For some drugs, safety is everything.
Biosante Pharmaceuticals (Nasdaq: BPAX) was up more than 9% at one point today after the company said the independent Data Monitoring Committee believed Biosante's female sexual dysfunction drug, LibiGel, was safe enough to allow the trial to continue.
Investors must have realized that "safe enough to continue" isn't the same as "safe enough to be approved" because it's given back all its gains and then some.
Still, the point remains: Safety is extremely important to LibiGel's success. In fact, the whole purpose of the clinical trial is to measure the cardiovascular and breast cancer risk in patients taking LibiGel.
There aren't any drugs approved for treating female sexual dysfunction, but that's not for lack of trying. Procter & Gamble (NYSE: PG) developed a testosterone patch, Intrinsa, but the Food and Drug Administration advisory panel shot it down. More recently, the panel of outside experts recommended against approving Boehringer Ingelheim's Girosa because of a host of issues including efficacy and side effects.
Female sexual dysfunction drugs are held to considerably higher safety standards than other drugs considering the problem that it treats isn't a life-or-death issue -- even on Valentine's Day. I'm not sure that erectile dysfunction drugs -- Pfizer's (NYSE: PFE) Viagra, Eli Lilly's Cialis, and Levitra sold by Merck (NYSE: MRK), GlaxoSmithKline, and Bayer -- would gain approval given the current FDA environment. The drugs have been linked to loss of vision and hearing.
Even if LibiGel doesn't increase the risk of cardiovascular events and breast cancer, investors have to be prepared for the FDA to find something else wrong with the drug. The obesity drugs being developed by Arena Pharmaceuticals (Nasdaq: ARNA), VIVUS (Nasdaq: VVUS) and Orexigen (Nasdaq: OREX) are a good example of lifestyle drugs being held to a higher standard.
At a market cap of less than $200 million, Biosante has a chance to get turned on if the FDA were to approve LibiGel next year -- the potential market for female sexual dysfunction is estimated at $2 billion -- but investors should be prepared for an extended cuddling session rather than a quickie approval.
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