FDA Panel to Discuss IDM Pharma's Osteosarcoma Drug

IDM Pharma announced that the FDA has scheduled an Oncologic Drugs Advisory Committee meeting for May 9 to discuss Junovan. IDM has filed applications for Junovan for the treatment of newly diagnosed resectable high-grade osteosarcoma following surgical resection in combination with multiple-agent chemotherapy in the U.S. and Europe.

IDM submitted its new drug application for Junovan (mifamurtide) to the FDA in October 2006. The application includes efficacy and safety data from 678 patients with nonmetastatic resectable osteosarcoma, 332 of whom received Junovan, and from 115 patients with metastatic or unresectable osteosarcoma, 39 of whom received Junovan, from a controlled Phase III trial sponsored by the National Cancer Institute. The biological effects and safety of Junovan are further supported by data from 17 Phase I and II clinical studies performed by Ciba-Geigy in which 248 patients received at least one dose of Junovan.

Junovan is a fully synthetic lipophilic derivative of the muramyl dipeptide. When encapsulated in liposomes, MTP-PE is delivered selectively to macrophages via the scavenger lipoprotein receptor pathway. When the multilamellar liposomes are degraded inside the macrophage, MTP-PE is released, activating tumoricidal activity through the cytoplasmic Nod2 receptor.