Sealing the deal
Two companies now have submitted BLAs for human thrombin products to control bleeding during surgery, looking to take over the space currently held by bovine-derived products. ZymoGenetics Inc., which filed last month, thinks its recombinant version will have an edge, while Omrix Biopharmaceuticals Inc., which filed in November, says its plasma-derived product will prosper because of its focus on the larger hemostasis market.
There are a handful of human plasma-derived thrombins on the market as parts of combination thrombin/fibrinogen sealants, known as fibrin sealants, including Omrix's Evicel and Quixil. But the marketed standalone thrombin products contain bovine-derived components, including Thrombin-JMI from King Pharmaceuticals Inc. (KG, Bristol, Tenn.) and FloSeal Hemostatic Matrix from Baxter International Inc. (BAX, Deerfield, Ill.)...