Healthcare Industry News: ferumoxytol
News Release - September 11, 2006
Advanced Magnetics Announces the Appointments of Louis Brenner, MD as Senior Vice President and Mohammed A. Salem, PhD as Vice President of Regulatory AffairsCAMBRIDGE, Mass., Sept. 11 (HSMN NewsFeed) -- Advanced Magnetics, Inc. (Nasdaq: AMAG ) today announced the appointment of Louis Brenner, MD as Senior Vice President and the appointment of Mohammed A. Salem, PhD as Vice President of Regulatory Affairs. Dr. Brenner joins Advanced Magnetics from his position as Senior Director of Business Development for the Renal and Transplantation Units of Genzyme Corporation. Dr. Salem joins the company from his position of Vice President of Regulatory Affairs and US Head of Regulatory Affairs at Fresenius Biotech North America.
In this new position, Dr. Brenner will assume responsibility for the success of the ferumoxytol program, including all aspects of the submission of the New Drug Application for ferumoxytol as an intravenous iron replacement therapeutic for the treatment of anemia in dialysis-dependent (DD) and non-dialysis dependent (NDD) chronic kidney disease patients (CKD) along with the planning and execution of subsequent indications for ferumoxytol. Additionally, Dr. Brenner will be responsible for building the Medical Affairs group at Advanced Magnetics.
Dr. Salem will provide strategic direction and leadership for all regulatory aspects of Advanced Magnetics' drug development programs. In this role, Dr. Salem will assume responsibility for the product development strategies for ferumoxytol and Combidex®, including providing oversight of the company's submission of a New Drug Application for ferumoxytol as an iron replacement therapeutic and the company's response to the March 2005 approvable letter from the U.S. Food and Drug Administration (FDA) with respect to Combidex®.
"We are pleased that two individuals like Lou and Mohammed have agreed to join our Advanced Magnetics team," stated Brian J.G. Pereira, MD, President of Advanced Magnetics, Inc. "We are excited to have someone of Lou's experience in nephrology to aid us in bringing ferumoxytol to anemic CKD patients."
Dr. Pereira continued, "Mohammed has nearly twenty years of experience in the pharmaceutical and biotechnology industries and interacting with regulatory agencies worldwide. His proven track record in getting products through the US Food and Drug Administration and other regulatory bodies is an important addition to our team at this time in our development."
ferumoxytol, the company's key product candidate, is in Phase III multi-center clinical trials for use as an intravenous iron replacement therapeutic in DD and NDD chronic kidney disease patients.
Combidex, the company's other product under development, is an investigational functional molecular imaging agent consisting of iron oxide nanoparticles for use in conjunction with magnetic resonance imaging, or MRI, to aid in the differentiation of cancerous from normal lymph nodes. In March 2005, the company received an approvable letter from the FDA with respect to Combidex, subject to certain conditions.
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.
Source: Advanced Magnetics
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