Genzyme and partner, Isis, get guidelines for drug approval

It looks like Genzyme Corp.'s partnership with Isis Pharmaceuticals Inc. to develop a new drug that lowers bad cholesterol is starting to bear fruit.

Cambridge, Mass.-based Genzyme (Nasdaq: GENZ) announced on Friday that the U.S. Food and Drug Administration has issued guidance on approval requirements for mipomersen. Those terms are crucial as the companies pursue a late-stage human clinical trial using the drug to treat patients with homozygous familiar hypercholesterolemia, a form of bad cholesterol that can create a high risk of premature cardiovascular disease.

Genzyme and Isis (Nasdaq: ISIS) inked a strategic alliance earlier this year that calls for Genzyme to develop and commercialize the drug.

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Genzyme, in fiscal 2008 financial numbers announced this week, said it took an after-tax charge of $56.5 million relating to its strategic investment in Isis.