ViroPharma Incorporated Presents New Cinryze™ (C1 Esterase Inhibitor [Human]) Data on Site of Care and Adherence at the 2012 Academy of Managed Care Pharmacy Educational Conference
Published: Oct 05, 2012
EXTON, Pa., Oct. 4, 2012 /PRNewswire/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced the results from an analysis of a patient-database involving Cinryze® (C1 esterase inhibitor [human]) demonstrating that ViroPharma's Path to Independence program, a self-administration training and support program for hereditary angioedema (HAE) patients receiving prophylactic Cinryze, positively impacts the site of care in favor of home/self-administration as well as adherence to routine preventive therapy. These findings were presented at the Academy of Managed Care Pharmacy (AMCP) Educational Conference in Cincinnati.
A similar analysis of this patient-database of 516 patients to assess the site of care was first conducted in June 2010. Six months later, ViroPharma's Path to Independence training and support program was implemented to educate eligible patients on self-administration of Cinryze. In early 2012, patient-reported demographic data from this Cinryze database of 789 HAE patients were examined. These results were compared to the 2010 analysis and reflect distributions of site of care for similar lengths of time before and after the initiation of the training and support program.
The site of care for patients receiving Cinryze (N=789) was 75.8 percent at home, 16.1 percent at an infusion center, and 8.1 percent at a physician's office, compared to 47.1, 23.3, and 27.5 percent, respectively, from the 2010 analysis. Of the 75.8 percent patients who infused at home, 57.9 percent self-administered, 26.6 percent were infused by a home health agency nurse, 14.7 percent by a family member, and 0.8 percent by other. Overall, self-administration was reported in 43.7 percent of patients compared to 20.0 percent from the 2010 analysis. Patients required an average of 5 visits to be successfully trained. Discontinuation rates of trained patients were 5 percent compared to 10 percent for untrained patients suggesting that non-program patients were twice as likely to stop therapy.
Patients who administered at home had a higher rate of adherence (1.85 doses per patient per week) compared to administration at an infusion center (1.40 doses per week) or physicians office (1.40 doses per week). In addition, after the initiation of the training and support program, home administration increased by 61 percent, and an increase was seen across all age groups.
"Our goal at ViroPharma is to ensure that every patient who is prescribed Cinryze for routine prevention of HAE gets the support they need to optimize their experience," commented Paul Firuta, ViroPharma's vice president and general manager, Americas. "This includes product and disease educational materials as well as self administration training and support through our Path to Independence program."
ViroPharma helps patients find their own path by offering the Path to Independence Program, which provides hands-on self-administration training and on-going support from specially trained infusion nurses to appropriate people who are receiving therapy with Cinryze. To learn more about the Path to Independence Program visit http://www.cinryze.com/hae-patient-independence.aspx.
About Cinryze® (C1 esterase inhibitor [human])
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 E.U., 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, and vomiting. Adverse events of sinusitis and upper respiratory infection also were observed in clinical trials. There were no serious adverse reactions in the randomized, placebo controlled crossover routine prophylaxis study. The only serious adverse reaction observed in clinical studies of Cinryze was cerebrovascular accident. 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, 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, cytomegalovirus (CMV); 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, adrenal insufficiency 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.
Certain statements in this press release may contain forward-looking statements that involve a number of risks and uncertainties. Forward-looking statements provide our current expectations or forecasts of future events. . Our actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. The commercialization of pharmaceutical products is subject to risks and uncertainties. The data that were discussed at AMCP are subject to different interpretations and may not be predictive of the results of any individual's results or of how Cinryze performs in commercial usage. The trends discussed at AMCP, including patient self administration and dosing rates, may not continue in future periods. 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 10-Q filings for the quarters ended March 31, 2012 and June 30, 2012 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