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IDM Pharma Provides Update on Mifamurtide (L-MTP-PE) Regulatory Status Following September Meeting of European Committee for Medicinal Products for Human Use (CHMP)
Date:9/26/2008

ompliance of the COG in terms of patient randomization and stratification, overall survival data collection, and study monitoring. The Company supported the COG in this effort.

Following the satisfactory GCP inspection in April and the June CHMP meeting, the CHMP requested that the Company provide additional data analyses from the Phase 3 L-MTP-PE trial (INT-0133), in addition to responding to the remaining CMC questions. The Company provided this information in accordance with the timeline for preliminary consideration by the CHMP at its plenary meeting in September and will respond to open questions ahead of the November SAG-O and CHMP oral explanation hearings.

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 regulatory review in November 2006.

L-MTP-PE U.S. Regulatory Status

As previously announced, in the United States the Company continues to work with the COG as well as external experts and advisors to gather patient follow-up data from the Phase 3 L-MTP-PE trial and to respond to other questions in the non-approvable letter the Company received from the U.S. Food and Drug Administration (FDA). The Company expects to submit the amended New Drug Application (NDA) in the fourth quarter of 2008.

L-MTP-PE was granted orphan drug status in the United States in 2001. The NDA was submitted to FDA in October 2006 and was accepted for review in December 2006. The non-approvable letter was received in August 2007.

About Osteosarcoma

Between two and three 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, an
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SOURCE IDM Pharma, Inc.
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