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New Clinical Trial Data Show Substantial Improvement With Eculizumab (Soliris®) In Patients With STEC-HUS

Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced the presentation of 28-week data from all enrolled patients in a multi-center trial of eculizumab (Soliris ®) in patients who developed Shiga-toxin-producing E. coli hemolytic uremic syndrome (STEC-HUS) during an outbreak in Germany from May 2011 to July 2011. In the study, eculizumab therapy was associated with rapid and sustained clinical improvements in thrombotic microangiopathy (TMA) and systemic organ complications. The study met its primary endpoint of global assessment of efficacy at 8 weeks with 94% of patients achieving a complete or partial response in systemic TMA and vital organ involvement. Key secondary endpoints were also met with high clinical and statistical significance, including global assessment of efficacy at 28 weeks as well as improvement in hematologic, renal and neurologic functions. Preliminary findings from an exploratory post hoc, matched-control analysis of patients with severe STEC-HUS receiving eculizumab versus other patients who received current best supportive care during the German epidemic were also reported, and showed that eculizumab treatment was associated with consistently higher rates of renal and neurological function improvement at weeks 8 and 28. 1

The eculizumab 28-week data, presented today at Kidney Week 2012, the annual meeting of the American Society of Nephrology (ASN) in San Diego, were consistent with previously presented interim data, in which 148 of the overall 198 patients with STEC-HUS treated with eculizumab were reported to have experienced substantial improvement in systemic TMA and vital organ complications 8 weeks following treatment initiation with eculizumab. 2

“In the study, patients had a robust response to eculizumab therapy. Patients achieved a substantial improvement in systemic TMA and vital organ involvement as early as 8 weeks, which was sustained through 28 weeks,” said Rolf Stahl, M.D., Chairman, Department of Nephrology, University Hospital Hamburg-Eppendorf UKE and lead investigator of the trial. “The rapid, sustained reduction in TMA and reversal of organ damage with eculizumab supports the important role of uncontrolled complement activation in the severe morbidities associated with STEC-HUS.”

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