GTC Biotherapeutics (fka GTCB)

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ATryn Nears Completion of US HD Clinical Study


Last update: 8:30 a.m. EST Jan. 7, 2008Print E-mail RSS Disable Live Quotes


FRAMINGHAM, Mass., Jan 07, 2008 (BUSINESS WIRE) -- GTC Biotherapeutics, Inc. (GTCB:gtc biotherapeutics inc com
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0.85, -0.04, -4.5%) announced today that it has completed recruitment into the historical arm of the comparative clinical study of ATryn(R) in the treatment of patients with hereditary antithrombin deficiency, or HD, undergoing high-risk surgical or childbirth procedures. This study is expected to support a Biologics License Application, or BLA, submission with the United States Food and Drug Administration, or FDA. Evaluable records for 37 patients were obtained, meeting the required minimum of 35 HD patients. The data from the historical records were gathered under a prospective clinical protocol observing patients who had been treated with plasma-derived antithrombin products.
A minimum of 31 evaluable HD patients are required for the ATryn(R) treatment trial. Results for 14 of these patients were already obtained from the study that supported ATryn(R)'s approval in the European Union for HD patients undergoing surgical procedures. Due to patient scheduling decisions, top line results of the clinical study are now expected to be available around the end of January. The ongoing study is designed to determine the non-inferiority of ATryn(R) to plasma-derived antithrombin products in reducing the incidence of deep vein thrombosis or other thromboembolisms in this challenging patient population.
"While the scheduling of patients into the active treatment arm of our comparative study has taken a little longer than originally forecasted, we have made good progress in working through the recruitment process, completing the historical arm, and moving the regulatory process forward," stated Geoffrey F. Cox, PhD, GTC's Chairman and CEO. "We are encouraged that we continue on track with our plans to commercialize and further develop ATryn(R) in the US, closely following its commercialization in Europe."
ATryn(R) was recently granted fast track status by the FDA and subsequently was designated an orphan drug for the HD indication. GTC has also been granted permission to submit the sections of the associated BLA on a rolling basis as the required sections are completed. The submission of the preclinical and manufacturing sections is anticipated shortly. The last section to be filed is expected to be the clinical study results, which are planned to support completion of the BLA by mid-year. GTC will be seeking priority review in conjunction with the BLA submission. On this basis, GTC anticipates approval of the BLA around the end of 2008.
Discussions with potential partners for the commercialization and further development of ATryn(R) in the US have continued through the end of 2007. GTC is planning to conclude an agreement during the first quarter of 2008.
ATryn(R) is partnered with LEO Pharma A/S in Europe, Canada, and the Middle East. LEO launched the product in the United Kingdom in the fourth quarter of 2007 and has also obtained pricing approval in Ireland and Greece. LEO is continuing to expand the commercial launch into additional European countries as pricing is established. LEO is also conducting a phase II dose ranging study in treating disseminated intravascular coagulation, or DIC, associated with severe sepsis. GTC retains rights to this indication in the US and the rest of the world. The US market opportunity for the DIC indication is estimated to be $2 - 3 billion.
About GTC Biotherapeutics
GTC Biotherapeutics develops, supplies, and commercializes therapeutic proteins produced through transgenic animal technology. In addition to ATryn(R), GTC is developing a portfolio of recombinant human plasma proteins with known therapeutic properties. These proteins include recombinant forms of human coagulation factor VIIa, factor VIII, factor IX, and alpha-1 antitrypsin. GTC also has a monoclonal antibody portfolio that includes a CD20 monoclonal antibody and a monoclonal antibody to CD137. 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 enabling 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.
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the timing of completion of GTC's current Phase III study of ATryn(R), filing and review of the associated BLA, and timing of partnering and commercialization activities. 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 uncertainties associated with conducting clinical studies, and the risks and uncertainties associated with dependence upon the actions of regulatory agencies and potential collaboration partners. 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.
SOURCE: GTC Biotherapeutics, Inc.
GTC Biotherapeutics, Inc.
Thomas E. Newberry, 508-370-5374
Vice President, Corporate Communications
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