ImClone Drug Fails in Head, Neck Cancer Study

ImClone Systems Inc.’s Erbitux drug, stalled by regulators’ refusal to review research on its use in colon cancer, failed in a separate study to show benefit in patients with head-and-neck cancer.

Erbitux failed to slow the disease or prolong patients’ lives in the study of 123 patients with head-and-neck cancer. Though more patients getting Erbitux with chemotherapy responded to treatment, they didn’t fare better over time than patients who received chemotherapy along with a placebo drug.

“You’d have to say this study failed,” said Barbara Burtness, a cancer specialist from the Yale University School of Medicine who presented the research at the annual meeting of the American Society for Clinical Oncology.

ImClone shares have lost three-quarters of their value since the Food and Drug Administration refused in December to consider Erbitux. ImClone still hopes to sway the FDA with additional colon cancer data, and strong results in the head-and-neck cancer study might have bolstered investor confidence in the drug’s prospects.

“It’s definitely a setback. I certainly think it is going to make people wonder, because it appears that there has been more negative data than positive” on Erbitux at the meeting, said Michael King, a biotechnology analyst at Robertson Stephens.

The disappointing results from the study, by the independent Eastern Cooperative Oncology Group, represent the second setback in less than a week for ImClone’s efforts to get its drug approved.

On Thursday, ImClone’s partner, Merck & Co., said it wouldn’t expand colon cancer studies that ImClone was counting on to help persuade the FDA to approve Erbitux.

Merck, which holds rights to Erbitux outside the United States, said it still plans to make its Erbitux research available to ImClone but has decided against expanding its studies to satisfy the FDA’s request, adding to concerns about further delays. ImClone shares fell 13% on the news.