Healthcare Industry News: bladder cancer
News Release - February 21, 2006
IDM and GENESIS Pharma Sign an Exclusive Marketing Agreement for Junovan(TM) in South East EuropeSAN DIEGO, Feb. 21 (HSMN NewsFeed) -- IDM Pharma, Inc. (Nasdaq: IDMI ) today announced that its subsidiary, IDM S.A., has signed an exclusive licensing and marketing agreement for Junovan(TM) in South East Europe with GENESIS Pharma, a privately owned Greek pharmaceutical company. These countries (Greece, Cyprus, Bulgaria, Croatia, Former Yugoslavian Republic Of Macedonia, Romania and Slovenia) represent approximately 50 million inhabitants.
In exchange, IDM will receive an upfront license fee and milestone payments on reaching certain sales levels in the territory.
Junovan is an immune system stimulator designed to destroy cancer cells by activating macrophages present in the patient. A Phase III trial, the largest ever published in osteosarcoma, has demonstrated improvement in disease-free and overall survival among patients with non-metastatic, resectable osteosarcoma, who were treated with Junovan, corresponding to a relative reduction of 25% in the risk of recurrence, and a relative reduction in the risk of death of 30%.
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 an appropriate pathway for product marketing approval. IDM expects to receive regulatory approval for Junovan in the U.S. and EU in 2007.
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.
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. 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.
About IDM Pharma
IDM Pharma is a biopharmaceutical company focused on the development of innovative products that activate the immune system to treat cancer. IDM is currently developing two types of products: the first is designed to destroy cancer cells by activating innate immunity, and the second to prevent tumor recurrence by triggering a specific adaptive immune response.
IDM Pharma currently has 5 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 one is in Phase I in colorectal cancer.
IDM Pharma has a major product development partnership with SANOFI-AVENTIS in cancer immunotherapy. 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 .
About GENESIS Pharma
Since its foundation in 1997, GENESIS Pharma -- one of the fastest growing Greek pharmaceutical companies -- has established itself as the premier marketer and distributor of biopharmaceutical products in Southeastern Europe. With its core business activity focusing on in-licensing, marketing, sales, and distribution of specialized pharmaceutical products stemming from biotechnology research, GENESIS Pharma has forged powerful strategic alliances through exclusive agreements with leading American and European companies of cellular and molecular technology, such as Amgen, Biogen Idec, Chiron, Cephalon, Shire and Vifor. The company has introduced and marketed an impressive portfolio of products in the region covering the fields of the Central Nervous System (CNS), Hematology / Oncology, Nephrology and Genetic disorders. Some products introduced by GENESIS Pharma include Aranesp, Avonex, Granulokine, Kineret, Modiodal, Neulasta, Tobi and Venofer.
For more information, visit http://www.genesispharma.com
This press release includes forward-looking statements that reflect management's current views of future events, including the timing for submission to U.S. and EU regulatory authorities for approval of Junovan, the potential benefits of Junovan in treating osteosarcoma, and the timing for approval to market Junovan by U.S. and EU regulatory authorities. Actual results may differ materially from the above forward-looking statements due to a number of important factors, including but not limited to whether U.S. and EU regulatory authorities 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 U.S. and EU regulatory authorities may require the Company to conduct additional clinical trials, 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 or at all, 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 IDM's Quarterly Report on Form 10-Q filed with the SEC for the quarter ended September 30, 2005 and other periodic reports filed with the SEC. IDM expressly disclaims any intent or obligation to update these forward- looking statements, except as required by law.
Source: IDM Pharma
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