Arcalyst is currently approved to treat Cryopyrin-Associated Periodic Syndromes, an ultra-orphan disease that only affects a handful of patients. Gout, the new indication that Regenron is testing Arcalyst in, is a considerably larger market.
The latest results confirmed earlier findings that Arcalyst is able to decrease painful flare-ups that gout patients often experience when they start taking allopurinol, an older medication for gout. The 72% decrease in mean number of gout flares compared with placebo is pretty significant.
While Arcalyst could theoretically be used by all gout patients starting therapy, doctors may wait to see if patients experience gout flare-ups before prescribing the drug that has to be injected weekly. In the placebo group, only 56% of patients had a flare-up during the 16-week trial.
The short time that the drug has to be taken -- compared to indefinite times for drugs like Pfizer's
Regeneron expects to file an application to sell the drug as a treatment for gout in the middle of the year. By the time it hears back from the agency, it could already have its second drug, VEGF Trap-Eye, on the market; the company submitted its marketing application for that drug to the FDA last week.
Despite the two major accomplishments, much of Regeneron's $3.2 billion market cap is tied up in its cancer drug, Aflibercept, which is partnered with sanofi-aventis
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