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IDM Pharma Announces Non-Binding Opinion of the European Committee for Medicinal Products for Human Use (CHMP) that Mifamurtide (L-MTP-PE) Provides a Possible Clinical Benefit in Survival
Date:1/25/2008

provides the Company a pathway to a potential positive opinion from the CHMP," said Timothy P. Walbert, president and chief executive officer, IDM Pharma. "We are encouraged by CHMP's preliminary consideration and look forward to completing the review process successfully with the goal of bringing this important treatment to the European market."

L-MTP-PE U.S. Regulatory Status

As previously announced, in the U.S. the Company continues to work with external experts and advisors to gather patient follow up data from the Phase 3 clinical trial of L-MTP-PE conducted by the Children's Oncology Group (COG) and to respond to other questions in the not approvable letter the Company received from the U.S. Food and Drug Administration (FDA).

The COG is assisting the Company in collecting this patient follow up data and the Company anticipates it will likely take until the second half of 2008 to prepare the amendment to the New Drug Application (NDA) for L-MTP-PE.

About Osteosarcoma

About 3 percent of all childhood cancers are osteosarcoma. Because osteosarcoma usually develops from osteoblasts, it most commonly affects children and young adults experiencing their adolescent growth spurt. Boys and girls have a similar incidence rate until later in their adolescence, when boys are more commonly affected. While most tumors occur in larger bones, such as the femur, tibia, and humerus, and in the area of the bone that has the fastest growth rate, they can occur in any bone. The most common symptom is pain, but swelling and limited movement can occur as the tumor grows.

Osteosarcoma is an orphan disease with fewer than 1,000 new cases diagnosed in the U.S. each year. A similar incidence of the disease exists in Europe. According to the Children's Oncology Group, the survival of children with osteosarcoma has remained at 60-65 percent since the mid-1980s. The standard treatment for osteosarcoma is tumor resection with combination chemother
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SOURCE IDM Pharma, Inc.
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