IDM PHARMA FILES FOR EU APPROVAL OF OSTEOSARCOMA DRUG

IDM Pharma has submitted a marketing authorization application in electronic format to the European Medicines Agency (EMEA) for Mepact (mifamurtide for injection), requesting approval for its use in the treatment of patients with newly diagnosed, respectable, high-grade osteosarcoma following surgical resection in combination with postoperative, multi-agent chemotherapy. Last month the company submitted a new drug application to the FDA for mifamurtide, called Junovan in the U.S.

The EMEA Committee for Medicinal Products for Human Use will evaluate the application to determine whether to recommend to the European Commission the approval of Mepact in all the member states of the European Union. Mepact was granted orphan drug status by the EMEA in 2004.

Mepact is a fully synthetic, lipophilic derivative of muramyl dipeptide. The product was originally developed by Ciba-Geigy and, after acquiring the product in 2003, IDM completed development of product manufacturing and analyzed the Phase III data to support the application submissions to the FDA and EMEA. The Children's Oncology Group performed the Phase III trial in which 678 patients with newly diagnosed non-metastatic, resectable, high-grade osteosarcoma were treated with Mepact in combination with chemotherapy following surgery. With a median follow up of almost five years, patients receiving Mepact had a significant improvement in disease-free survival and overall survival.

IDM has entered into an agreement with Cambridge Laboratories for the commercialization of Mepact in the UK and Ireland and with Genesis Pharma for Southeastern Europe.