Alexion
Pharmaceuticals, Inc. (Nasdaq: ALXN) today reported positive preliminary
six month interim results from SHEPHERD, its second Phase III trial testing
Soliris(TM) (eculizumab) in a broader population of Paroxysmal Nocturnal
Hemoglobinuria ("PNH") patients. SHEPHERD is an open-label, non-placebo
controlled 12 month Phase III PNH study which is primarily focused on
examining safety, as well as efficacy measures. Interim results show that
Soliris(TM) (eculizumab) appeared to be safe and well tolerated.
All pre-specified primary and secondary efficacy endpoints in the
international trial were achieved with statistical significance. The
pre-specified primary surrogate of efficacy endpoint was intravascular
hemolysis, the underlying disease process and primary clinical
manifestation in PNH, as measured by lactate dehydrogenase area under the
curve (LDH AUC). The LDH AUC was significantly decreased (P