IDM Successfully Manufactures First Lot Of Junovan(TM)

San Diego, CA - IDM Pharma, Inc. today announced that it has produced a first lot of Junovan (previously known as L-MTP-PE or MEPACT) that meets current specifications as well as the prior specifications for the product used in the conduct of the Phase III study in patients with high grade non-metastatic osteosarcoma, the indication for which IDM will be seeking marketing authorization. The Company achieved this important milestone with its key contract manufacturers, Genzyme Pharmaceuticals, Liestal, Switzerland; NOF Corporation, Tokyo, Japan; Ben Venue Laboratories, Cleveland, Ohio and Solvias AG, Basel, Switzerland.

"We are pleased to be working with world-class contract manufacturers as this is an essential step for IDM to ensure we have GMP product that not only meets current requirements, but that will also be sufficiently comparable to the previous product utilized during clinical development so that the development data can be used to support approval," said Jean-Loup Romet-Lemonne, IDM's Chairman and CEO. "We intend to initiate comparability studies with the new IDM product immediately. A proposed protocol for demonstration of comparability is currently under review by the FDA."

SOURCE: Junovan