Friday, November 18, 2011

The risks of eliminating drug risks

Metabolex Inc. closed three big diabetes drug deals last year, lining up millions of dollars in upfront cash and potential milestone payments.
But now, even as the number of U.S. diabetics skyrockets beyond 20 million, the privately held Hayward biotech company wants little to do with the disease.
Instead, it is focusing on arthritis-like gout, with a patient population of about 6 million.
“Gout is viewed well by investors,” Metabolex President and CEO Harold Van Wart said. “There’s a large unmet medical need, and Phase III trials are manageable.”
Therein lies the rub: As the Food and Drug Administration weighs the benefits and risks of drugs — especially in areas like diabetes, cardiovascular and obesity — it is asking companies to undertake extraordinary, some say excessive, additional clinical trials to prove that the drugs are safe. As a result, drug developers and their venture capital backers are abandoning those diseases — or biotech — altogether.

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