West Coast Editor

Saying it wants a more robust data package for the FDA-stalled cancer drug cetuximab, Merck KGaA is delaying until the first half of next year the European regulatory filing, but now aims to include colorectal data as well as the originally planned head and neck cancer study results.

Darmstadt, Germany-based Merck, which had aimed to file for European approval in the second half of this year, is the overseas partner of New York-based ImClone Systems Inc. for cetuximab, the monoclonal antibody known as Erbitux in the U.S. where FDA skepticism about the drug has caused ImClone serious woes, especially in its potential $2 billion deal with Bristol-Myers Squibb Co., also of New York.

ImClone’s already-beaten stock (NASDAQ:IMCL) faltered more on the Merck news, closing Wednesday at $17.42, down $2.34, or 11.8 percent.

“With anything related to ImClone, people assume the worst,” said analyst Patrick Mooney, with Thomas Weisel Partners LLC in New York, who called the market response an overreaction.

“The stock initially traded down to $17.80, down considerably when [the delay] was first announced by Merck,” he noted. “The knee-jerk reaction was, Oh my gosh, the drug doesn’t work in head and neck [cancer],’ although there’s no indication of that.

“We’ve always maintained ImClone needs final Merck colorectal cancer data to get the drug approved in the U.S., and this doesn’t impact that at all,” Mooney told BioWorld Today. “In all honesty, I don’t think [the delay] means anything.”

The latest ImClone strategy, devised through talks with the FDA, may let the company use data from the almost-finished European colorectal trial and reanalyzed data from U.S. Phase II trials to support the biologics license application. (See BioWorld Today, Feb. 28, 2002.)

Merck, which reported a 19 percent dip in after-tax profits for the first quarter (along with what it called a “satisfying” sales rise of 7 percent, in line with expectations), said it would not revise its earnings estimate despite the cetuximab filing delay of a few months, since the ultimately broader filing with colorectal cancer promises more gain.

In Europe, about 185,000 new cases of colorectal cancer surface each year, as compared to about 70,000 new cases of head and neck cancer.

Enrollment in the European trials for colorectal cancer is moving along faster than expected and almost is finished, and Merck is compiling data from the head and neck cancer trial. The German firm had planned to use data for head and neck cancer from its own trials and data from ImClone’s colorectal trial, but that was before ImClone hit the FDA snag.

Merck’s plan to submit in Switzerland using ImClone’s FDA filing also was foiled, and Merck said it will use its own data there, too.

“People are skeptical of ImClone and its management, but they don’t have reason to be that skeptical of Merck and [its] management,” Mooney said. “I’m assuming the drug works,” he added, noting that all the data points so far suggest as much.

Mooney sticks to his earlier prediction that Erbitux will launch in the U.S. around February 2004. “That’s the best-case scenario we can envision,” he said.