ALEXION COMPLETES RANDOMIZATION OF ECULIZUMAB TRIAL

Alexion Pharmaceuticals announced that it has completed randomization of its Phase III TRIUMPH efficacy trial of eculizumab, a monoclonal antibody drug that blocks the terminal complement part of the immune system, in patients with the chronic orphan blood disorder Paroxysmal Nocturnal Hemoglobinuria (PNH). In accordance with the trial's design, enrolled patients first entered a screening phase of up to three months to confirm their eligibility to be included in the trial, and were then randomized to receive either eculizumab or placebo in a six month treatment phase. There currently is no drug specifically available for treatment of patients with PNH, whose blood cells are deficient in natural inhibitors of terminal complement.

Eculizumab, an investigational drug therapy, has been granted orphan drug status from both the U.S. and European regulatory agencies to treat PNH. If approved for PNH, eculizumab would represent the first approved drug from a new class of anti-inflammatory therapeutics-terminal complement inhibitors-as well as the first drug available specifically for patients suffering from PNH.