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Biotech / Medical : Alexion Pharmaceuticals, Inc. (ALXN) -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (394)	11/26/2003 5:47:50 PM
From: Icebrg	Read Replies (1) \| Respond to of 824

[From the shelf filing. It appears they are resigned to run another phase III study]. One of our antibody product candidates, pexelizumab, is an antibody fragment under development in acute cardiovascular disorders. We completed a Phase III clinical trial of pexelizumab, known as the PRIMO-CABG trial, in approximately 3,000 patients undergoing coronary artery bypass graft surgery, or CABG, with cardiopulmonary bypass, or CPB. The PRIMO-CABG trial was conducted in collaboration with Procter & Gamble Pharmaceuticals, or P&G. In November 2003 at the Late-Breaking Clinical Trials Session of the 2003 Scientific Sessions Meeting of the American Heart Association, we disclosed results of the Phase III clinical trial that indicated that although there was reduction in the primary endpoint, it was not achieved with statistical significance. The primary endpoint in this trial was a composite of the incidence of death or myocardial infarction, measured at 30 days post-procedure, in the subpopulation of patients undergoing CABG without concomitant valve surgery. However, key pre-specified secondary endpoints consisting of the same composite in the overall study population, which included all patients undergoing CABG with or without concomitant valve surgery, were achieved. While our objective to achieve statistical significance in the primary endpoint was not met, and although this trial alone may not provide a basis for us to seek approval for further development of pexelizumab, because of our view regarding the potential clinical benefit observed with pexelizumab in this trial, we have initiated discussions with the FDA. We expect these discussions to continue. We also expect to commence planning for a subsequent CABG clinical trial to expand upon and confirm observations from the PRIMO-CABG trial. In September 2000 the FDA granted “Fast Track” status for the development of pexelizumab in CPB. Fast Track designation provides for expedited development and application review for approval of a drug through the FDA. We are not currently able to predict the determination of the FDA and other regulatory agencies regarding the results of this Phase III trial. Such determinations may include, but not be limited to, the view that the results may be sufficient for filing and approval of a Biologics License Application, or BLA, supportive of the filing and approval of a BLA together with additional studies, or not supportive of the filing or approval of a BLA. Further, we are not currently able to predict the reaction of P&G, our collaborative partner, to the results of this Phase III trial, including how those results may affect P&G’s views of pexelizumab for CABG or other indications. P&G retains the development rights and the rights to terminate the collaboration or sublicense its collaboration rights at any time. sec.gov