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

n levels increased from a median of 7.6 g/dL (7.9 +/- 0.3) at baseline to a median of 9.0 g/dL (8.9 +/- 0.4) following 12 weeks of Soliris treatment (P<0.001). -- Patient fatigue levels, as measured by the FACIT-Fatigue instrument, significantly improved within one week of Soliris treatment, with a median increase of 5.0 points at 12 weeks (P<0.001). A change of three or more points is considered clinically meaningful. -- An exploratory analysis was also performed to evaluate the effect of Soliris on Chronic Kidney Disease (CKD), measured as an improvement or worsening in CKD stage during treatment according to the KDOQI CKD published guidelines. (3) Chronic eculizumab treatment was associated with a 12-fold likelihood of an improvement in CKD level (P<0.001;CKD improved in 41 percent (12/29) of patients, CKD was unchanged in 55 percent (16/29), CKD worsened in 3.4 percent (1/29)).

The drug appeared to be safe and well tolerated in study patients. The most frequent adverse events (AEs) were headache (52 percent), nasopharyngitis (41 percent), and nausea (21 percent). Most AEs were mild to moderate in severity. No serious AEs related to study drug were reported following treatment with Soliris.

"The AEGIS results show that Soliris treats the hallmarks of PNH in Japanese patients with levels of safety and efficacy consistent with those demonstrated in U.S. and European study populations," said Leonard Bell, M.D., Chief Executive Officer of Alexion. "This is an important step in the process of bringing Soliris to the substantial numbers of patients with PNH in Japan, which is tied to our objective that every patient who can benefit from Soliris will have access to Soliris."

The AEGIS study was authorized by Japan's Pharmaceutical and Medical Device Administration (PMDA). Alexion expects to include data
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SOURCE Alexion Pharmaceuticals, Inc.
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