FRAMINGHAM, Mass.--(BUSINESS WIRE)--Feb. 23, 2006--GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) announced today that it has been told that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) intends to issue a negative opinion on the market authorization application (MAA) for ATryn(R), GTC's recombinant form of human antithrombin. On the basis of recent conversations, GTC understands that the CHMP, after excluding data from pregnant patients, determined that an insufficient number of surgical patients were enrolled to support approval. In addition, GTC understands that the CHMP has concerns about sufficient immunologic data and the lack of clinical data from ATryn(R) produced with an additional filtration step. GTC intends to take advantage of the appeal process to request a CHMP re-examination of GTC's submission.
