Bayer Submits Recombinant Human Thrombin for European Approval

Recothrom® would be the first recombinant human thrombin for use as a topical aid to surgical hemostasis in Europe
Berlin.– Bayer Schering Pharma has submitted a Marketing Authorization Application to the European Medicines Agency (EMEA) for recombinant human thrombin (INN: thrombin alfa) as a topical aid to control surgical bleeding.

Thrombin alfa is being commercialized in a global collaboration between ZymoGenetics and Bayer which began in June 2007. Bayer acquired the global rights to thrombin alfa for all markets outside the US. ZymoGenetics retains US market rights and Bayer provides its sales force to support the first three years of the US market launch. Thrombin alfa received United States Food and Drug Administration (FDA) approval in January 2008 and is marketed as Recothrom® Thrombin, topical (Recombinant). Bayer plans using the product name Recothrom® globally, pending regulatory approval.

Thrombin alfa is a recombinant form of human thrombin that is structurally and functionally similar to the natural enzyme which is an important factor in the blood clotting cascade. Used in surgery, the product is applied topically to the operation wound and may be administered as a spray or with a surgical sponge. Upon application, thrombin alfa activates the final steps of the coagulation cascade to stop the bleeding.

The biotechnologically produced recombinant thrombin alfa provides surgeons with a plasma-free thrombin alternative for surgical hemostasis. As it is not derived from animal or human blood, it does not imply the risk of infections which is generally associated with plasma products.

In Europe, there are in excess of 4 million surgical procedures performed annually where a hemostatic product may be used and surgeons currently have to rely on either sponges or tissue sealants. Thrombin alfa would be the first stand-alone thrombin product to control bleeding during surgery and may improve the therapeutic options in Europe.