Alexion Commences Dosing in AEGIS Registration Study of Soliris(R) (eculizumab) in Patients with PN...(apan the same innovative therapy that is...),Health

Date:1/7/2008

apan the same innovative therapy that is already available to patients in the U.S. and Europe," said Dr. Yuzuru Kanakura, M.D. Ph.D., Professor and Chairman Department of Hematology and Oncology, Osaka University Graduate School of Medicine. "We are excited to be participating in such an important study and look forward to the Soliris program progressing to registration in Japan."

"After consultation with the leading PNH clinical investigators in Japan and with the PMDA, we are pleased to have commenced dosing with Soliris in the AEGIS study, our single Japanese registration trial," said Leonard Bell, M.D., Chief Executive Officer of Alexion. "After completing enrollment and dosing, and comparing these results in Japanese patients to our earlier PNH studies, we expect to submit a licensing application for Soliris in PNH to the Japanese regulatory authority. Initiating this Japanese registration study is an important component of reaching our global goal that every PNH patient who can benefit from Soliris will 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 - 2,000 patients in Japan. (3) PNH often strikes people in the prime of their lives, with an average age of onset in the early 30's. (4) Approximately ten percent of all patients first develop symptoms at 21 years of age or younger. (5) 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. (6) The estimated median survival for PNH patients is between 10 and 15 years from the time of diagnosis. (4,6)

PNH has been identified more commonly among patients with disorders of the bone marrow, including aplastic anemia (AA) and myelodysplastic syndrome (MDS). (7,8,9,10) In patients with thrombosis of unknown ori
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SOURCE Alexion Pharmaceuticals, Inc. Copyright©2008 PR Newswire. All rights reserved

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