FRAMINGHAM, Mass.--(BUSINESS WIRE)--GTC Biotherapeutics, Inc. announced that it has entered into an agreement with its strategic partner, LFB Biotechnologies (Les Ulis, France), pursuant to which LFB has agreed to provide $7 million of new loan financing to GTC. The financing will be in the form of a 4%, 36-month secured term loan with a single payment of principle and interest at maturity. The transaction is expected to close on February 24, 2009 and is subject to customary closing conditions.
“This loan arrangement is a further important demonstration of LFB’s continuing commitment to the GTC transgenic technology platform and the portfolios of products under development,” said Geoffrey Cox, Ph.D., Chairman, President and CEO of GTC Biotherapeutics. “This provides valuable support to GTC as we progress our FVIIa program into the clinic and advance our partnering efforts for our portfolio.”
“LFB is encouraged by the continuing progress in our collaboration with GTC and the planned advancement of FVIIa into the clinic in the second quarter of 2010,” stated Christian Béchon, President and CEO of LFB. “We believe that this funding will help sustain the progress for the key strategic programs in our transgenic portfolio, and confirm our long term commitment in the Company vis-a-vis new partners. We believe that GTC has been successful in prioritizing the most valuable projects and in reducing costs, and that the Company is now in a stronger position to succeed.”
About GTC Biotherapeutics
GTC Biotherapeutics develops, supplies and commercializes therapeutic proteins produced through transgenic animal technology. ATryn®, GTC’s recombinant human antithrombin, has been approved for use in the United States and Europe. ATryn® is the first and only therapeutic product produced in transgenic animals to be approved anywhere in the world. Building upon the 2009 FDA approval of ATryn®, GTC is collaborating with its US commercialization partner, Lundbeck Inc., to develop a protocol for a pivotal study of patients with acquired antithrombin deficiencies in cardiac surgery. GTC aims to initiate a clinical trial in this indication in the second half of 2010. In addition to ATryn®, GTC is developing a portfolio of recombinant human plasma proteins with known therapeutic properties. These proteins include recombinant forms of human coagulation factors VIIa and IX, which are being developed for the treatment of patients with hemophilia, and recombinant alpha-fetoprotein, which is being developed for the treatment of Myasthenia Gravis and Multiple Sclerosis. GTC plans to advance its human recombinant factor VIIa program into a Phase I clinical study in the first half of 2010 and its alpha-fetoprotein program into a Phase II study in Myasthenia Gravis in the second half of 2010 after securing a partner for that program. GTC is also developing a portfolio of monoclonal antibodies for use as follow-on biologics. The portfolio includes antibodies targeting HER2, EGFR and TNF, which currently address markets with aggregate sales in excess of $16 billion, as well as a CD20 antibody with enhanced ADCC (antibody-dependent cell-mediated cytotoxicity). Production animals for these programs are in development, and are already established for CD20 and HER2 monoclonal antibodies. In 2010, GTC plans to characterize each of these transgenically-derived antibodies as they become available and to initiate non-clinical studies.
GTC’s intellectual property includes a patent in the United States through 2021 for the production of any therapeutic protein in the milk of any transgenic mammal. GTC’s transgenic production platform is particularly well suited to enable cost effective development of proteins that are difficult to express in traditional recombinant production systems as well as proteins that are required in large volumes. Additional information is available on the GTC web site, http://www.gtc-bio.com.
LFB Biotechnologies (a French société par actions simplifiée) is both a strategic shareholder in GTC and the strategic partner of GTC in their joint venture called LFB/GTC LLC. LFB is a biopharmaceutical group that develops, manufactures and markets medicinal products for the treatment of serious and often rare diseases in several major therapeutic fields, namely Hemostasis, Immunology and Intensive Care. The LFB Group is the leading manufacturer of plasma-derived medicinal products in France and 6th worldwide and is also among the leading European companies for the development of monoclonal antibodies and new-generation proteins based on biotechnologies. With its strong focus on research, the LFB Group is pursuing a growth strategy that seeks to extend its activities at the international level and develop innovative therapies. In 2008, the LFB Group reported total turnover of 352,4 million euros, an increase of 9%, and invested 66,6 million euros in product development. The LFB Group markets its products in 20 countries around the world.
This press release contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995, including without limitation statements related to GTC’s plans to enter into partnerships and advance its programs relating to recombinant factor VIIa, alpha-fetoprotein, ATryn and monoclonal antibodies for use as follow-on biologics, and the closing of the term loan financing with LFB. 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 filed with the Securities and Exchange Commission, including the risks and uncertainties associated with securing and depending upon partners, designing and conducting clinical trials and pre-clinical studies, developing new biological products and depending upon the actions of regulatory agencies. 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.
GTC Biotherapeutics, Inc.
John B. Green, 508-370-5279
Senior Vice President & Chief Financial Officer