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Soliris(R) Improved Fatigue Independent of Changes in Anemia in Patients with PNH by Controlling Hemolysis
Date:6/14/2008

oglobin

levels did not improve.

* Importantly, Soliris-treated PNH patients still experienced a moderate

improvement in fatigue (ES: +0.61) even when hemoglobin levels

decreased, while EPO-treated anemic cancer patients experienced a

small worsening of fatigue (ES:-0.33) when hemoglobin levels

decreased.

The improvement in fatigue associated with Soliris therapy in clinical trials was observed within the first week of treatment and has been sustained for more than two years. (10)

"As in cancer patients, fatigue in PNH patients is often severe enough to make the ordinary activities of daily life impossible," said Leonard Bell, M.D., Chief Executive Officer of Alexion. "This study indicates that patients can experience life-changing improvements in fatigue with long-term Soliris therapy regardless of changes in their anemia. This, and the other compelling clinical benefits that Soliris offers patients with PNH, are the basis for our commitment that every patient who can benefit from Soliris should have access to it."

About PNH

PNH is a rare blood disease that affects an estimated 8,000 to 10,000 people in North America and Europe and, using similar prevalence estimates, potentially 1,000 to 2,000 patients in Japan. (11) Although affecting all age groups, PNH often has an average age of onset in the early 30's. (12) Approximately 10 percent of all patients first develop symptoms at 21 years of age or younger. (4) PNH develops without warning and can occur in men and women of all races, backgrounds and ages. PNH often goes unrecognized, with delays in diagnosis often ranging from one to more than 10 years. (3) The estimated median survival for PNH patients is between 10 and 15 years from the time of diagnosis. (3,12)

PNH has been identified more commonly among patients with disorders of the bone marrow, including aplastic anemia (AA) and myelodysplastic syndrome (MDS). (13,14,15
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SOURCE Alexion Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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1. Alexion Completes Enrollment in AEGIS Registration Study of Soliris(R) (eculizumab) in Patients with PNH in Japan
2. Alexion Commences Dosing in AEGIS Registration Study of Soliris(R) (eculizumab) in Patients with PNH in Japan
3. 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
4. Long-Term Soliris(R) Therapy Improved or Stabilized Kidney Function in Patients With PNH
5. Soliris(R) Demonstrates Reductions in Hemolysis and Improvements in Fatigue, Overall Quality of Life and Anemia in a Broad Population of PNH Patients
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