EXTON, Pa., Aug. 6, 2012-- ViroPharma Incorporated (Nasdaq: VPHM) today announced the U.S. Food and Drug Administration (FDA) has approved the supplement to the Cinryze Biologics License Application (BLA) for industrial scale manufacturing changes. As previously announced, the company expects completion of labeling for previously produced vials to take approximately six weeks before entering into the trade.
The company also announced that it expects to release its financial results for the second quarter of 2012 on Thursday, August 9, 2012 before the open of the U.S. financial markets.
The company will host a conference call and live audio webcast at 9:00 a.m. Eastern Time on the same day. During the conference call, ViroPharma management will discuss the 2012 second quarter financial results and other business.
The press release and the live webcast of the conference call will be accessible via ViroPharma's corporate website at http://www.viropharma.com. An audio archive will be available at the same address until August 20, 2012.
To participate in the conference call, please dial (800) 874-4559 (domestic) and (302) 607-2019 (international). After placing the call, please tell the operator you wish to join the ViroPharma investor conference call.
"We believe the approval of our supplement for industrial scale manufacturing now enables us to ensure Cinryze is available to any patient who chooses prophylaxis against their attacks of hereditary angioedema," stated Dan Soland, ViroPharma's chief operating officer.
Continued Soland, "With the addition of the industrial scale process to our current production, we believe we now have the means to ensure the market is fully served and build adequate safety stock levels. We also believe we have flexibility to increase our production even further through additional shifts should the need arise."
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