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Granting of the centralized marketing authorization will allow L-MTP-PE tobe marketed in the 27 Member States of the European Union (EU), as well as inIceland, Liechtenstein and Norway. L-MTP-PE would be the first approved newtreatment in more than 20 years for patients with osteosarcoma. L-MTP-PE wasgranted orphan medicinal product status in Europe in 2004. Therefore, underEuropean pharmaceutical legislation, L-MTP-PE is entitled to a period of 10years market exclusivity in respect of the approved indication.
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The Company is expected to implement a pharmacovigilance plan for MEPACT,as is normally required for all medicinal products, as part of the marketingauthorization. Full details of the CHMP positive opinion, including safetyinformation and the approved indication for MEPACT can be found athttp://www.emea.europa.eu/htms/human/opinion/opinion.htm.
L-MTP-PE U.S. Regulatory Status
As previously announced, in the United States the Company continues towork with the Children's Oncology Group as well as external experts andadvisors to gather patient follow up data from the Phase 3 clinical trial ofL-MTP-PE and to respond to other questions in the non-approvable letter theCompany received from the U.S. Food and Drug Administration (FDA). TheCompany expects to submit the amended New Drug Application (NDA) in the firstquarter of 2009 given the recent focus on completing review activities for theMarketing Authorization Application (MAA) in the European Union.
L-MTP-PE was granted orphan drug status in the United States in 2001 andthe NDA was submitted to FDA in October 2006 and was accepted for review inDecember 2006.
About Osteosarcoma
Between two and three percent of all childhood cancers are osteosarcoma.Because osteosarcoma usually develops from osteoblasts, it most commonlyaffects children and young adults experiencing their adolescent growth spurt.Boys and girls have a similar incidence rate until later in their adolescence,when boys are more commonly affected. While most tumors occur in larger bones,such as the femur, tibia, and humerus, and in the area of the bone that hasthe fastest growth rate, they can occur in any bone. The most common symptomis pain, but swelling and limited movement can occur as the tumor grows.
Osteosarcoma is an orphan disease with fewer than 1,000 new casesdiagnosed in the United States each year. A similar incidence of the diseaseexists in Europe. According to the Children's Oncology Group, the survival ofchildren with osteosarcoma has remained at 60-65 percent since the mid-1980s.The standard treatment for osteosarcoma is tumor resection with combinationchemotherapy before and after surgery.
About IDM Pharma
IDM Pharma is focused on the development of innovative cancer productsthat either destroy cancer cells by activating the immune system or preventtumor recurrence by triggering a specific adaptive immune response. IDM Pharmais dedicated to maximizing the full therapeutic and commercial potential ofeach of its innovative products to address the needs of patients and thephysicians who treat these patients.
The Company believes it has adequate cash resources to support itsoperations into the first half of 2009 based on its current development andoperating plans. The Company does not currently have operational sales andmarketing infrastructure for L-MTP-PE and does not currently have plans orsufficient funds to secure this capability. The Company continues to evaluatestrategic alternatives, which may include seeking strategic partners, a mergerand/or the sale of all or part of its operations and assets, or raisingadditional capital to secure operational sales and marketing infrastructurefor L-MTP-PE.
For more information about the company and its products, visithttp://www.idm-pharma.com.
Forward-Looking Statements
This press release includes forward-looking statements that reflectmanagement's current views of future events including statements regarding thetimeframe in which the Company's cash will be sufficient to meet plannedoperations, the Phase 3 L-MTP-PE trial (INT-0133), the potential for L-MTP-PEas a treatment for osteosarcoma, the Company's belief that the data from theL-MTP-PE Phase 3 study warrants regulatory approval of L-MTP-PE from anoverall clinical benefit/risk standpoint in Europe and the United States, theexpected timing and receipt of a final regulatory decision regarding the MAAin the European Union, and plans for the conduct of post-authorization studiesand analyses, as well as the Company's plans to collect, analyze and submitadditional Phase 3 data in an amended NDA for L-MTP-PE, including the expectedtiming for such amended NDA, and to respond to other matters raised by the FDAand the Company's plans to evaluate strategic alternatives. Actual results maydiffer materially from the forward-looking statements due to a number ofimportant factors, including, but not limited to, whether the EuropeanCommission will follow the final opinion of the CHMP once issued, whether thetiming for the regulatory decision in Europe will occur as expected by theCompany, the timing of filing an amended NDA with the FDA, the possibilitythat additional data from the Phase 3 clinical trial of L-MTP-PE and otherinformation in any amendment to the NDA for L-MTP-PE submitted by the Companymay not provide adequate support for regulatory approval of L-MTP-PE in theUnited States within the timeframe expected by the Company, if at all, whetherthe Company will be able to complete any potential strategic transaction onterms acceptable to the Company's stockholders, how the volatile economicenvironment will affect the Company's efforts to complete a strategictransaction, and whether the cash resources of the Company will be sufficientto fund operations as planned. These and other risks affecting the Company andits drug development programs, intellectual property rights, personnel andbusiness are more fully discussed in the Company's Quarterly Report on Form10-Q filed with the SEC for the quarter ended September 30, 2008 and otherperiodic reports filed with the SEC. The Company expressly disclaims anyintent or obligation to update these forward-looking statements, except asrequired by law.
SOURCE IDM Pharma, Inc.
