In August of 2006, following a positive opinion by the CHMP, the European Commission approved the MAA for ATrynŽ for treatment of patients with hereditary antithrombin deficiency, undergoing high-risk surgical or childbirth procedures.
In the United States, ATrynŽ has met the statistical requirements for the primary endpoint of a pivotal study for the treatment of patients with the hereditary deficiency indication. GTC has also initiated the filing of the associated Biologics License Application, or BLA, by submitting the preclinical and manufacturing sections. The last section to be filed is expected to be the full clinical study results once all reviews of the data have been completed. GTC previously received approval to commence the BLA filing on a rolling basis when ATrynŽ was granted fast track status by the Food and Drug Administration, or FDA. Separately, ATrynŽ has also been designated an orphan drug for the HD indication.
Photo compliments of LEO Pharma. For use only in the approved indication in Europe. Not intended to constitute a full product description.
In late 2005, GTC entered into a collaboration agreement with with LEO Pharma A/S to develop and market ATrynŽ for markets in Europe, the Middle East, and Canada. Under this agreement, LEO will be responsible for the development of ATrynŽ in Europe, Canada and the Middle East in acquired antithrombin deficiency, or AD indications.
AD can result from a wide array of conditions such as burns, disseminated intravascular coagulation, sepsis, cardiopulmonary bypass surgery, acute liver failure and others. The launch of this product has begun by LEO Pharma on a country-by-country basis. GTC retains all rights to ATrynŽ in all other territories. The acquired deficiency indication which LEO Pharma intends to focus on is DIC, disseminated intravascular coagulation, when it occurs in association with severe sepsis.
DIC is the widespread formation of clots within blood vessels. LEO has received scientific advice from the EMEA on the appropriate design for Phase II studies in DIC. It is planned that recruitment into a Phase II study will begin by the year end. 
GTC is also developing recombinant forms of additional human plasma proteins, such as albumin and alpha-1 antitrypsin. GTC expresses these proteins in the milk of a well-cared for and controlled herd of animals that have the appropriate human therapeutic gene linked to a milk-protein promoting gene. This approach provides a unique opportunity to produce highly purified and well-characterized recombinant forms of these biologic medicines.
ATrynŽ Press Release Archive March 6, 2008 - GTC Biotherapeutics Reports Fourth Quarter and Year End 2007 Financial Results
February 25, 2008 - Last Patient Enrolled in ATrynŽ Pivotal Study
February 4, 2008 - ATrynŽ Meets Primary Endpoint/Rolling BLA Submission Initiated
January 7, 2008 - ATrynŽ Nears Completion of US HD Clinical Study
December 10, 2007 - GTC Obtains FDA Orphan Drug Designation for ATrynŽ
November 26, 2007 - LEO Pharma announces "ATrynŽ - a safe drug without use of donor blood"
November 1, 2007 - GTC Biotherapeutics Reports Third Quarter 2007 Financial Results
August 9, 2007 - GTC Biotherapeutics Reports Second Quarter 2007 Financial Results
August 6, 2007 - First Patient Enrolled into ATrynŽ Phase II Study in DIC Indication
July 11, 2007 - ISTH CONGRESS HIGHLIGHTS: Continuous peri-operative infusion of antithrombin alfa normalises VTE risk in patients with hereditary anti-thrombin deficiency; Oral dabigatran can prevent VTEs in hip surgery patients
July 9, 2007 - ATrynŽ Introduced at International Society
on Thrombosis and Haemostasis Congress
May 24, 2007 - GTC Biotherapeutics Reports Results of 2007 Annual Meeting
May 3, 2007 - GTC Biotherapeutics Reports First Quarter 2007 Financial Results
March 5, 2007 - GTC Biotherapeutics Reports Fourth Quarter and Year End 2006 Financial Results
January 3, 2007 - ATrynŽ Market Authorization Transferred to LEO Pharma A/S
November 2, 2006 - GTC Biotherapeutics Reports Third Quarter 2006 Financial Results
August 2, 2006 - European Commission Approves ATrynŽ
June 14, 2006 - GTC Biotherapeutics Receives $1 Million Milestone Payment from LEO Pharma
June 2, 2006 - ATrynŽ Receives CHMP Recommendation to Grant Market Authorization
March 6, 2006 - GTC Biotherapeutics Reports Fourth Quarter and Year End 2005 Financial Results
February 23, 2006 - GTC Biotherapeutics Expects CHMP to Issue Negative Opinion on ATrynŽ
November 1, 2005 - GTC Biotherapeutics and Leo Pharma to Develop and Market ATrynŽ in Europe, the Middle East, and Canada
September 16, 2005 - GTC Biotherapeutics Anticipates EMEA Opinion on ATrynŽ in February 2006
July 6, 2005 - GTC Biotherapeutics Files Response to EMEA List of Outstanding Issues
April 25, 2005 - GTC Biotherapeutics Plans to Respond to EMEA by July 8, 2005
April 6, 2005 - GTC Biotherapeutics to Begin ATrynŽ US Clinical Studies
March 16, 2005 - GTC Biotherapeutics Provides Update on European Regulatory Review of ATrynŽ
March 3, 2004 - GTC Biotherapeutics Reports Fourth Quarter and Year End 2003 Financial Results
February 27, 2004 - GTC Biotherapeutics' Presents ATrynŽ Safety and Efficacy DataFebruary 27, 2004 - GTC Biotherapeutics' Announces EMEA Accepts MAA Submission For Review of ATrynŽ
January 26, 2004 - GTC Biotherapeutics Submits a
European Market Authorization Application for ATrynŽ
December 17, 2003 - GTC Biotherapeutics Completes Enrollment in European Efficacy Study
April 2, 2003 - GTC's rhATIII Used in Preclinical Study of Acute Lung Injury Treatment
February 18, 2003 - GTC Biotherapeutics Announces Presentations of Patient and Process Data on rhATIII at the 47th Annual Meeting of the Society of Thrombosis and Haemostasis Research
December 6, 2002 - GTC Initiates Clinical Safety and Efficacy Trial of rhATIII in Patients with Hereditary Deficiency of Antithrombin
September 6, 2002 - GTC Biotherapeutics Presents ATIII PK Study Results
July 16, 2002 - GTC Biotherapeutics completes ATIII PK Study
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