CSL Behring receives the approval of the European health authorities for the self management of Berinert (R).

Marburg, Germany, August 25, 2011- / PRNewswire / – CSL Behring announced today that the European health authorities have approved the self-management of Berinert r, a concentrate of inhibitor of esterase of C1 (C1-INH) indicated in Europe for the treatment of acute attacks of hereditary angioedema (HAE), for its acronym in English, a rare genetic disorderserious and sometimes fatal. The expanded European label allows patients to auto – manage Berinert by intravenous injection, after consultation with a doctor and after receiving the appropriate training.

“Once an attack of HAE symptoms begin to appear, any delay in the commencement of treatment can increase the severity of the attack.” This can lead to hospitalization of the patient. “However, if a patient is given treatment himself in the right way, can be avoided these and other problems”, said Associate Professor Wolfhart Kreuz M.D., of the Comprehensive Care Centre for Hereditary and Acquired Angioedema of the Goethe University Hospital in Frankfurt, Germany. “For example, auto-administrando treatment, the patient can reduce time from work or school.” “The self-management of Berinert allows an individualized, increasing patient confidence in its ability to auto-tratar his attacks of HAE and therapy to improve their quality of life.”

“With the European approval of Berinert for the self-management, doctors and patients have another important option to help reduce the suffering caused by HAE, said Henrik Boysen, executive director of HAEi, the international patient organization for C1 Inhibitor deficiencies. “It is well known that early treatment dramatically reduces the severity and duration of an attack of hereditary angioedema, and can also save the life of the patient.” “As defenders of patients around the world in HAEi we welcome this new indication of label for Berinert and hope that the self-management will be normal for the treatment of HAE, as it is to treat hemophilia, another type of rare and serious disease.”

Berinert is permitted in Europe for the treatment of HAE acute attacks in all parts of the body. Clinical studies have shown that with Berinert intervention on the occurrence of an attack of HAE is a much faster relief to a patient and reduces the severity of the attack when compared with the placebo.

“CSL Behring is delighted that the patients of HAE in Europe might already auto – manage Berinert”, said Ingolf Sieper, Executive Vice President of global business operations. “We know that the self-management of Berinert helps to restore normality and independence for patients.” “Our commitment to improve the lives of those affected by rare diseases is underlined by this good news.”

To approve the expanded label for Berinert, European authorities recognize the experience and existing clinical practice during the past 25 years, showing the safety and efficacy of the self-management of C1-INH. In 2010, medical experts in HAE published a consensus document in Allergy, Asthma and Clinical Immunology to conclude therapy and self-management in the home would HAE patients treat their symptoms more proactively in a way that will keep the safety of patients, and you minimize the inconvenience to their lives.

CSL Behring has marketed the concentrate of inhibitor of esterase Germany C for more than 30 years. In December 2008, the company completed a European Mutual Recognition Procedure (MRP) for Berinert for the treatment of acute attacks of HAE in 23 European countries and later received all respective national licences. In October 2009, the food and drugs of United States Administration adopted Berinert for treating abdominal attacks or easy acute HAE in patients adolescents and adults in United States. National marketing authorisations were granted for Berinert in Australia in January 2010, Canada in June 2010, and Israel in January 2011. CSL Behring also sells Berinert in Argentina, Japan and Switzerland.

About hereditary angioedema

The HAE is a rare genetic disorder caused by a deficiency of C1-INH. It is inherited in an autosomal dominant manner. HAE symptoms include episodes of edema or swelling, hands, feet, face, abdomen, or larynx. Patients who have abdominal attacks of HAE may experience episodes of extreme pain, diarrhea, nausea and vomiting caused by the swelling of the intestinal wall. HAE attacks involving the face and throat can result in the closure of the respiratory tract, asphyxia, and, if untreated, death. Diagnosis of HAE requires a blood test to confirm low or abnormal levels of C1-INH.

About Berinert r

Berinert r is a concentrate of inhibitor of human, highly purified plasma-derived C1 esterase. As intravenous therapy, it quickly the root cause of the symptoms of hereditary angioedema (HAE) providing patients with deficiency of C1-INH the human protein which is lacking. Berinert is a therapy of only HAE for its reliable record of efficacy and safety demonstrated in more than 30 years of international clinical use in more than 500,000 treatments.

About CSL Behring

CSL Behring is a global leader in the industry bioterapéutica of plasma proteins. Committed to saving lives and improving the quality of life of people with rare and serious diseases, the company manufactures and markets a wide range of recombinant products and derivatives of the plasma around the world. CSL Behring therapies are used in the treatment of disorders of diseases of clotting, including hemophilia, von Willebrand, primary immune deficiencies, hereditary angioedema and hereditary respiratory disease.

The company’s products are also used in cardiac surgery, organ transplantation and treatment of Burns and to prevent hemolytic disease in the newborn. The company also manages one of the largest networks in the world collection of plasma, CSL Plasma. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical based in Melbourne, Australia.