This designation provides Antigenics with, among other benefits, 10 years of potential market exclusivity if the product is approved for marketing in the EU.
This is the second indication for which the European Medicines Agency has granted orphan drug status to Oncophage. In April 2005, Oncophage received orphan drug designation in the EU for the treatment of renal cell carcinoma.
Garo Armen, chairman and CEO of Antigenics, said: “We are committed to supporting the evaluation of Oncophage in patients diagnosed with glioma, as this remains a life-threatening disease with limited treatment options. Furthermore, orphan drug status has the potential to accelerate the development of Oncophage in this patient population, which is critical given the poor survival rates.”