Washington Editor

WASHINGTON - Former ImClone Systems Inc. CEO Samuel Waksal has been subpoenaed by a House subcommittee to answer questions surrounding the business transactions and development of the investigational cancer drug Erbitux.

A spokesman for the House Energy and Commerce Subcommittee on Oversight and Investigations told BioWorld Today that while Waksal previously cooperated with the committee, he refused to testify at a hearing scheduled for June 13. Specifically, the committee wants Waksal to answer questions concerning possible misleading information surrounding Erbitux's success in clinical trials that may have attracted investors and its partner, Bristol-Myers Squibb Co., of New York.

"All along Dr. Waksal has cooperated to some degree," Ken Johnson, the committee spokesman, said. "He met with our investigators for about four hours in the middle of last month. He agreed to a follow-up interview because frankly, we were only able to get answers to a few of the many questions we have. He agreed to cooperate, and then at the last minute he pulled a no-show. We tried, unsuccessfully, to convince him to meet with us again, but on the advice of his attorney, he refused. As a result, we felt compelled to issue the subpoena."

A complete witness list will be finalized next week, a statement from the committee said.

Waksal, who had been at ImClone for nearly two decades and led the effort to develop the cancer drug, quit his job in late May, citing "recent events and the distractions they have caused." His brother, Harlan Waksal, the previous executive vice president and chief operating officer, is now in charge. (See BioWorld Today, May 23, 2002.)

Samuel Waksal's spokesman, Scott Tagliarino, confirmed that the subpoena was received. "We are continuing to evaluate the situation to determine if Dr. Waksal will appear," Tagliarino BioWorld Today.

Johnson said the committee expects Samuel Waksal to appear, "but again, that's a decision he will make after consulting with his attorney. But I can only tell you, if he pulls a no-show, there is a very good possibility we will seek contempt of Congress charges."

Meanwhile, Harlan Waksal also is expected to testify. Tagliarino deferred all questions related to Harlan to New York-based ImClone, which did not return phone calls Wednesday. However, the company released a statement late Tuesday saying it "continues to work closely with, and cooperate fully with the subcommittee in the course of its inquiry. ImClone Systems welcomes any opportunity to discuss with the public the development of Erbitux."

The committee will give ImClone that chance. "We have a great deal of concern about the hype relating to Erbitux and we have a great deal of concern about the run-up in stock prices, and we have more general concerns with some of the practices of the FDA," Johnson said. "Frankly, we're going to ask tough questions."

He said the committee wants to discuss how cancer drugs are approved and whether there is a risk associated with the secretive FDA approval process that can facilitate misleading premarket promotion and stock manipulation. Furthermore, he said Congress wants to re-examine laws that prohibit the disclosure of "refuse-to-file" (RTF) letters.

Indeed, the investigation into ImClone was launched after Cancer Letter, a Washington-based trade publication, published excerpts from the FDA's confidential RTF letter to ImClone indicating that the problems with the Erbitux rolling biologics license application were more serious than Samuel Waksal had indicated in a conference call Dec. 28. (See BioWorld Today, Jan. 3, 2002, and Jan. 22, 2002.)

Since then, the pressure on ImClone has intensified, as disagreements with Bristol-Myers have become headlines, along with allegations of insider trading and unreported deaths in clinical trials. (See BioWorld Today Jan. 27, 2002, and Feb. 28, 2002.)

In September, Bristol-Myers bought 20 percent of ImClone for $1 billion and agreed to pay as much as $1 billion more to obtain the U.S. marketing rights to Erbitux. Erbitux is a monoclonal antibody designed to target and block the epidermal growth factor receptor and treat irinotecan-refractory colorectal cancer.

Bristol-Myers did not return phone calls Wednesday, however, a committee spokesman said it is possible that a representative of the company will testify next week.

ImClone filed its rolling BLA in October. Several months after meeting with the FDA to discuss the RTF letter, ImClone officials said they hoped the agency would accept the BLA without additional trials if the company reanalyzed Phase II data from the U.S. and combined it with data from a trial being conducted by partner Merck KGaA, of Darmstadt, Germany. Merck said it would not alter its European colorectal cancer trials to fit ImClone's needs. (See BioWorld Today, May 23, 2002.)

ImClone's stock (NASDAQ:IMCL) closed Wednesday at $8.68, down 27 cents.