BUDAPEST, Hungary and EXTON, Pa., May 26 /PRNewswire-FirstCall/ -- ViroPharma Incorporated today announced the presentation of five abstracts relating to Cinryze(TM) (C1 esterase inhibitor [human]) therapy at the 6th Annual C1 Inhibitor Deficiency Workshop.
Cinryze was approved by the U.S. Food and Drug Administration in October 2008 for routine prophylaxis against hereditary angioedema (HAE) attacks in adults and adolescents. In February 2009, ViroPharma was granted priority review of a supplemental Biologics License Application for Cinryze for the treatment of acute attacks of HAE. If approved, Cinryze would be the first C1 esterase inhibitor available for the acute treatment for this condition. ViroPharma’s PDUFA date for Cinryze in the acute setting is June 3, 2009.
“With the C1 Inhibitor Deficiency Workshop presentations focusing on items including HAE treatment considerations and the potential for subcutaneous infusion, among others, ViroPharma is demonstrating our commitment to meeting the needs of patients with C1 deficiency diseases today, and tomorrow,” commented Glenn Tillotson, ViroPharma’s senior director and head of Medical Affairs.
The following abstracts from studies supported by Lev Pharmaceuticals, a company acquired by ViroPharma Incorporated in October 2008, were presented:
Abstract book page 27: Prophylactic Therapy Considerations in Hereditary Angioedema
Abstract book page 46: Subcutaneous Infusion of Cinryze in Pigs
Abstract book page 47: The Effect of Cinryze on Key Pathways in HAE
Abstract book page 37: Phase 3 Results of Cinryze as Prophylactic and Acute Treatment of HAE
Abstract book page 18: Cinryze in Pregnant Women
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 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.
Cinryze has been generally well tolerated. 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. Severe hypersensitivity reactions may occur. Thrombotic events have occurred in patients receiving high dose off-label C1 inhibitor therapy well above the approved treatment dosage regimen. 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 patients for prior exposure to certain virus infections and by manufacturing steps to reduce the risk of viral transmission including pasteurization and nanofiltration.
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 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 unrestricted, 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 6000 people with HAE in the United States.
For more information on HAE, visit the U.S. HAE Association’s website at: www.haea.org.
About ViroPharma Incorporated
ViroPharma Incorporated is a biopharmaceutical company dedicated to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma commercializes Vancocin(R) (vancomycin hydrochloride capsules, USP), 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, and Cinryze(TM) (C1 esterase inhibitor [human]) for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE), also known as C1 inhibitor deficiency (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 cytomegalovirus (CMV), HAE and C. difficile.
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 the Company’s current expectations or forecasts of future events. Forward-looking statements in this press release include statements regarding ViroPharma’s supplemental Biologics License Application for Cinryze for the treatment of acute attacks of HAE and the potential for subcutaneous infusion. Our actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. The development and commercialization of pharmaceutical products is subject to risks and uncertainties. The data that were submitted to the U.S. Food and Drug Administration include data from two separate studies including the pivotal Phase 3 study of Cinryze in acute HAE attacks and the ongoing open-label study of Cinryze for acute treatment of HAE, which includes partial data from an ongoing open label study. There can be no assurance that the complete data from the open label study will demonstrate that Cinryze successfully treats all types of acute hereditary angioedema (HAE) attacks and may not be predictive of the results of any future testing. The FDA may view the data regarding the use of Cinryze for acute treatment of HAE we have submitted as a supplemental BLA as insufficient or inconclusive, not accept our submission, 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 of HAE or approve a competing product which has been granted orphan drug designation thereby preventing Cinryze from reaching the market for acute treatment of HAE. We have not conducted any human studies related to the subcutaneous infusion of Cinryze and there can be no assurance that any future studies will demonstrate that subcutaneous infusion of Cinryze is safe or effective or that a subcutaneous formulation of Cinryze will receive regulatory approval. These factors, and other factors, including, but not limited to those described in ViroPharma’s annual report on Form 10-K and quarterly reports on Form 10-Q filed with the Securities and Exchange Commission during 2009, could cause future results to differ materially from the expectations expressed in this press release. The forward-looking statements contained in this press release may become outdated over time. ViroPharma does not assume any responsibility for updating any forward-looking statements.
CONTACT: Media, Kristina M. Broadbelt, Assistant Director, PR & Advocacy,
+1-610-321-2358, or Investors, Robert A. Doody Jr., Assistant Director,
Investor Relations, +1-610-321-6290, both of ViroPharma Incorporated
Web site: http://www.viropharma.com/
