IDM Pharma to submit NDA for Junovan for treatment of osteosarcoma

By Elaine Rigoli

Tampa, Fla., Feb. 28 - IDM Pharma, Inc. said it plans to submit a New Drug Application for Junovan, the company's investigational immunotherapy for the treatment of osteosarcoma, a bone cancer that occurs predominantly in adolescents and young adults.

The company said it recently had a pre-NDA meeting with the Office of Oncology Drug Products of the Food and Drug Administration regarding its plans to submit an NDA for Junovan.

During the meeting, IDM reviewed with the FDA its plan for the submission of preclinical, clinical, manufacturing and quality data to support an NDA for Junovan for treatment of patients with newly diagnosed, non-metastatic osteosarcoma, according to a company news release.

Based on current information, the company said it plans to respond to FDA requests and submit the NDA for Junovan in 2006.

Junovan is a liposomal formulation of MTP-PE (muramyl tripeptide phosphatidylethanolamine) specifically designed for in vivo targeting of macrophages by intravenous infusion. It is a fully synthetic derivative of muramyl dipeptide, a naturally occurring component of bacterial cell walls, the release said.

Junovan has been evaluated in phase 2 and phase 3 clinical trials for the treatment of osteosarcoma, and it has received orphan drug status in both the United States and European Union. IDM said it expects to receive regulatory approval for Junovan in the United States and European Union in 2007.

San Diego-based IDM is a biopharmaceutical company focused on the development of products that activate the immune system to treat cancer.

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