDA, are
a significant decrease over placebo in both the number and severity
of hot flashes at Week 4 and Week 12 of treatment. Across the low,
mid, and high Bio-E-Gel doses tested in the Phase III trial, there
was a clear dose response in the reduction in the number and
severity of hot flashes. 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, therefore 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). There were no significant differences in the
safety profile of any dose of Bio-E-Gel compared to placebo. A full
report of the Phase III trial data is targeted for a medical
meeting in the fall with publication in a peer-reviewed journal to
follow. "We are very pleased the Phase III trial results indicate
the lowest effective dose of Bio-E-Gel thereby establishing the
safest dose for women to begin treatment for reducing hot flashes.
We look forward to completing the preparation and submission of the
NDA as soon as possible," said Dr. Leah M. Lehman, vice president
of product development of BioSante. "We believe the low dose of
Bio-E-Gel shown to be safe and effective in this trial will be an
attractive alternative to currently marketed estrogen therapies."
"This successful Phase III trial and the anticipated Bio-E-Gel NDA
represent important milestones for BioSante," said Stephen M.
Simes, president and CEO of BioSante. "We believe Bio-E-Gel will be
well positioned to compete in the U.S. estrogen therapy market,
currently estimated to total approximately $1.4 billion in annual
sales." Note: BioSante will hold a conference call for investors
today at 11:00 a.m. ET. To participate, dial toll-free
877-407-9210. To access the live broadcast in listen only mode,
please visit: http://www.vcall.com/CEPage.asp?ID=92620, which will
be available until October 6, 2005. About Bio-E-Gel(TM) Bio-E-Gel
is a gel formulation of estradiol (bioidentical human estrogen)
designed to be quickly absorbed through the skin after topical
application on the arms and shoulders 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 bioidentical estradiol and testosterone. BioSante's lead
products include Bio-E-Gel(TM) (bioidentical estradiol gel) for the
treatment of women with menopausal symptoms, and LibiGel(TM)
(bioidentical 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 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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