IDM Pharma Announces Updated Data From Mifamurtide (L-MTP-PE) Compassionate Acce...(lsurvival and quality of life benefits f...),Health

Date:5/15/2008

l survival and quality of life benefits for patients treated with L-MTP-PE continue to be supported through physician experience and we remain committed to advancing L- MTP-PE through the European and U.S. regulatory processes to bring this important treatment to market."

Update on L-MTP-PE Regulatory Status

In January 2008 the Company announced that following presentation of data at an oral explanation hearing before the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, 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 allows 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) and the Company expects to provide responses and data regarding these issues to the CHMP in advance of its meeting scheduled for June 23-26, although the CHMP may have additional questions or require additional information regarding these issues. In April, the European regulatory authorities conducted an inspection of the Children's Oncology Group (COG) to assess the quality of the overall survival data from the 2006 confirmatory database included in our applications for regulatory approval, and to review Good Clinical Practices compliance of COG in terms of patient randomization and stratification, overall survival data collection, and study monitoring. The Company supported the COG in this effort.

The Company expects to receive a final opinion from the CHMP in the third quarter and a final decision fro
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SOURCE IDM Pharma, Inc. Copyright©2008 PR Newswire. All rights reserved

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