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., Feb. 8 /PRNewswire-FirstCall/ --
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
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
http://www.cytogen.com or by calling 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.
ABOUT SAVIENT
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 http://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 ongoing 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.
SOURCE Cytogen Corporation
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Related links:
http://www.cytogen.com
http://www.savientpharma.com
CONTACT:
Jack Domeischel, Savient Pharmaceuticals,
Inc., +1-732-565-4716, jdomeischel@savientpharma.com; or Cytogen
Corporation, Media/Investors contact: Jonathan Fassberg, The
Trout Group, +1-212-477-9007, ext. 16
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