IDM Pharma, Inc. (NASDAQ: IDMI) announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 to 2 that the results of INT 0133, the Phase 3 trial, do not provide substantial evidence of effectiveness of Junovan (mifamurtide) in the treatment of patients with non-metastatic, resectable osteosarcoma receiving combination chemotherapy.
The FDA will consider ODAC’s recommendation when reviewing the new drug application for Junovan. The Company anticipates a decision in late August 2007.
“We are disappointed with the outcome of today’s advisory panel meeting,” said Jean-Loup Romet-Lemonne, M.D., IDM’s President and CEO. “As acknowledged by the panel, there is a significant unmet need for safe and effective treatments for children and young adults suffering from osteosarcoma (bone cancer), as there have been no new treatments in over 20 years. We will focus on working with FDA in the coming weeks to address the issues raised in order to complete the evaluation of our New Drug Application.”
The Company will host a conference call today, May 9th, at 5:00 PM ET to discuss the outcome of the U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee meeting. A webcast of the call will be accessible through the company’s website at www.idm-biotech.com. A replay of the call will be available on the website for 30 days.