Scientific Data Relating to Cinryze Presented at 6th Annual C1 Inhibitor Deficiency Workshop
BUDAPEST, Hungary and EXTON, Pa., May 26 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (NASDAQ:VPHM) 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
-- In an abstract entitled, 'When Should Prophylactic Therapy be Considered for Hereditary Angioedema?', Dr. Tim Craig, et al. described how a literature review, guideline analysis from other countries, expert panel meeting, and consensus development were conducted in order to develop therapy considerations for prophylaxis of HAE in the U.S.; -- The abstract suggested that patients with frequent HAE attacks, severe attacks, past laryngeal attacks, excessive loss of work or school, significant anxiety and poor quality of life could be considered for prophylaxis therapy, especially for those that fail, are intolerant, have adverse events or are not candidates for androgens; -- This abstract was the result of a consensus group on the treatment considerations for patients with HAE, which was paid for and organized by Lev Pharmaceuticals. Abstract book page 46: Subcutaneous Infusion of Cinryze in Pigs -- From the laboratory of Dr. Michael Frank at Duke University, Dr. H. Jiang et al. described the results of a comparative pharmacokinetic study of subcutaneous and intravenous doses of C1 Inhibitor in an abstract entitled, 'Subcutaneous (SQ) Versus Intravenous (IV) Infusion of C1 Inhibitor (INH) on Blood Levels in Swine'; -- In this study, 50 units/kg of human C1 inhibitor were infused either IV or SQ into swine. Blood levels of C1 inhibitor after IV infusion were compared to that after SQ infusion; animals received 3 infusions of C1 inhibitor at 3 day intervals, as in an earlier study of IV infusion in HAE patients. Abstract book page 47: The Effect of Cinryze on Key Pathways in HAE -- As described in an abstract entitled, 'Infusion of C1 Inhibitor as Therapy for Swelling in Hereditary Angioedema Patients Reverses Abnormalities of the Plasma Bradykinin-forming Pathway and Fibrinolysis,' Dr. K. Joseph et al. described a study of samples of plasma from nine HAE patients experiencing an attack in ViroPharma/Lev's Phase 3 CHANGE (C1 inhibitor in Hereditary Angioedema Nanofiltration Generation evaluating Efficacy) trial; -- Samples of plasma were obtained from nine HAE patients at baseline, during an attack of swelling, and at one, four and 12 hours after termination of an infusion of C1 inhibitor; -- Factor XIIa, kallikrein and plasmin were each measured by cleavage of specific synthetic substrates; these parameters were reassessed after treatment of episodes of swelling with intravenous C1 inhibitor.
Abstract book page 37: Phase 3 Results of Cinryze as Prophylactic and Acute Treatment of HAE
-- In an abstract entitled, 'Safety and Efficacy of Nanofiltered C1 Inhibitor Concentrate for Acute and Prophylactic Treatment of Hereditary Angioedema due to C1 Inhibitor Deficiency,' Dr. M. Frank described two double-blind randomized placebo-controlled multi-center studies to determine the efficacy and safety of nanofiltered C1 inhibitor (C1-INH; Cinryze); -- This is the first presentation of both acute and prophylactic data of Cinryze. One trial examined the use of C1-INH for the treatment of acute attacks of hereditary angioedema due to C1 inhibitor deficiency. The second trial evaluated prophylactic treatment with C1-INH to prevent attacks; -- Cinryze is not approved for acute attacks of HAE. Abstract book page 18: Cinryze in Pregnant Women -- An abstract entitled, 'Cinryze Replacement Therapy in Hereditary Angioedema and Pregnancy' was presented by Dr. J.W. Baker et al.; -- Pregnancy is recognized as a trigger for attacks of HAE, and may increase the number and severity of such attacks. Cinryze should be given to a pregnant woman only if clearly needed; -- Six patients received 1000U of Cinryze replacement therapy 1-2 times per week as prophylaxis of HAE attacks during pregnancy. One patient self administered Cetor, a Dutch C1 inhibitor product, after the first two trimesters. An additional patient received Cinryze 1000U immediately prior to delivery and again two days later; -- Data on side effects, frequency of HAE attacks, and number of emergency medical visits prior to and following initiation of Cinryze therapy were presented. 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.
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.
Source: ViroPharma Incorporated
CONTACT: Media, Kristina M. Broadbelt, Assistant Director, PR &
Advocacy, +1-610-321-2358, or Investors, Robert A. Doody Jr., Assistant
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Web Site: http://www.viropharma.com/
Posted: May 2009