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DRUG DEVELOPMENT

A Bear Market

    
The Burrill Report

page 3 of 3

The question of why Pfizer and Eli Lilly aren’t throwing money at Steer and his colleagues highlights the chicken-and-egg problem at the heart of the biotech venture capital industry. “When I first made these discoveries, I probably wrote 50 letters to big pharmaceutical companies,” Steer says. “But the molecule isn’t patentable—they said to come back when you have one.”

Since the original patent has run out, the only way to make money from UDCA today (besides marketing its generic form) is to patent a new, clinically proven use for it, or else discover a new formulation or application method. With this in mind, Steer and two partners formed SMG Therapeutics in 2006 to license the patents held by the University of Minnesota for new uses of UDCA. The next step is to raise funding to formulate the drug and run the difficult, expensive human placebo trials required by the FDA.

In the end, says Dennis McWilliams, one of Steer’s partners, “you have to be able to show investors that you can make money.” In other words, it takes money to make money and to heal people. “That’s how the industry works.”

“The preclinical work in animals is nothing short of astounding,” says Martin Carey of Harvard’s Brigham and Women’s Hospital. Still, he says, large-scale doubleblind clinical trials on people will be necessary to pass a final verdict. So far, all testing has been on animals, with the exception of ongoing studies on Lou Gehrig’s disease at the University of Minnesota. (These Phase 1 trials have already shown that UDCA can cross the blood-brain barrier, a crucial hurdle for any drug meant to treat brain disorders.)

With degenerative disorders such as Alzheimer’s, Huntington’s disease, and strokes, it’s especially difficult to set up clinical trials to prove that a compound works. The bar is typically higher, therefore, for pharmaceutical companies to become involved in treatments. Luckily, says McWilliams, “since the drug is already wellknown and well-tolerated, a lot of the safety and toxicity risks are eliminated.” They hope to start human testing in a year or two, depending on financing.

Ultimately, Big Pharma will almost certainly step in, says McWilliams, either to help with clinical trails or to market and distribute the new drugs. “There’s always a decision to make: At what point do you turn it over to them?”

If ursodeoxycholic acid has half the therapeutic potential researchers like Steer think it might, that raises another question: Could trumpeting the effects of an ingredient of bear bile encourage bear farming? Could the magic bullet backfire? Concerns like this bring people like Steer and Robinson together in a collaboration of conservationist and laboratory scientist trying to align their goals to make sure one doesn’t undermine the other.

“The only time I ever come in contact with bears is at a zoo,” says Steer, who nonetheless shares the results of his work with Animals Asia in part to help convince its audience that not only do bear bile acids work, but that there are alternatives to farmed sources.

It’s vital to persuade Asian doctors and patients, who prefer natural (i.e. farmed) sources of bear bile, to choose alternatives such as synthetic sources or herbs, says Robinson. It won’t be easy, when a single poached bear can equal a year’s income in Vietnam. The Chinese government has strongly resisted international pressure to close or regulate bear farms, claiming that the practice actually protects wild populations by satisfying consumer demand.

A showdown may be coming with the approach of the “green” Olympics in Beijing in 2008. The European Parliament has already called on China to end bear farming by the beginning of the games.

As groups like Animals Asia rescue caged bears (218 as of 2006), Steer and his colleagues explore UDCA’s inner workings and entrepreneurs like McWilliams woo VC funds. In the meantime, both animals and potential patients must continue to wait.

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May 17, 2007
http://www.burrillreport.com/article-a_bear_market.html

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