PDF / 64 KB 
collectBayerNews_20080902_0375_en.pdf BayerNews_20080902_0375_en.pdf
Recothrom® would be the first recombinant human thrombin for use as a topical aid to surgical hemostasis in Europe
Berlin, September 2, 2008 - 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.
About Bayer Schering Pharma
The Bayer Group is a global enterprise with core competencies in the fields of
health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary
of Bayer AG, is one of the world's leading, innovative companies in the
healthcare and medical products industry and is based in Leverkusen, Germany.
The company combines the global activities of the Animal Health, Consumer Care,
Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business
operates under the name Bayer Schering Pharma. Bayer HealthCare's aim is to
discover and manufacture products that will improve human and animal health
worldwide. Find more information at www.bayerhealthcare.com.
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company.
Its research and business activities are focused on the following areas:
Diagnostic Imaging, General Medicine, Specialty Medicine and Women's
Healthcare. With innovative products, Bayer Schering Pharma aims for leading
positions in specialized markets worldwide. Using new ideas, Bayer Schering
Pharma aims to make a contribution to medical progress and strives to improve
the quality of life. Find more information at www.bayerscheringpharma.de.
