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Update From Mipomersen Extended Dosing Study Continues to Show That Mipomersen Is Well Tolerated and Maintains Activity in Patients Treated for Up to 16 Months
Date:4/14/2008

e patients:

-- Mild injection site reactions remain the most common side effect

observation.

-- Injection site reactions did not worsen with longer-term dosing and

were not more prevalent in patients who self-administered mipomersen.

-- The incidence and severity of ALT elevations was less in the OLE study

than in the initial studies.

-- The maximal ALT seen in this study was 172 U/L.

-- No patient experienced an elevation of transaminase (ALT) associated

with increased bilirubin (Hy's Law). There were no bilirubins greater

than the upper limit of normal (ULN) observed in any subject.

-- Several patients who experienced increased ALTs either in the OLE

study or in the initial studies continued to receive mipomersen and

experienced decline in ALTs. No patient who experienced increased

ALTs greater than three times the ULN in their initial trial had

increased ALT values when they were retreated with mipomersen in the

OLE study.

"This open-label extension study suggests that mipomersen can be administered with a satisfactory safety profile and continued LDL reductions for prolonged periods of time in patients with familial hypercholesterolemia being treated with maximal doses of statins and other lipid lowering agents," said Evan Stein, M.D., Ph.D., Director, Metabolic and Atherosclerosis Research Center, Cincinnati, Ohio.

Conference Call Information

At 8:30 a.m. Eastern Time Monday, April 14, Isis will conduct a live webcast conference call to discuss mipomersen safety results. Interested parties may access the webcast at http://www.isispharm.com or listen to the call by dialing 877-856-1960. A webcast replay will be available for a limited time.

ABOUT MIPOMERSEN

On January 7, 2008, Isis announced the licensing of mipomersen to Genzyme as
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SOURCE Isis Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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