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ViroPharma Provides Update on Industrial Scale Supplement for Cinryze® (C1 Esterase Inhibitor [Human])

Feb 8, 2012 | www.viropharma.com

EXTON, Pa., Feb. 7, 2012 /PRNewswire/ — ViroPharma Incorporated (Nasdaq: VPHM) today announced the U.S Food and Drug Administration (FDA) issued a complete response letter regarding Cinryze® (C1 Esterase Inhibitor [Human]) industrial scale manufacturing expansion activities. Specifically, the FDA has three comments related to a portion of the cleaning validation for industrial scale manufacturing, of which only one requires additional unplanned activity. The company expects that the additional activity required to address this comment can be completed in a short time frame. The FDA also noted that it has not yet completed the review of ViroPharma’s January 2012 updated responses to observations specific to the September 2011 inspection of the Amsterdam facility. There are no remaining technical comments posed by FDA in the complete response letter. The company intends to provide an update to shareholders on specific timing of resubmission and expected action dates during the 2011 Financial Results conference call to be held later this month.

“We and our partner Sanquin will begin working immediately to respond to the FDA as expeditiously as possible,” said Robert Pietrusko, Pharm.D., ViroPharma’s vice president, global regulatory affairs and quality. “We remain confident in our ability to gain approval of the industrial scale manufacturing of Cinryze in 2012.”