Healthcare Industry News: Takeda Pharmaceutical
News Release - August 27, 2007
IDM Pharma Names Dr. Jeffrey W. Sherman Chief Medical Officer and Senior Vice President of Research and DevelopmentIRVINE, Calif., Aug. 27 (HSMN NewsFeed) -- IDM Pharma (Nasdaq: IDMI ) today announced that Jeffrey W. Sherman, M.D., F.A.C.P. has been appointed as the Company's Chief Medical Officer and Senior Vice President of Research and Development. Dr. Sherman will join the Company in September and will report to President and CEO Timothy P. Walbert.
Dr. Sherman brings close to 20 years of pharmaceutical experience to IDM Pharma and will lead the regulatory and clinical strategy for L-MTP-PE and the development of the Company's pipeline, including UVIDEM and IDM-2101. He joins IDM Pharma from Takeda Global Research & Development Center, Inc., a subsidiary of Takeda Pharmaceutical Company Limited, where he served as Vice President of Clinical Science and was focused on developing Takeda's oncology pipeline.
"Dr. Sherman's depth of oncology experience and pharmaceutical and biotechnology expertise will be an asset as we continue to work through the regulatory process with L-MTP-PE and develop our oncology pipeline," said Timothy P. Walbert, President and Chief Executive Officer of IDM Pharma, Inc. "In the near-term, Dr. Sherman will oversee the preparation and submission of the L-MTP-PE NDA amendment in the US and work closely with regulatory authorities in Europe to complete the L-MTP-PE review process."
About Dr. Jeffrey Sherman
Dr. Sherman joins IDM Pharma from Takeda Global Research & Development Center, Inc., a subsidiary of Takeda Pharmaceutical Company Limited, where he served as Vice President of Clinical Science, Oncology. Prior to Takeda, Dr. Sherman served as Chief Medical Officer and Executive Vice President at NeoPharm, Inc. where he was responsible for developing clinical drug research and development strategies.
Before joining NeoPharm, Dr. Sherman held various roles at Searle/Pharmacia Research and Development, and Medical Marketing, including Executive Director of Clinical Research and Head of Oncology Medical Operations. In these roles, he managed clinical development activities for a variety of therapeutic areas, including oncology, infectious diseases, women's health, sleep and central nervous system. Prior to Searle/Pharmacia, Dr. Sherman was at Squibb/Bristol-Myers Squibb in Clinical Pharmacology and Clinical Research.
Dr. Sherman received his medical degree from the Rosalind Franklin University/Chicago Medical School. He completed both an internship and residency in internal medicine at the Northwestern University McGaw Medical Center, where he also served as a chief medical resident. In addition, Dr. Sherman completed fellowship training at the University of California, San Francisco (UCSF) and also served as a research associate at the Howard Hughes Medical Institute at UCSF. Dr. Sherman is currently a Board Member of the Drug Information Association (DIA) and will be chairing the DIA 2008 Annual Meeting.
About IDM Pharma
IDM Pharma is focused on the development of innovative cancer products that either destroy cancer cells by activating the immune system or prevent tumor recurrence by triggering a specific adaptive immune response. IDM Pharma is dedicated to maximizing the full therapeutic and commercial potential of each of its innovative products to address the needs of patients and the physicians who treat these patients.
For more information about the company and its products, visit http://www.idm-pharma.com.
This press release includes forward-looking statements that reflect management's current views of future events including statements regarding the Company's plans to collect, analyze and submit additional Phase 3 data in an amended NDA for L-MTP-PE and to respond to other matters raised by ODAC and the FDA, the Company's confidence that the proposed NDA amendment will provide substantial evidence for the continued regulatory approval process, the Company's belief that the supplemental data to be submitted in the amended NDA will overcome the need for additional trials, the review of the submissions for marketing approval of L-MTP-PE by the FDA and the EMEA, and the Company's goal of making L-MTP-PE available to patients as quickly as possible. Actual results may differ materially from the forward-looking statements due to a number of important factors, including, but not limited to, the possibility that the Company may not be able to collect, analyze and submit additional data in an amendment to the NDA for L-MTP-PE by the first quarter of 2008, if at all, the possibility that such data will not support the benefit of L-MTP-PE in the treatment of non-metastatic osteosarcoma, will not allow a more robust analysis of L-MTP-PE, will not continue to support its overall survival benefit in osteosarcoma, and may not provide substantial evidence for the potential regulatory approval of L-MTP-PE, the timing of the FDA's and EMEA's review of the submissions for marketing approval of L-MTP-PE, the ability of the Company 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 L-MTP-PE, although the FDA is not bound by the decision of any advisory panel, the possible negative impact that the opinion of the FDA's Oncologic Drugs Advisory Committee that the results of the Company's Phase 3 trial do not provide substantial evidence of effectiveness of L-MTP-PE in the treatment of patients with non-metastatic, resectable osteosarcoma receiving combination chemotherapy would have upon the determination by the FDA whether to approve the marketing application for L- MTP-PE, 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 3 trial conducted by Children's Oncology Group as adequate for their assessment of L-MTP-PE, which may cause delays in review, may result in the regulatory authorities requiring the Company to conduct additional clinical trials, or may result in a determination by the regulatory authorities that the data does not support marketing approval, whether regulatory authorities will approve L-MTP-PE within the time frame expected by the Company or at all, and whether the Company will be able to manufacture and commercialize L-MTP-PE even if it is approved by regulatory authorities. Other risks affecting the Company and its drug development programs include whether the Company or any of its collaborators will be able to develop pharmaceutical products using the technologies of the Company, 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 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, including any further clinical trials of any of the Company's product candidates; whether any steps taken by the Company to contain costs will in fact result in sufficient reduction in expenses; reliance on key employees, especially senior management; 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 Quarterly Report on Form 10-Q filed with the SEC for the quarter ended June 30, 2007 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.
Source: IDM Pharma
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