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Soliris(R) Demonstrates Reductions in Hemolysis and Improvements in Fatigue, Overall Quality of Life and Anemia in a Broad Population of PNH Patients
Date:12/4/2007

ficial impact of eculizumab on multiple aspects of patients' lives observed in both SHEPHERD and TRIUMPH reinforces Alexion's goal that every patient who can benefit from Soliris will have access to Soliris."

Fatigue, as measured by the FACIT-Fatigue instrument, significantly improved within one week of eculizumab treatment; this improvement was maintained throughout the 52 weeks of the study period (P < 0.001). The mean plus or minus SE change from baseline in FACIT-Fatigue score at 52 weeks was 12.2 plus or minus 1.1 (P < 0.001).

Quality of life assessments were also determined using the EORTC QLQ-C30 instrument. A significant improvement in fatigue scores was demonstrated on the EORTC QLQ-C30 fatigue scale by study week 1; this improvement was maintained at each study visit through week 52 (P < 0.001, mixed model analysis). Significant improvement in scores was shown with the instrument for global health status (P < 0.001), on all 5 scales for patient functioning (P < 0.001), on all 3 symptom scales (P less than or equal to 0.002), and on 4 of 6 single-item measures (P < 0.001).

Soliris treatment also led to an improvement in anemia. The increase in hemoglobin occurred despite a reduction in transfusion requirements from a median of 8.0 units of packed red cells per patient during the year prior to the study to 0.0 units per patient during the 52 week study (P < 0.001). Overall, transfusions were reduced 52% from a mean of 12.3 to 5.9 units of packed red cells per patient. Forty-nine patients (51%) achieved transfusion independence for the entire study period. Improvements in hemolysis, fatigue, and transfusion requirements with Soliris were independent of baseline levels of hemolysis and degree of thrombocytopenia.

About PNH

PNH is an acquired genetic blood disorder defined by hemolysis, in which patients' red blood cells are destroyed by complement, a component of the body's immune system. PNH is a rare disease that affects an
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SOURCE Alexion Pharmaceuticals, Inc.
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