FDA Advisory Committee Reviews Data on IDM Pharma's Junovan(TM) (mifamurtide) for Treatment of Osteosarcoma.IRVINE, Calif. -- IDM (1) See identity management. (2) (Integrated Device Manufacturer) A company that performs every step of the chip-making process, including design, manufacture, test and packaging. Examples of IDMs are Intel, AMD, Motorola, IBM, TI and Lucent. Pharma, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : IDMI IDMI Integrated Digital Media Institute (Polytechnic Institute of New York University) ) today announced that the U.S. Food and Drug Administration's (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) Oncologic Drugs Advisory Committee (ODAC ODAC Old Dominion Athletic Conference ODAC Oracle Data Access Components ODAC Oil Depletion Analysis Centre ODAC Oncologic Drugs Advisory Committee ODAC Open Democracy Advice Centre ODAC Open Document Architecture Consortium ODAC Old Dominion Aquatic Club ) voted 12 to 2 that the results of INT 0133, the Phase 3 trial, do not provide substantial evidence of effectiveness of Junovan (mifamurtide) in the treatment of patients with non-metastatic, resectable re·sect·a·ble adj. Suitable for resection. osteosarcoma osteosarcoma /os·teo·sar·co·ma/ (os?te-o-sahr-ko´mah) a malignant primary neoplasm of bone composed of a malignant connective tissue stroma with evidence of malignant osteoid, bone, or cartilage formation; it is subclassified as receiving combination chemotherapy. The FDA will consider ODAC's recommendation when reviewing the new drug application for Junovan. The Company anticipates a decision in late August 2007. "We are disappointed with the outcome of today's advisory panel meeting," said Jean-Loup Romet-Lemonne, M.D., IDM's President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "As acknowledged by the panel, there is a significant unmet need for safe and effective treatments for children and young adults suffering from osteosarcoma (bone cancer), as there have been no new treatments in over 20 years. We will focus on working with FDA in the coming weeks to address the issues raised in order to complete the evaluation of our New Drug Application." The Company will host a conference call today, May 9th, at 5:00 PM ET to discuss the outcome of the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee meeting. A webcast of the call will be accessible through the company's website at www.idm-biotech.com. A replay of the call will be available on the website for 30 days. Dial-In Information: Date: May 9, 2007 Time: 5:00 pm ET / 4:00 pm CT / 3:00 pm MT / 2:00 pm PT U.S. Dial-In: 1-866-510-0712 Ex-U.S. Dial-In: 1-617-597-5380 Passcode (both U.S, and Ex-U.S.): 92333282 About the Phase III trial with Junovan The Junovan marketing applications include efficacy and safety data from 678 patients with non-metastatic resectable osteosarcoma, 332 of whom received Junovan, and from 115 patients with metastatic or unresectable osteosarcoma, 39 of whom received Junovan in the controlled Phase III trial conducted by the Pediatric Oncology Group The Pediatric Oncology Group (POG) was a U.S. and Canadian clinical trial cooperative group created with the mission of studying childhood cancers. It was formed by the merger of the pediatric divisions of two other cooperative groups, the Southwest Oncology Group (SWOG) and the (POG POG Pediatric Oncology Group POG Player of the Game POG Price of Gold POG Paths of Glory (board game) POG Pot of Gold POG Priorities of Government POG Planogram POG Psychological Operations Group POG Piece of Garbage ) and the Children's Oncology Group (COG), sponsored by the Division of Cancer Treatment and Diagnosis of the National Cancer Institute (NCI See Liberate. ). The biological effects and safety of Junovan are further supported by data from 17 Phase I and II clinical studies performed by Ciba-Geigy in which an additional 248 patients received at least one dose of Junovan. Junovan (mifamurtide - Liposomal Muramyl Tripeptide tripeptide /tri·pep·tide/ (tri-pep´tid) a peptide that on hydrolysis yields three amino acids. tripeptide a peptide formed from three amino acids. Phosphatidyl Ethanolamine ethanolamine /eth·a·nol·amine/ (eth?ah-nol´ah-men) monoethanolamine. ethanolamine oleate MTP-PE) is selectively delivered to macrophages via the scavenger lipoprotein receptor pathway, activating the tumoricidal activity through the cytoplasmic Nod2 receptor. When administered in combination with chemotherapy and after tumor resection to osteosarcoma patients in the Phase III trial, Junovan provided a significant improvement in Disease Free Survival (DFS (Distributed File System) An enhancement to Windows NT/2000 and 95/98 that allows files scattered across multiple servers to be treated as a single group. With Dfs, a network administrator can build a hierarchical file system that spans the organization's LANs and ) (p less than 0.0245) and Overall Survival (OS) (p less than 0.0183). At 6 years, the probability of survival when Junovan is combined with adjuvant chemotherapy is 77% (95%CI:72-83%) compared to 66% (95%CI:59-73%) without Junovan, a clinically meaningful finding in a pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. population where the longer the survival, the greater the chance that the patient is cured of cancer. Additional survival data from the COG (median follow up of 7.7 years) supports the survival benefit of Junovan in the treatment