Biotech companies like to talk up the discipline it takes to move a drug through years of development, but discovery sometimes depends on plain serendipity. I got an interesting reminder of that the other day from Barry Quart, the CEO of San Diego-based Ardea Biosciences.
Back in late 2007, Ardea (NASDAQ: RDEA) scientists were looking through some of the data from the company’s lead drug candidate for HIV, including the various blood measurements taken to see if the drug is being metabolized. They found a curious effect. The drug reduced the amount of uric acid in the blood. This is the stuff that can accumulate in the joints of some people, creating intensely painful crystals there, and ugly bumps. It’s the disease known as metabolic arthritis, or gout.
The unexpected finding in the HIV trial sparked the curiosity of Ardea’s scientists and management. Digging into the data, they saw the anti-uric acid activity was caused by a byproduct of the HIV drug, a so-called metabolite. That was important because it showed this wasn’t some kind of clinical trial fluke. Plus, the byproduct also had been safely excreted by more than 150 patients in HIV trials, which meant it would likely be a safe drug. The company got more interested when looking at the business opportunity. About 2.1 million people, mostly over age 40, have gout, according to the National Institutes of Health. Incidence has more than tripled in the past 20 years, as the disease is correlated with being overweight, drinking too much alcohol, or having diets too high in meat or fish. ( Gout was once known as the “Disease of Kings,” thought to afflict leaders like Henry VIII and Benjamin Franklin.)
Then came the best part if you’re a drug developer. Only one new drug for treating gout has been approved by the FDA in the past 40 years, and there was really only one other competitor on the horizon (East Brunswick, NJ-based Savient Pharmaceuticals). It was quite a contrast to the competition Ardea was sizing up for HIV, in which there are already 33 FDA approved drugs setting a high bar for anything new.
“When we first noticed this effect in the HIV trial, I was intrigued, but figured it was probably not going to be of much consequence,” Quart says. “I definitely didn’t see building the company up as a gout company.”
Now he does. Ardea expects to report results from a small pilot study of gout patients this month, Quart says. It ought to be able to move quickly into a Phase II clinical trial of gout patients this year, and then into the final stage of clinical trials in 2010, Quart says. “Unlike a lot of drugs, you can get an answer on this product’s efficacy very quickly,” he says.
Ardea in its current form was started in December 2006. Quart, formerly the president of Napo Pharmaceuticals and an executive vice president of Pfizer’s Global R&D, took over the shell of a dead public company (IntraBiotics). The company had $48.5 million left in cash, and Ardea combined that with about 50 scientific staff and some drug candidates acquired from Valeant Pharmaceuticals, Quart says. The original labs were in Orange County (Costa Mesa, CA), until the company moved to San Diego in March 2008.
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