Results of Two Phase 3 Trials of Mipomersen; Studies Meet Primary Endpoints with 36 and 37 Percent LDL-C Reductions in Severe Hypercholesterolemia and High-Risk Patients

CAMBRIDGE, Mass. & CARLSBAD, Calif.--(BUSINESS WIRE)--Genzyme Corp. (NASDAQ: GENZ - News) and Isis Pharmaceuticals Inc. (NASDAQ: ISIS - News) today announced results of two phase 3 studies of mipomersen in patients who had high cholesterol levels while on maximally tolerated lipid-lowering therapy. In the study of patients with severe hypercholesterolemia, mipomersen reduced LDL-C, the primary endpoint, by 36 percent compared with a 13 percent increase for placebo. In the study of patients with high cholesterol at high cardiovascular risk, mipomersen reduced LDL-C by 37 percent compared with a 5 percent reduction for placebo. Both studies met all of their secondary endpoints. Frequently observed adverse events were injection site reactions, flu-like symptoms and elevations in liver transaminases, as seen in previous studies.