To: Ish who wrote (219971 ) 1/18/2002 7:31:15 PM From: JEB Read Replies (1) | Respond to of 769670 U.S. House panel to probe ImClone Systems FRIDAY, JANUARY 18, 2002 5:59 PM - Reuters U.S. Company News (Adds comment from board member) By Toni Clarke NEW YORK, Jan 18 (Reuters) - A government committee said on Friday it will investigate allegations that ImClone Systems Inc. misled investors by hiding negative information about research into its experimental cancer drug Erbitux. The House Energy and Commerce Committee said it will seek records from the U.S. Food and Drug Administration, ImClone (IMCL) and ImClone partner Bristol-Myers Squibb Co. (BMY) , to establish the validity of ImClone's clinical research into Erbitux. Shares of ImClone fell $8.93, or 29.7 percent, to close at $21.15 on Nasdaq. The stock has plunged nearly 65 percent since Dec. 28, when the FDA refused to review what it considered a deficient marketing application for the drug. "It's not a good situation," said Brian Rye, an analyst for Raymond James & Associates. "A congressional investigation means more negative publicity for ImClone and Bristol-Myers, but particularly for ImClone since almost the whole value of the company is tied up in Erbitux." Over the past three weeks, close to a dozen lawsuits have been filed against ImClone by angry investors who claim the company made false or misleading statements about the prospects for Erbitux, an experimental treatment for colon cancer. Now the government is weighing in. "We have several serious concerns," said W.J. Tauzin, chairman of the Subcommittee on Oversight and Investigations, in a letter to ImClone, Bristol-Myers and acting FDA Commissioner Bernard Schwetz. One concern, Tauzin said, is that ImClone failed to disclose negative information in a Dec. 28 press release in which it announced the FDA had rejected the Erbitux marketing application. The release contained "questionable descriptions" of the FDA's rejection letter and did not mention the crucial news that the agency believed a new clinical trial would be needed for Erbitux, Tauzin said. ImClone and Bristol-Myers declined to comment except to say they would cooperate with the investigation. But an ImClone board member and co-discoverer of Erbitux defended the drug. "I've been working on this for well over a decade, and we've been doing the clinical trials for a very long period of time," said Dr. John Mendelsohn. "This is a delay, this is not a turn-down. It's a delay in getting approved what we believe is an excellent drug, and we hope the data will speak for itself the next time around." The government committee also plans to look into whether ImClone's top management, including Chief Executive Samuel Waksal and Chief Operating Officer Harlan Waksal, his brother, sold shares in ImClone at a time they had reason to believe the drug would not be reviewed. "Adding to the controversy are sales of stock by ImClone executives in the weeks just before FDA issued the refusal-to-file letter," Tauzin said in his letter. On July 12, the Waksals borrowed a combined $33.9 million from New York-based ImClone in the form of interest-bearing promissory notes to exercise options and warrants on nearly 3 million shares of ImClone common stock, according to regulatory documents. They purchased the stock at about $8 a share when it was trading at nearly $41.60. Two months later Bristol-Myers paid $70 a share, or $1 billion, for a 20 percent stake in the company, and agreed to pay up to $1 billion more in milestone payments as Erbitux reached certain stages of development. Bristol-Myers has since lost about $640 million of its investment. ImClone has made consistently upbeat projections for the drug and for the company, telling investors repeatedly that they expected the drug to come before the FDA Oncology Drug Advisory Committee in February and the drug to be approved shortly thereafter.bigcharts.marketwatch.com {3A360524-5EA9-4061-80C7-2CFD426F8C71}&newsid=795852161&symb=IMCL&sid=8185