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

"The filing of our PAS for industrial scale manufacturing takes us one step closer toward making product at enhanced capacity available to many more patients with HAE," stated Dan Soland, ViroPharma's chief operating officer. "We now have increased confidence in our goal of gaining approval for this scale up initiative for Cinryze this year."

This announcement follows the May 26th disclosure that Cinryze manufactured through ViroPharma's initial parallel chromatography process had entered the trade and is in use by patients suffering from HAE.

Continued Soland, "Our primary focus since the launch of this important drug has been on ensuring supply to all patients who choose prophylaxis against their attacks of hereditary angioedema, rather than to treat their dangerous attacks when they occur.  Thanks to our current parallel chromatography scale manufacturing process, we are already doing so for even more patients suffering from the debilitating manifestations of HAE."  

About Cinryze™ (C1 esterase inhibitor [human])

Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product that has been approved by U.S. FDA for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE. C1 inhibitor therapy has been used acutely for more than 35 years in Europe to treat patients with C1 inhibitor deficiency. Cinryze is not currently approved in the European Union or any of its member states.

The most common adverse reactions observed in clinical trials have been upper respiratory infection, sinusitis, rash and headache. No drug-related serious adverse events (SAEs) have been observed in clinical trials. Severe hypersen
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SOURCE ViroPharma Incorporated
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