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CSL Behring Receives National Marketing Authorization of Berinert(R) in Israel


1/28/2011 6:43:42 AM

MARBURG, Germany, Jan. 27, 2011 /PRNewswire/ -- CSL Behring announced today it has been granted national marketing authorization in Israel to market Berinert® for the treatment of acute hereditary angioedema (HAE) attacks in any body location. With this most recent approval, Berinert is now licensed in 30 countries, including Europe, Japan, North America, South America and Australia.

CSL Behring completed a European Mutual Recognition Procedure (MRP) for Berinert for the treatment of acute attacks of HAE, a rare and serious genetic disorder, in 23 European countries in December 2008. It was subsequently granted all respective national licenses. In October 2009, the United States Food and Drug Administration approved Berinert for the treatment of acute abdominal or facial attacks of HAE in adolescent and adult patients in the United States. National marketing authorizations were also granted for Berinert in Australia in January 2010 and Canada in June 2010. CSL Behring has marketed its C1-esterase inhibitor concentrate in Germany for more than 30 years. CSL Behring also markets it in Argentina, Japan and Switzerland.

The approvals for Berinert are mainly based on the results of the phase II/III prospective, double-blind placebo-controlled International Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T.1), the largest single placebo-controlled HAE trial ever, that studied the efficacy of a C1-esterase inhibitor (C1-INH) concentrate.

"The approval of Berinert in Israel is a very important step toward optimal treatment of patients with HAE, many of whom have suffered with the symptoms of this debilitating disease for years," said Dr. Avner Reshef, Head of the Allergy & Immunology Unit of Sheba Medical Center, Israel. "Because it is rare, and symptoms can appear similar to other medical conditions, HAE is often misdiagnosed. Swellings are wrongly treated as allergic reactions and abdominal pain can often lead to unnecessary surgery."

"For years, most HAE patients in Israel had to rely on therapy with drugs that are associated with severe side-effects or which were not effective enough in treating symptoms. Other patients had no therapy at all and were forced to endure often very painful or disfiguring attacks," explained Tali Levy, head of the national patient association EDEMA. "However, a patient's biggest fear is usually the prospect of having an attack of the larynx or throat, which can be life-threatening. Only the assurance that an effective treatment such as Berinert is immediately available can remove this fear and allow such people to live a normal life."

About Hereditary Angioedema

HAE is a rare genetic disorder caused by a deficiency of C1-INH. It is inherited in an autosomal dominant manner. Symptoms of HAE include episodes of edema, or swelling, in the hands, feet, the face, the abdomen, and/or the larynx. Patients who have abdominal attacks of HAE can experience episodes of extreme pain, diarrhea, nausea, and vomiting caused by swelling of the intestinal wall. HAE attacks that involve the face or throat 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. For further information about HAE, please visit the website of the International HAE Patient Organization: www.HAEI.org, the website of the national patient organization in Israel: www.edema.co.il and the disease information website www.allabouthae.com.

About I.M.P.A.C.T.

I.M.P.A.C.T. 1 was a randomized controlled trial of 124 HAE patients with acute, moderate, or 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, proportion of subjects with worsening clinical HAE symptoms, and safety.

The I.M.P.A.C.T. 1 study found that C1-esterase inhibitor concentrate (C1-INH) is 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.

I.M.P.A.C.T. 2 was an open-label extension study conducted in North-America. The results showed the efficacy and safety of multiple open-label treatments with C1-INH concentrate for HAE attacks at any body location. A total of 1,085 attacks in 57 patients were successfully treated with C1-INH, including 48 laryngeal attacks in 16 patients. The median time to onset of symptom relief was 22 minutes and the median time to complete resolution of all HAE symptoms was 14.3 hours (per-attack analysis). Across all types of attack, median times to onset of relief ranged from 15 minutes (laryngeal attacks) to 30 minutes (peripheral attacks) and median times to complete resolution ranged from 8.4 hours (laryngeal attacks) to 28.3 hours (facial attacks). A single dose of 20 U/kg plasma-derived C1-INH was sufficient to effectively treat 99 percent of all HAE attacks in this study.

About Berinert®

Berinert® is a highly purified, human, plasma-derived C1-esterase inhibitor concentrate. As intravenous therapy, it rapidly treats the fundamental cause of hereditary angioedema (HAE) symptoms by providing C1-INH deficient patients with the missing human protein. Berinert is a unique HAE therapy because of its reliable record of proven efficacy and safety in over 30 years of international clinical use in more than 500,000 treatments. In Israel, Berinert is distributed exclusively by Mediline Ltd. (www.mediline.co.il).

About CSL Behring

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, hereditary angioedema, 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, 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.

Media contact: Sheila A. Burke, CSL Behring, +1 610-878-4209 (US)

SOURCE CSL Behring



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