EXTON, Pa., Nov. 6, 2013 /PRNewswire/ -- ViroPharma Incorporated (NASDAQ: VPHM) today announced it will present data relating to the quality of life in patients with Hereditary Angioedema (HAE) receiving nanofiltered C1 Inhibitor (C1 INH-nf) replacement therapy for prophylaxis as well as data relating to the Angioedema Clinical Epidemiology Testing Initiative for the study of Hereditary Angioedema (ACET) at the 70th American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting. The meeting will take place at the Baltimore Convention Center and the Hilton Baltimore Hotel in Baltimore, Md., Nov. 7-11, 2013.
Saturday, November 9 and Sunday, November 10: Embargo lifts November 8 at 12:01 am EST
Poster ID: P289
Presenter: William Lumry, MD, FAAAI, FACAAI, Medical Director of Asthma and Allergy Research Associates in Dallas, TX
Title: "Quality of Life in Patients with Hereditary Angioedema Receiving Nanofiltered C1 Inhibitor for Prophylaxis: Results of a Randomized, Placebo-Controlled, Crossover Study"
Authors Present: Saturday, November 9: 12:30 – 1:30 p.m. EST; and Sunday, November 10: 12:00 – 1:00 p.m. EST
Location: Halls E & F, Baltimore Convention Center
Monday, November 11:
Presenter: Marc Riedl, MD, MS, Associate Professor of Medicine, Director of Clinical Trials, Food, and Drug Allergy Care Center, Section Head, Clinical Immunology and Allergy, UCLA David Geffen School of Medicine in Los Angeles, CA
Title: "Prevalence of Diagnosed and Undiagnosed Hereditary Angioedema (HAE) in First-Degree Blood Relatives of Known Subjects with Hereditary Angioedema"
Time: 1:00 p.m. – 1:15 p.m. EST
Location: Rooms 316-317, Baltimore Convention Center
Monday, November 11:
Presenter: H. Henry Li, MD, PhD of the Institute for Asthma and Allergy in Wheaton, MD
Title: "Comparison of Chromogenic and Enzyme-Linked Immunosorbent Assay (ELISA) Testing Methods of Functional C1 Inhibitor (C1 INH) in Diagnosing Hereditary Angioedema (HAE)"
Time: 1:30 p.m. – 1:45 p.m. EST
Location: Rooms 316-317, Baltimore Convention Center
About Cinryze® (C1 esterase inhibitor [human])
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, that 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 at least 6,500 people with HAE in the United States and at least 10,000 people in the European Union.
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 in this press release include statements regarding the quality of life in patients taking Cinryze. There can be no assurance that the data presented during the 70th American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting regarding Cinryze or testing of patients with HAE is predictive of how Cinryze will perform in commercial usage. In addition, the data that were discussed in this abstract and presentation are subject to different interpretations. The commercialization of pharmaceutical products is subject to risks and uncertainties. Our actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. 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, 2012 and 10-Q for the quarter ended March 31, 2013, June 30, 2013, and September 30, 2013 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 Incorporated|
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