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CSL Behring Study Shows Berinert® Is Least Costly On-demand

Analysis reveals greater cost savings to payer versus U.S. competitors

MARBURG, GERMANY — 23 February 2013

CSL Behring announced the results of a cost-effectiveness analysis showing that on-demand treatment of hereditary angioedema (HAE) attacks with Berinert®, C1 Esterase Inhibitor (Human), provides cost savings to payers when compared with the use of two other therapies approved in the U.S. for the acute treatment of HAE. The data were presented at the 2013 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. The cost study, which compared Berinert to Firazyr® and Kalbitor™, analyzed differential dosing and administration costs indirectly using current, publically available prices. Results were weighted by typical re-dosing frequencies. The study included no head-to-head comparison of product efficacy or safety.

“On-demand treatment options for acute swelling attacks of HAE differ widely in the doses administered per patient and price per administration, weighted partially by the need for re-dosing,” said Timothy J. Craig, D.O., Professor of Medicine and Pediatrics at Penn State University in Hershey, Pennsylvania, and one of the study’s investigators. “These factors significantly impact the overall cost of therapy. Our first-ever analysis of the differential costs to resolve HAE attacks found Berinert to be the least costly of these treatments, reflecting its minimal re-dosing frequency as the therapy is prescribed based on each individual’s weight.”

Estimates for re-dosing frequencies for the HAE treatments were based on clinical trial data for all three Food and Drug Administration-approved products. The re-dosing frequency for Berinert (studied in the I.M.P.A.C.T. 1 and I.M.P.A.C.T. 2 trials) was 1 percent, while Firazyr® (FAST-1, FAST-2 and FAST-3) was 7 percent and Kalbitor™ (EDEMA1, EDEMA3 and EDEMA4) was 20 percent. Berinert is dosed based on weight, ranging from two to five vials (500 IU each) for patients weighing 50 to 150 kg. Berinert was the least costly on-demand treatment option for HAE in a typical patient with 75 kg per body weight needing three vials per treatment episode. Per attack, Berinert was estimated to save patients $79.29 to $4,659 compared to Firazyr® and $2,628 to $7,208 compared to Kalbitor™.

Berinert is approved for on-demand treatment of acute abdominal, facial or laryngeal attacks of HAE in adults and adolescents, and is approved for patient self-administration after proper training by a healthcare professional.

About Hereditary Angioedema HAE is a rare genetic disorder caused by a deficiency of C1 Esterase Inhibitor. It is inherited in an autosomal dominant manner. Symptoms of HAE include episodes of edema – or swelling – in the face, abdomen, larynx and extremities. 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 Esterase Inhibitor.

About Berinert®
Berinert, C1 Esterase Inhibitor (Human), a pasteurized, nanofiltered, plasma-derived intravenous therapy, treats acute facial, abdominal and laryngeal hereditary angioedema (HAE) symptoms by providing C1 Esterase Inhibitor deficient adult and adolescent patients with the missing human protein. Without C1 Esterase Inhibitor, people with HAE suffer from recurrent episodes of rapid swelling of areas of the skin and underlying tissues, including the face, mouth, throat and abdomen. CSL Behring has marketed its pasteurized and nanofiltered C1 Esterase Inhibitor concentrate, Berinert, in Germany for more than 30 years. The product is also approved and marketed in 23 other European countries, the United States, Australia, Canada, Israel, Argentina, Japan and South Korea.

Berinert is contraindicated in individuals with a history of life-threatening systemic reactions to C1 Esterase Inhibitoro preparations, including anaphylaxis. The most serious adverse reaction reported in subjects who received Berinert in clinical studies was an increase in the severity of pain associated with HAE. In placebo-controlled clinical trial, dysgeusia was the most common adverse reaction reported in over 4 percent of subjects who received Berinert and more frequently than in the placebo group. Thrombotic events have been reported in patients receiving C1 Esterase Inhibitor product, including Berinert, at the recommended dose as well as when used off-label or at higher-than-labeled doses.

Berinert is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated. Please see full prescribing information for Berinert.

About CSL Behring
CSL Behring is a leader in the plasma protein therapeutics industry. Committed to saving lives and improving the quality of life for people with rare and serious diseases, the company manufactures and markets a range of plasma-derived and recombinant therapies worldwide.

CSL Behring therapies are used around the world to treat coagulation disorders including hemophilia and von Willebrand disease, primary immune deficiencies, hereditary angioedema and inherited respiratory disease, and neurological disorders in certain markets. The company’s products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic diseases in the newborn. For more information, visit www.cslbehring.com. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma.

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Media Contacts:
Sheila A. Burke
Director, Worldwide Commercial Operations Communications & Public Relations
CSL Behring
610-878-4209

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