Merck KGaA has announced that it had been informed by its partner ImClone Systems Inc., that more time would be needed for finalizing the data processing for its application for marketing approval of Erbitux for treatment of head and neck cancer.
As Merck's dossier for the European Medicines Agency (EMEA) is based partially on ImClone data, Merck has determined that it cannot fully compensate for this delay as it prepares its own Erbitux approval application for the same indication to the EMEA. However, Merck will make every effort to submit its application still in the third quarter, at the latest, before the end of 2005, the company said.
Merck received marketing authorization for Erbitux for the treatment of colorectal cancer in December 2003 from Swiss medical authorities and in June 2004 from the EMEA. ImClone Systems and Bristol-Myers Squibb received US marketing approval of Erbitux for the same indication in February 2004.