The recommendation is subject to the European Commission's approval.
The orphan drug designation ensures EU market exclusivity for the drug for a period of ten years following marketing authorization.
The intent of the EU orphan drug program is to support the development of therapies for rare and severe diseases.
MediGene's EndoTAG technology aims at “starving out” tumors. EndoTAG works by destroying blood vessels, thus suppressing the tumor's nutrient supply.
EndoTAG-1 is the first drug candidate based on this technology. Currently a clinical phase II trial is in progress to test EndoTAG-1 for the treatment of pancreatic cancer. Initiation of another phase II trial in the indication hormone-resistant breast cancer is planned before the end of this year.