Biosante Pharma (AMEX:BPA)
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BioSante Pharmaceuticals (Amex:BPA) announced its
support of today's World Menopause Day, established by the
International Menopause Society to raise awareness of this important
phase in a woman's life.
"Millions of women are now experiencing menopause, yet many are
unaware of the advances made in the understanding and alleviation of
its undesirable effects," said Stephen M. Simes, president and chief
executive officer of BioSante. "As part of BioSante's commitment to
women's health, BioSante supports World Menopause Day and is pleased
to be developing important new treatment options to allow physicians
to provide therapy in accordance with individual patient needs and
preferences, and in the safest possible manner."
At the recent annual meeting of the North American Menopause
Society, researchers presented positive results of a Phase III
clinical study with Bio-E-Gel(TM) (bio-identical estradiol gel), being
developed by BioSante for the treatment of moderate-to-severe hot
flashes in menopausal women. The study showed that the most effective
Bio-E-Gel dose significantly decreased the number of hot flashes by 88
percent, from 12.9 per day at baseline to 1.6 after treatment (p less
than 0.0001). The decrease was also significant versus placebo, with a
mean decrease of 11.3 hot flashes per day with Bio-E-Gel versus a
decrease of 6.1 per day with a placebo (p less than 0.0001).
Bio-E-Gel produced markedly low estradiol blood levels and had a
safety profile similar to that observed in the placebo group.
Moreover, there was minimal application site irritation reported, a
side effect commonly associated with transdermal patches.
"Almost two million women in the U.S. become menopausal every year
as the populous baby boom generation reaches the susceptible age,"
Simes said. "We are very pleased with the results of the Phase III
trial and look forward to submitting Bio-E-Gel to the Food and Drug
Administration for marketing approval."
More than two-thirds of American women experience hot flashes
during or after menopause, according to the North American Menopause
Society. Currently, the leading product for the treatment of
menopausal symptoms is oral conjugated estrogen, which is derived from
pregnant horses' urine and is metabolized first-pass through the
liver. Transdermal
Bio-E-Gel offers an advantage over oral estrogen products by
providing bio-identical estrogen that is not subject to first-pass
liver metabolism, thereby avoiding known side effects associated with
oral administration of conjugated estrogen.
The Phase III trial was a 12-week, randomized, double-blind,
placebo-controlled study of 484 symptomatic menopausal women, using
three dosage levels of Bio-E-Gel in order to establish the lowest
effective dose and optimal safety profile.
World Menopause Day is designated by the International Menopause
Society to raise awareness of the changes a woman's body goes through
in this phase of life, as well as to challenge every woman age 45 or
older to talk to her physician about her individual health history,
her risks for diseases, the benefits and risks associated with hormone
therapy, and steps she can take now to take charge of her health.
About Bio-E-Gel
Bio-E-Gel is a gel formulation of estradiol (bio-identical human
estrogen) designed to be quickly absorbed through the skin after
topical application on the arm or shoulder, 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 bio-identical
estradiol and testosterone. BioSante's lead products include Bio-E-Gel
(bio-identical estradiol gel) for the treatment of women with
menopausal symptoms, and LibiGel(TM) (bio-identical testosterone gel)
for the treatment of female sexual dysfunction (FSD). The transdermal
gel formulations used in the women's gel products are licensed by
BioSante from Antares Pharma Inc. 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.