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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

eceived feedback from the CHMP that there are no major objections remaining related to chemistry, manufacturing and controls (CMC)."

Mr. Walbert continued, "While we have satisfactorily addressed issues related to the positive benefit/risk assessment reached at the oral explanation meeting with the CHMP in January 2008, we have been invited by the CHMP to meet with SAG-O and CHMP in November to address certain open issues arising from the assessment by the Rapporteur and Co-Rapporteur. We welcome the opportunity to present to both the SAG-O and CHMP to complete the L-MTP-PE MAA review and we remain confident that L-MTP-PE provides a significant overall survival benefit for osteosarcoma patients and meets an important unmet treatment need."

With the final CHMP opinion now anticipated in November, IDM Pharma expects a final decision from the European Commission in the first quarter of 2009. If approved for Marketing Authorization by the European Commission, L-MTP-PE will be the first treatment in more than 20 years approved for patients with osteosarcoma.

In January 2008, the Company announced that, following presentation of data at an oral explanation hearing, 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 to allow IDM Pharma additional time to respond to questions regarding the MAA. At that time, 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 was required to address a number of remaining questions relating to CMC.

In April 2008, the European regulatory authorities conducted an inspection of the COG to assess the quality of the overall survival data from the 2006 confirmatory database included in the Company's applications for regulatory approval, and to review GCP c
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SOURCE IDM Pharma, Inc.
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