and German drug development partner
backpedaled slightly from comments Thursday suggesting ImClone would get no help from overseas in getting its cancer drug Erbitux approved in the U.S.
On Friday, the companies issued a joint statement in which they "reiterated Merck KGaA's commitment to sharing clinical data with its partner" in support of the resubmission of a U.S. biological license application for the drug, which is for colorectal cancer. "Under the terms of the 1998 license agreement for Erbitux, both ImClone Systems and Merck KGaA are contractually obligated to share all clinical data from their respective territories to support all regulatory submissions," the companies said.
At issue in Thursday's news was whether Merck would expand its clinical trial of the drug in such a way that data collected from it could be submitted to beef up ImClone's domestic studies, which were found lacking by the FDA.
Friday's release said: "ImClone Systems,
and Merck KGaA have had an ongoing dialogue on the clinical and regulatory development of Erbitux, including discussions regarding the size of the European colorectal trial. Merck KGaA has increased the size of the trial from 225 patients to approximately 330 patients." The company indicated Thursday it had rejected an ImClone request to expand the trial to 500 people.