7:30AM ISIS Pharm and Genzyme, a Sanofi co (SNY), announced that the Committee for Medicinal Products for Human Use of the EMA has adopted a negative opinion for its marketing authorization application for KYNAMRO (ISIS) 9.61 : Isis Pharmaceuticals and Genzyme, a Sanofi co (SNY), announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion for its marketing authorization application (MAA) for KYNAMRO (mipomersen) for the treatment of patients with Homozygous Familial Hypercholesterolaemia (HoFH). Genzyme plans to request a re-examination of the CHMP Opinion. Isis will review the CHMP opinion on KYNAMRO in a conference call and webcast today at 8:30 a.m. Eastern Time.
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