SAN DIEGO, Oct. 31 /PRNewswire-FirstCall/ -- IDM Pharma, Inc. today confirmed plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) to market Junovan(TM), the Company’s investigational immunotherapy for the treatment of osteosarcoma.
This decision follows a Protocol Assistance (PA) procedure completed earlier this year in which the Company received detailed scientific advice from the EMEA on its plans to submit a MAA based on the preclinical and early clinical development programs conducted by Ciba-Geigy, the manufacturing plans and activities conducted by IDM, and the efficacy data from the Phase III randomized clinical trial (INT-0133) conducted by the Children’s Oncology Group under an Investigational New Drug application (IND) held by the National Cancer Institute. In its feedback, the Committee for Medicinal Products for Human Use (CHMP) indicated that, while the PA response should not be considered a pre-assessment of the clinical data, there is no regulatory requirement that a MAA must include a new confirmatory study and further, that they did not foresee that further exploratory studies would provide a regulatory meaningful reinforcement of available data. The CHMP further agreed with the prior opinion of the Committee for Orphan Medicinal Products (COMP) that if a full analysis of the INT-0133 data leads to the conclusion that the increased survival probability is due to the beneficial effects of Junovan, this would be considered as sufficient demonstration that Junovan is of significant benefit for patients suffering from osteosarcoma. Additional constructive feedback and suggestions related to IDM’s plans for inclusion of preclinical and manufacturing information in a future MAA submission were also provided.
In a pre-MAA meeting between the Company and EMEA representatives earlier this month, the timelines and details of the planned MAA submission by mid-2006 were discussed and confirmed. The prior designation of Junovan as an orphan drug for treatment of osteosarcoma provides IDM the opportunity to request fee reductions for the MAA under the centralized procedure, which if approved, would allow marketing in all member states of the EU, as well as Iceland, Liechtenstein and Norway.
“Our decision to move forward with a MAA submission reflects our commitment to this patient population which has not seen any advances in treatment in more than 15 years and we appreciate the feedback we have received from the EMEA in recent meetings,” said Jean-Loup Romet-Lemonne, M.D., IDM’s chief executive officer. “We look forward to working closely with the Agency to bring to market in Europe the first drug developed specifically for the treatment of osteosarcoma.”
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 Osteosarcoma
Osteosarcoma is a bone tumor that occurs predominantly in adolescents and young adults. It is the most common form of bone cancer and accounts for approximately 5% of all childhood tumors. There are approximately 900 new cases of osteosarcoma per year in each of the United States and Europe.
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 www.idm-pharma.com.
Forward-Looking Statements
This press release includes forward-looking statements that reflect management’s current views of future events, including the timing for submitting a MAA to the EMEA for approval of Junovan, the possibility of fee reductions for the MAA under the EU’s centralized procedure due to Junovan’s designation as an orphan drug, the potential benefits of Junovan in treating osteosarcoma, the timing for approval to market Junovan by U.S. and EU regulatory authorities and the status of development of IDM’s product candidates. Actual results may differ materially from the above forward-looking statements due to a number of important factors, including but not limited to whether feedback received to date from the EMEA will be useful to the Company in its MAA submission, whether such initial feedback will be predictive of or consistent with future decisions by the EMEA, whether the EMEA will consider preclinical and early clinical development work conducted by Ciba-Geigy and efficacy data from the Phase III trial conducted by Children’s Oncology Group as adequate for its assessment of Junovan, the possibility that the new product manufactured by IDM will not demonstrate comparability with previously manufactured product used in clinical development, whether regulatory authorities will approve Junovan within the time frame expected by the Company, whether the Company will be able to manufacture Junovan even if it is approved by regulatory authorities, whether the Company or any of its collaborators will be able to develop pharmaceutical products using the technologies of the Company, risks associated with completing clinical trials of product candidates, risks involved in the regulatory approval process for the Company’s product candidates, the possibility that clinical testing may reveal undesirable and unintended side effects or other characteristics that may prevent or limit the commercial use of proposed products, whether the cash resources of the Company will be sufficient to fund operations as planned, the uncertainty of the Company’s future access to capital, the risk that the Company may not secure or maintain relationships with collaborators, and the Company’s dependence on intellectual property. These factors are more fully discussed in the Company’s Annual Report on Form 10-K/A for the year ended December 31, 2004 (filed under Epimmune Inc.), the Proxy Statement filed with the Securities and Exchange Commission (SEC) on June 30, 2005, and other periodic reports filed with the SEC. The Company expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
IDM Pharma, Inc.
CONTACT: Robert De Vaere, Chief Financial Officer of IDM Pharma, Inc,+1-858-860-2500
