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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

CHMP grants Company extension to address remaining questions on Marketing

Authorization Application

IRVINE, Calif., Jan. 25 /PRNewswire-FirstCall/ -- IDM Pharma, Inc. (Nasdaq: IDMI) today announced that the Company recently presented to the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Evaluation Agency (EMEA), regarding the Marketing Authorization Application (MAA) for mifamurtide (L-MTP-PE) for the treatment of patients with non-metastatic, resectable osteosarcoma. L-MTP-PE was granted orphan drug status in Europe in 2004. The Marketing Authorization Application for L-MTP-PE was submitted to the EMEA and accepted for regulatory review in November 2006.

The Company attended an oral explanation hearing before the CHMP on January 23, 2008. The CHMP considered that the data presented by the Company suggested a possible clinical benefit in terms of survival. However, the CHMP requested clarification of the existing data in order to gain assurance about the quality of the data before drawing any final conclusions from the data presented. In addition, the Company is required to address a number of remaining questions relating to chemistry, manufacturing and controls (CMC). As a result of the CHMP's non-binding opinion, the Company was granted a clock stop, or time extension, to allow the Company additional time to respond to all the remaining questions regarding the MAA. The Company now expects to receive a final opinion from the CHMP in the third quarter and a final decision from the European Commission in the fourth quarter of 2008.

"The feedback from the CHMP regarding the positive survival benefit offered by L-MTP-PE, while not binding,
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SOURCE IDM Pharma, Inc.
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