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ViroPharma Initiates Phase 2 Study of C1 Esterase Inhibitor [Human] for Treatment of Antibody-Mediated Rejection (AMR)
Date:3/29/2011

scientific basis for the European Commission to issue a binding decision for a Centralized Marketing Authorization, which is expected in the second quarter of 2011.

Severe hypersensitivity reactions to Cinryze may occur.  Thrombotic events have occurred in patients receiving Cinryze for routine prophylaxis, 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 observed have been upper respiratory infection, sinusitis, rash and headache. No drug-related serious adverse events (SAEs) have been observed in clinical trials.

Cinryze is for intravenous use only. A dose of 1000 Units of Cinryze can be administered every 3 or 4 days for routine prophylaxis against angioedema attacks in HAE patients. Cinryze is administered at an injection rate of 1 mL per minute.

About ViroPharma Incorporated

ViroPharma Incorporated is an international biopharmaceutical company committed to developing and commercializing innovative products for physician specialists to enable the support of patients with serious diseases for which there is an unmet medical need, and providing rewarding careers to employees.  ViroPharma commercializes Cinryze® (C1 esterase inhibitor [human]) for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE).  ViroPharma commercializes Vancocin®, approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium d
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Related medicine technology :

1. ViroPharma Launches HAE and Me, A New Online Community to Unite People Living With Hereditary Angioedema
2. ViroPharma Announces Positive CHMP Opinion for Cinryze® (C1 Inhibitor [Human]) in European Union
3. ViroPharma Announces Securities Repurchase Program
4. ViroPharma to Participate in Two March Healthcare Conferences
5. ViroPharma to Release 2010 Fourth Quarter and Full Year Financial Results on February 24, 2011
6. ViroPharma to Participate in Several Upcoming Healthcare Investor Conferences
7. ViroPharma Receives Complete Response Letter for Cinryze™ (C1 Esterase Inhibitor [Human]) Industrial Scale Supplement
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9. ViroPharma to Present at the Jefferies 2010 Global Healthcare Conference
10. ViroPharma Announces Presentation of Data from Non-Toxigenic Clostridium difficile (VP20621) Phase 1 Study
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