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ImClone Says It Bungled Drug Application

Medicine: CEO explains FDA rejection of Erbitux to irate investors. New clinical trials may be necessary.


The chairman and chief executive of embattled ImClone Systems Inc. told irate investors Wednesday that the biotechnology company had "screwed up" its application for a highly touted cancer drug.

The Food and Drug Administration rejected the drug, known as Erbitux, on Dec. 28. ImClone, a New York-based start-up with no products, has been hit with eight shareholder suits since details of the FDA's rejection were disclosed in an industry journal Monday.

At the same time, the company's stock has lost more than 50% in the last month. It was trading as high as $75 in early December. On Wednesday, it lost an additional 14%, closing at $31.85, down $50, on Nasdaq.

Chief Executive Sam Waskal told investors attending a health-care conference in San Francisco that the company was working with its partner, industry giant Bristol-Myers Squibb Co., to refile the application for the drug. But Waskal said he did not know when a new application would be ready and said the company may have to conduct new clinical trials on patients to prove that Erbitux works.

Erbitux was regarded by investors and oncologists as one of the most promising cancer drugs in development. ImClone had been seeking approval to use the drug in colorectal cancer, but said it expected the drug to be useful in treating pancreatic cancer and cancers affecting the head and neck.

Last spring, ImClone announced that Erbitux, used with the chemotherapy drug irinotecan, shrank colo-rectal cancer tumors in 22.5% of the patients who used it. The company said all 120 patients in the study had failed to respond to irinotecan alone.

Bristol Myer-Squibb, citing the blockbuster potential of the drug, last fall paid $1 billion for 20% of ImClone and agreed to pay as much as $1billion more for marketing rights to the drug.

The last two weeks have yielded nothing but bad news. On Dec. 31, ImClone told investors that the FDA could not review its application for the cancer drug. ImClone said at the time that the agency needed more documentation, which the firm hoped to provide by the end of March. The FDA wanted ImClone to show how it concluded patients had responded to the combination of Erbitux and irinotecan but not irinotecan alone.

But the Cancer Letter, a Washington-based newsletter, reported this week that the FDA's nine-page letter to ImClone raised additional concerns. It said the FDA warned ImClone as far back as August 2000 that it would have to show why irinotecan, a toxic chemical, was needed with Erbitux, which has mild side effects.

The FDA, according to Cancer Letter, told ImClone that it did not justify the dose it used and did not fully report on patients who died. The FDA rejection letter said "new clinical trials would be needed to provide more robust data documenting response."

Waskal acknowledged many of those problems in a session with several hundred investors. "We put together a faulty package. We screwed up," he said.

Waskal said ImClone expects to meet with FDA officials soon to discuss its options. He called Bristol-Myers "highly supportive" and said, "We could not have a better partner at this time."

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