Genmab's head and neck cancer drug zalutumumab performed well enough in a Phase III trial versus the standard platinum-based therapy that they will go for approval in the EU. However, it looks like the FDA will require new studies costing hundreds of millions.
Now, Genmab is out looking for an appropriate "big bucks" partner to fund these US directed clinical trials. Based on EU regulatory feedback, Genmab feels the new partner will be able to file in the EU now while chasing the needed data for the US. Fierce Biotech notes in their coverage of this story that GSK may be one company interested in Genmab and as they have been rumored to be a takeover suitor in the recent past and currently have a co-development project with them on ofatumumab.
Posted by Bruce Lehr October 19th 2010.