Erbitux Approval Triggers Final ImClone Milestone

Merck KGaA has been granted marketing authorization by the European Commission to extend the use of Erbitux in combination with radiotherapy, to treat patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). Erbitux will be available in all 25 member states of the EU as well as Iceland and Norway. Erbitux is already licensed in 53 countries for metastatic colorectal cancer after failure of irinotecan-based chemotherapy.

The license application is based on the results from a randomized, international Phase III trial, conducted by ImClone Systems and Merck KGaA, which examined the impact of combining Erbitux with radiation on overall survival and locoregional control in 424 patients with locally or regionally advanced SCCHN.

ImClone has received a $250 million milestone payment under its commercial agreement with Bristol-Myers Squibb, for the approval of Erbitux. The milestone payment is the final payment under the commercial agreement. Total milestone payments received to date under the agreement are $900 million.

“This milestone payment marks the first full FDA approval of Erbitux, as our marketing application included data on its survival benefit in the treatment of certain patients with head and neck cancer,” stated Joseph L. Fischer, interim chief executive officer of ImClone Systems. “While it is the final milestone payment under our commercial agreements with corporate partners, our efforts in developing Erbitux and in exploring its ability to treat human cancers continue in over 20 different tumor types.”