EXTON, Pa., March 22, 2011 /PRNewswire/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced data presented in two poster presentations relating to Cinryze® (C1 esterase inhibitor [human]) at the 2011 American Academy of Allergy Asthma & Immunology (AAAAI) Annual Meeting, March 18 through 22, in San Francisco, CA.
Cinryze is the first and only U.S. FDA-approved C1 esterase inhibitor therapy indicated for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE), a rare, debilitating and potentially fatal disease. Cinryze is currently available only in the United States, and is not approved in the U.S. to treat acute angioedema attacks, for children with HAE, or for pre-procedure administration.
"As leaders in hereditary angioedema medical education, we continue to expand the body of data available on Cinryze usage," commented David Mariano, PharmD, ViroPharma's director of medical communications. "Our goal is to leverage educational initiatives to reinforce the understanding and awareness of HAE and its management for physicians and other healthcare professionals who may care for patients suffering from HAE."
AAAAI Poster Presentations
In a poster entitled, 'Pre-procedural Administration of Nanofiltered C1 Esterase Inhibitor (Human) (Cinryze®) for the Prevention of Hereditary Angioedema (HAE) Attacks after Medical, Dental, or Surgical Procedures,' Dr. William Lumry, M.D., of the University of Texas Southwestern Medical School in Dallas, Texas discussed the potential for Cinryze to prevent attacks of HAE that are triggered by trauma such as dental work, elective medical procedures and surgery. Data compiled from all completed studies with Cinryze were presented on the experience of 41 subjects who received Cinryze prior to 91 procedures. Cinryze 1000U IV was administered within 24 hours before a procedure. The results cited on the poster included the following:
- Forty-one unique subjects (8 children, 33 adults) received Cinryze for 91 procedures (40 in children, 51 in adults);
- Approximately 55 percent of procedures involved dental work and 37 percent involved surgeries or interventional diagnostic procedures. Among the 8 children (aged 6-17 years), 90 percent of procedures involved dental work;
- Pre-procedural administration of Cinryze prevented HAE attacks during or following 98 percent of medical, dental, or surgical procedures;
- Only 2 HAE attacks were reported within 72 hours after dosing: 1 genitourinary attack after dental work and 1 laryngeal attack after laparoscopy. Both resolved after treatment with an additional dose of Cinryze;
- Seven subjects reported adverse events within 7 days after receiving Cinryze; none were considered related to Cinryze by the investigator.
In a poster entitled, 'Safety and Efficacy of Nanofiltered C1 Esterase Inhibitor (human) (Cinryze®) for the Treatment of Laryngeal Attacks in Subjects with Hereditary Angioedema (HAE),' Dr. Marc Riedl, M.D., of the University of California, Los Angeles, David Geffen School of Medicine presented the experience of 85 subjects who received Cinryze to treat 267 laryngeal attacks of HAE. These data were compiled from all completed studies with Cinryze. These subjects received Cinryze 1000U IV for HAE attacks; a second 1000U dose could be administered 1 hour later if necessary. The results cited on the poster included the following:
- Across all studies, 85 unique subjects (74 adults, 11 children) received Cinryze for treatment of 267 laryngeal attacks; of them, only 1 subject required intubation;
- Four subjects reported SAEs that were not HAE manifestations; none were considered related to Cinryze and none led to discontinuation of treatment;
- In the open-label treatment study in which 87 laryngeal attacks occurred in 37 subjects:
- Median time to beginning of relief of the first treated laryngeal attacks was 60 minutes, comparable to the overall median response time for attacks at all anatomic locations (45 minutes);
- In subjects treated for more than one laryngeal attack, the effect of Cinryze was not reduced with subsequent repeated administration; median time to beginning of relief for the second and third laryngeal attacks were 30 and 38 minutes, respectively.
About Cinryze® (C1 esterase inhibitor [human])
Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product that has been approved by U.S. FDA for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE. C1 inhibitor therapy has been used acutely for more than 35 years in Europe to treat patients with C1 inhibitor deficiency.
Severe hypersensitivity reactions to Cinryze may occur. Thrombotic events have occurred in patients receiving Cinryze for routine prophylaxis, 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 observed have been upper respiratory infection, sinusitis, rash and headache. No drug-related serious adverse events (SAEs) have been observed in clinical trials.
Cinryze is for intravenous use only. A dose of 1000 Units of Cinryze can be administered every 3 or 4 days for routine prophylaxis against angioedema attacks in HAE patients. Cinryze is administered at an injection rate of 1 mL per minute.
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.
About ViroPharma Incorporated
ViroPharma Incorporated is an international biopharmaceutical company committed to developing and commercializing innovative products for physician specialists to enable the support of patients with serious diseases for which there is an unmet medical need, and providing rewarding careers to employees. ViroPharma commercializes Cinryze® (C1 esterase inhibitor [human]) for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE). ViroPharma commercializes Vancocin®, approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains (for prescribing information on ViroPharma's commercial products, please download the package inserts at http://www.viropharma.com/Products.aspx). ViroPharma currently focuses its drug development activities in diseases including C1 esterase inhibitor deficiency and C. difficile infection.
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. There can be no assurance that that the data presented during the 2011 American Academy of Allergy Asthma & Immunology (AAAAI) Annual Meeting regarding Cinryze is predictive of how Cinryze will perform in commercial usage. Cinryze is currently available only in the United States. Cinryze is not approved in the U.S. for acute treatment of attack, children with HAE or for pre-procedure prophylaxis. We cannot assure that current or future studies with Cinryze in the patient populations described in the AAAAI presentations will demonstrate the same or similar safety and efficacy profile of Cinryze as described in the data presented during the 2011AAAAI. 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 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