ImClone falls after H&Q presentation

IMCL's presentation at the 20th Annual JPMorgan H&Q Healthcare Conference in San Francisco apparently did little to allay investor concerns regarding the company's BLA for Erbitux, as the stock fell $5 (14%) to $31.85 on 16.9 million shares - a slide that began immediately upon conclusion of the company's presentation. IMCL used its presentation to address a refusal-to-file letter from the FDA for IMCL's BLA for Erbitux ( IMC-C225) to treat colorectal cancer refractory to irinotecan.

IMCL President and CEO Samuel Waksal reiterated that FDA's primary concern was that the filing did not include documents to support conclusions on whether patients were refractory to irinotecan (see BioCentury, Jan. 7). Waksal said that if IMCL could not correct its database the company would have to provide new data or run a new trial. He also said that other issues in FDA's refusal-to-file letter included a lack of clinical trial narratives for patients who died within 30 days of their last Erbitux treatment and pharmacokinetic analyses. Waksal said he believes these issues did not contribute to FDA's refusal-to-file decision. ...