EXTON, Pa., Aug. 6, 2012 /PRNewswire/ --ViroPharma Incorporated (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."
About Cinryze (C1 esterase inhibitor [human])Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product. In the U.S., Cinryze is approved by the FDA for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE. In the E.U., the product is approved by the EMA for the treatment and pre-procedure prevention of angioedema attacks in adults and adolescents with hereditary angioedema (HAE), and routine prevention of angioedema attacks in adults and adolescents with severe and recurrent attacks of hereditary angioedema (HAE), who are intolerant to or insufficiently protected by oral prevention treatments or patients who are inadequately managed with repeated acute treatment. Cinryze is for intravenous use only.
Severe hypersensitivity reactions to Cinryze may occur. Thrombotic events have occurred in patients receiving Cinryze, and in patients receiving off-label high dose C1 inhibitor therapy. Monitor patients with known risk factors for thrombotic events. With any blood or plasma derived product, there may be a risk of transmission of infectious agents, e.g. viruses and, theoretically, the CJD agent. The risk has been reduced by screening donors for prior exposure to certain virus infections and by manufacturing steps to reduce the risk of viral transmission including pasteurization and nanofiltration.
The most common adverse reactions in clinical trials associated with Cinryze were rash, headache, nausea, erythema, phlebitis and local reactions at the injection site. Adverse events of sinusitis and upper respiratory infection also were observed in clinical trials. No drug-related serious adverse events (SAEs) were reported in clinical trials.
Please visit http://www.viropharma.com/products/cinryze.aspx for the full U.S. Prescribing Information; the prescribing information for other countries can be found at http://www.viropharma.com.
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ViroPharma Receives FDA Approval of Cinryze® (C1 Esterase Inhibitor [Human]) Industrial Scale Manufacturing