LEO Pharma AB Information

"LEO is firmly committed to establishing the Critical Care area as a strong and growing segment of our business. ATryn® has significant growth potential and is a natural extension of our current Critical Care portfolio. We are pleased to work with GTC to bring the first recombinant antithrombin product to our markets. Also, we are delighted that ATryn® will be the first antithrombin product that would be approved in all the countries of the European Union, providing a consistent and secure source of supply to all of our customers," says Ernst Lunding, President and Chief Executive Officer of LEO. LEO has a long history in the treatment of thromboembolic disorders. innohep®, a low-molecular-weight heparin product is a well-known LEO product in which antithrombin binds with heparin to produce a greater anticoagulant effect. LEO has over 250 sales representatives in Europe, the Middle East, and Canada focused on Critical Care and coagulation management out of a total sales and marketing work force of 1,000 people. GTC has developed goats with the human antithrombin gene linked to a milk-protein promoter so that they express the antithrombin protein in their milk. This transgenic approach provides the opportunity to produce recombinant forms of proteins, such as antithrombin, which are difficult to express in conventional production methods. The European Medicines Agency (EMEA) is reviewing GTC's Marketing Authorization Application (MAA) for the use of ATryn® in the prophylactic treatment of patients with hereditary antithrombin deficiency (HD) during high-risk situations. The review of the MAA is expected to conclude with a determination by the EMEA in late February 2006 and will include the results of the inspections of GTC's farm and manufacturing facilities and certain clinical sites. Potential acquired deficiency indications include severe burns, coronary artery bypass graft surgery, disseminated intravascular coagulation and sepsis. A determination of which acquired deficiency to pursue first is ...