BioSante Pharmaceuticals Announces FDA Filing and Review of NDA for Bio-E-Gel(R)

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.