GTC BIOTHERAPEUTICS RECEIVES $1 MILLION MILESTONE PAYMENT FROM LEO PHARMA
FRAMINGHAM, MA – June 14, 2006 -- GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) announced today that it has received a $1 million payment from LEO Pharma A/S for achieving the milestone of a positive opinion on the market authorization application for ATryn® from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). The CHMP has recommended that ATryn®, GTC’s recombinant form of human antithrombin, be granted market authorization for the prophylaxis of venous thromboembolism in surgery of patients with congenital antithrombin deficiency. Final market authorization by the European Commission, which is expected in about three months, will trigger an additional $2 million milestone payment from LEO Pharma.
In November 2005, GTC and LEO Pharma entered into a collaboration to develop and market ATryn® in Europe, Canada, and the Middle East. In addition to marketing and sales of ATryn® for any approved indication in these territories, LEO is responsible for additional clinical development of ATryn® in Europe. GTC is responsible for ATryn® production and will receive a transfer payment from LEO for all product used in additional clinical studies in the LEO territories, in addition to transfer payments and royalties on any future commercial sales in the LEO territories.
The EMEA’s review process was the first regulatory examination of a transgenically produced therapeutic protein anywhere in the world and is the only available antithrombin product that is not derived from the human blood supply. Upon approval, ATryn® will also be the first antithrombin product approved for use in all 25 countries of the European Union.
“This milestone payment is an important marker of achieving the positive opinion,” stated Geoffrey F. Cox, Ph.D., GTC’s Chairman of the Board and Chief Executive Officer. “We look forward to working with LEO on developing the commercial launch of ATryn® as well as continuing development in larger market indications.”
LEO has begun development of ATryn® in Europe as a potential treatment for disseminated intravascular coagulation, or DIC, associated with severe sepsis. DIC occurs in an estimated 220,000 severe sepsis cases in the European Union each year, of which approximately 50% are fatal, representing a major unmet medical need of significant interest in critical care. LEO has requested scientific advice from the EMEA as the basis for clinical studies in DIC.
GTC anticipates using the results from both the completed study of hereditary deficient patients reviewed by the CHMP and GTC’s ongoing pivotal phase III study to prepare a Biologics License Application for the United States Food and Drug Administration, which is planned for mid-2007.
Antithrombin is a protein in human plasma that has anticoagulant and anti-inflammatory properties.