ViroPharma Hits FDA Snag (VPHM)
ViroPharma Incorporated (NASDAQ: VPHM) shares were halted this morning after the FDA issued a complete response letter to the company. The complete response letter is regarding Cinryze™, the company’s C1 Esterase Inhibitor, industrial scale manufacturing expansion activities.
The problem with complete response letters is that it generally translates to delays. That appears to be the case here at ViroPharma. The company gave few details but noted that the FDA has requested additional information related to observations from the pre-approval inspection and review of the technical processes.
The company said that it and partner Sanquin will begin working immediately to respond to the FDA “as expeditiously as possible.” The company also noted that it plans to commence manufacturing industrial scale lots at risk in the first quarter of 2011.
CEO Vincent Milano noted, “We remain committed to provide patients with an uninterrupted supply of Cinryze. In addition to our efforts around our industrial scale, we expect our currently approved manufacturing process alone will yield up to 60,000 doses annually.”
Shares are now down 16% at $13.60 before the open, and shares have a 52-week range of $7.28 to $16.77.
JON C. OGG
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