EXHIBIT 99.1
[CYTOGEN LOGO]
COMPANY CONTACTS:
Advanced Magnetics, Inc. Cytogen Corporation
Jerome Goldstein, CEO Michael Becker, CEO
or Lisa Gordon, Investor Relations or Stacy Shearer, Investor Relations
(617) 497-2070 (609) 750-8289
ADVANCED MAGNETICS SUBMITS RESPONSE
TO FDA APPROVABLE LETTER FOR COMBIDEX(R)
CAMBRIDGE, MA, AND PRINCETON, N.J., (JUNE 25, 2004) -- Advanced Magnetics, Inc.
(Amex: AVM) and Cytogen Corporation (Nasdaq: CYTO) today announced that Advanced
Magnetics submitted a response to the approvable letter received from the U.S.
Food and Drug Administration (FDA) for Combidex(R), Advanced Magnetics'
investigational molecular imaging agent to aid in the non-invasive diagnosis of
metastatic lymph nodes.
In response to the submission, the FDA requested that Advanced Magnetics provide
certain additional details underlying the existing supporting data submitted.
The FDA subsequently communicated that the data Advanced Magnetics is in the
process of gathering, once submitted, look encouraging to provide a complete
response to the approvable letter.
"We are pleased by these positive steps forward in the approval process for
Combidex," stated Jerome Goldstein, Chairman, President and CEO of Advanced
Magnetics.
Combidex (ferumoxtran-10) is an investigational molecular imaging agent
consisting of iron oxide nanoparticles for use in conjunction with magnetic
resonance imaging (MRI) to aid in the differentiation of cancerous from
non-cancerous lymph nodes. Lymph nodes are frequently the site for metastases of
many different types of cancer, particularly breast cancer and prostate cancer.
Computed tomography (CT) and MRI are the methods currently used for imaging
lymph nodes. Current guidelines for imaging lymph nodes are that nodes greater
than 10 mm in size are usually deemed cancerous while nodes less than 10 mm in
size are generally presumed normal. CT and MRI cannot distinguish between lymph
nodes that are enlarged due to the infiltration of cancerous cells as opposed to
inflammation nor can these methods reliably detect disease in nodes that are not
enlarged. Clinical studies have shown that Combidex accumulates in non-cancerous
lymph node tissue which could enable doctors using MRI to have improved
diagnostic confidence in differentiating between normal and diseased lymph
nodes. Combidex received an approvable letter from the FDA, subject to certain
conditions, in June of 2000.
ABOUT ADVANCED MAGNETICS
Advanced Magnetics, Inc. is the premier 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 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,
oncology-focused biopharmaceutical company that develops and commercializes a
balanced portfolio of oncology products that address the unmet medical needs of
patients and the physicians that serve them. Cytogen directly markets
QUADRAMET(TM) (samarium Sm-153 lexidronam injection), PROSTASCINT(R) (capromab
pendetide) kit for the preparation of Indium In-111 capromab pendetide, and
NMP22(R) BLADDERCHEK(R) (nuclear matrix protein-22) in the United States.
Cytogen has exclusive United States marketing rights to COMBIDEX(R)
(ferumoxtran-10), an investigational molecular imaging agent consisting of iron
oxide nanoparticles for use in conjunction with magnetic resonance imaging to
aid in the differentiation of cancerous from non-cancerous lymph nodes, which is
under review by the U.S. Food and Drug Administration. Cytogen is also
developing 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 www.cytogen.com or by calling 1-800-833-3533. For more
information, please visit the Company's website at www.cytogen.com, which is not
part of this press release.
For Advanced Magnetics:
This document contains forward-looking statements. 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: uncertainties relating to
Advanced Magnetics' ability to successfully address the comments and concerns of
the FDA contained in the approvable letter for Combidex, including uncertainties
relating to the sufficiency of the additional details to be submitted to the FDA
by Advanced Magnetic; the timing of FDA actions regarding Combidex, including
the timing of its review of the supporting data or the additional details
submitted in relation thereto; the outcome of FDA actions in response to the
submission, including the possibility that the FDA will not consider the
submission complete or that the FDA will require additional information in
support of the submission; the possibility that even if the response is 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; the ability to resolve final labeling for
Combidex with the FDA; uncertainties regarding market acceptance of Combidex;
uncertainties relating to third-party reimbursements; uncertainties relating to
Advanced Magnetics' ability to continue to operate at commercial scale in
compliance with FDA regulations and other applicable manufacturing requirements;
uncertainties relating to patents and proprietary rights and other risks
identified in Advanced Magnetics, Inc.'s 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 our
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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