ViroPharma Inc. fell as much as 11 percent after the U.S. Food and Drug Administration sought additional information following a pre-approval inspection of manufacturing facilities for its Cinryze treatment.
ViroPharma declined $1.39, or 8.6 percent, to $14.80 at 10:03 a.m. New York time in Nasdaq Stock Market Composite trading. The shares earlier dropped to as low as $14.39 for the biggest intraday decline since May. The Exton, Pennsylvania- based company said in a statement that it will work “immediately” to respond to the FDA.
Cinryze is administered by infusion every three to four days to prevent swelling attacks in patients with hereditary angioedema, a life-threatening disorder that affects about 6,500 people in the U.S. The drug sells for about $4,000 a dose and if the new facilities are allowed to open, sales may top $250 million next year, said Phil Nadeau, an analyst with Cowen & Co. in New York.
“This is a disappointment, as the manufacturing expansion was expected to be approved on its action date yesterday,” Nadeau said in a note to clients today. “The expansion is necessary to increase Cinryze’s capacity from 60,000 doses annually today to 160,000 doses per year.”
ViroPharma said in the statement that it plans to start manufacturing industrial-scale lots “at risk” in the first quarter of next year.
“We remain committed to provide patients with an uninterrupted supply of Cinryze,” said Vincent Milano, chief executive officer at ViroPharma, in the statement.
Kristina Broadbelt, a spokeswoman for ViroPharma, didn’t immediately return a phone call for comment.
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