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Company contacts:
Savient Pharmaceuticals, Inc. Cytogen Corporation
Jack Domeischel, 732-565-4716 Media/Investors contact:
jdomeischel@savientpharma.com Jonathan Fassberg
The Trout Group
(212) 477-9007 x16
Cytogen and Savient Sign Letter of Intent for Marketing of SOLTAMOX(TM)
The first oral liquid tamoxifen in the U.S. represents a new option
for women with breast cancer including patients unable to
tolerate solid oral dosage forms
PRINCETON AND EAST BRUNSWICK, N.J., (FEBRUARY 8, 2006) -- Cytogen Corporation
(NASDAQ: CYTO) and Savient Pharmaceuticals (NASDAQ: SVNT) announced today the
execution of a binding letter of intent to negotiate a definitive agreement
granting Cytogen exclusive marketing rights for SOLTAMOX(TM) (tamoxifen citrate)
in the United States. SOLTAMOX, a cytostatic estrogen receptor antagonist, is
the first oral liquid hormonal therapy approved in the U.S. It is indicated for
the treatment of breast cancer in adjuvant and metastatic settings and to reduce
the risk of breast cancer in women with ductal carcinoma in situ (DCIS) or with
high risk of breast cancer.
"We are extremely pleased to announce our new strategic relationship with
Savient," stated Michael D. Becker, president and chief executive officer of
Cytogen. "SOLTAMOX represents a novel and synergistic addition to Cytogen's
portfolio of oncology products."
Under the terms of the final transaction, Cytogen will pay to Savient upon
closing an upfront licensing fee of $2 million and additional contingent
sales-based milestone payments of up to a total of $4 million. Savient will also
receive royalties on net sales of SOLTAMOX. Additionally, Rosemont
Pharmaceuticals Ltd., a wholly owned subsidiary of Savient, will enter into a
supply agreement with Cytogen for the manufacture and supply of SOLTAMOX.
Consummation of the transaction, which has been approved by the boards of
directors of both companies, is subject to a number of conditions, including
satisfactory completion of due diligence by Cytogen and negotiation and
execution of definitive licensing and supply agreements by Cytogen, Savient and
Rosemont. The parties expect the transaction to close by March 30, 2006. HSBC
Securities (USA) Inc. acted as an advisor to Cytogen.
"Our agreement with Cytogen represents a major step forward in the advancement
of our strategic plan to position Savient as an emerging specialty
pharmaceutical company," said Christopher Clement, President and Chief Executive
Officer of Savient. "SOLTAMOX is the first of what we hope will be many oral
liquid product entries into the U.S. from Rosemont in support of the strategy to
expand and maximize on the geographic reach of its oral liquids pharmaceutical
business and the niche product opportunities that Rosemont affords. Cytogen's
established commercial infrastructure and demonstrated ability to maximize niche
oncology product opportunities brings together the optimal combination of
experience and resources to develop and execute the successful launch and
ongoing commercialization strategies that will bring this important product to
the many patients who need it," he said.
SOLTAMOX is a product of Rosemont Pharmaceuticals Ltd., Savient's wholly owned
subsidiary based in Leeds, United Kingdom. SOLTAMOX received U.S. regulatory
approval in October 2005 and is licensed in the United Kingdom, Ireland and
Germany.
About Hormone Therapy
Estrogen is known to promote the growth of approximately two thirds of breast
cancers that contain estrogen or progesterone receptors. Breast cancer treatment
often involves agents designed to block the effect of estrogen or lower estrogen
levels. The antiestrogen drug that has been used most often is tamoxifen, which
is taken daily in pill form and has been shown to greatly reduce the risk of
cancer returning and improves overall survival in all age groups.
About SOLTAMOX
Dysphagia (swallowing difficulty) in women suffering from breast cancer can
arise from several causes, including patients receiving combination chemotherapy
and/or radiation therapy for metastatic breast cancer. It may also arise from
either esophageal or stomach metastasis. Irrespective of the cause, many women
with dysphagia are unable to tolerate the solid oral dosage forms of hormonal
therapy and might benefit from a liquid dosage form, such as SOLTAMOX.
Currently, SOLTAMOX is the only liquid hormonal therapy solution available in
the United Kingdom, Ireland and Germany, and will soon be launched in the United
States. The availability of an oral liquid dosing option could allow more women
to benefit from hormonal treatment for estrogen receptor positive breast cancer.
