ImClone to meet with FDA
Biotech firm, Bristol-Myers to discuss fate of cancer drug Erbitux with agency.
February 25, 2002: 7:23 p.m. ET
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NEW YORK (CNN/Money) - Drugmaker Bristol-Myers Squibb and biotech company ImClone Systems plan to meet with U.S. Food and Drug Administration officials Tuesday to discuss the fate of cancer drug Erbitux.
A once-happy partnership between the two companies has deteriorated rapidly since the FDA decided not to approve Erbitux in December because of deficiencies in clinical trial data.
ImClone was hit with a barrage of shareholder class-action suits alleging misleading comments from management, and then became the subject of informal federal investigations.
Bristol-Myers, which had taken a $1 billion equity stake in the biotech and also pledged milestone payments of up $1 billion in return for 40 percent of Erbitux profit, called on ImClone to restructure the financials of the deal.
The drugmaker also asked ImClone to relinquish control of the Erbitux approval process and temporarily replace President and CEO Sam Waksal and COO Harlan Waksal until the cancer drug is approved.
But ImClone stood its ground, refusing to restructure, and Bristol-Myers did not follow through with threats to abandon its development and marketing deal, instead saying it would explore options, including possible legal action, after the meeting with the FDA.
Now the FDA will decide whether or not to accept further data collected by Bristol-Myers since December or ask the companies to conduct new clinical trials.
Analysts say, however, that the FDA is unlikely to accept a renewed application based on ImClone's current data, which they say is inadequate.
More likely, they say, is that the companies will present, and the FDA will accept, data from Erbitux trials being conducted by Germany's Merck KGaA, which licensed rights from ImClone to sell the drug in Europe and other markets.
"There's a very good chance that the trials being conducted by Merck will be acceptable, or acceptable pending positive results," Lehman Brothers analyst Michael Wood said.
"The FDA will be asking the toughest questions you can imagine and the investment community will be on pins and needles to find out what the agency wants," said John McCamant, executive editor of the Medical Technology Stock Letter. 
-- from staff and wire reports
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