WASHINGTON A House committee on Thursday sent ImClone Systems Inc. a letter scolding the New York-based company for failing to respond to “repeated requests” for information on stock trading habits of employees’ family members.
ImClone found itself under the House Energy and Commerce Committee’s microscope after the FDA issued a “refuse-to-file” letter regarding the company’s rolling biologics license application for Erbitux, a colorectal cancer drug. There have been allegations that company officials misled investors about potential FDA approval of Erbitux, which is being developed with Bristol-Myers Squibb Co., of New York. (See BioWorld Today, Jan. 3, 2002, and Jan. 22, 2002.)
Now the committee wants, among other things, ImClone CEO Sam Waksal to provide names, addresses and telephone numbers of family members or other persons with whom “investment or disinvestments in ImClone stock since Sept. 1” may have been discussed.
ImClone could not be reached for comment Friday.
The committee cited a New York Times article dated March 14, 2002, that said Waksal’s daughter, Aliza Waksal, sold nearly $2.5 million in ImClone stock on Dec. 27, 2001, the day before the FDA’s refuse-to-file letter. Waksal’s brother, Harlan, is ImClone’s chief operating officer.
On Dec. 28, 2001, in a conference call with about 800 listeners, Samuel Waksal downplayed the refuse-to-file letter. He reported that the Erbitux BLA lacked sufficient data on response rates and eligibility requirements for patients entering the trials. Also, he characterized the problem as a “delay” and emphasized that it did not mean ImClone would be required to conduct additional trials for FDA clearance.
Since then, the agency and ImClone have discussed amending the rolling BLA with data from an ongoing European trial and reanalyzing data from the U.S. Phase II study. (See BioWorld Today, Feb. 28, 2002.)
Regardless of talks between the FDA and ImClone, the House committee remains interested in ImClone’s actions. A few weeks ago, the committee, chaired by Rep. Billy Tauzin (R-La.), contacted seven pharmaceutical companies that originally negotiated with ImClone on Erbitux and asked them to turn over all documentation related to the discussions. (See BioWorld Today, Feb. 25, 2002.)
Partner Bristol-Myers Squibb threatened to abandon ImClone amid the alleged scandal, news that sent ImClone’s stock tumbling 29.7 percent on Jan. 18, closing at $21.15. As recently as December, ImClone’s stock was as high as $73.83. The companies have since resolved differences and the partnership remains. (See BioWorld Today, March 7, 2002.)
ImClone’s stock (NASDAQ:IMCL) closed Friday at $26.06, down 94 cents.