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IMCLONE FILES ERBITUX APPLICATION

August 31, 2005

ImClone Systems has submitted an application to U.S. regulators to expand the approval of its Erbitux cancer treatment to include head and neck cancer, meeting a revised filing schedule.

The company said it is seeking a priority review for the drug, which is already approved to treat certain colon cancers. If the FDA agrees to put Erbitux on the priority review track, the agency could rule on the new indication within six months.