European Approval Will Be Delayed for ImClone's Erbitux

German drugmaker

Merck KgaA

said Wednesday that it will delay the European regulatory filing for the experimental cancer drug, Erbitux, in order to submit a strong approval package.

Merck, which purchased European rights to Erbitux from

ImClone Systems

(IMCL)

, says an approval application for the drug will be submitted to European regulators in the first half of 2003, instead of the latter part of this year.

Merck says it is delaying the filing so it can seek the drug's approval to treat both colon and head and neck cancers, instead of just head and neck cancer. The company now says it expects approval, and launch of Erbitux in Europe will take place in 2004, a "few months later than planned."

Merck was hoping to seek European approval for Erbitux in colon cancer based on test data provided by ImClone, but the quality of that data was called into question by U.S. drug regulators in December. ImClone is now working with partner

Bristol-Myers Squibb

(BMY) - Get Report

to get a delayed U.S. approval for Erbitux back on track.

Merck will now rely on Erbitux data from its own colon cancer clinical trial, which is nearly complete. The company's head and neck cancer trial is complete and results are being compiled, the company says.

Separately, ImClone cut the 2001 bonus awarded to CEO Sam Waksal by 55% to $450,000, according to a proxy statement filed Wednesday with the

Securities and Exchange Commission

. Waksal's salary rose 10% to $550,000.

In 2001, Waksal exercised options on 2.3 million shares of ImClone stock, valued on paper at $72 million.