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IDMI > SEC Filings for IDMI > Form 8-K on 18-Nov-2008All Recent SEC Filings

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Form 8-K for IDM PHARMA, INC.


18-Nov-2008

Other Events


Item 8.01 Other Events.
On November 18, 2008, IDM Pharma, Inc. (the "Company") issued a press release announcing that the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMEA") has issued a positive opinion, recommending the grant of a centralized marketing authorization for mifamurtide ("L-MTP-PE"), known as MEPACT® in Europe, for the treatment of patients in Europe with non-metastatic, resectable osteosarcoma, a rare and often fatal bone tumor that typically affects children and young adults. The CHMP recommendation will be adopted at the next CHMP meeting in December with final European Commission approval expected within 60 to 90 days thereafter. 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.
A copy of this press release is attached as Exhibit 99.1 to this Current Report and is incorporated herein by reference. Item 9.01 Financial Statements and Exhibits.
(d) Exhibits

Exhibit No. Description

99.1 IDM Pharma, Inc. press release.


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