BioSante Pharmaceuticals, Inc. (NDAQ: BPAX) insiders appeal to be bullish on the stock as it approaches its 52-week low. The biopharmaceutical company, which is developing a female sexual dysfunction drug, saw executives and directors purchase some 151,000 shares in just the last month between $3.59 and $3.98. Meanwhile, not a single insider has sold stock – even when it was trading at a 52-week high last May. So, should individual investors consider buying into this stock?

BioSante currently has a market cap of $110 million with a strong balance sheet, $30 million in cash, no debt, and a promising drug in the pipeline – LibiGel. The new drug is a low-dose testosterone in a gel formulation designed to increase sexual desire in women. A recent study conducted by the Journal of the American Medical Association found that 43% of American women (40 million or so) are estimated to experience some degree of impaired sexual function. The company believes that LibiGel will be the first FDA-approved product for FSD, with an estimated 1.4 million off-label prescriptions written during 3006. The minimum estimated US market for LibiGel is $2 to $4 billion with blockbuster sales potential.

What does the competition look like? Well, Procter & Gamble (NYSE: PG) developed their own twice-weekly testosterone skin patch in 2004, but it was rejected by the FDA and only approved for use in Europe. Since then, they have failed to launch any additional safety studies, so it appears that they will not attempt approval in the United States. Meanwhile, the FDA recently sent warning letters to compounding pharmacies that are pushing “bio-identical hormone replacement therapy” products designed to do the same thing as the testosterone gel. Moreover, BioSante’s FDA approval enables patients to get insurance to cover the drug in many cases – which means more sales.

So, where does the drug stand now? LibiGel needs just 12 months of safety data before a new drug application (NDA) will be considered by the FDA. The Phase 3 trial for the drug launched last week and is designed to demonstrate the product’s safety in low doses. The first efficacy trial is now underway and the company plans to initiate a second in early 2008. Clearly, insiders are also bullish on the prospects of this drug as they are buying up a record amount of stock. Combined, these factors make BPAX a stock worth watching!

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