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    BioSante: Study Generates Confidence For Future Treatment

    Wed, 09/14/2011 - 11:18 EDT - Seeking Alpha
    • BPAX
    • Len Zehr
    • TEVA

    By Len Zehr:
    BioSante Pharmaceuticals’ (BPAX) successful pharmacokinetic study of its LibiGel (testosterone gel) treatment for female sexual dysfunction, specifically hypoactive sexual desire disorder (HSDD), is adding to the company’s overall confidence that its ongoing, long-term safety study also will be favorable, as will its efficacy trials.

    “This pharmacokinetic study seems to corroborate our LibiGel safety study, which appears to show the safety of LibiGel versus placebo,” CEO Stephen M. Simes says in an exclusive interview with BioTuesdays. “What we’re seeing over time, although we remain blinded, is that there does not appear to be safety issues for LibiGel versus placebo in these women. In addition, the blood levels of free testosterone produced in this PK study support the potential efficacy of LibiGel.”
    An independent Data Monitoring Committee has reviewed the unblinded safety data six times and recommended each time that the study keep going. A seventh review will be conducted in earlyComplete Story »

    • Original article
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      By M.E. Garza: BioSante Pharmaceuticals, Inc. (BPAX) has just shared some additional data from its principal LibiGel (testosterone gel) pharmacokinetic (pK) study. Will that be enough to break shares away from down-trending resistance levels?

    • With Libigel A Failure, Where Will Biosante Bottom Out?

      By Ganaxi Small Cap Movers:Biosante Pharmaceuticals (BPAX) announced after the market closed today that its lead product in development, Libigel, often incorrectly called Viagra for women, had failed based on an initial analysis of data from two pivotal phase 3 efficac

    • Biosante: Key Catalysts Should Renew Investor Interest

      Sheff Station submits:Biosante’s potential breakthrough product, Libigel, is in Phase III clinical trials for the treatment of female sexual dysfunction. Libigel does not have a partner for the product, and currently there is no pharmaceutical product approved in the U.S.

    • Why BioSante Expects a Positive Review of Drug for Female Sexual Disorder

      Kaushik Paul submits:By May 2011, an independent Data Monitoring Committee (DMC) is expected to review the Phase III safety trial data of BioSante Pharmaceuticals, Inc.'s (BPAX) Libigel, a drug designed for the treatment of female sexual dysfunction (FSD) in surgically menopausal women.

    • Will Biosante's Libigel Make A Comeback?

      By James Stocklasar Thomas Jr.:Biosante (BPAX) deserves attention from the Seeking Alpha community, especially since it was at center stage of the penny-land biotech community going into December 2011. The question on Biosante's investors' minds is: Will Libigel make a comeback? I imagine answers range from the pejorative to unbridled optimism, from, 'No way!' to 'Yes way!'

    • BioSante: LibiGel Lives On, FDA Word On Bio-T-Gel May Come At Any Time

      By Kinetic Investments: By Bert Wilkison

    • Reviving The Blockbuster Potential Of Libigel For Biosante And Antares Pharma

      ByAli Yasar:The news of failed Phase III efficacy studies on Libigel (testosterone gel) being used as a treatment for female sexual dysfunction (FSD) was a surprise to many Biosante Pharmaceuticals (BPAX) investors.

    • BioSante Pharmaceuticals Poised for Continued Success

      By Williams Equity Analysis: BioSante Pharmaceuticals (BPAX) is a biotech company based out of Illinois. The stock has risen about 40% since June 20th with the absence of any major news, so there is significant risk of a short-term pullback. Pipeline

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    • BioSante CEO Pleased With LibiGel Progress

      M.E. Garza submits: On Monday, BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), officially announced additional positive safety data from its ongoing LibiGel® Phase III clinical development program.

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