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

from the AEGIS study in an application for marketing authorization to be submitted to the PMDA in 2009. The Company has begun to establish its commercial organization in Japan in anticipation of a commercial launch of Soliris in that country in 2010.

About PNH

PNH is a rare blood disorder 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. (4) PNH strikes people of all ages, with an average age of onset in the early 30s. (5) Approximately 10 percent of all patients first develop symptoms at 21 years of age or younger. (6) 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 ranging from one to more than 10 years. (7) The estimated median survival for PNH patients is between 10 and 15 years from the time of diagnosis. (5,7)

PNH has been identified more commonly among patients with disorders of the bone marrow, including aplastic anemia (AA) and myelodysplastic syndromes (MDS). (8,9,10) In patients with thrombosis of unknown origin, PNH may be an underlying cause. (6,11)

Prior to approval of Soliris, there were no therapies specifically available for the treatment of PNH. PNH treatment was limited to symptom management through periodic blood transfusions, non-specific immunosuppressive therapy and, infrequently, bone marrow transplantations -- a procedure that carries considerable mortality risk. (6,11)

About Soliris

Soliris was approved in March 2007 by the U.S. Food and Drug Administration (FDA) as the first treatment for PNH, a rare, debilitating and life-threatening blood disorder defined by hemolysis, or the destruction of red blood cells. In June 2007, the European Commission (EC) also approved the use of Soliris for the treatment of patients with PNH.
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SOURCE Alexion Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
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2. Alexion Completes Enrollment in AEGIS Registration Study of Soliris(R) (eculizumab) in Patients with PNH in Japan
3. Alexion Commences Dosing in AEGIS Registration Study of Soliris(R) (eculizumab) in Patients with PNH in Japan
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