Antigenics’ Oncophage Cancer Vaccine Receives European Orphan Drug Designation for Brain Cancer

10 March 2009

Antigenics Inc. today announced that Oncophage® (vitespen) has been granted a positive recommendation for orphan drug designation for the treatment of glioma by the Committee for Orphan Medical Products (COMP) of the European Medicines Agency (EMEA). This designation provides Antigenics with, among other benefits, 10 years of potential market exclusivity if the product is approved for marketing in the European Union (EU).

This is the second indication for which the EMEA has granted orphan drug status to Oncophage. In April 2005, Oncophage received orphan drug designation in the European Union for the treatment of renal cell carcinoma (kidney cancer). Subsequently, Antigenics submitted a Marketing Authorization Application (MAA) to the EMEA in October 2008 requesting approval for Oncophage in earlier-stage, localized renal cell carcinoma.

“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,” stated Garo Armen, PhD, chairman and CEO of Antigenics. “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.”

The EMEA regulation on orphan medicinal products is designed to promote the development of drugs, which may provide significant benefit to patients suffering from rare diseases identified as “life-threatening or very serious.” In addition to potential 10-year EU market exclusivity following marketing approval, orphan drug status provides regulatory assistance, reduced regulatory fees associated with applying for marketing approval, and protocol assistance.

Source BusinessWire