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PNH Patients Treated with Soliris(TM) Experienced Dramatic Reduction in Blood Clots During Clinical Trials
Date:8/20/2007

tial thrombosis increases the relative risk of death by five- to ten-fold for PNH patients.(3,7) Thrombosis is related to hemolysis in patients with PNH, and patients with both smaller and larger PNH clones are reported to experience this complication.(8,9,10,11,12) Research involving a small group of PNH patients, including those without a history of blood transfusion, found that 60 percent had sub-clinical thrombosis, which could later develop into blood clots.(13)

"For decades, people with PNH have lived with debilitating symptoms, including the threat of blood clots and their complications," said Leonard Bell, MD, Chief Executive Officer of Alexion. "This publication reinforces the importance of our goal to ensure that every PNH patient who can benefit from Soliris will have access to it."

"Many PNH patients face not only devastating symptoms, but a sharply increased risk for developing life-threatening blood clots as a result of their disease," said John Huber, Executive Director of the Aplastic Anemia & MDS International Foundation. "This news provides additional hope for patients struggling with PNH and the danger of PNH-related blood clots. We look forward to seeing the impact this new analysis has on treatment of patients with PNH."

Clinical Data

The publication, titled "Effect of the complement inhibitor eculizumab on thromboembolism in patients with paroxysmal nocturnal hemoglobinuria," analyzed data from 195 patients studied in the Soliris Phase II and Phase III trials, including the TRIUMPH and SHEPHERD studies. Patients were enrolled in the United States, Europe, Australia and Canada and treated with Soliris for up to 54 months. Soliris reduced hemolysis in all treated patients and reduced thrombosis by 92 percent, with three events during Soliris treatment compared to 39 events during the same period of time prior to treatment (P<0.0001). The collection of thrombotic events was defined prospectively by clinical trial protocols.
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SOURCE Alexion Pharmaceuticals, Inc.

Copyright©2007 PR Newswire.

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