Health Canada Approves New Drug Submission for Cinryze™ (C1 inhibitor [human])
- Cinryze Now Approved in Canada for Routine Prevention of Attacks of Hereditary Angioedema (HAE) -
EXTON, Pa., Oct. 22, 2012 /PRNewswire/ -- ViroPharma Incorporated (NASDAQ: VPHM) today announced that Health Canada has granted a Notice of Compliance (NOC) and approved a New Drug Submission (NDS) for Cinryze™ (C1 inhibitor [human]). Approval of Cinryze was granted for routine prevention of angioedema attacks in adult and adolescents with hereditary angioedema (HAE). Until now, there have been no approved plasma derived C1 inhibitor therapies for routine prevention of HAE attacks in Canada. ViroPharma's Canadian headquarters are located in Oakville, Ontario. We anticipate Cinryze to be commercially available in Canada as early as the second quarter of 2013.
"Hereditary angioedema is a complex and life threatening disease that must be managed carefully by physicians," said Dr. Tom Bowen, clinical professor of medicine and pediatrics at the University of Calgary. "The approval of Cinryze to help prevent HAE attacks provides an essential addition to the patient care arsenal of physicians across Canada. Disease management options that provide choices for patients for both treatment and prevention of hereditary angioedema can help patients reach their own personal health and wellness goals."
"It is important to have a number of disease management options available for those living with hereditary angioedema," said Della Cogar, founder, HAE Canada. "Hereditary angioedema is a potentially fatal disease that affects patients and their families throughout their lives, and is often passed on from generation to generation. This important addition of Cinryze as the first and only approved preventative option for patients with HAE is wonderful news for families living with the disease, and the physicians who help them manage it."
HAE is a rare, debilitating and potentially life-threatening genetic disorder estimated to affect up to 3,400 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 approval of Cinryze by Health Canada marks an important milestone for ViroPharma, and more importantly, for people living with HAE in Canada," said Pamela di Cenzo, ViroPharma's general manager, Canada. "We are thrilled to bring a new medication to the Canadian market that can prevent attacks of hereditary angioedema for patients suffering with this debilitating disease."
Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product. In the U.S. and Canada, Cinryze is approved for routine prophylaxis (prevention) against angioedema attacks in adolescent and adult patients with HAE. In the EU, the product is approved 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.
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 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.
SOURCE ViroPharma Incorporated
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