Advanced Magnetics, Inc. develops superparamagnetic iron oxide nanoparticles used in pharmaceutical products. The company is dedicated to the development and commercialization of its proprietary nanoparticle technology for use in therapeutic iron compounds to treat anemia as well as novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease. Advanced Magnetics has two approved products, Feridex I.V. and GastroMARK, and two product candidates, ferumoxytol and Combidex. Ferumoxytol, the key product in the company's development pipeline, is in Phase III multi-center clinical trials for use as an iron replacement therapeutic in chronic kidney disease patients, whether or not on dialysis. In August 2005, Advanced Magnetics announced its plan to revise the Phase III development program for ferumoxytol in intravenous (IV) iron replacement therapy based on discussions with the U.S. FDA. The modifications to the Phase III program will, among other things, result in additional patients being enrolled in the ferumoxytol chronic kidney disease (CKD) efficacy studies and the re-design of the hemodialysis efficacy study under way. The company plans to add additional patients to its large-scale safety study. In 2005 the company also announced the formation of a Scientific Advisory Board to advise it on clinical development, market preparation, pre-launch and other strategic activities and a Data Monitoring Committee to provide independent oversight. Advanced Magnetics expects to submit an New Drug Application for ferumoxytol in IV iron replacement therapy to the FDA in 2007. 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 MRI to aid in the differentiation of cancerous from normal lymph nodes. In March 2005, Advanced Magnetics received an approvable letter from the FDA with respect to Combidex, subject to certain conditions. The company has submitted a formal meeting request to the FDA to discuss next steps in the regulatory process for Combidex. Due to its limited resources and the priority it is placing on completion of the Phase III development program for ferumoxytol, Advanced Magnetics does not intend to sponsor additional clinical studies for Combidex. Feridex I.V., the company's liver contrast agent, is approved and marketed in Europe, Japan, U.S. and other countries. GastroMARK, its oral contrast agent used for delineating the bowel in MRI, is approved and marketed in Europe, the U.S. and other countries.
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