ImClone soars on FDA reprieve
Agency allows drugmaker to resubmit Erbitux application with European data.
February 27, 2002: 3:34 p.m. ET
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NEW YORK (CNN/Money) - ImClone Systems shares soared more than 33 percent Wednesday afternoon after the company said it can resubmit data for its cancer drug Erbitux without conducting new clinical trials.
The day after a meeting with the U.S. Food and Drug Administration, ImClone (IMCL: up $5.46 to $20.98, Research, Estimates) said it will resubmit its Erbitux data along with data collected by its strategic partner, European drugmaker Merck KGaA.
There were concerns the FDA, which initially rejected Erbitux, would ask the company to conduct new clinical trials, which would seriously delay the drug's launch and further disrupt ImClone's partnership with Bristol-Myers Squibb (BMY: up $1.63 to $47.14, Research, Estimates), which also attended the meeting.
"We view the meeting with the FDA as very productive," ImClone CEO Sam Waksal said.
"We assured the FDA that we are committed to working closely with them to resolve issues raised in the Refusal to File letter, and on our approach moving forward," Waksal said.
"The FDA provided clarity that the addition of the ongoing Merck KGaA colorectal trial will be required to bolster the existing ImClone database," Bristol-Myers spokesman Wilson Grabill said. "We are actively evaluating our options in view of yesterday's meeting."
Speaking at a Lehman Bros. health-care conference, another Bristol-Myers spokesman called ImClone's statement "a fairly standard response," adding that the FDA "is extremely hard to read in this process."
The spokesman said it was encouraging that ImClone management viewed the meeting as productive.
He said the Erbitux agreement will work for shareholders if the timing of approval works, and Bristol-Myers is working with ImClone on that issue now.
Merck KGaA said it shared ImClone's view that the meeting was productive.
It is unclear what stage the Merck KGaA clinical trials are at, and the companies have not estimated when Erbitux might be approved.
Moors Cabot analyst Jim McCamant said if an application is filed in December or January, then marketing approval would come about mid-2003, about 15 months after approval initially was expected.
"My sense is that the FDA's response to all this publicity is to slow down and be even more careful," McCamant said. "And that's absolutely the wrong thing to do."
He said ImClone also has conducted trials for Erbitux to treat head and neck cancer and an application for approval could be filed for that in the second quarter of this year. 
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