Stock Alert for BioSante Pharmaceuticals Inc. (BPAX)
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    Small-Cap Stock on Watch: BioSante Pharmaceuticals Inc. (BPAX)

    Small-Cap Stock on Watch: BioSante Pharmaceuticals Inc. (BPAX)

    Shares of specialty pharmaceutical company BioSante Pharmaceuticals Inc. (NASDAQ: BPAX) climbed as much as $0.55 Tuesday before closing the session at $0.52.  Over 7.53 million shares were traded. BPAX is currently trading below its 50-day and 200-day moving averages of $2.02 and $2.53, respectively.  Market capitalization currently stands at 56.90 million and it has 110.01 million outstanding shares.

    Based in Lincolnshire, Ill., BioSante is focused on developing products for female sexual health and oncology. Its lead products include LibiGel (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development according to a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA).

    The company’s first FDA-approved product is Elestrin (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante’s licensee. The company also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel, a testosterone gel for male hypogonadism, for which a New Drug Application (NDA) is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development.

    Shares of BioSante plunged earlier this month after the company reported that LibiGel failed to achieve primary endpoints in the treatment of hypoactive sexual desire disorder in postmenopausal women.  While there were no statistical differences in the endpoints, the company said all results were in the appropriate directions.  Importantly, the company said that, as seen in previous pharmacokinetic data, the LibiGel groups in both trials showed an increase in free testosterone levels compared to baseline and placebo.

    The trials demonstrated that LibiGel was generally well tolerated with a safety profile that appears to be comparable to placebo, the company said in a statement.

    “We will continue to analyze the efficacy trial data fully and determine plans for our next steps in the LibiGel development plan, and provide an update at a later time, commented BioSante’s president and CEO Stephen M. Simes.  “While the LibiGel Phase III cardiovascular and breast cancer safety study currently continues as planned, we will be analyzing the best path forward for the study given the results reported today. I want to thank our entire BioSante clinical team and the clinical investigators for their tireless efforts in these trials, and I also want to thank the women enrolled in the BLOOM trials for their participation.”

    BPAX shares gained 24.5% in the last five days, though the stock dropped 76.7% in the last month.  Year-to-date, the stock is down 74.1%.

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