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PNH Patients With Lower Levels of Hemolysis, Mild Anemia and Minimal Transfusion Support Have Significant Disease Burden; Soliris(R) Therapy Provided Clinical Improvements in PNH Patients Regardless of Disease Severity
Date:12/11/2007

patient population includes a wide range of patients with a broad clinical profile," said Leonard Bell, MD, Chief Executive Officer of Alexion Pharmaceuticals. "The results presented today provide further evidence for the utility of Soliris therapy in patients with diverse manifestations of PNH. We remain committed to our goal that all patients who can benefit from Soliris will have access to it."

Soliris, developed by Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN), is the first therapy approved for the treatment of patients with PNH, a rare, debilitating and life-threatening blood disorder defined by the destruction of red blood cells, or hemolysis. Soliris is a complement inhibitor indicated for the treatment of patients with PNH to reduce hemolysis. In patients with PNH, hemolysis can cause thromboses, kidney disease, liver dysfunction, disabling fatigue, impaired quality of life, recurrent pain, shortness of breath, pulmonary hypertension, intermittent episodes of dark colored urine (hemoglobinuria), and anemia. (2-4)

Clinical Data

In the ongoing open-label clinical study, investigators examined the long- term clinical effect of Soliris in patient subgroups, including those with lower levels of hemolysis, mild anemia and minimal transfusion requirements.

Data were analyzed by levels of baseline hemolysis (as indicated by baseline quartiles of lactate dehydrogenase, LDH), anemia (Hgb < 10.5 g/L vs greater than or equal to 10.5 g/L), and transfusion requirements (transfusion episodes in prior year greater than 1 vs 1 or 0 episodes). Hemolysis, fatigue and transfusion requirements were examined using a ranking test to measure efficacy during both the first and the most recent six months of Soliris therapy; patients rec
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SOURCE Alexion Pharmaceuticals, Inc.
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