Alexion Pharma's (ALXN) Soliris(R) Receives Positive Opinion from Clinical Investigators

June 8, 2009 8:13 AM EDT

Clinical investigators observed that Soliris(R) (eculizumab), a first-in-class terminal complement inhibitor developed by Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN), reduced hemolysis (red blood cell destruction) and improved symptoms in nine patients with paroxysmal nocturnal hemoglobinuria who had received no blood transfusions prior to initiating Soliris therapy.

In a separate study of 11 patients with PNH, researchers observed sustained platelet recovery with Soliris treatment in a subset of seven patients with thrombocytopenia (reduced platelet levels), indicating a likely reversal of platelet consumption with Soliris in these thrombocytopenic PNH patients. These and other data sets were presented on June 6 and 7 at the European Hematology Association Congress in Berlin. Soliris is the only therapy approved in the European Union, United States, Australia and Canada for the treatment of patients with PNH, an ultra-rare, debilitating, and life-threatening blood disorder.

"All patients with PNH, including those who do not require transfusion and may appear to be stable, are at increased risk for blood clots, kidney dysfunction, pulmonary hypertension and disabling fatigue caused by hemolysis," noted Leonard Bell, M.D., CEO of Alexion. "Research presented at EHA is a sobering reminder of the clinical consequences of this progressive, ultra-rare disease. These data further underscore the clinical impact of Soliris for the treatment of patients with PNH, and also provide insight into the potential role of complement inhibition in addressing other complement-mediated diseases."

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