Alexion Reports Positive Results from AEGIS Registration Study of Soliris in Japanese Patient...( CHESHIRE Conn. Dec. 8 /- Alexion Phar...),Health

CHESHIRE, Conn., Dec. 8 /PRNewswire-FirstCall/ -- Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today reported positive results from AEGIS, an open-label registration study examining Soliris(R) (eculizumab) treatment of Japanese patients with paroxysmal nocturnal hemoglobinuria (PNH). The pre-specified primary efficacy endpoint of change in hemolysis was achieved with an 86 percent reduction (P<0.001). Key secondary endpoints including fatigue (P<0.001) and transfusions/anemia (P<0.001) were also achieved.

Top-line results from AEGIS were presented today at the 50th Annual Meeting of the American Society of Hematology in San Francisco in a poster session titled, "Safety and Efficacy of the Terminal Complement Inhibitor Eculizumab in Japanese Patients with Paroxysmal Nocturnal Hemoglobinuria: AEGIS Phase II Clinical Study Results." The study was conducted to evaluate the safety and efficacy of Soliris in Japanese patients with PNH relative to the previously reported SHEPHERD and TRIUMPH (1,2) Phase III Soliris trials, which were conducted in the United States, Europe and Australia.

"These results show clinical improvements from eculizumab for Japanese patients with PNH, consistent with those observed in the clinical trials conducted in the United States and Europe," said Yuzuru Kanakura, M.D., Ph.D., Professor of Hematology and Oncology at Osaka University Hospital in Suita, Japan, and lead author of the study. "Consistent with the results from the SHEPHERD and TRIUMPH trials, these patients experienced significant reductions in hemolysis, anemia, transfusion dependence, and fatigue. Perhaps most noteworthy was the improvement in kidney function observed with eculizumab treatment. These are important and potentially life-changing improvements for patients with PNH."

Clinical Data

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