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Alexion Reports Positive Results from AEGIS Registration Study of Soliris in Japanese Patients With PNH
Date:12/8/2008

he AEGIS open-label clinical study, investigators examined the safety and efficacy of Soliris in Japanese patients with PNH relative to the SHEPHERD and TRIUMPH studies. The primary endpoints of the study were reduction of hemolysis and safety following 12 weeks of Soliris treatment. The AEGIS study included 29 patients at nine institutions with minimal transfusion requirements (one or more transfusion episodes in the preceding two years) and permitted enrollment of patients with significant thrombocytopenia (platelet counts greater than or equal to 30x10(9)/L). Forty-five percent of the AEGIS patients had a history of aplastic anemia or myelodysplastic syndromes. Patients were dosed in accordance with the Soliris product labels approved in the United States and European Union in 2007.

Key clinical efficacy data from the AEGIS trial presented at the ASH meeting included:

    -- Hemolysis, the primary trial endpoint, was rapidly and significantly
       reduced with Soliris treatment. A standard measure of hemolysis,
       lactate dehydrogenase (LDH), decreased 86 percent from a median of
       1,814 U/L at baseline to a median of 244 U/L following 12 weeks of
       treatment (P<0.001; normal range 103-223 U/L).
    -- Control of hemolysis resulted in an improvement in anemia as indicated
       by a reduction in packed red blood cell (PRBC) transfusion
       requirements. Transfusions were reduced 71 percent from a mean (SE) of
       5.2 (+/-1.04) PRBC units/patient during the 12-week pre-treatment
       period to 1.5 (+/-0.67) units/patient following 12 weeks of Soliris
       treatment (P<0.001 for the pre-specified median change). Transfusion
       independence was achieved in 67 percent (14/21) of patients who were
       transfusion dependent prior to treatment (P<0.001).
    -- The improvement in anemia with Soliris treatment was also indicated by
       increased hemoglobin levels. Hemoglobi
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SOURCE Alexion Pharmaceuticals, Inc.
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