ImClone wins in product rights fight with Merck KGaA

ImClone Systems of the USA says that the arbitrator has decided in favor the company in a dispute with Merck KGaA of Germany over rights to develop and commercialize the ImClone-developed IgG1 monoclonal antibody IMC-11F8. The decision, which is binding and cannot be appealed, leaves the exclusive rights to develop and commercialize IMC-11F8 outside the USA and Canada to ImClone. Commercial rights to this antibody in the USA, Canada and Japan fall within the scope of ImClone's commercial agreement with Bristol-Myers Squibb regarding Erbitux (cetuximab).

IMC-11F8, currently in Phase I testing in Europe, is a fully-human, high-affinity antibody that blocks ligand-dependent activation of the epidermal growth factor receptor (EGFR). The preliminary results of the Phase I trial, which is projected to achieve its objectives and close to patient accrual in the second half of 2006, will be reported at the American Society of Clinical Oncology 2006 annual meeting.

Disease-directed developmental trials of IMC-11F8 are expected to begin in the second half of 2006. Preclinical in vitro studies have shown that the antibody inhibits EGFR activation, downstream signaling pathways and growth of human tumor cells. In preclinical human tumor xenograft models, IMC-11F8 suppressed the growth of EGFR-positive tumors and enhanced the activity of chemotherapeutic drugs when used in combination.