ImClone Resubmits Erbitux to FDA

ImClone Systems Inc. said Thursday that it resubmitted its marketing application for a closely watched colon cancer drug that U.S. regulators refused to review two years ago, sending its shares higher.

ImClone said it had asked the Food and Drug Administration to approve the drug, Erbitux, in combination with a standard chemotherapy medicine called irinotecan.

The ImClone drug, which the company plans to market with Bristol-Myers Squibb Co., blocks a protein found on the surface of tumor cells, called epidermal growth factor.

Erbitux is one of the most closely followed new cancer drugs because it works by a new mechanism of action and because Bristol-Myers in 2001 agreed to pay tiny ImClone up to $2 billion for rights to co-market the injectable medicine.

Only months after Bristol-Myers signed the record-setting cancer drug partnership, the FDA shook Wall Street by refusing to review the medicine -- citing sloppy design of the U.S. trial and inadequate clinical data.

The refusal led to an insider trading scandal that culminated in the imprisonment of former ImClone Chief Executive Samuel D. Waksal and obstruction-of-justice charges against his friend Martha Stewart.

ImClone’s new Erbitux marketing application includes favorable data from a separate trial of the medicine conducted by Merck & Co., ImClone’s European marketing partner.

That trial showed Erbitux, in combination with chemotherapy, shrank tumors in 23% of colon cancer patients that had exhausted all other options. The results almost exactly reflected those of ImClone’s previous trial that was criticized by the FDA.

But after talks between ImClone and the FDA earlier this year, the agency agreed to consider the European trial data and to review Erbitux on a “fast-track” basis -- meaning its fate will be decided within six months instead of the customary 12-month FDA review period.

“Erbitux will face a difficult review process. I expect the FDA to carefully scrutinize ImClone’s application because of all the controversies we’ve seen with ImClone and Waksal in the past 18 months,” said Sena Lund, a Cathay Financial drug analyst.

Shares of ImClone rose 46 cents to $40.23 on Nasdaq after climbing as high as $43.25.