Biosante Pharma (AMEX:BPA)
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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.