BioSante Pharmaceuticals, Inc. (NYSE:BPA)
Industry: Healthcare

Listed 5 Consecutive Market Days. On List as of 07/07/2006 Through 07/14/2006

Biosante Pharmaceuticals, Inc. (Biosante) is a development-stage biopharmaceutical company that is developing a pipeline of hormone therapy products to treat men and women. Hormone therapy gel products include Bio-E-Gel, LibiGel, Bio-E/P-Gel, LibiGel-E/T and Bio-T-Gel Symptoms addressed by these hormone therapies include impotence, lack of sex drive, muscle weakness and osteoporosis in men and menopausal symptoms in women, including hot flashes, vaginal atrophy, decreased libido and osteoporosis. The Company is also engaged in the development of its calcium phosphate (CaP) nanotechnology, for vaccine adjuvants or immune system boosters and drug delivery systems. CaP products in development are BioVant, BioOral and BioAir. In March 2005, the Company completed the pivotal Phase III clinical trial for the proposed Bio-E-Gel product, and in February 2006, submitted a New Drug Application (NDA) to the United States Food and Drugs Administration (FDA). The proposed LibiGel product completed a Phase II clinical trial and is being prepared for Phase III clinical trials, expected to begin during 2006. Hormone Therapy Products The hormone therapy products are gel formulations of testosterone, estradiol, a combination of estradiol and testosterone and a combination of estradiol and progestogen The gels are designed to be absorbed through the skin after application on the arms, shoulders, abdomen or thighs, delivering the hormone to the bloodstream evenly and in a non-invasive, painless manner. The gels are formulated to be applied once per day. Bio-E-Gel is a once daily gel designed to deliver estrogen without the skin irritation associated with, and the physical presence of, transdermal patches. Bio-E-Gel contains bioidentical estradiol versus conjugated equine estrogen contained in the most commonly prescribed oral estrogen. Pivotal Phase III clinical trial of Bio-E-Gel, in March 2005, was completed and an NDA with the FDA was submitted in February 2006. The NDA submitted, in February 2006, 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. FDA requirements for approval of estradiol products include one 12-week Phase III clinical trial. In March 2005, Phase III Bio-E-Gel clinical trial for the treatment of moderate-to-severe hot flashes and vaginal atrophy in menopausal women was completed. 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. Over 80% of women who used Bio-E-Gel reported moderate or great results with Bio-E-Gel (p<0.0001). The filed NDA is seeking approval for all three doses. The LibiGel product is a once daily transdermal testosterone gel designed to treat female sexual dysfunction, specifically HSDD. The majority of women with FSD are postmenopausal, experiencing FSD due to hormonal changes due to aging or following surgical menopause. A Phase II clinical trial of LibiGel has been completed and a Phase III development plan is underway. Results indicate an effective LibiGel dose for the treatment of HSDD in women, and that LibiGel was well tolerated during the course of the trial, and had a safety profile similar to that of the placebo, with none of the patients discontinuing use due to adverse events. Biosante also has patents claiming triple hormone therapy via any route of administration (the combination use of estrogen plus progestogen plus androgen, such as testosterone) and patents pertaining to triple hormone contraception. The Bio-E/P-Gel, which is a combined estrogen/progestogen gel product, has been licensed to Solvay Pharmaceuticals, B.V., which has been responsible for all costs of development to date. The Company competes with Procter & Gamble Company, Noven Pharmaceuticals, Inc., Novavax, Inc., Auxilium Pharmaceuticals, Inc., Watson Pharmaceuticals, Inc. and Solvay Pharmaceuticals, Inc. CaP Te

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