GENZYME REPORTS INTERIM RESULTS FROM PHASE II MS TRIAL

Genzyme announced two-year interim results from a Phase II trial comparing Campath (alemtuzumab) with Rebif (interferon beta-1a) for the treatment of multiple sclerosis (MS). The results derive from a pre-specified analysis conducted after two years of treatment for 334 patients in the planned three-year trial. This review was conducted in conjunction with an independent data and safety monitoring board.

Dosing of alemtuzumab in this study was suspended in September 2005 after three patients developed immune thrombocytopenic purpura (ITP), a treatable condition in which patients experience a low platelet count as a result of an immune response directed against the platelets. At that time, most patients had received two cycles of therapy with alemtuzumab. Treatment with Rebif in the control arm has continued without interruption. The trial remains on clinical hold in the United States, and Genzyme is working closely with clinical investigators and regulatory agencies to complete the study and ensure that the risk of ITP is managed.

Analysis of the first co-primary endpoint showed that patients taking alemtuzumab at high and low doses experienced at least a 75 percent reduction in the risk for relapse after at least two years of follow up when compared with patients treated with interferon beta-1a. Analysis of the other co-primary endpoint showed that patients taking alemtuzumab at high and low doses experienced at least a 65 percent reduction in the risk for progression of clinically significant disability when compared with patients treated with interferon beta-1a. These differences were statistically significant in favor of the alemtuzumab patients at both high and low doses.