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IDM Pharma Announces Phase 3 Mifamurtide (L-MTP-PE) Study Demonstrating Improved Survival Published in the Journal of Clinical Oncology
Date:2/4/2008

e a final opinion from the CHMP in the third quarter and a final decision from the European Commission in the fourth quarter of 2008.

L-MTP-PE was granted orphan drug status in Europe in 2004. The MAA for L-MTP-PE was submitted to the EMEA and accepted for review in November 2006.

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

L-MTP-PE was granted orphan drug status in the United States in 2001. The new drug application (NDA) for L-MTP-PE was submitted to FDA in October 2006 and was accepted for review in December 2006.

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 chemotherapy before and after surgery.

About IDM Pharma

IDM Pharma is focused on the development of innovative cancer products that
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SOURCE IDM Pharma, Inc.
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