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Jan 01, 2007
 |  BioCentury  |  Product Development

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.).

Human thrombin does not show an increase in efficacy over bovine thrombin, but both ZymoGenetics (ZGEN, Seattle, Wash.) and Omrix (OMRI, New York, N.Y.) have shown in the clinic that their products have superior immunogenicity profiles over the bovine-derived product. Thrombin-JMI has a black box warning that hemostatic abnormalities sometimes occur, probably because of the...

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