Oncologic Drugs Advisory Committee Recommends Against Approval of a Broad Indication For Combidex(R)
March 03 2005 - 1:57PM
PR Newswire (US)
Oncologic Drugs Advisory Committee Recommends Against Approval of a
Broad Indication For Combidex(R) CAMBRIDGE, Mass. and PRINCETON,
N.J., March 3 /PRNewswire-FirstCall/ -- 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.
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. DATASOURCE: Advanced Magnetics, Inc.; Cytogen
Corporation CONTACT: Lisa Gordon, VP of Business Development
+1-617-497-2070, ext. 3024, or Lynn Kettleson, +1-617-512-5922,
both of Advanced Magnetics, Inc.; or Media - Bill Daddi of Belsito
& Company, +1-917-620-3717; or Investors - Brian Korb of The
Trout Group, +1-917-653-5122 Web site:
http://www.advancedmagnetics.com/ http://www.cytogen.com/
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