Erbitux's Numbers Look as Good as in 2001

Merck has already announced plans to use this Erbitux data to seek regulatory approval for the drug in Europe this summer. Expectations are for the drug to be approved there by 2004.

The plans for ImClone and its U.S. partner Bristol-Myers Squibb (BMY Quote) are not yet as clear. Neither company has divulged its timetable for getting Erbitux back to the FDA. But the companies might use the Merck data, combined with revised data from their original application, to refile later this year, possibly as early as this summer. That could get Erbitux approved in the U.S. by early next year, if not sooner, given the approve-drugs-faster attitude adopted by the new FDA hierarchy.

ImClone shares closed Friday at $28.50, just off a 52-week high reached intraday, as investors anticipated the results released today. ImClone shares have jumped 160% since the beginning of the year.

In other Merck-sponsored findings released today from its study, patients taking the combination of Erbitux and irinotecan showed no tumor progression for a median of 4.1 months, compared to 1.5 months for patients receiving Erbitux alone. The one-year survival rates for both groups was about 30%.