BioSante Pharmaceuticals Honors World Menopause Day
October 18 2005 - 8:00AM
Business Wire
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.
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