Independent Panel Affirms Positive Erbitux Trial Data

An independent review of data from a European clinical trial of the experimental drug Erbitux has led to a new burst of optimism that the treatment for advanced colorectal cancer may be approved in Europe early next year.

Merck KGaA, which has licensed the rights to develop and market Erbitux outside of North America, said a panel of independent radiologists has confirmed its belief the data from the trial is powerful enough to win approval from the European Medicines Evaluation Agency.

Merck KGaA said it would present detailed results of the clinical trial on 330 patients at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago on June 1.

"After this assessment of trial data by outside experts, we remain optimistic that we will be able to submit an application to European regulatory authorities in mid-year as planned," said Chief Executive Bernhard Scheuble.

Erbitux has been the subject of controversy since December 2001 when the U.S. Food and Drug Administration declined to review an application for approval by ImClone Systems, citing a faulty trial design.

Some experts now believe that the European trial results may help ImClone and its U.S. marketing partner Bristol-Myers Squibb Co. win regulatory approval for Erbitux in the United States.

Other Sources: Merck KGaA