BioSante Pharmaceuticals Announces FDA Filing and Review of NDA for Bio-E-Gel(R)
April 19 2006 - 8:00AM
Business Wire
BioSante Pharmaceuticals, Inc. (Amex:BPA) announced today that its
new drug application (NDA) for Bio-E-Gel (transdermal estradiol
gel), an innovative low-dose topical therapy for moderate-to-severe
hot flashes in menopausal women, has been accepted for filing and
review by the U.S. Food and Drug Administration (FDA). "This marks
an important milestone for the company, and we are hopeful that
Bio-E-Gel may become a significant advance in women's health," said
Stephen Simes, president and chief executive officer of BioSante.
"This bio-identical estrogen gel formulation may not only offer
greater comfort and convenience over a pill or a patch, but we
believe the lowest effective dose was identified in clinical trials
at unusually low daily delivery of estrogen. Thus, if and when
approved, Bio-E-Gel may become the lowest dose of estrogen
available to treat hot flashes, making it an attractive alternative
to currently marketed estrogen therapies." Bio-E-Gel is a gel
formulation of estradiol, the same estrogen produced naturally in
women, developed to be quickly absorbed through the skin after
topical application on the upper arm , delivering estradiol to the
bloodstream evenly over time at minimal dosage and in a fast
drying, non-invasive, painless manner. A 12-week, double-blind,
placebo-controlled Phase III study of 484 symptomatic menopausal
women was designed to identify the lowest effective dose in order
to implement estrogen therapy in the safest possible manner. The
women in the study were randomly assigned to one of four treatment
arms: low-dose, mid-dose or high-dose Bio-E-Gel, or matching
placebo. The four co-primary endpoints, as defined by the FDA, were
a significant decrease over placebo in both the number and severity
of hot flashes at week 4 and week 12 of treatment. There was a
clear dose response in the reduction in the number and severity of
hot flashes across the low, mid, and high doses tested in the Phase
III trial. The most effective Bio-E-Gel dose decreased the number
of hot flashes by 85 percent, from 12.9 per day at baseline to 1.6
per day after 12 weeks of treatment. 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 with
placebo (p less than 0.0001). 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, 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, more than 80 percent of women who used
Bio-E-Gel reported "moderate" or "great" results (p less than
0.0001). The company in its NDA is seeking approval for all three
doses. The lowest dose of Bio-E-Gel produced low estradiol blood
levels with a safety profile similar to that observed in the
placebo group. There were no significant differences in the safety
profile of any dose of Bio-E-Gel compared to placebo other than
predictable estrogen effects such as breast tenderness. "Bio-E-Gel
offers an important additional advantage over oral estrogen
products by providing bio-identical estrogen that is not subject to
first-pass liver metabolism, thus avoiding further potential side
effects associated with oral administration of conjugated
estrogen," Simes noted. "It is also less conspicuous than wearing a
patch, with less potential for irritation." According to the North
American Menopause Society, more than two-thirds of North American
women have hot flashes during menopause. At present, oral
conjugated estrogen is the primary treatment for menopausal
symptoms. The U.S. estrogen therapy market is currently estimated
at approximately $1.3 billion in annual sales, of which the
transdermal segment, mostly patches, already is about $250 million
and growing. The NDA includes data from the pivotal Phase III
clinical trial of Bio-E-Gel and data from three additional clinical
trials, including a transfer study, a sunscreen study and a
pharmacokinetic study. 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, breast
cancer or dementia. The Women's Health Initiative (WHI) study
reported increased risk of stroke and deep vein thrombosis in
postmenopausal women (50 to 79 years of age) during 6.8 years of
treatment with 0.625 mg of oral conjugated equine estrogens 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 five years of daily treatment with 0.625 mg of
oral conjugated equine estrogens combined with 2.5 mg of
medroxyprogesterone acetate per day. Although studies involving
hormone use and breast cancer risk have produced varied results,
newly reported estrogen-only data provide strong evidence that
estrogen-alone does not increase the risk of breast cancer, and in
fact may decrease the risk. 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 (transdermal estradiol gel) for the treatment of
women with menopausal symptoms, and LibiGel(R) (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 news release that are not
historical in nature, particularly those that utilize terminology
such as "may," "will," "should," "likely," "expects,"
"anticipates," "estimates," "believes," "plans," "hopes," 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 22 to 34 in BioSante's most recent Form
10-K, which discussion also is incorporated herein by reference.
Additional risk factors include the risk that the FDA will not
approve Bio-E-Gel for marketing or that if approved, Bio-E-Gel may
not achieve commercial success. 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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