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IDM Pharma Provides Update on Mifamurtide (L-MTP-PE) Regulatory Status Following June Meeting of European Committee for Medicinal Products for Human Use (CHMP)
Date:7/1/2008

that typically affects children and young adults.

In January 2008, the Company announced that, following presentation of data at an oral explanation hearing before the 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 allowed IDM Pharma additional time to respond to remaining 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 Good Clinical Practice (GCP) compliance 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 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 believes that the additional data analyses requested will further confirm the overall survival benefit of L-MTP-PE seen in the data analyses previously provided.

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 dat
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SOURCE IDM Pharma, Inc.
Copyright©2008 PR Newswire.
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