GTC says committee to issue negative opinion on ATryn

By Lisa Kerner

Erie, Pa., Feb. 23 - GTC Biotherapeutics, Inc. said the Committee for Medicinal Products for Human Use of the European Medicines Agency intends to issue a negative opinion on the market authorization application for ATryn, GTC's recombinant form of human antithrombin.

In recent conversations with the committee, GTC learned that an insufficient number of surgical patients (excluding data from pregnant patients) were enrolled in trials to support approval, according to a company news release.

The committee also noted insufficient immunologic data and the lack of clinical data from ATryn produced with an additional filtration step, GTC said.

GTC said it intends to take advantage of the appeal process to request a committee re-examination of the submission.

LEO Pharma A/S, GTC's European development and commercialization partner, remains committed to the project and will continue to pursue development of an acquired deficiency indication for Europe.

GTC said it is continuing a multinational study of ATryn in hereditary antithrombin-deficient patients in preparation for submission of a Biologics License Application in the United States. Enrollment is expected to be completed in 2006, with a BLA submission slated for the first half of 2007.

"Although we are very disappointed with the late-breaking concerns on the clinical data and the negative opinion, we are pleased by the commitment of LEO Pharma to continue working on further development of this important product in Europe in acquired antithrombin deficiency," chairman and chief executive officer Geoffrey F. Cox said in the release.

Antithrombin, a protein in human plasma, has anticoagulant and anti-inflammatory properties. Patients with a hereditary deficiency of antithrombin are prone to developing blood clots during high-risk procedures, such as surgery and childbirth.

GTC develops and commercializes therapeutic proteins through transgenic animal technology. The company is based in Framingham, Mass.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.