Important safety information for SOLTAMOX
Use of SOLTAMOX in risk reduction setting (women at high risk for cancer and
women with DCIS) has shown to cause cancer of the uterus, stroke, and blood
clots. The benefits of SOLTAMOX outweigh its risks in women already diagnosed
with breast cancer. SOLTAMOX should not be used in women who require concomitant
use of coumarin-type anticoagulant, or in women with history of deep vein
thrombosis or pulmonary embolus. Women who are pregnant or plan to become
pregnant should not take SOLTAMOX. Cataracts and cataract surgery can also occur
more frequently with SOLTAMOX. The most frequently reported adverse reactions
with SOLTAMOX were hot flashes and vaginal discharge.
ABOUT CYTOGEN CORPORATION
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Founded in 1980, Cytogen Corporation of Princeton, NJ, is a biopharmaceutical
company that acquires, develops and commercializes innovative molecules
targeting the sites and stages of cancer progression. 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. 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 www.cytogen.com or by calling 800-833-3533. For more
information, please visit the Company's website at www.cytogen.com, which is not
part of this press release.
ABOUT SAVIENT
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Based in East Brunswick, New Jersey, Savient Pharmaceuticals, Inc., is an
emerging specialty pharmaceuticals company, is engaged in developing,
manufacturing, and marketing pharmaceutical products that address unmet
medical needs in both niche and broader markets. The Company's lead product
development candidate, Puricase(R) (PEG-uricase), for the treatment of
refractory gout has reported positive Phase 1 and 2 clinical data. Savient's
experienced management team is committed to advancing its pipeline and expanding
its product portfolio by in-licensing late stage compounds and exploring
co-promotion and co-development opportunities that fit the Company's expertise
in specialty pharmaceuticals and initial focus in rheumatology. Savient markets
its product Oxandrin(R) (oxandrolone, USP) in the United States. The Company's
subsidiary, Rosemont Pharmaceuticals Ltd., develops, manufactures, and markets
through its own sales force oral liquid formulations of prescription products
for the UK pharmaceutical market. Rosemont's product portfolio includes over 90
liquid formulations primarily targeting the geriatric population. Savient's
product Mircette(R) (desogestrel/ethinyl estradiol and ethinyl estradiol), an
oral contraceptive, is marketed by its licensee, Duramed Pharmaceuticals, Inc.
Puricase is a registered trademark of Mountain View Pharmaceuticals, Inc.
Further information on the Company can be accessed by visiting
www.savientpharma.com.
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
successfully consummating the strategic relationship with Savient; the risk of
obtaining additional capital; 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;
the risks associated with Cytogen's strategic relationships, 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.
For Savient:
This news release contains forward-looking statements within the meaning of
Section 21E of the Securities Exchange Act of 1934. All statements, other than
statements of historical facts, included in this report regarding the Company's
strategy, expected future financial position, results of operations, cash flows,
financing plans, discovery and development of products, strategic alliances,
competitive position, plans and objectives of management are forward-looking
statements. Words such as "anticipate," "believe," "estimate," "expect,"
"intend," "plan," "will" and other similar expressions help identify
forward-looking statements, although not all forward-looking statements contain
these identifying words. In particular, the statements regarding the closing of
the Soltamox transaction with Cytogen are forward-looking statements. These
forward-looking statements involve substantial risks and uncertainties and are
based on current expectations, assumptions, estimates and projections about the
Company's business and the biopharmaceutical and specialty pharmaceutical
industries in which the Company operates. Such risks and uncertainties include,
but are not limited to, the Company's ability to complete the restatement of its
financial statements described above on a timely basis, delay or failure in
developing Puricase and other product candidates; difficulties of expanding the
Company's product portfolio through in-licensing; introduction of generic
competition for Oxandrin; fluctuations in buying patterns of wholesalers;
potential future returns of Oxandrin or other products; the Company's continuing
to incur
substantial net losses for the foreseeable future; difficulties in obtaining
financing; potential development of alternative technologies or more effective
products by competitors; reliance on third-parties to manufacture, market and
distribute many of the Company's products; economic, political and other risks
associated with foreign operations; risks of maintaining protection for the
Company's intellectual property; risks of an adverse determination in on-going
or future intellectual property litigation; and risks associated with stringent
government regulation of the biopharmaceutical and specialty pharmaceutical
industries. The Company may not actually achieve the plans, intentions or
expectations disclosed in its forward-looking statements, and you should not
place undue reliance on the Company's forward-looking statements. Actual results
or events could differ materially from the plans, intentions and expectations
disclosed in the forward-looking statements that the Company makes. The
Company's forward-looking statements do not reflect the potential impact of any
future acquisitions, mergers, dispositions, joint ventures or investments that
the Company may make. The Company does not assume any obligation to update any
forward-looking statements.
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