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Dowpharma and Cytogen Agree to Develop PSMA
Antibody for Treatment of Cancer
Agreement applies ChelaMed(sm)
radiopharmaceutical services from Dowpharma(sm) to Cytogen's Proprietary
7E11.C5.3 Monoclonal Antibody
MIDLAND, MI and PRINCETON, N.J.-(May 10, 2005)-Cytogen Corporation (Nasdaq: CYTO),
a product-driven biopharmaceutical company, and Dowpharma(sm) contract
manufacturing services, a business unit of The Dow Chemical Company (NYSE: DOW),
today announced a collaboration to create a targeted oncology product designed
to treat prostate and other cancers. Under the agreement, Dowpharma's
proprietary MeO-DOTA bifunctional chelant technology will be used to radiolabel
Cytogen's prostate-specific membrane antigen (PSMA) antibody with a therapeutic
radionuclide. PSMA is a protein highly expressed on the surface of prostate
cancer cells and the neovasculature of many solid tumors.
"We are extremely pleased to expand our long-standing relationship with this
well respected and established company," said Michael D. Becker, Cytogen's
president and chief executive officer. "We believe that Dowpharma's MeO-DOTA
technology is a perfect complement to Cytogen's expertise in developing and
commercializing innovative molecules and this agreement marks a significant step
in the development of our therapeutic franchise in oncology."
Under the agreement, proprietary chelation technology and other capabilities,
provided through ChelaMed(sm) radiopharmaceutical services from Dowpharma, will
be used to attach a therapeutic radioisotope to the same murine monoclonal
antibody utilized in Cytogen's PROSTASCINT(r) (capromab pendetide) molecular
imaging agent. This antibody, called 7E11-C5.3 (or 7E11), is directed against
an intracellular epitope of PSMA. The 7E11 antibody was excluded from the PSMA
technology licensed to the PSMA Development Company LLC, the Company's joint
venture for PSMA product development. Consequently, the joint venture is not
involved in this development initiative.
"We are delighted that we are applying our capabilities in chelation,
conjugation, process and radiochemistry to enable Cytogen to develop this novel
cancer therapy," said Nick Hyde, business director, Dowpharma. "Monoclonal
antibodies labeled with radionuclides have proven successful for both the
diagnosis and treatment of several tumors."
Dowpharma's MeO-DOTA bifunctional chelant will be utilized to attach the beta
emitting radionuclide lutetium-177 as a payload to the 7E11 antibody, enabling
targeted delivery of this cytotoxic agent. The Company intends to develop the
resulting innovative molecule for the treatment of various cancers, initially in
prostate, that express the PSMA marker.
"DOTA-based bifunctional chelating agents have been shown to provide exceptional
stability to insure that therapeutic radionuclides do not separate from the
monoclonal antibodies that target them to tumors," said William Goeckeler,
Ph.D., senior vice president of operations at Cytogen. "Dow is a world leader in
the development of this technology and having the opportunity to collaborate
with them should hasten the development process for our therapeutic radiolabeled
7E11 product candidate."
Cytogen's PROSTASCINT molecular imaging agent is the first and only commercial
product targeting PSMA. PROSTASCINT consists of the 7E11 monoclonal antibody
directed against PSMA that is linked to the radioisotope Indium-111. Due to the
selective expression of PSMA, the PROSTASCINT molecular imaging procedure can
detect the extent and spread of prostate cancer using a standard gamma camera.
Clinical studies have demonstrated that overexpression of PSMA determined by
immunohistochemical staining using 7E11 in primary prostate cancer not only
correlates with other adverse traditional prognostic factors, but can
independently predict disease recurrence.
About Dowpharma
Dowpharma(sm) contract manufacturing srevices, serves the pharmaceutical and
biopharmaceutical industries with innovative technologies, products, and
services in drug discovery, development, delivery and manufacturing. Dowpharma
has one of the broadest and deepest capabilities in the global outsourcing
industry with service that include process development, route selection, methods
development, custom solubilization, chiral capabilities, and associated
analytical services, as well as manufacturing and scale-up from feasibility,
through clinical trials, to commercial manufacturing.
Dowpharma manufactures small molecule Active Pharmaceutical Ingredients (APIs)
and intermediates, nucleic acid medicines, cGMP polymers, peptides and
therapeutic proteins from microbial fermentation and plant-based systems.
Dowpharma draws upon over 30 years of excellent cGMP regulatory compliance in
the organic synthesis of APIs and pharmaceutical intermediates with the ability
to provide client support in filing and validation strategies. Dowpharma
operates research, process development, and manufacturing facilities in North
America and Europe. More information is available at
www.dowpharma.com
.
In June 2003, Dowpharma announced the addition of ChelaMed(sm)
radiopharmaceutical services to its portfolio. This service offering includes
technology and capabilities to enable biopharmaceutical companies to transform
their breakthrough targeting molecules into biotargeted radiopharmaceuticals,
with integrated development capabilities from benchtop through manufacturing.
The business model for the service is based on funding for feasibility studies,
with successful progression toward regulatory approval entailing milestone and
royalty payments to Dow. While the launch of ChelaMed services represents Dow's
first broad introduction of radiopharmaceutical services, the company has been
working in this field for several years. In addition, over the course of more
than 100 years as a manufacturing leader, Dow has built strength and expertise
in radiochemistry, chelation chemistry, synthetic organic chemistry, analytical
sciences and process chemistry -- all of which support success in development of
biotargeted radiopharmaceuticals.
About Dow
Dow is a leader in science and technology, providing innovative chemical,
plastic and agricultural products and services to many essential consumer
markets. With annual sales of $40 billion, Dow serves customers in 175 countries
and a wide range of markets that are vital to human progress: food,
transportation, health and medicine, personal and home care, and building and
construction, among others. Committed to the principles of sustainable
development, Dow and its 43,000 employees seek to balance economic,
environmental and social responsibilities.
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. 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 many 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.
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.
# # #
For editorial information:
Kathleen Davis
The Dow Chemical Company
(989) 636-2760
kadavis@dow.com
Josiah McClellan
Gibbs & Soell
(212) 697-2600
jmcclellan@gibbs-soell.com
Cytogen
Jonathan Fassberg
The Trout Group
(212) 477-9077 x16
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