Representatives from ImClone Systems Inc. and Bristol-Myers Squibb Co. met Tuesday with the FDA regarding the stalled biologics license application for Erbitux, a cancer drug.
The agency and the New York-based companies were expected to discuss which course of action should be taken to move the colorectal cancer drug to the market. Possible scenarios include the FDA accepting additional data from the completed trials, the agency allowing submission of data from ongoing European trials, or the requirement for new studies.
Officials at the companies were not commenting as of Tuesday evening.
From an investor standpoint, the House Energy and Commerce Committee became interested in ImClone’s business practices when the FDA issued the company a “refuse-to-file” letter for Erbitux after Christmas. The committee raised concerns that investors and Wall Street may not have been fully informed of the drug’s likelihood to win FDA approval. (See BioWorld Today, Jan. 22, 2002.)
The FDA’s letter became news after the Cancer Letter, a Washington-based newsletter, published excerpts from it, including the agency’s comment that it had identified 21 patients who died within a month of their last Erbitux treatment, compared to ImClone’s count of three. Also, the FDA had warned ImClone that it would have to demonstrate Campostar (irinotecan) was required to be dosed with Erbitux, but ImClone never provided such data.
ImClone lost a $300 million milestone payment from partner Bristol-Myers Squibb when the BLA wasn’t accepted. BMS, however, did purchase 20 percent of ImClone before the setback. (See BioWorld Today, Jan. 3, 2002.)
Following the recent downward spiral, Bristol-Myers has proposed restructuring the deal with ImClone. The company offered to take regulatory and clinical matters out of ImClone’s hands, alter senior management at ImClone until the drug is approved, expand Bristol-Myers’ rights to intellectual property related to the drug and lift some restrictions on Bristol-Myers’ ability to resell ImClone shares. (See BioWorld Today, Feb. 7, 2002, and Feb. 13, 2002.)
ImClone refused the offer and Bristol-Myers responded that it is “considering our business and legal options with respect to our relationship with ImClone but will wait until after the FDA meeting.”
ImClone’s stock (NASDAQ:IMCL) closed Tuesday at $15.52, up 79 cents.