BioSante Pharmaceuticals Presents Bio-E-Gel(R) Data at North American Menopause Society Meeting.

Bio-E-Gel effective at dose 50% lower than lowest dose of estradiol available to treat hot flashes 

LINCOLNSHIRE, Ill. -- BioSante Pharmaceuticals, Inc. (Amex: BPA) announced today that it will present safety and efficacy data for Bio-E-Gel([R]) (transdermal estradiol gel), an innovative low-dose topical therapy for moderate-to-severe hot flashes in menopausal women, at the 17th annual meeting of the North American Menopause Society (NAMS) in Nashville October 11-14, 2006. Bio-E-Gel has been shown to be effective at a daily dose of estradiol that is 50 percent lower than the lowest dose currently available for the treatment of hot flashes.

"This will be the first public presentation of the actual Bio-E-Gel doses used in our Phase III clinical study, and we believe that our results suggest 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 the study identified the lowest effective treatment dose at an unusually low level of estrogen. In fact, the lowest effective dose of Bio-E-Gel observed in our study delivers approximately 12.5 micrograms of estradiol per day whereas the lowest dose estradiol treatment currently marketed for hot flashes requires twice as much estrogen, 25 micrograms per day. Thus, if and when approved,

Bio-E-Gel will become the lowest dose of estradiol available to treat hot flashes, making it an attractive, lower-dose alternative to currently marketed estrogen therapies."

Numerous regulatory and professional groups including the Food and Drug Administration (FDA), The American College of Obstetricians and Gynecologists (ACOG), and NAMS recommend use of the lowest effective dose of estrogen consistent with treatment objectives. Bio-E-Gel will add a new lowest dose treatment option.

Bio-E-Gel is a fast-drying gel formulation of estradiol, the same estrogen produced naturally in women. Bio-E-Gel was developed to be absorbed through the skin after topical application on the upper arm, and delivers estradiol to the bloodstream evenly over time in a non-irritating, painless manner. Bio-E-Gel is administered using a metered dose applicator that delivers 0.87 g of gel per actuation, thereby allowing for precise titration from dose to dose. The gel dries quickly in one to two minutes.

A 12-week, double-blind, placebo-controlled Phase III study of 484 symptomatic menopausal women was designed to identify the lowest effective dose to allow estrogen treatment in the safest possible manner. The lead investigator for the multicenter study was Dr. James A. Simon, director of the Women's Health Research Center in Washington, D.C. The women in the study were randomly assigned to one of four treatment arms: low-dose (0.87 g), mid-dose (1.7 g) or high-dose (2.6 g) of Bio-E-Gel, or matching placebo. The U.S. Food & Drug Administration (FDA) defined endpoints were a significant decrease over placebo in both the number and severity of hot flashes at week 4 and week 12 of treatment.

Study results showed a clear dose response in the reduction in the number and severity of hot flashes in the low, mid, and high doses tested. The most effective Bio-E-Gel dose decreased the number of hot flashes by 85 percent by 12 weeks of treatment, from 12.9 hot flashes per day at baseline to 1.6 per day at the end of the 3 month study. The decrease compared to placebo treatment was significant (p<0.0001), with a mean decrease of 11.3 hot flashes per day with Bio-E-Gel and a decrease of 6.1 per day with placebo by study end.

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<0.0001), and this significant response was maintained from week 4 through week 12 of treatment (p<0.0001).

The 12.5 microgram/day dose of Bio-E-Gel showed a highly significant decrease in the number (p<0.001) and severity (p<0.01) of hot flashes versus placebo by Week 5. Since a lower dose would not be as effective as quickly this implies identification of the lowest effective estrogen dose for hot flash treatment. With this low dose, the significant decrease in the number and severity of hot flashes was maintained through week 12 (p<0.0001).

Importantly, more than 80 percent of women who used Bio-E-Gel reported "great" or "moderate" results, a highly significant improvement over placebo treatment(p<0.0001). In its new drug application (NDA), BioSante is seeking approval for all three doses of Bio-E-Gel.

The lowest dose of Bio-E-Gel studied produces very low estradiol blood levels and exhibits 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. Further, the application site reactions were minimal and very infrequent, and no subjects discontinued the study due to application site reactions. Nearly all subjects, 97 percent, in the lowest dose group completed the Phase III study.

"Additionally, Bio-E-Gel offers an important advantage over oral estrogen products by providing bio-identical estrogen that is not subject to first-pass liver metabolism, thus avoiding potential side effects associated with oral administration of conjugated estrogen," Simes noted. "It is less conspicuous than wearing a patch, and is less likely to cause irritation."

According to NAMS, more than two-thirds of North American women have hot flashes during menopause. At present, oral conjugated estrogen is the primary treatment for this menopausal symptom. The U.S. estrogen therapy market is currently estimated at approximately $1.3 billion in annual sales, of which the transdermal segment, mostly patches, is about $250 million.

The NDA for Bio-E-Gel currently is undergoing FDA review and includes data from the pivotal Phase III clinical trial of Bio-E-Gel and data from three additional clinical trials; 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 bio-identical 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). A Bio-E-Gel NDA was submitted to the FDA in the first quarter 2006. The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion. The transdermal gel formulations used in the women's gel products are licensed by BioSante from Antares Pharma Inc. The company also is developing its calcium phosphate nanotechnology (CaP) for novel vaccines, including avian flu and 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 in BioSante's most recent Forms 10-K and 10-Q, which discussion also is incorporated herein by reference. Additional risk factors include the risk that Bio-E-Gel may not be approved by the FDA or that Bio-E-Gel may not be successfully marketed. 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.