GTC BIOTHERAPEUTICS AND LAUREATE PHARMA ENTER STRATEGIC COLLABORATION
FRAMINGHAM, MA and PRINCETON, NJ – March 9, 2004 -- GTC Biotherapeutics, Inc.
("GTC", Nasdaq: GTCB) and Laureate Pharma L.P. (“Laureate Pharma”)
have entered into a strategic collaboration for serving the clinical and
commercial development, production, and purification needs of the
biopharmaceutical industry. GTC and Laureate Pharma will coordinate their industry marketing efforts to provide
strategic access to clients for recombinant protein production services
required from small scale through tonnage quantities as well as for
difficult-to-express products. GTC and
Laureate Pharma will also be able to offer process design and development, in
addition to downstream purification, for initial clinical material through
commercial launch in accordance with the standards set by good manufacturing
practices.
“We are pleased to enter this strategic collaboration with Laureate Pharma, who
will provide GTC with access to large-scale downstream purification for
commercial products, which is an important capability in the commercialization
of our transgenic platform,” stated Geoffrey F. Cox, Ph.D., GTC’s Chairman of
the Board and Chief Executive Officer. “In addition, our companies will also be able to offer a broad range of
production technologies and manufacturing capabilities to external partners.”
“We are excited about this collaboration with GTC and view it as a good way to
leverage the technical synergies of our organizations,” said Robert J. Broeze,
Ph.D., President of Laureate Pharma. “Working together, Laureate Pharma and GTC
offer the industry a broad menu of manufacturing solutions.”
Financial
terms of the collaboration, which do not include any initial payments, were not
disclosed.
About GTC Biotherapeutics
GTC
Biotherapeutics is a leader in the development, production, and
commercialization of therapeutic proteins through transgenic animal
technology. GTC has three internal
proprietary products in its pipeline and a portfolio of external program
production opportunities. GTC’s lead
program is ATryn®, its recombinant form of human antithrombin. A Market Authorization Application was recently
accepted for review by the European Medicines Evaluation Agency for the use of
ATryn® in patients with a hereditary antithrombin deficiency. In addition to the ATryn® program,
GTC is developing a recombinant human serum albumin and a malaria vaccine. In its portfolio of external programs, GTC's
technology is used to develop transgenic production of its partners’
proprietary products, including both large-volume protein therapeutics as well
as products that are difficult to produce in significant quantities from
conventional bioreactor systems. GTC's
external program collaborations are developing transgenic versions of products
such as monoclonal antibodies and immunoglobulin fusion proteins for conditions
such as rheumatoid arthritis, HIV/AIDS and cancer. One of the external programs recently entered
clinical trials with a transgenically produced product. Additional information is available on the
GTC web site, http://www.gtc-bio.com.
About Laureate Pharma
Laureate Pharma is a privately held contract
manufacturing services company with headquarters in Princeton, NJ. The company is dedicated to supporting the
development and commercialization of pharmaceutical products for pharmaceutical
and biopharmaceutical companies. Laureate Pharma's biopharmaceutical division,
located in Princeton, NJ, provides a wide range of product development
services from process design and development to full-scale cGMP production,
purification and aseptic filling, as well as corresponding analytical services
and regulatory support. The division is focused on two active segments of the
biopharmaceutical industry: monoclonal antibodies and recombinant protein
products. Mammalian cells are grown in stirred-tank or hollow-fiber bioreactors
for production of biopharmaceutical proteins, which are purified by
state-of-the-art semi-automated chromatography systems. Laureate Pharma's
extended release technologies division, located in Totowa, NJ, supplies
sustained release development, formulation and filling services through
commercial scale at its cGMP manufacturing facility. For more information on
Laureate Pharma, contact the company directly at (609) 919-3400, by email at info@laureatepharma.com or visit www.laureatepharma.com.
Forward Looking Statement for GTC Biotherapeutics
This
press release contains forward-looking statements as defined in the Private
Securities Litigation Reform Act of 1995, including without limitation
statements regarding the potential for collaborative work between GTC and
Laureate Pharma, and the progress of GTC’s internal products and portfolio of
external programs. Such forward-looking
statements are subject to a number of risks, uncertainties and other factors
that could cause actual results to differ materially from future results
expressed or implied by such statements. Factors that may cause such differences include, but are not limited to,
the risks and uncertainties discussed in GTC's most recent Annual Report on
Form 10-K and its other periodic reports as filed with the Securities and
Exchange Commission, including the uncertainties associated with conducting
clinical studies, and the risks and uncertainties
associated with dependence upon the actions of regulatory agencies and
partners, including those in new marketing and strategic activities with
GTC. GTC
cautions investors not to place undue reliance on the forward-looking
statements contained in this release. These
statements speak only as of the date of this document, and GTC undertakes no
obligation to update or revise the statements, except as may be required by
law.
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