Recently IDM Pharma, announced that mifamurtide (known as MEPACT® in Europe), a new class of therapy for the treatment for metastatic, non-resectable osteosarcoma received Centralized marketing authorization from the European Commission. This means that mifamurtide - the first new treatment for osteosarcoma in more than 20 years - can now be marketed in the 27 Member States of the EU, as well as in Iceland, Liechtenstein and Norway.
IDM continues to work on bringing this important treatment to the United States. They have Compassionate Use trials taking place at MD Anderson Cancer Center in Houston and Memorial Sloan-Kettering Cancer Center in New York. They continue to work with the Children’s Oncology Group, as well as external experts and advisors to gather patient follow up data from the Phase 3 clinical trial of mifamurtide and to respond to other questions in the non-approvable letter the Company received from the U.S. Food and Drug Administration (FDA). Given the outcome in Europe, they expect to submit an amended New Drug Application (NDA) in the first half of 2009.
Results from the largest Phase 3 trial completed in osteosarcoma, enrolling approximately 800 patients, demonstrated that the addition of mifamurtide to chemotherapy resulted in approximately a 30 percent reduction in the risk of death. In addition, overall survival after six years of follow-up in patients treated with chemotherapy and mifamurtide was 78 percent, compared to 70 percent in patients treated with chemotherapy alone.
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