AVM Advanced Magnetics

CAMBRIDGE, Mass., Aug. 11 /PRNewswire-FirstCall/ -- Advanced Magnetics, Inc. (AMEX:AVM) today announced that after a recent meeting with the U.S. Food and Drug Administration (FDA) to evaluate its Phase III development program for ferumoxytol in IV iron replacement therapy, the company plans to revise the program to include a new primary efficacy analysis suggested by the FDA. The revised efficacy analysis is consistent with the analysis upon which a recent approval of another IV iron product was based. These modifications will result in additional patients being enrolled in the ferumoxytol chronic kidney disease (CKD) efficacy studies and will involve the re-design of the hemodialysis protocol currently under way. The Company also plans to add additional patients to the large-scale safety study in order to provide a more robust safety database for the New Drug Application (NDA). Based on the currently planned revisions to the ferumoxytol development program, the Company projects an addition of $5 to $7 million to the total budget for the Phase III program and a submission of the NDA in mid 2007. The Company plans to continue its ongoing dialogue with the FDA to ensure a clear regulatory path for submission, review and approval of the NDA for ferumoxytol as an iron replacement therapeutic. "We believe that what we have learned in our discussions with the FDA, combined with our review of a recent iron product approval, provides us with a clearer understanding of what it will take to bring ferumoxytol through the approval process," stated Jerome Goldstein, Chairman, President and CEO of Advanced Magnetics. "We are leveraging our existing resources, including the funds raised in the Company's June 2005 financing, to expand our capabilities and ensure the successful development of ferumoxytol in IV iron replacement therapy." Adds Scientific Advisory Board, Data Monitoring Committee Advanced Magnetics also announced that it has assembled a Scientific Advisory Board (SAB) to advise the company on clinical development, market preparation, pre-launch and other strategic activities in its efforts to complete its Phase III development program for ferumoxytol. The SAB will be comprised of: * Allen R. Nissenson, MD, FACP, FAHA, Professor of Medicine and Director of the Dialysis Program at the David Geffen School of Medicine, University of California, Los Angeles as Chair of the SAB; * Vaidyanathapuram Balakrishnan, MD, MRCP, PhD, Assistant Professor of Medicine, Tufts University School of Medicine and Staff Physician, Division of Nephrology, Tufts-New England Medical Center; * Anatole Besarab, MD, Director of Clinical Research, Division of Nephrology and Senior Staff Physician, Henry Ford Hospital; * Allan Collins, MD, FACP, Director, United States Renal Data System (USRDS) and Professor of Medicine, University of Minnesota School of Medicine; * Bertrand L. Jaber, MD, FASN, Vice Chairman for Clinical Affairs, Department of Medicine, Caritas St. Elizabeth's Medical Center and Associate Professor of Medicine, Tufts University School of Medicine; * Robert Provenzano, MD, FACP, Clinical Associate Professor of Medicine, Wayne State University School of Medicine, Chief of the Section of Nephrology, Hypertension and Transplantation, St. John Hospital and Medical Center and President of the Renal Physicians Association; and * Ravi Thadhani, MD, MPH, Associate Professor of Medicine, Harvard Medical School and Director of Clinical Research in Nephrology, Massachusetts General Hospital. "We have assembled an outstanding group of world-class nephrologists and clinicians to advise us as we progress through our Phase III development program for ferumoxytol in IV iron replacement therapy," stated Brian J.G. Pereira, MD, President and Chief Executive Officer, NEHCF, Tufts-News England Medical Center, Professor of Medicine, Tufts University School of Medicine, and member of the Board of Directors at Advanced Magnetics. "The Scientific Advisory Board will play an important role in the achievement of both the short- and long-term milestones for ferumoxytol through commercial launch of the product. We are very excited that such outstanding individuals have joined us to aid in our efforts to develop and commercialize ferumoxytol as an iron replacement therapeutic." Additionally, Advanced Magnetics announced that it has assembled a Data Monitoring Committee (DMC) to provide independent oversight of the Phase III iron therapy program. The DMC will be comprised of: * Marc Pohl, MD, Ray W. Gifford MD Endowed Chair in Hypertension, Head, Section of Clinical Hypertension, Department of Nephrology and Hypertension, Cleveland Clinic Foundation, as DMC chair; * James Kaufman, MD, Staff Physician, Renal Section, VA Boston Healthcare System and Professor of Medicine, Boston University School of Medicine; and * Christopher H. Schmid, PhD, Associate Professor, Tufts University and Senior Statistician, Institute for Clinical Research and Health Policy Studies, Tufts-New England Medical Center. About Advanced Magnetics Advanced Magnetics, Inc. is a developer of superparamagnetic iron oxide nanoparticles used in pharmaceutical products. As a leader in our field, we are dedicated to the development and commercialization of our proprietary nanoparticle technology for use in therapeutic iron compounds to treat anemia, as well as novel imaging agents to aid in the diagnosis of cardiovascular disease and cancer. For more information about us, please visit our website at http://www.advancedmagnetics.com/, the content of which is not part of this press release. This document contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and federal securities laws. Any statements contained in this press release that do not describe historical facts, including but not limited to, statements regarding changes to the primary efficacy analysis for our Phase III clinical trials for ferumoxytol in iron therapy, the need to enroll additional patients in our Phase III efficacy and safety studies for ferumoxytol, the proposed re-design of the hemodialysis protocol, the amount of the projected increase in the budget for the Phase III ferumoxytol development program, the projected date for filing the NDA for ferumoxytol, the role of the Scientific Advisory Board and the Data Monitoring Committee, and our ability to obtain FDA approval for ferumoxytol, are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include the following: (1) the possibility that we may not be able to successfully complete the clinical development of ferumoxytol, one of our two products currently under development, or may not be able to complete the development in a timely or cost-effective manner, due to the timing of enrollment of patients in the Phase III studies, unexpected results from our clinical sites, inadequate performance by third-party service providers involved in the conduct of the clinical trials, deficiencies in the design or oversight by us of these trials, or any other factor causing an increase in expenses, a delay and/or a negative effect on the results of the clinical studies for ferumoxytol; (2) uncertainties surrounding the timing and results of FDA interactions regarding the clinical development of ferumoxytol and our ability to obtain regulatory approval for ferumoxytol from the FDA; (3) the possibility that the results of past ferumoxytol studies may not be replicated in future studies; (4) uncertainties relating to our ability to continue to operate at commercial scale in compliance with FDA regulations and other applicable manufacturing requirements when producing ferumoxytol; and (5) uncertainties relating to patents and proprietary rights and other risks identified in our Securities and Exchange Commission filings. We caution readers not to place undue reliance on any forward-looking statements which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Contact: Jerome Goldstein, CEO or Lisa Gordon, VP of Business Development Advanced Magnetics, Inc. (617) 497-2070 DATASOURCE: Advanced Magnetics, Inc. CONTACT: Jerome Goldstein, CEO or Lisa Gordon, VP of Business Development, , both of Advanced Magnetics, Inc., +1-617-497-2070 Web site: http://www.advancedmagnetics.com/

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