Regeneron has unleashed a torrent of promising late-stage safety and efficacy data on Arcalyst, teeing up a strong new regulatory filing backing its quest to market the drug against gout.
In one of its Phase III studies a pair of doses triggered a 72 percent mean reduction in gout flares compared to placebo, confirming the results of an earlier study. And in a separate Phase III safety trial the weekly, self-administered subcutaneous dose of rilonacept--an IL-1 Trap--was well tolerated with a higher rate of site injection reactions running higher than the placebo arm. Serious adverse events like infection were about equal in both groups.
The new data drop positions Regeneron to file a biologics license application by the middle of this year, following up on an approval it had achieved for a rare inflammatory condition. As Forbes' Matthew Herper notes, the data is important for Regeneron. Analysts estimate the drug could generate up to $500 million in annual sales for gout. And the developer owns the drug outright.
"Gout, a serious and sometimes debilitating disease, is rapidly growing in prevalence throughout the world. Unfortunately, its management is often hampered by the occurrence of painful gout flares early during treatment with standard-of-care uric acid-lowering therapy," said George Yancopoulos, president of Regeneron Research Laboratories. "With these positive Phase III trials in patients with gout initiating uric acid-lowering therapy, we plan to submit a supplemental Biologics License Application for U.S. regulatory approval in mid-2011."
- here's the Regeneron release
- see the report from Forbes