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First Clinical Experience With Soliris(R) in Treating Patients With Two Rare Complement-Mediated Diseases Presented at ASH Annual Meeting
Date:12/7/2008

ment Inhibitor Eculizumab in a Patient with Cold Agglutinin Disease" was presented today at the ASH annual meeting by Dr. Alexander Roeth of the Department of Hematology at the University Hospital of Essen in Essen, Germany.

Dr. Roeth and his colleagues investigated the potential effect of eculizumab therapy in one patient with CAD, a rare and severe disease characterized by the production of circulatory cold agglutinins, a type of monoclonal antibody that lead to hemolysis. Conventional treatments for CAD, including corticosteroids and immunosuppressive drugs, are ineffective in many patients.

"We currently lack effective treatment options for patients with CAD," noted Dr. Roeth. "Given these promising initial observations, clinical research is needed to determine the therapeutic potential of eculizumab in patients with CAD."

About Soliris

Soliris was approved in March 2007 by the U.S. Food and Drug Administration (FDA) as the first treatment for PNH, a rare, debilitating and life-threatening blood disorder defined by hemolysis, or the destruction of red blood cells. In June 2007, the European Commission (EC) also approved the use of Soliris for the treatment of patients with PNH. Soliris is the first therapy approved in Europe for the treatment of PNH and was the first medicinal product to receive EC approval under the EMEA Accelerated Assessment Procedure. Soliris is not approved for the treatment of atypical Hemolytic Uremic Syndrome (aHUS) and Cold Agglutinin Disease (CAD).

Important Safety Information

Soliris is generally well tolerated. The most frequent adverse events observed in clinical studies were headache, nasopharyngitis (a runny nose), back pain and nausea. Treatment with Soliris should not alter anticoagulant management because the effect of withdrawal of anticoagulant therapy during Soliris treatment has not been established.

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SOURCE Alexion Pharmaceuticals, Inc.
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