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.