IDM/Genesis sign Junovan accord for SE Europe

US firm IDM Pharma says that its subsidiary, IDM SA, has signed an exclusive licensing and marketing agreement for Junovan (a liposomal formulation of muramyl tripeptide phosphatidylethanolamine) in south east Europe with Genesis Pharma, a privately-owned Greek pharmaceutical company. These countries (Greece, Cyprus, Bulgaria, Croatia, former Yugoslavian Republic of Macedonia, Romania and Slovenia) represent around 50 million inhabitants. In exchange, IDM will receive an upfront license fee and milestone payments on reaching certain sales levels in the territory.

Junovan is an immune system stimulator designed to destroy cancer cells by activating macrophages present in the patient. A Phase III trial, the largest ever published in osteosarcoma, has demonstrated improvement in disease-free and overall survival among patients with non-metastatic, resectable osteosarcoma, who were treated with the compound, corresponding to a relative reduction of 25% in the risk of recurrence, and a relative reduction in the risk of death of 30%.

Junovan has received Orphan Drug Status in both the USA and European Union, and the company is working with US and EU regulatory agencies regarding an appropriate pathway for product's marketing approval. IDM expects to receive regulatory approval for Junovan in both regions in 2007.