BioSante Pharmaceuticals Announces Bio-E-Gel(TM) NDA Submission

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.