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

om/. The company encourages investors to consult these sections for more information on ViroPharma and our business.

Forward-Looking Statements

Certain statements in this press release contain forward-looking statements that involve a number of risks and uncertainties. Forward-looking statements provide our current expectations or forecasts of future events, and include without limitation statements related to the anticipated capacity of the industrial scale manufacturing process; increased future demand for Cinryze and our ability to meet projected demand growth for Cinryze; our belief that the industrial scale data meet the FDA's required equivalence criteria; the timing and outcomes of FDA review of the data; when product produced by the industrial scale manufacturing process may be commercially available; and our ability to ensure that patients will have access to Cinryze. Biologics such as Cinryze require processing steps that are more difficult than those required for most chemical pharmaceuticals, and as such we can not assure you that the industrial scale process will be considered by the FDA to be equivalent to our existing manufacturing process. The FDA may view the data regarding equivalence of the industrial scale manufacturing process as insufficient or inconclusive, request additional data, require additional studies, delay any decision past the time frames anticipated by us, or deny the approval of the industrial scale manufacturing process. If the manufacturing capacity expansion projects at Sanquin are delayed, or do not result in the capacity we anticipate, or if Sanquin cannot obtain necessary regulatory approvals for the contemplated facility expansions in the time frames we anticipate, we may not be able to satisfy patient demand. Our inability to obtain adequate product supplies to satisfy our patient demand may create opportunities for our competitors and we will suffe
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SOURCE ViroPharma Incorporated
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