Positive Opinion Formally Adopted by CHMP

IRVINE, Calif., Dec. 18 /PRNewswire-FirstCall/ -- IDM Pharma, Inc. (Nasdaq: IDMI) today announced that the Committee for Medicinal Products for Human Use (CHMP) formally adopted a positive opinion for mifamurtide (L-MTP- PE), known as MEPACT(R) in Europe, for the treatment of patients with non- metastatic, resectable osteosarcoma, a rare and often fatal bone tumor that typically affects children and young adults. The formal adoption of the positive opinion follows the CHMP recommendation previously announced in November. The marketing authorization is likely to be issued by the European Commission in Q1 2009.

Granting of the centralized marketing authorization will allow L-MTP-PE to be marketed in the 27 Member States of the European Union (EU), as well as in Iceland, Liechtenstein and Norway. L-MTP-PE would be the first approved new treatment in more than 20 years for patients with osteosarcoma. L-MTP-PE was granted orphan medicinal product status in Europe in 2004. Therefore, under European pharmaceutical legislation, L-MTP-PE is entitled to a period of 10 years market exclusivity in respect of the approved indication.

The Company is expected to implement a pharmacovigilance plan for MEPACT, as is normally required for all medicinal products, as part of the marketing authorization. Full details of the CHMP positive opinion, including safety information and the approved indication for MEPACT can be found at http://www.emea.europa.eu/htms/human/opinion/opinion.htm.

L-MTP-PE U.S. Regulatory Status

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).