Bristol-Myers Exec to Testify in ImClone Probe

WASHINGTON — Bristol-Myers Squibb Co. executive Brian Markison will be asked today about how he learned four days beforehand that regulators would reject a cancer drug developed by ImClone Systems Inc., Bristol-Myers’ partner, said the chairman of the panel holding the hearing.

The Food and Drug Administration on Dec. 28 rejected ImClone’s application for Erbitux.

Four days earlier, a FDA employee told a Bristol-Myers attorney Dec. 24 that the agency found the application flawed, said Rep. James C. Greenwood (R-Pa.), chairman of the House Energy and Commerce Committee’s oversight panel. The attorney passed the information on to Markison, the company’s vice president of oncology, Greenwood said.

“That may have been inadvertent, but that’s what we have to get to,” Greenwood said.

Shares of New York-based ImClone have dropped 86% since the FDA’s announcement Dec. 28. The House committee, which oversees the FDA, announced its investigation of ImClone on Jan. 18.

Laurie Smaldone, Bristol-Myers’ senior vice president of worldwide regulatory affairs, will be the company’s primary witness, according to the witness list released by the committee. Bristol-Myers owns a 20% stake in ImClone and was helping develop Erbitux.

ImClone Chief Executive Harlan Waksal, brother of former CEO Samuel Waksal, also will testify before lawmakers today, a panel spokesman said.

Five FDA employees, including Richard Pazdur, head of the division that reviews cancer drugs, and Patricia Keegan, a senior official in the division that reviews biologic products, will be questioned about when the agency realized the Erbitux application was inadequate and what the FDA told the company during the review process.

The FDA workers were subpoenaed by the panel last week.

The Securities and Exchange Commission and the Justice Department are investigating ImClone’s handling of the Erbitux matter.