Company contacts:
Advanced Magnetics, Inc. Cytogen Corporation
Lisa Gordon, VP of Business Development FOR MEDIA: FOR INVESTORS:
617- 497-2070 x 3024 Bill Daddi Brian Korb
Lynn Kettleson Belsito & Company The Trout Group
617-512-5922 917-620-3717 917-653-5122
FOR IMMEDIATE RELEASE
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ONCOLOGIC DRUGS ADVISORY COMMITTEE RECOMMENDS AGAINST APPROVAL OF A BROAD
INDICATION FOR COMBIDEX(R)
CAMBRIDGE, MA AND PRINCETON, NJ - March 3, 2005 - Advanced Magnetics, Inc.
(Amex: AVM) and Cytogen Corporation (Nasdaq: CYTO) announced today that the U.S.
Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC)
voted 15 to 4 to not recommend approval of the proposed indication for
Combidex(R), Advanced Magnetics' investigational functional molecular imaging
agent.
In making its recommendation, the committee cited insufficient clinical data to
support a broad indication for use of Combidex to differentiate metastatic from
non-metastatic lymph nodes across all cancer types.
A decision by the FDA on Combidex is expected by the FDA-designated user fee
goal date of March 30, 2005.
"We understand the advisory committee's position relative to a broad label for
Combidex and look forward to meeting with the FDA to determine appropriate next
steps. We remain committed to the ongoing development of Combidex," said Jerome
Goldstein, Chairman, President and Chief Executive Officer of Advanced
Magnetics.
ABOUT THE ODAC
The ODAC is a committee formed by the FDA of external experts to provide the FDA
with independent opinions and recommendations in the evaluation of marketed and
investigational drugs for use in the treatment of cancer. The ODAC is comprised
of a core of voting members from the fields of general oncology, pediatric
oncology, hematologic oncology, immunologic oncology, biostatistics and other
related professions, as well as a consumer and patient representatives.
-more-
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
functional 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 Advanced
Magnetics' inability to obtain regulatory approval for Combidex in general and,
in particular, the following risks: (1) 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; (2) the ability to resolve final labeling for Combidex with
the FDA; (3) 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; (4) uncertainties
regarding market acceptance of Combidex; (5) uncertainties relating to
third-party reimbursements to Advanced Magnetics or its partners for Combidex
when patients are prescribed Combidex; (6) 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; (7) uncertainties relating
to patents and proprietary rights and (8) 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.
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