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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

the preferred partner to continue development, commercialize and market the drug. Isis will transition development responsibility for mipomersen to Genzyme over the next year. In addition to the up-front payment ($150 million for Isis stock at $30 per share and $175 million mipomersen license fee), Isis also has the opportunity to receive from Genzyme up to $825 million in development and regulatory milestone payments plus up to $750 million in commercial milestone payments. Genzyme and Isis will share mipomersen profits. The profit share begins with a 70/30 Genzyme/Isis split and increases linearly to 50/50 when revenue reaches $2 billion.

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.

Currently in Phase 3 development, mipomersen has been shown in Phase 2 trials to reduce cholesterol and other atherogenic lipids more than 40 percent beyond reductions achieved with standard lipid-lowering drugs, enabling more patients to achieve LDL-cholesterol targets. These trials have shown that treatment with mipomersen is well-tolerated, and that mipomersen has an attractive safety profile, and works equally well in the presence and absence of other lipid-lowering therapies including statins. A weekly injectable therapeutic, mipomersen is being developed primarily for patients at high cardiovascular risk who are unable to achieve target cholesterol levels with statins alone or who are into
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SOURCE Isis Pharmaceuticals, Inc.
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