of non-metastatic osteosarcoma. The most common adverse events include chills, fever, nausea, vomiting, myalgia, headache, tachycardia (fast heart rate), hypo- and hypertension, fatigue and shortness-of-breath, generally mild to moderate in nature and consistent with the activation of monocytes monocytes, n.pl the largest of the white blood cells. They have one nucleus and a large amount of grayish-blue cytoplasm. Develop into macrophages and both consume foreign material and alert T cells to its presence. and macrophages by Junovan and the flu-like symptoms that follow cytokine release. About Osteosarcoma About 3% of all childhood cancers are osteosarcoma. Because osteosarcoma usually develops from osteoblasts Osteoblasts Cells in the body that build new bone tissue. Mentioned in: Bone Grafting, Osteoporosis , it most commonly develops in teenagers who are experiencing their adolescent growth spurt adolescent growth spurt, n a period of rapid increase in height, weight, and muscle mass, which for boys takes place at age 12 to 16 and for girls at age 11 to 14. See also adolescence. . Osteosarcoma is an orphan disease and there are approximately 1000 new cases in the US each year. A similar incidence of the disease exists in Europe. According to the Children's Oncology Group (http://www.curesearch.org/our_research/index_sub.aspx?id=1761), the survival of children with osteosarcoma has remained at 60-65% since the mid-1980s. The standard treatment for osteosarcoma is tumor resection with combination chemotherapy before and after surgery. 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's lead product candidate, Junovan(TM), (mifamurtide for injection), known as Mepact in Europe, is part of a new family of immunotherapeutic agents designed to destroy residual cancer cells by activating the body's natural defenses. IDM's applications requesting marketing approval of Junovan for use in the treatment of newly diagnosed resectable high-grade osteosarcoma patients in combination with multiple agent chemotherapy in review by the FDA in the United States and by the European Medicines Agency The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products. Roughly parallel to the U.S. , or EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. , in Europe. IDM is jointly developing Uvidem, a cell-based vaccine product candidate in Phase II clinical trials for the treatment of melanoma, with sanofi-aventis. This press release includes forward-looking statements that reflect management's current views of future events including statements regarding the ODAC vote and the effect of the ODAC recommendation upon the determination by the FDA whether to approve Junovan for the treatment of newly diagnosed resectable high grade osteosarcoma following surgical resection in combination with multiple agent chemotherapy, the expected timing for a decision from the FDA, and IDM's plans with regard to Junovan. Actual results may differ materially from the above forward-looking statements due to a number of important factors, including, but not limited to: whether the FDA will make its decision regarding the submission for marketing approval for Junovan when expected; the ability of IDM to respond to questions raised by the FDA and EMEA in a satisfactory manner; the time needed to respond to any issues raised by the FDA and EMEA with regard to regulatory submissions for Junovan; although the FDA is not bound by the decision of any advisory panel, the possible negative impact that ODAC's recommendation against approval of Junovan would have on the FDA's decision whether to approve the applicable for marketing approval for Junovan, which would have a material and adverse affect on IDM's business; the possibility that regulatory authorities may not 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, or the Phase III study conduct and analysis, to be adequate for their assessment of Junovan, which may cause delays in review, may result in a refusal to accept the filings for marketing approval, may result in the regulatory authorities requiring IDM to conduct additional clinical trials, or may result in a determination by the regulatory authorities that the data does not support marketing approval; and whether IDM will be able to manufacture Junovan even if it is approved by regulatory authorities. Other risks affecting IDM and its drug development programs include whether IDM or any of its collaborators will be able to develop pharmaceutical products using IDM's technologies, whether clinical trial results to date are predictive of results of any future clinical trials, risks associated with completing clinical trials of product candidates, risks involved in the regulatory approval process for IDM'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 IDM will be sufficient to fund operations as planned; whether any steps taken by IDM to contain costs will in fact result in sufficient reduction in expenses; reliance on key employees, especially senior management; the uncertainty of IDM's future access to capital; the risk that IDM may not secure or maintain relationships with collaborators, and IDM's dependence on intellectual property. These factors are more fully discussed in IDM's Annual Report on Form 10-K filed with the SEC for the year ended December 31, 2006 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. |
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