Regeneron's Arcalyst Treatment Shown to Help Prevent Gout Flares in Study
Regeneron Pharmaceuticals Inc. said its only marketed product, Arcalyst, helped prevent gout flares in a late-stage study of patients starting therapy to lower uric acid levels.
Those taking an injection of 80 or 160 milligrams a week of Arcalyst over four months had a decrease of 72 percent in gout flares compared with placebo, Tarrytown, New York-based Regeneron said today in a statement. The data, from the third and final stage of testing generally required for approval, will support an application with U.S. regulators by mid-2011, the company said.
About 750,000 gout patients start taking uric acid-lowering therapy such as allopurinol each year, Mark Monane, an analyst with Needham & Co. in New York, wrote in a Feb. 17 research note. During the first few months of therapy, the breakup of uric acid crystals can cause flares of joint pain, which Arcalyst aims to prevent. If successful, the medicine may generate up to $500 million in annual revenue, Monane estimated.
Arcalyst “may have significant potential as a co-treatment in allopurinol initiation for chronic gout,” Monane said in his note. “We were impressed by the drastic reduction in the mean number of gout flares” in an earlier study, he said.
The medicine was generally well-tolerated, and the incidence of severe adverse events was similar in both arms of the study reported today, Regeneron said. Mild injection-site reactions were more common in the Arcalyst arm, the company said.
Arcalyst was approved in February 2008 for the treatment of rare, inherited autoinflammatory diseases known as Cryopyrin- Associated Periodic Syndromes. The drug had $25.3 million in revenue last year, according to a Feb. 17 Regeneron statement.
Regeneron fell 73 cents, or 2 percent, to $36.27 at 4 p.m. New York time in Nasdaq Stock Market trading. The shares gained 48 percent in the past 12 months.
To contact the reporter on this story: Meg Tirrell in New York at mtirrell@bloomberg.net.
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net.
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