Alexion/P&G Pexelizumab Failed Phase III Could Compromise Development Partnership
This article was originally published in The Pink Sheet Daily
Executive Summary
The APEX-AMI study of pexelizumab in patients with acute myocardial infarction failed to meet its endpoint of reduction in mortality.
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A development partnership between Alexion and Procter & Gamble could be called into question following negative results of two Phase III trials of the terminal complement inhibitor pexelizumab. The monoclonal antibody fragment failed to meet the primary endpoint of reduction in mortality at 30 days following primary percutaneous coronary intervention in patients with acute myocardial infarction. A separate clinical trial - PRIMO-CABG2 - evaluating the biologic in coronary artery bypass graft surgery patients also turned in negative results. Alexion said it "expects to discuss its pexelizumab partnership with P&G following complete analysis of the APEX-AMI data." The companies had developed both studies under a Special Protocol Assessment with FDA (1 (Also see "Alexion Pexelizumab Additional Studies Approved Under Special Protocol Assessment" - Pink Sheet, 14 Jun, 2004.)). The APEX-AMI trial was a randomized, double-blind, parallel-group study evaluating pexelizumab in patients with AMI undergoing primary percutaneous coronary intervention. The trial enrolled approximately 5,700 patients and compared the safety and efficacy of pexelizumab to placebo in reducing death in patients experiencing a heart attack and undergoing angioplasty. Alexion and P&G had decided in February to finalize the trial with fewer patients than initially anticipated following the negative results in PRIMO-CABG2. Alexion said it will remain focused on its lead candidate, Soliris (eculizumab), which it is studying for the blood disorder paroxysmal nocturnal hemoglobinuria. The company is on track to submit a BLA for Soliris during the second half of the year, but is awaiting the full results of a Phase III trial (2 (Also see "Alexion Will Submit Soliris BLA By Year-End" - Pink Sheet, 12 Jun, 2006.)). -Jessica Merrill |