ViroPharma provides update on recent progress in Cinryze manufacturing expansion activities

Jun 21 2010

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.

"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."