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IDM Pharma Reports 2007 Financial Results
Date:3/20/2008

Medicinal Products for Human Use (CHMP), the CHMP determined in a non-binding opinion that L-MTP-PE suggested a possible clinical benefit in terms of survival and granted the Company a clock stop, or time extension. The clock stop will allow the Company additional time to respond to all the remaining questions regarding the marketing authorization application for L-MTP-PE (MAA). The CHMP has 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). The Company 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.

As previously announced, in the United States the Company continues to work with the Children's Oncology Group as well as external experts and advisors to gather patient follow up data from the Phase 3 clinical trial of L-MTP-PE 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 and in Europe in 2004. In Europe, the MAA was filed in November 2006 and in the U.S., the NDA was submitted to FDA in October 2006 and was accepted for review in December 2006.

As previously announced, the Company is evaluating the Company's research and development programs, including related assets and costs, and strategic alternatives available to the Company.

About IDM Pharma

IDM Pharma is focused on the development of innovative cancer products that either destroy cancer cells by activating the immune system or prevent tumor recurrence by triggering a specific ad
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SOURCE IDM Pharma, Inc.
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