15.02.2007 21:00:00
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Cytogen Announces Settlement Agreement with Advanced Magnetics
Cytogen Corporation (NASDAQ: CYTO) today announced the settlement of its
lawsuit against Advanced Magnetics, Inc., as well as Advanced Magnetics'
counterclaims against Cytogen, by mutual agreement.
Under the terms of the settlement agreement, Advanced Magnetics will pay
$4 million to Cytogen and release 50,000 shares of Cytogen common stock
currently being held in escrow. In addition, both parties agreed to
early termination of the 10-year license and marketing agreement and
supply agreement established in August 2000, as amended, for two imaging
agents being developed by Advanced Magnetics, Combidex®
(ferumoxtran-10) and ferumoxytol, previously Code 7228. The license and
marketing agreement and supply agreement would have expired in August
2010.
Under the terms of the original agreement, Cytogen acquired the U.S.
commercial rights to Combidex and ferumoxytol for oncology imaging
applications only in exchange for 200,000 shares of Cytogen common
stock, of which 150,000 were available for resale within four months of
the closing and 50,000 were placed in escrow.
"After a strategic analysis of (i) the remaining term of the license and
marketing agreement, (ii) the delayed approval timeframe, (iii) the
ongoing regulatory risks, (iv) the time and expenditures associated with
continued litigation, and (v) Cytogen’s
commercial launch of two oncology therapeutics, the Company concluded it
was in the best interest of its stockholders to reach an amicable
resolution of this matter at this time," said Michael D. Becker,
president and chief executive officer. "This settlement is consistent
with our transformation to an oncology therapeutics company and the
monetization of assets that are not aligned with our business
objectives."
In October 2004, Advanced Magnetics submitted a complete response to an
approvable letter received from the U.S. Food and Drug Administration
(FDA) dated June 2000 for Combidex. In March 2005, the Oncologic Drugs
Advisory Committee voted against recommending approval of Combidex for
use in conjunction with magnetic resonance imaging (MRI) to aid in the
differentiation of cancerous from normal lymph nodes. Subsequently,
Advanced Magnetics received a second approvable letter from FDA with
certain conditions. Advanced Magnetics has stated that it hopes to
announce its strategy for responding to the March 2005 approvable letter
during calendar 2007.
About Cytogen
Founded in 1980, Cytogen is a biopharmaceutical company dedicated to
advancing the care of cancer patients by building, developing, and
commercializing a portfolio of specialty pharmaceutical products. The
Company’s specialized sales force currently
markets QUADRAMET®,
PROSTASCINT®, and
SOLTAMOX™ to the U.S.
oncology market. QUADRAMET is approved for the treatment of pain in
patients whose cancer has spread to the bone, PROSTASCINT is a
PSMA-targeting monoclonal antibody-based agent to image the extent and
spread of prostate cancer, and SOLTAMOX is the first liquid hormonal
therapy approved in the U.S. for the treatment of breast cancer in
adjuvant and metastatic settings. In the first half of 2007, Cytogen
plans to introduce its fourth approved oncology product to the U.S.
market, CAPHOSOL®, a
prescription medical device for the treatment of oral mucositis and dry
mouth. The Company is also developing CYT-500, a third-generation
radiolabeled antibody to treat prostate cancer. Cytogen’s
product-focused strategy focuses on attaining sustainable growth through
clinical, commercial, and strategic initiatives. Further information
about Cytogen and this press release can be found at http://www.cytogen.com.
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 successfully marketing its products; 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. All
information in this press release, including 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 this
information to reflect subsequent events or circumstances.
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