BioSante Pharmaceuticals Announces Bio-E-Gel(TM) NDA Submission
February 16 2006 - 10:30AM
Business Wire
BioSante Pharmaceuticals, Inc. (Amex:BPA) announced today it has
submitted a New Drug Application (NDA) to the Food and Drug
Administration (FDA) for Bio-E-Gel(TM) (transdermal estradiol gel)
to treat moderate-to-severe hot flashes in menopausal women. The
NDA includes data from one pivotal Phase III clinical trial of
Bio-E-Gel and data from three additional clinical trials required
by the FDA, including a transfer study, a sunscreen study and a
pharmacokinetic study. 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). Importantly, over 80 percent of women who
used Bio-E-Gel reported "moderate" or "great" results with
Bio-E-Gel (p less than 0.0001). The company in its NDA is seeking
approval for all three doses. There were no significant differences
in the safety profile of any dose of Bio-E-Gel compared to placebo
other than for predictable estrogen effects such as breast
tenderness. "We are very pleased to have submitted the Bio-E-Gel
NDA. Bio-E-Gel Phase III trial results indicate the lowest
effective dose of Bio-E-Gel thereby establishing the safest dose of
Bio-E-Gel for women to reduce hot flashes. We believe the low dose
of Bio-E-Gel shown to be safe and effective in this trial also may
be the lowest dose of estrogen available on the market to treat hot
flashes, if and when approved, and will be an attractive
alternative to currently marketed estrogen therapies," said Stephen
M. Simes, president and CEO of BioSante. "We believe Bio-E-Gel if
and when approved by the FDA will be well positioned to compete in
the U.S. estrogen therapy market, currently estimated to total
approximately $1.4 billion in annual sales." About Bio-E-Gel(TM)
Bio-E-Gel is a gel formulation of estradiol (the same estrogen made
by women) designed to be quickly absorbed through the skin after
topical application on the arm and shoulder delivering estradiol to
the bloodstream evenly over time at minimal dosage and in a
non-invasive, painless manner. 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
or dementia. The Women's Health Initiative (WHI) study reported
increased risks of stroke and deep vein thrombosis in
postmenopausal women (50 to 79 years of age) during 6.8 years of
treatment with oral conjugated equine estrogens (CEE 0.625 mg)
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 5 years of
treatment with oral conjugated equine estrogens (CEE 0.625 mg)
combined with medroxyprogesterone acetate (MPA 2.5 mg) per day.
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)
(transdermal estradiol gel) for the treatment of women with
menopausal symptoms, and LibiGel(TM) (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 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. Examples of forward-looking statements
in this release include the statement regarding Bio-E-Gel becoming
an attractive alternative to currently marketed estrogen therapies
and BioSante's belief that Bio-E-Gel will be well positioned to
compete in the U.S. estrogen therapy market. 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 of BioSante's most recent Form 10-Q,
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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