Genzyme and Isis Begin Second Phase 3 Trial Of ... (ign of the morbidity and mortalityoutcom...)

Genzyme and Isis Begin Second Phase 3 Trial Of Mipomersen

Date:8/6/2008

ign of the morbidity and mortality outcome study for potential expansion of mipomersen's label to include a broader group of at-risk, high cholesterol patients on maximally tolerated, currently available therapies.

Following the finalization in June of the mipomersen license and collaboration agreement between Genzyme and Isis, the mipomersen IND and all regulatory authority has been transferred to Genzyme. Now that this transition has taken place, the companies are looking forward to Genzyme beginning discussions with the FDA and regulatory authorities in Europe, where the development path for mipomersen may differ from that in the U.S.

New Patent

The patent entitled "Antisense Modulation of Apolipoprotein B (apoB) Expression," U.S. Patent No. 7,407,943 is the first allowance in a series of broad filings protecting the therapeutic use of targeting apoB for the lowering of all atherogenic lipids, including LDL cholesterol and triglycerides. The patent covers the use of both single-stranded and double-stranded (siRNA) antisense drugs complementary to any site of the mRNA of human apoB regardless of their chemistry or antisense mechanism of action. The allowance provides broad protection of the Isis-Genzyme apoB franchise, including mipomersen and potential future follow-on compounds.

About Mipomersen

Mipomersen is a second-generation antisense drug currently in phase 3 development that reduces the production of apoB-100, a protein critical to the synthesis and transport of "bad" cholesterol.

In phase 2 studies, mipomersen, a weekly injectable therapeutic, was observed to reduce cholesterol and other atherogenic lipids beyond reductions achieved with standard lipid-lowering drugs, enabling more patients to achieve LDL-C targets. In 2008 Genzyme and Isis completed a licensing agreement that provides Genzyme with exclusive worldwide rights to mipomersen, which was discovered and initially developed by Isis.

About Genzyme
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