Drug Pipeline Series: Submissions, Nov 6 - Nov 13, 2006

IDM Pharma Submits Filing for European Market Approval of Mepact™ (mifamurtide, Junovan™ in the US) in the Treatment of Osteosarcoma
IDM Pharma announced that the company has submitted a Marketing Authorization Application (MAA) in eCTD format (electronic common technical document) to the European Medicines Agency (EMEA) for Mepact (mifamurtide for injection), requesting approval for its use in the treatment of patients with newly diagnosed resectable high-grade osteosarcoma following surgical resection in combination with post-operative multi-agent chemotherapy. This announcement follows the October 25, 2006 submission of a New Drug Application (NDA) for Junovan (mifamurtide for injection) to the Food and Drug Administration (FDA) in the United States.
As a result of the filing and after administrative validation of the submission, the EMEA Committee for Medicinal Products for Human Use (CHMP) 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.