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Genzyme/Isis Expand Clinical Trial Program For Mipomersen

This article was originally published in The Pink Sheet Daily

Executive Summary

Design for cholesterol-lowering candidate’s outcomes study, to start in 2010, depends on data from four additional clinical trials.

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Genzyme/Isis On Track To Submit Cholesterol Drug Mipomersen In 1H 2011

Mipomersen, Genzyme/Isis Pharmaceuticals' second-generation antisense drug for severe high cholesterol, is four for four in terms of collecting positive outcomes in Phase III trials. But in addition to lowered cholesterol, patients in all of those studies had elevated liver enzymes, leaving open the question whether regulators will consider the side effect a manageable trade off for filling an unmet medical need

Genzyme/Isis On Track To Submit Cholesterol Drug Mipomersen In 1H 2011

Mipomersen, Genzyme/Isis Pharmaceuticals' second-generation antisense drug for severe high cholesterol, is four for four in terms of collecting positive outcomes in Phase III trials. But in addition to lowered cholesterol, patients in all of those studies had elevated liver enzymes, leaving open the question whether regulators will consider the side effect a manageable trade off for filling an unmet medical need

Genzyme/Isis On Track To Submit Severe High Cholesterol Drug Mipomersen In 1H 2011

The second-generation antisense drug is four for four in positive Phase III outcomes, but in addition to lowered cholesterol, patients in those studies had elevated liver enzymes, leaving observers to wonder whether FDA will consider the side effect a manageable trade-off for filling an unmet need.

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