IDM Pharma 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 US.
"The filing for European approval of this therapy represents an important step towards the goal of making Mepact available to children and young adults suffering from osteosarcoma" said Dr. Jean-Loup Romet-Lemonne, CEO of IDM Pharma.
Dr. Ian Lewis, a leading Paediatric and Adolescent oncologist at St. James University Hospital, Leeds in the UK, said: "Mifamurtide, when added to combination chemotherapy in this large phase III trial, provided a significant benefit on disease free survival and on overall survival of young osteosarcoma patients. If approved, this product will represent an important therapeutic advancement for patients with this disease."
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.
IDM Pharma's European affiliate, IDM SA, was granted the status of "Pharmaceutical establishment" by the French health agency on October 18, 2006. This status allows IDM SA to submit an MAA to EMEA and, more generally, to import and sell approved pharmaceutical products in all the member states of the European Union. Combined with its prior status of "Cell Therapy Establishment", it gives IDM SA broad freedom to operate under the European regulatory framework.
Mepact (Mifamurtide - Liposomal Muramyl Tripeptide Phosphatidyl Ethanolamine, L-MTP-PE) 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 marketing application for FDA and EMEA submission. 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. Mepact was administered at a dose between 2mg/m2 and 2mg/m2 + 2mg twice a week for 12 weeks and then once a week for 24 weeks. With a median follow up of almost 5 years, patients receiving Mepact had a significant improvement in Disease Free Survival (DFS) and Overall Survival (OS). At 6 years, the probability of survival when Mepact is combined with adjuvant chemotherapy is 77 per cent (95 per cent CI: 72-83 per cent) compared to 66 per cent (95 per cent CI: 59-73 ) without Mepact, a clinically meaningful finding in a pediatric population where the longer the survival, the greater the chance that the patient is cured of cancer. additional survival data from the COG (median 7.7 years) support the survival benefit of Mepact in the treatment of non-metastatic osteosarcoma. Mepact was generally well tolerated. The most common adverse events include chills, fever, nausea, vomiting, myalgia, headache, tachycardia (fast heart rate), hypo- and hypertension, fatigue and shortness-of-breath, generally mild to moderate in nature and consistent with the activation of monocytes and macrophages by Mepact.
IDM Pharma has entered into an agreement with Cambridge Laboratories for the commercialization of Mepact in the UK and the Republic of Ireland, and with Genesis Pharma for South East Europe.