CSL Behring Receives Canadian Notice of Compliance for Berinert®
Berinert is now the first and only licensed treatment in Canada for acute episodes of Hereditary Angioedema, a rare and potentially fatal genetic disorder
Ottawa, Canada — 01 June 2010
CSL Behring Canada announced today that it has received Notice of Compliance for Berinert® (Human C1 Esterase Inhibitor). The company may now market Berinert for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) of moderate and severe intensity. HAE is a rare and serious genetic disorder.
Berinert is the first and only therapy approved for the treatment of hereditary angioedema in Canada. The approval is based on the results of the phase II/III prospective, double-blind, placebo-controlled, randomized, International Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T.), which studied the efficacy of pasteurized Human C1esterase inhibitor (C1-INH) concentrate. I.M.P.A.C.T. was the world’s largest HAE trial ever.
“The approval of Berinert in Canada marks an important milestone in CSL Behring Canada’s ongoing commitment to addressing the unmet needs of hereditary angioedema patients,” said Dr. Heinz Neuhaus, General Manager of CSL Behring Canada. “CSL Behring is a leader in developing safe, effective and innovative therapies for use in treating patients who have rare and serious disorders. We are pleased to once again expand our rapidly growing portfolio of such products.”
The approval of Berinert marks a historic turning point for patients with Hereditary Angioedema and their families, according to Tina Morgan, President, Canadian Immunodeficiencies Patient Organization. “Now that this treatment is available, patients suffering from hereditary angioedema attacks related to C1 Esterase Inhibitor Deficiency have access to a licensed replacement therapy that replaces what their own body fails to produce adequately. This treatment also has a favorable long term side effects profile, which is particularly important for patients suffering from HAE,” said Morgan.
HAE patients looking for more information on HAE or on physicians who treat HAE can refer to the Canadian HAE Network website at www.haecanada.com. They may also contact the Canadian Immunodeficiency Patient Organization (CIPO) via its website at www.cipo.ca or may contact Tina Morgan directly at 1-877-262-2476, ext #252.
HAE is an inherited genetic disorder, caused by a deficiency of C1-INH. Symptoms of HAE include episodes of edema or swelling in the hands, feet, face, abdomen, and/or larynx. Patients who have abdominal attacks of HAE can experience episodes of severe pain, diarrhea, nausea, and vomiting caused by swelling of the intestinal wall. HAE attacks that involve the face and larynx can result in airway closure, asphyxiation, and, if untreated, death. Diagnosis of HAE requires a blood test to confirm low or abnormal levels of C1-INH. Estimates indicate that HAE occurs in 1 in 10,000 to 1 in 50,000 people worldwide.
“Rapidly relieving the painful, frightening and life-threatening symptoms of an HAE attack is critical to the management of this debilitating and potentially fatal disorder,” said Bruce Ritchie, MD, FRCPC, Associate Professor, Division of Hematology, Department of Medicine, University of Alberta. “The approval of Berinert is important and encouraging news, as healthcare professionals in Canada will now have access to a safe and effective therapy for treating attacks in HAE patients.”
CSL Behring markets C1-Esterase Inhibitor, Human concentrate in Germany, Austria, Switzerland, Italy, Japan, Australia, and several other countries under the trade name Berinert. The U.S. Food and Drug Administration recently approved Berinert for the treatment of acute abdominal or facial attacks. In the past, in Canada, patients have received Berinert as part of the Canadian Special Access Programme (SAP), which provides access to non-marketed drugs for practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed or are unsuitable or unavailable.
About I.M.P.A.C.T. Study
The I.M.P.A.C.T. study 1 was a multinational, prospective, randomized, parallel-group, placebo-controlled, dose-finding, 3-arm and double-blind Phase II/III study conducted in 124 HAE patients with acute, moderate to severe abdominal or facial attacks. C1-INH concentrate was administered at two different dose levels and compared to placebo. The main study endpoints were: time to onset of symptom relief from HAE attacks (abdominal or facial), proportion of subjects with worsening clinical HAE symptoms, and safety.
The I.M.P.A.C.T. 1 study found that C1esterase inhibitor concentrate (C1-INH) is highly effective and safe in rapidly treating acute abdominal and facial skin swellings in patients with HAE. The study found that the median time to symptom relief was 30 minutes after receiving C1-INH compared to 1.5 hours with a placebo.
Berinert is the only HAE therapy available in Canada. It offers over 30 years of international clinical use experience with more than 400,000 treatments given in Germany, Austria, Switzerland, Japan, Australia and several other countries where it is manufactured and sold by CSL Behring.
“Safety at the Source”
CSL Behring owns a series of more than 70 plasma collection centers in the United States and Europe, where the highest possible standards are maintained. These high standards apply to the centers and the plasma donors. Each donor undergoes a series of health checks including family history, before qualifying as a donor. The donated plasma is subjected to a series of serological and nucleic acid amplification tests on single donation, minipool or plasma pool level exceeding regulatory requirements to ensure the maximum possible level of safety for patients.
About CSL Behring
Committed to saving lives and improving the quality of life for Canadians with rare and serious diseases, CSL Behring is a growing, research-based biopharmaceutical company that offers a wide range of plasma-derived and recombinant therapeutic products, including a variety of products used in the hospital setting for critical care, for primary immunological disorders, and as thrombolytic agents. A reliable partner for such Canadian healthcare organizations as Canadian Blood Services and Héma-Québec, CSL Behring Canada is the largest supplier of bleeding disorder treatments in the province of Quebec, and also provides toll manufacturing services to Canadian Blood Services for the fractionation of Canadian plasma. A scientific innovator, CSL Behring Canada markets HELIXATE® FS, Antihemophilic Factor [Recombinant] and Humate-P®, Antihemophilic Factor/von Willebrand Factor Complex (Human), Dried, Pasteurized, the only factor concentrate for von Willebrand disease, and is also the only company in Canada to offer two modes of human immunoglobulin (Ig) administration, including Vivaglobin®, Immune Globulin Subcutaneous (Human), the first subcutaneous Ig (SCIg) replacement therapy approved in Canada. For more information, please visit www.cslbehring.ca.
CSL Behring is a global leader in the plasma protein biotherapeutics industry. Passionate about improving the quality of patients' lives, CSL Behring manufactures and markets a range of safe and effective plasma-derived and recombinant products and related services. The company's therapies are used in the treatment of immune deficiency disorders, hemophilia, von Willebrand disease, other bleeding disorders and inherited emphysema. Other products are used for the prevention of hemolytic diseases in the newborn, in cardiac surgery, hereditary angioedema, organ transplantation and in the treatment of burns. The company also operates one of the world's largest plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company with headquarters in Melbourne, Australia. For more information, visit www.cslbehring.com.
Sheila A. Burke, Director, Communications & Public Relations
Worldwide Commercial Operations
610-878-4209 (o), 484-919-2618 (c)