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ViroPharma Files Prior Approval Supplement (PAS) for Cinryze™ (C1 Esterase Inhibitor [Human]) Industrial Scale Manufacturing
Date:6/21/2010

EXTON, Pa., June 21 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) today provided an update on recent progress in Cinryze™ (C1 Esterase Inhibitor [Human]) manufacturing expansion activities.  

ViroPharma is increasing its Cinryze manufacturing capacity through two concurrent efforts.  The first project, the parallel chromatography process, was implemented earlier this year and allows production to run across multiple shifts, effectively doubling the capacity of the current manufacturing line and increasing the amount of drug supply available to patients suffering from hereditary angioedema, or HAE.  The addition of the industrial scale project is expected to significantly increase capacity for Cinryze, providing adequate supply to meet the company's projected demand growth for prophylaxis against attacks of HAE.

ViroPharma today announced that it has filed a Prior Approval Supplement, or PAS, with the U.S. Food and Drug Administration (FDA) seeking approval to commercialize Cinryze manufactured using the industrial scale process. The supplemental data filed with the FDA include in-depth comparability testing at critical manufacturing stages from three conformance lots of industrial scale produced product, as well as stability data and lot release data.  The company believes these data demonstrate that product manufactured at industrial scale meets the required equivalence criteria compared to Cinryze manufactured at current scale.  ViroPharma anticipates receiving approval for product manufactured at industrial scale in the fourth quarter of 2010.  The company expects that the impact to sales from industrial scale manufacturing will begin in 2011.


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SOURCE ViroPharma Incorporated
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