CSL Behring completes national marketing authorizations of Berinert
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`CSL Behring announces completion of national marketing authorizations of
`Berinert® after MRP in 23 European countries
`
`First and Only Human C1-Esterase Inhibitor Approved for Treatment of Acute Attacks of Hereditary Angioedema
`throughout Europe, US and other countries
`
`Milan, Italy — 27 May 2010
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`CSL Behring announced today it has been granted national marketing authorization in Italy and Luxembourg to market Berinert® for the
`treatment of acute hereditary angioedema (HAE) attacks in any body location. This latest authorization brings to 28 the number of
`countries (in Europe, Asia, North America, South America and Australia) in which Berinert is now licensed.
`
`In October 2009, the United States Food and Drug Administration approved Berinert for the treatment of acute abdominal and facial
`attacks of HAE, a rare and serious genetic disorder, in adolescent and adult patients. CSL Behring completed the European Mutual
`Recognition Procedure (MRP) for Berinert in 23 countries in December, 2008. Marketing authorization was also granted for Australia in
`January, 2010, and applications for licensing in Canada and Israel have also been filed with authorities. Berinert has been marketed in
`Germany for more than 30 years.
`
`The approvals 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.), the largest single placebo-controlled HAE trial ever, that studied the efficacy
`of pasteurized C1-esterase inhibitor (C1-INH) concentrate.
`
`“It is very good news that this well-established therapy, which has helped so many patients to live without the fear of life-threatening
`and debilitating HAE attacks, is now available to even more HAE patients in Europe,” said Dr. Marco Cicardi, professor of Internal
`Medicine at the University of Milan, Italy. “CSL Behring is to be commended for its dedication to this relatively small patient community
`for whom treatment options have been limited for so long.”
`
`HAE is a 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 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.
`
`The effective date of the marketing authorization in Italy and Luxembourg was 29 March, 2010.
`
`About I.M.P.A.C.T. Studies
`I.M.P.A.C.T. was a study 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 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.
`
`The I.M.P.A.C.T. 2 study results showed the efficacy and safety of multiple open-label treatments with C1-INH concentrate for HAE
`attacks at any body site. The median time to onset of symptom relief was most rapid for laryngeal attacks (15 minutes), followed by
`abdominal attacks (20 minutes), facial attacks (28 minutes), and peripheral attacks (31 minutes). The median times to complete
`resolution of symptoms were less than 8 hours for laryngeal attacks, 10 hours for abdominal and 24 hours for peripheral attacks and 31
`hours for facial attacks. Findings of I.M.P.A.C.T. 2 were based on treatment with 20 U/kg bodyweight of C1-INH concentrate in 975
`episodes of HAE attacks involving any location on the body, in 57 patients.
`
`About Berinert®
`Berinert®, a plasma-derived intravenous therapy, treats the fundamental cause of hereditary angioedema (HAE) symptoms by
`providing C1-INH deficient patients with the missing human protein. Without C1-INH, patients with HAE suffer from recurrent episodes
`of rapid swelling of areas of the skin and underlying tissues including the face, mouth and throat. In rare circumstances, these episodes
`can be life-threatening. Berinert is a well-established 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 Germany, Austria, Switzerland, and several other countries.
`
`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, and hereditary angioedema. 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
`610-878-4209 (US)
`
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`http://www.cslbehring.com/PRelease/Berinert-Approved.htm?tabSelections=1255923338674&currentPag...
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`5/23/2017
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`CSL EXHIBIT 1062
`CSL v. Shire
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`Page 1 of 1
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