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IDM Pharma Joins NORD to Raise Awareness of Rare Diseases
Date:2/26/2009

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 data from the Phase 3 clinical trial of mifamurtide 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 plans to submit an amended New Drug Application (NDA) for mifamurtide in mid-2009 and expects to be in a position to provide an update on the progress of the filing, including timing, following a meeting scheduled with the FDA in March.

Mifamurtide was granted orphan drug status in the United States in 2001. The NDA was submitted to FDA in October 2006 and was accepted for review in December 2006.

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 adaptive immune response. IDM Pharma is dedicated to maximizing the full therapeutic and commercial potential of its innovative products to address the needs of patients and the physicians who treat these patients.

The Company believes it has adequate cash resources to support its operations through the first half of 2009 based on its current development and operating plans. The Company does not currently have operational sales and marketing infrastructure for mifamurtide and does not currently have plans or sufficient funds to secure this capability.

The Company continues to evaluate strategic alternatives, which may include seeking strategic partners, a merger and/or the sale of all or part of its operations and assets, or raising additional capital to secure operational sales and marketing infrastructure for mifamurtide.

For more information about the company and its products,
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SOURCE IDM Pharma, Inc.
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