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Press release from PR Newswire

Health Canada Grants Priority Review Status For New Drug Submission (NDS) For Cinryze? (C1 Inhibitor [human])

Friday, January 13, 2012

Health Canada Grants Priority Review Status For New Drug Submission (NDS) For Cinryze? (C1 Inhibitor [human])07:30 EST Friday, January 13, 2012- Priority Review Granted for Prevention, Pre-procedure Prevention, and Acute Treatment of Attacks of Hereditary Angioedema (HAE) -EXTON, Pa., Jan. 13, 2012 /PRNewswire/ -- ViroPharma Incorporated (NASDAQ: VPHM) today announced that Health Canada has granted the company Priority Review status for its New Drug Submission (NDS) for Cinryze? (C1 inhibitor [human]).  Priority Review allows for an expedited review of critical new drugs faster than a standard review. ViroPharma has 60 days from the time of issuance of this acceptance letter to submit its full submission to Health Canada; once submitted, review by Health Canada is expected to be completed in the second half of 2012.  Priority Review allows for an expedited review of a NDS for a serious, life-threatening or severely debilitating disease, or condition for which there is substantial evidence of clinical effectiveness that the drug provides effective treatment or prevention of a disease or condition for which no drug is presently marketed in Canada.  Priority Review status is not a decision by Health Canada on the drug's approvability; the safety and efficacy are still under investigation and market authorization has not yet been obtained in Canada.  Priority Review for Cinryze was granted for all three requested indications: treatment of angioedema attacks in adults, adolescents and children six years of age and above with hereditary angioedema (HAE); pre-procedure prevention of angioedema attacks in adults, adolescents and children six years of age and above with HAE; and routine prevention (prophylaxis) of angioedema attacks in adults, adolescents and children six years of age and above with HAE.  There are currently no approved therapies for prevention of HAE attacks in Canada.  HAE is a rare, debilitating and potentially life-threatening genetic disorder estimated to affect up to 3400 people across Canada.  HAE is a variable disease, and patients can experience unpredictable, recurrent and disabling attacks of swelling that can affect the upper airway, abdomen, face, extremities and urogenital tract due to a deficiency of C1 inhibitor, a human plasma protein that prevents swelling. "The receipt of priority review status from Health Canada marks another important milestone in our efforts to make Cinryze available around the globe to people living with HAE through prevention and treatment of their attacks," said Daniel Soland, ViroPharma's chief operating officer.  "We will submit the NDS to Health Canada before the end of this quarter, and look forward to a Canadian regulatory decision later this year."About Cinryze 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 EU, 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 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 Incorporated ViroPharma 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 Statements Certain 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 without limitation statements related to potential regulatory timelines, the likelihood of regulatory success and the scope of indications for which Cinryze may be approved.  Health Canada may view the data regarding the use of acute treatment, pre-procedural prevention and/or prevention of HAE we have submitted to Health Canada as insufficient or inconclusive, request additional data, require additional clinical studies, delay any decision past the time frames anticipated by us, limit any approved indications, deny the approval of Cinryze for acute treatment, pre-procedural prevention and/or prevention of HAE.  For example, in June 2009, the U.S. FDA issued a complete response letter and requested an additional clinical study, due to their opinion that the placebo controlled study submitted in support of the sBLA for acute treatment of HAE lacked robustness.   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, 2010 and Quarterly Report on Form 10-Q for the period ended September 30, 2011 filed with the Securities and Exchange Commission, 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.SOURCE ViroPharma IncorporatedFor further information: Kristina M. Broadbelt (Media), Associate Director, PR & Advocacy, +1-610-321-2358, or Pamela di Cenzo, General Manager, ViroPharma Canada, +1-610-321-2316