IDM Successfully Manufactures First Lot of Junovan(TM) to Support Filing for Marketing Authorization
SAN DIEGO, Sept. 22 /PRNewswire-FirstCall/ — IDM Pharma, Inc.
(Nasdaq: IDMI) 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.”
About Junovan(TM)
Junovan is a liposomal formulation of MTP-PE (Muramyl Tripeptide
Phosphatidylethanolamine) specifically designed for in vivo targeting of
macrophages by intravenous infusion. It is a fully synthetic derivative of
muramyl dipeptide, a naturally occurring component of bacterial cell walls.
Junovan has been evaluated in Phase II and Phase III clinical trials for the
treatment of osteosarcoma. The IDM Phase III trial was the largest ever
published in osteosarcoma and demonstrated improvement in disease-free and
overall survival among patients with non-metastatic, resectable osteosarcoma,
who were treated with L-MTP-PE, corresponding to a relative reduction in the
risk of recurrence of 25% and a relative reduction in the risk of death of
30%. Adverse events associated with the use of Junovan are generally mild to
moderate and thought to be associated with its biological activity. Severe
adverse events in the Phase III study were those typically associated with
high dose multiple-drug chemotherapy, which was used together with Junovan in
the Phase III trial.
Junovan for the treatment of osteosarcoma is IDM’s lead product candidate.
Junovan has received Orphan Drug Status in both the U.S. and EU, and the
Company is working with U.S. and EU regulatory agencies regarding the
appropriate pathway for product marketing approval. The Company expects to
receive regulatory approval for Junovan in the U.S. and EU in 2007.
About IDM Pharma
IDM is a biopharmaceutical company focused on the development of
innovative products that activate the immune system to treat cancer and
infectious disease. IDM is currently developing three types of products: the
first is designed to destroy cancer cells by activating innate immunity, the
second to prevent tumor recurrence by triggering a specific adaptive immune
response, and the third to treat chronic infectious disease with therapeutic
vaccines.
IDM currently has 7 products in clinical development. The most advanced
product, Junovan(TM), has completed a Phase III clinical trial in
osteosarcoma. Three products are in Phase II clinical trials in bladder
cancer, melanoma and non-small cell lung cancer, and three are in Phase I in
colorectal cancer, hepatitis B and HIV infection.
IDM has major product development partnerships with SANOFI-AVENTIS in
cancer immunotherapy, and with INNOGENETICS in vaccine development for the
treatment of chronic hepatitis B and C and papilloma virus infection. MEDAREX
and SANOFI-AVENTIS are corporate partners and shareholders of IDM or its
affiliate since 1993 and 2001 respectively.
For more information, visit http://www.idm-pharma.com.
SOURCE IDM Pharma, Inc.
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