Healthcare Industry News: bladder cancer
News Release - March 14, 2006
IDM and Medison Pharma Sign an Exclusive Marketing Agreement for Junovan(TM) in IsraelSAN DIEGO, March 14 (HSMN NewsFeed) -- IDM Pharma, Inc. (Nasdaq: IDMI ) today announced that its European subsidiary, IDM S.A., has signed an exclusive licensing and marketing agreement for Junovan(TM) in Israel with Medison Pharma, a privately owned Israeli pharmaceutical company. In exchange, IDM will receive an upfront license fee and will be entitled to receive a milestone payment upon regulatory approval of Junovan(TM) in Israel and royalties on net sales.
"We are very pleased to have finalized a partnership with Medison Pharma for the sales and marketing of Junovan(TM) in Israel. Medison Pharma is a recognized leader in the field, as demonstrated by its portfolio of high quality life-saving drugs coming from successful alliances with prestigious biopharmaceutical companies," said Guy-Charles Fanneau de la Horie, IDM S.A. General Manager.
Junovan(TM) is an immune system stimulator designed to destroy cancer cells by activating macrophages present in the patient's tissues. A Phase III trial was conducted on 664 patients with osteosarcoma, the largest ever osteosarcoma clinical trial. Patients treated with Junovan(TM) demonstrated statistically significant benefits, showing a relative reduction of 25% of the risk of recurrence, and of 30% in the risk of death.
Junovan(TM) has received Orphan Drug Status in the US and EU, and IDM is working with US and EU regulatory agencies regarding an appropriate pathway for product marketing approval. IDM expects to receive regulatory approval for Junovan(TM) in the US 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. Approximately 900 new cases of osteosarcoma are diagnosed per year in both the United States and in Europe.
Junovan(TM) 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(TM) has been evaluated in Phase II and Phase III clinical trials for the treatment of osteosarcoma. Adverse events associated with the use of Junovan(TM) 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(TM) in the Phase III trial.
About IDM Pharma
IDM Pharma (IDM) 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 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 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 www.idm-pharma.com.
About Medison Pharma
Medison is partnering with biotech companies beginning in Phase III through marketing in the Israeli market. To date, Medison partnered with more than 20 companies. Among them are Biogen Idec, Shire, Cephalon and more. Medison registered and currently markets more than 20 products for various indications and diseases in the areas of Oncology, Hematology, Cardiovascular, Dermatology, CNS and more.
For more information, visit www.medisonpharma.com
This press release includes forward-looking statements that reflect management's current views of future events, including the possibility of receipt of milestone payments and royalty payments in Israel, timing for submission to U.S. and EU regulatory authorities for approval of Junovan(TM), the potential benefits of Junovan(TM) in treating osteosarcoma, and the timing for approval to market Junovan(TM) 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 timing for obtaining regulatory approval to market Junovan(TM) in Israel, ability to achieve milestone events upon which milestone payments are due under the agreement with Medison, if regulatory approval is obtained in Israel, the level of sales of Junovan(TM) in Israel, whether U.S., EU and other 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(TM), the possibility that U.S., EU and other 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(TM) within the time frame expected by the Company or at all, whether the Company will be able to manufacture Junovan(TM) 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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