Monday August 14, 2:51 pm Eastern Time
NEW YORK, Aug 14 (Reuters) - The chief executive of ImClone Systems Inc (NasdaqNM:IMCL - news) said on Monday he expects the firm by the first quarter of 2001 to seek U.S. marketing approval of its experimental drug C225 for patients with colorectal cancer who have failed on previous standard chemotherapy treatments.
Samuel Waksal, CEO of the New York-based firm, added in an interview that he expects ``toward the end of the first half of 2001'' to seek U.S. marketing approval of the drug for patients with head and neck cancer who have also failed earlier therapies.
Phase II clinical trials of C225 are now under way in patients with colorectal and head and neck cancer. Final data from the trials, when obtained, will be the basis for the separate marketing applications, Waksal said.
``If all goes well, C225 will be on the market in the fourth quarter of 2001'' for colorectal cancer, said Waksal, whose brother Harlan is chief operating officer of ImClone.
But for C225 to reach doctors by that optimistic timetable, the drug will have to receive a six-month fast-track review by the U.S. Food and Drug Administration. Usually the agency takes 12 months to decide whether to approve new medicines, but it acts more swiftly when drugs are novel or target especially difficult-to-treat diseases.