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FDA Provides Clarity to Isis Regarding the Development Path for Mipomersen
Date:4/25/2008

f Executive Officer of Isis. "Conducting an outcome study in parallel with our continued evaluation of the effects of mipomersen on atherogenic lipids will allow us to submit a much stronger NDA for high risk patients. We are confident that mipomersen will bring benefit to patients with high cholesterol and remain committed to its development and commercialization."

"We are pleased that the FDA has given clear direction on what will be required for the approval of mipomersen, and has acknowledged its potential to help high risk patients whose needs are not being met by current therapies," said Henri A. Termeer, Genzyme's chairman and chief executive officer. "Having outcome data earlier on in the development process will be important to patients and serve to enhance the value of this treatment. We plan to engage in discussions with regulatory agencies in Europe and the rest of the world, and look forward to receiving their feedback."

ABOUT MIPOMERSEN

In early 2008, Isis and Genzyme announced that they had entered into a strategic alliance in which Genzyme will develop and commercialize mipomersen. Final contracts are still being negotiated and are expected to be completed this quarter.

Mipomersen is a second-generation antisense drug that reduces the production of apoB-100, a protein critical to the synthesis and transport of "bad" cholesterol. Cholesterol can be carried in the bloodstream in a variety of forms, with high-density lipoprotein, or HDL-cholesterol, being the good form, and low-density lipoproteins, or LDL-cholesterol, and very low-density lipoproteins, or VLDL-cholesterol, being bad forms directly involved in heart disease. Collectively lowering LDL-cholesterol, VLDL-cholesterol, and other bad forms of cholesterol are a key component in the prevention and management of cardiovascular disease.

Mipomersen is currently in phase 3 development for patients with homozygous familial hypercholesterolemia, a disease which crea
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SOURCE Genzyme Corp. and Isis Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
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