IDM Pharma Receives Not Approvable Letter for Mifamurtide (L-MTP-PE) for the Treatment of Os...( - Company Amending NDA and Commi...)

- Company Amending NDA and Committed to Addressing Unmet Needs of

Critically Ill Children and Young Adults -

- Conference Call Scheduled for 4:30 p.m. ET -

IRVINE, Calif., Aug. 27 /PRNewswire-FirstCall/ -- IDM Pharma, Inc. (Nasdaq: IDMI) announced today that it received a not approvable letter from the U.S. Food and Drug Administration (FDA) after completing the review of the new drug application (NDA) for the investigational drug mifamurtide (L-MTP-PE), formerly known as Junovan, for the treatment of non-metastatic osteosarcoma, a rare and often fatal bone tumor that typically affects children and young adults.

The FDA has requested data from additional clinical trials to demonstrate the benefit of L-MTP-PE. Additionally, the FDA has requested information or clarification with respect to other sections of the NDA.

"We continue to strongly believe in the overall survival benefit and safety profile of L-MTP-PE for the treatment of osteosarcoma and are committed to obtaining regulatory approval to provide L-MTP-PE to the critically ill children and young adults who have not had a new treatment option in more than 20 years," said Timothy P. Walbert, President and Chief Executive Officer of IDM Pharma, Inc. "In anticipation of a not approvable letter from the FDA, in July we announced our intent to amend the current NDA with additional survival data with the goal of bringing L-MTP-PE to market as quickly as possible. While the FDA has asked for data from additional clinical trials, we believe that this decision was made in context of the lack of complete data in the submitted NDA and that capturing supplemental data will overcome the need for additional trials and fu
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