AVM Advanced Magnetics

FDA Posts Briefing Documents Related to March 3rd Oncologic Drugs Advisory Committee on COMBIDEX(R) (ferumoxtran-10) CAMBRIDGE, Mass. and Princeton, N.J., March 2 /PRNewswire-FirstCall/ -- Advanced Magnetics, Inc. (AMEX:AVM) and Cytogen Corporation (NASDAQ:CYTO) announced today that the U.S. Food and Drug Administration (FDA) has posted on its website briefing documents for the Oncologic Drugs Advisory Committee (ODAC) meeting to be held March 3, 2005 relating to Combidex(R), Advanced Magnetics' investigational functional molecular imaging agent. Documents posted on the FDA website include briefs submitted by Advanced Magnetics and the FDA. The briefing documents can be accessed at http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4095b1.htm. Combidex (ferumoxtran-10) consists of iron oxide nanoparticles for use in conjunction with magnetic resonance imaging (MRI) to image lymph nodes. Clinical studies have shown that Combidex is taken up by macrophages in normal lymph node tissue, which aids clinicians in differentiating between normal and cancerous lymph nodes when using MRI. About Advanced Magnetics Advanced Magnetics, Inc. is a developer of superparamagnetic iron oxide nanoparticles used in pharmaceutical products. As a leader in its field, Advanced Magnetics 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 cardiovascular disease and cancer. For more information about Advanced Magnetics, please visit the company's website at http://www.advancedmagnetics.com/, the content of which is not part of this press release. About Cytogen Corporation Founded in 1980, Cytogen Corporation of Princeton, NJ is a product-driven biopharmaceutical company that develops and commercializes innovative molecules that can be used to build leading franchises across multiple markets. Cytogen's marketed products include QUADRAMET(R) (samarium Sm-153 lexidronam injection) and PROSTASCINT(R) (capromab pendetide) kit for the preparation of Indium In-111 capromab pendetide in the United States. Cytogen also has exclusive United States marketing rights to COMBIDEX(R) (ferumoxtran- 10) for all applications, and the exclusive right to market and sell ferumoxytol (previously Code 7228) for oncology applications in the United States. COMBIDEX, an investigational molecular imaging agent consisting of iron oxide nanoparticles, is currently being developed for use in conjunction with magnetic resonance imaging to aid in the differentiation of cancerous and non-cancerous lymph nodes, and is under review by the U.S. Food and Drug Administration. Cytogen's development pipeline consists of therapeutics targeting prostate-specific membrane antigen (PSMA), a protein highly expressed on the surface of prostate cancer cells and the neovasculature of solid tumors. Full prescribing information for the Company's products is available at http://www.cytogen.com/ or by calling 1-800-833-3533. For more information, please visit the Company's website at http://www.cytogen.com/, which is not part of this press release. For Advanced Magnetics 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 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) that the FDA advisory committee does not recommend approval, or delays the recommendation of approval, of Combidex; (2) the convening and recommendation of an FDA advisory committee does not ensure approval or disapproval of Combidex; (3) the possibility that the division of medical imaging may not agree with the recommendations of the ODAC; (4) the possibility that even though Advanced Magnetics' response regarding Combidex was deemed complete by the FDA, the FDA could respond to this submission by issuing an additional approvable letter with additional conditions for approval or the FDA could issue a not approvable letter; (5) the ability to resolve final labeling for Combidex with the FDA; (6) the possibility that even though the FDA has assigned a user fee goal date of March 30, 2005, the FDA may not act by such date; (7) uncertainties regarding market acceptance of Combidex; (8) uncertainties relating to third-party reimbursements to Advanced Magnetics or its partners for Combidex when patients are prescribed Combidex; (9) uncertainties relating to Advanced Magnetics' ability to continue to operate at commercial scale in compliance with FDA regulations and other applicable manufacturing requirements when producing Combidex; (10) uncertainties relating to patents and proprietary rights and (11) other risks identified in Advanced Magnetics' Securities and Exchange Commission filings. Advanced Magnetics cautions readers not to place undue reliance on any forward-looking statements which speak only as of the date they are made. Advanced Magnetics disclaims 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. For Cytogen This press release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, included in this press release regarding Cytogen's strategy, future operations, financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and investors are cautioned not to put any undue reliance on any forward-looking statement. There are a number of important factors that could cause Cytogen's results to differ materially from those indicated by such forward-looking statements. In particular, Cytogen's business is subject to a number of significant risks, which include, but are not limited to: the risk of obtaining the necessary regulatory approvals; the risk of whether products result from development activities; the risk of shifts in the regulatory environment affecting sales of Cytogen's products such as third-party payor reimbursement issues; the risk associated with Cytogen's dependence on its partners for development of certain projects, as well as other factors expressed from time to time in Cytogen's periodic filings with the Securities and Exchange Commission (the "SEC"). As a result, this press release should be read in conjunction with Cytogen's periodic filings with the SEC. The forward-looking statements contained herein are made only as of the date of this press release, and Cytogen undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances. DATASOURCE: Cytogen Corporation and Advanced Magnetics CONTACT: Company: Lisa Gordon of Advanced Magnetics, Inc., VP of Business Development, +1-617-497-2070 x3024; Lynn Kettleson of Kettleson Group, +1-617-512-5922; Bill Daddi of Belsito & Company for Cytogen Corporation, +1-212-981-5678, +1-917-620-3717, Web site: http://www.belsitoco.com/ http://www.cytogen.com/

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