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Monday, November 1, 2010

Investorideas.com - Featured Biotech/Pharma Stock Profile Update for Biotech Investors; BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX)

Investorideas.com - Featured Biotech/Pharma Stock Profile Update for Biotech Investors; BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX)

Recent Key Highlights; BioSante Pharmaceuticals Reports Positive LibiGel® Data Monitoring Committee Recommendation

Visit this company: www.biosantepharma.com

Point Roberts, WA, LINCOLNSHIRE, Ill - November 1, 2010 (Investorideas.com newswire, www.biotechindustrystocks.com) updates the showcase biotech stock profile for BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) for investors following biotech and pharma stocks.

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) reports recent news; "BioSante Pharmaceuticals Reports Positive LibiGel® Data Monitoring Committee Recommendation."

The BPAX company profile is available at http://www.investorideas.com/CO/BPAX/ for interested biotech investors.

Full Media Kit at: http://www.biosantepharma.com/downloads/BioSante-Fact-Sheet.pdf

Company Overview:
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante’s lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration(FDA) Special Protocol Assessment and Elestrin™ (estradiol gel) for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, which is marketed in the U.S. by Azur Pharma, BioSante’s licensee. BioSante also is developing a portfolio of cancer vaccines (GVAX), three of which have been granted orphan drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in PhaseII clinical development using BioSante patented technology. The company also is developing its calcium phosphate technology (CaP) for aesthetic medicine (BioLook™), among other uses, as well as seeking opportunities for its 2A/Furin and other technologies.

Lead Products – Multi-Billion Dollar Markets
BioSante is focused on developing innovative products for female sexual health and oncology. The current market for testosterone and estrogen products is approximately $2.5 billion dollars in the U.S. alone, with estimates for female sexual dysfunction (FSD) potentially adding more than $2.0 billion. In addition, the current market for hormonal contraception is approximately $3.0 billion. The market for oncology products is over $20 billion.
BioSante’s lead near term product in development is LibiGel® (testosterone gel) for the treatment of FSD. LibiGel’s clinical development program consists of two Phase III safety and efficacy trials, being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. Each trial will enroll approximately 500 surgically menopausal women for six months of treatment in double-blind placebo-controlled trials. Also ongoing is one Phase III cardiovascular events-driven safety study, enrolling between 2,500 and 4,000 women with cardiovascular risk factors, on therapy for one year and then followed for an additional four years after New Drug Application (NDA) submission and potential FDA approval. To date, over 2,500 women have been enrolled in the safety study. A completed LibiGel Phase II clinical trial has shown excellent results with a significant 238% increase in the total number of satisfying sexual events. There are currently no pharmaceutical products approved for the treatment of FSD in the U.S. however over 4 million prescriptions for testosterone were written off-label by physicians for women in 2009.

BioSante’s marketed product, ElestrinTM, is FDA approved to reduce hot flashes in menopausal women. The lower of the two approved Elestrin doses is 67% lower than the lowest dose transdermal patch available for the treatment of hot flashes. Elestrin is marketed in the U.S. by Azur Pharma.

BioSante is focused primarily on LibiGel, however, the Company also is seeking future development opportunities for its cancer vaccines, which are non patient-specific therapies comprised of whole tumor cells that have been modified to secrete GM-CSF (granulocyte-macrophage colony-stimulating factor), an immune stimulatory cytokine, and then irradiated for safety and are administered via intradermal injections on an outpatient basis. Currently, several of BioSante’s cancer immunotherapies are in Phase II clinical trials at Johns Hopkins Cancer Center and BioSante has been granted FDA Orphan Drug designation for its pancreatic cancer, acute myloid leukemia and chronic myeloid leukemia vaccines.

Recent Company News:
BioSante Pharmaceuticals Reports Positive LibiGel® Data Monitoring Committee Recommendation
"LINCOLNSHIRE , Illinois (October 25, 2010) - BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced that the Phase III LibiGel (testosterone gel) cardiovascular and breast cancer safety study will continue without modifications and will continue to enroll new subjects as a result of the fourth unblinded review of adverse events and the first unblinded statistical analysis for sample-size determination by its independent Data Monitoring Committee (DMC). The review and statistical analysis were based on 2,500 subjects who have been enrolled in the study. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is currently no FDA approved product."
Full News: http://www.investorideas.com/CO/BPAX/news/10252.asp

Financial Highlights
At September 30, 2010, BioSante had approximately $36M in cash
Monthly burn rate of approximately $3.5M

Investment Highlights
Financial resources to implement plan
Late stage pharmaceutical product portfolio with significant growth potential
LibiGel in three ongoing Phase III safety and efficacy clinical studies
Elestrin is FDA approved and marketed in the U.S.
Proprietary cancer vaccines in Phase II clinical trials
Focused growth strategy
Management's proven ability to gain FDA approval, implement plans and increase stockholder value

Key Products
LibiGel® - In development under an SPA for treatment of female sexual dysfunction. Three Phase III safety and efficacy clinical studies are ongoing.

ElestrinTM - FDA approved transdermal gel for treatment of hot flashes; currently marketed in the U.S. by Azur Pharma.

The Pill-PlusTM - Triple hormone contraceptive in Phase II clinical development combining hormone contraceptive and androgen. Licensed to and being developed by Pantarhei Bioscience for oral uses.

Bio-T-GelTM - In development by TEVA USA for the treatment of hypogonadism in men.

Cancer Vaccines - A portfolio of cancer vaccines in Phase II clinical trials for various cancer types, conducted at Johns Hopkins Cancer Center.

Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp

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If you have any questions regarding information in this press release please contact the company listed in the press release.

Contact BioSante Pharmaceuticals
For Media:The Trout Group LLCTricia Swanson(646) 378-2953tswanson@troutgroup.com
or
For Investors:McKinney/ChicagoAlan Zachary(312) 944-6784 ext. 316azachary@mckinneychicago.com

The content from the investor Fact sheet and opinions from http://www.biosantepharma.com/downloads/BioSante-Fact-Sheet.pdf are not the opinion of Investorideas.com or related websites.

Disclaimer: The following news is paid for by BPAX (three thousand per month) Investorideas.com is a third party publisher of news and research .Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
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Source: Investorideas.com, BioSante

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