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Health Canada Approves New Drug Submission For Cinryze™ (C1 Inhibitor [human])

Stocks in this article: VPHM

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 www.viropharma.com

About Hereditary Angioedema (HAE)HAE is a rare, severely debilitating, life-threatening genetic disorder caused by a deficiency of C1 inhibitor, a human plasma protein. This condition is the result of a defect in the gene controlling the synthesis of C1 inhibitor. C1 inhibitor maintains the natural regulation of the contact, complement, and fibrinolytic systems, and when left unregulated, can initiate or perpetuate an attack by consuming the already low levels of endogenous C1 inhibitor in HAE patients. Patients with C1 inhibitor deficiency experience recurrent, unpredictable, debilitating, and potentially life threatening attacks of inflammation affecting the larynx, abdomen, face, extremities and urogenital tract. Patients with HAE experience approximately 20 to 100 days of incapacitation per year. There are estimated to be up to 3,400 people in Canada with HAE.

For more information on HAE, visit US HAE Association's website at www.haea.org, the HAEi's (International Patient Organization for C1 Inhibitor Deficiencies) website at http://www.haei.org/; or the HAE Canada site at http://www.haecanada.org/

About ViroPharma IncorporatedViroPharma Incorporated is an international biopharmaceutical company committed to developing and commercializing novel solutions for physician specialists to address unmet medical needs of patients living with diseases that have few if any clinical therapeutic options.  ViroPharma is developing a portfolio of therapeutics for rare and Orphan diseases including C1 esterase inhibitor deficiency, Friedreich's Ataxia, and adrenal insufficiency; and recurrent C. difficile infection (CDI). Our goal is to provide rewarding careers to employees, to create new standards of care in the way serious diseases are treated, and to build international partnerships with the patients, advocates, and health care professionals we serve.  ViroPharma's commercial products address diseases including hereditary angioedema (HAE), seizures and C. difficile-associated diarrhea (CDAD); for full U.S. prescribing information on our products, please download the package inserts at http://www.viropharma.com/Products.aspx; the prescribing information for other countries can be found at www.viropharma.com

ViroPharma routinely posts information, including press releases, which may be important to investors in the investor relations and media sections of our company's web site, www.viropharma.com. The company encourages investors to consult these sections for more information on ViroPharma and our business.

Forward Looking StatementsCertain statements in this press release contain forward-looking statements that involve a number of risks and uncertainties.  Forward-looking statements provide our current expectations or forecasts of future events, including our regulatory filing in Canada related to Cinryze, including without limitation statements related to physician and patient acceptance of Cinryze and the estimated number of HAE patients in Canada.  There can be no assurance that our commercial launch of Cinryze in the Canada will occur in the timeframe we anticipate or be successful.  The commercial success of Cinryze in Canada will depend on a number of factors including, the actual number of HAE patients in Canada, physician and patient acceptance of Cinryze, the timing and level of pricing approvals obtained in Canada, and the level of manufacturing and supply of Cinryze produced by third party manufacturers.  These factors, and other factors, including, but not limited to those described in our annual report on Form 10-K for the year ended December 31, 2011 and quarterly reports on Form 10-Q filed with the Securities and Exchange Commission for the periods ended March 31, 2012 and June 30, 2012 could cause future results to differ materially from the expectations expressed in this press release. The forward-looking statements contained in this press release are made as of the date hereof and may become outdated over time. ViroPharma does not assume any responsibility for updating any forward-looking statements. These forward looking statements should not be relied upon as representing our assessments as of any date subsequent to the date of this press release.

 

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