Investorideas.com - Biotech/Pharma Stock Profile Update; BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX)
Recent News; BioSante Pharmaceuticals Reports Positive LibiGel® Data Monitoring Committee Recommendation
Point Roberts, WA, LINCOLNSHIRE, Ill –October 27, 2010 (Investorideas.com Newswire, www.biotechindustrystocks.com) reports the following updates for showcase biotech stock BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) Recent updates to the company profile include company news on its lead near term product LibiGel®, in addition to media kit highlights for investors.
The company reports recent news; “BioSante Pharmaceuticals Reports Positive LibiGel® Data Monitoring Committee Recommendation.”
The 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
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 Phase II clinical development using BioSante patented technology. The company also is developing its calcium phosphate technology (CaP) for aesthetic medicine (BioLook™), as a vaccine adjuvant, including for an H1N1 (swine flu) vaccine, and drug delivery as well as seeking opportunities for its 2A/Furin and other technologies.
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
Lead Products – Multi-Billion Dollar Markets
BioSante is focused on developing innovative products for female sexual health and oncology. he current market for testosterone and estrogen products is approximately $2.5billion dollars in the U.S. alone, with estimates for female sexual dysfunction 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 also is a multi-billion dollar market. BioSante’s lead near term product in development is LibiGel® (testosterone gel) for the treatment of female sexual dysfunction (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. 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 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 will focus primarily on LibiGel, BioSante’s testosterone gel in Phase III clinical development for the treatment of female sexual dysfunction (FSD). The Company also will seek 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 myeloid leukemia and chronic myeloid leukemia vaccines.
• 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
• Proprietary CaP technology with aesthetic medicine potential
• Focused growth strategy
• Management’s proven ability to gain FDA approval, implement plans and
increase stockholder value
• At March 31, 2010, BioSante had approximately $41M in cash
• Monthly burn rate of approximately $2.5-$3.0M
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.
Cancer Vaccines — A portfolio of
cancer vaccines in Phase II clinical trials for
various cancer types, conducted at Johns
Hopkins Cancer Center.
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Contact BioSante Pharmaceuticals
The Trout Group LLC
(312) 944-6784 ext. 316
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