World Hemophilia Day

On World Hemophilia Day 2010, April 17, meet the many faces of bleeding disorders - united to achieve Treatment for All. Each year hemophilia organizations around the world celebrate World Hemophilia Day, increasing awareness of hemophilia and other bleeding disorders.

The World Federation of Hemophilia (WFH) will launch “The Many Faces of Bleeding Disorders” video podcast on World Hemophilia Day. This video podcast celebrates the whole bleeding disorders community – people with hemophilia and symptomatic carriers, males and females with von Willebrand disease, as well as rarer factor deficiencies, and inherited platelet disorders. It features the impact of these conditions through global patient perspectives and includes a call-to-action for access and improved patient standard of care.

“The goal of the World Federation of Hemophilia is that, one day, treatment will be available for all those with inherited bleeding disorders, regardless of where they live,” said Mark Skinner, WFH president. “Our vision of Treatment for All means expanding services beyond hemophilia.”


Visit www.wfh.org/whd : for more information about World Hemophilia Day. The World Hemophilia Day website is supported by Bayer, Baxter, and Novo Nordisk. View “The Many Faces of Bleeding Disorders” video podcast, made possible with funding from Baxter Healthcare Corporation, at www.wfh.org/whd : .

ZymoGenetics shares fall on regulatory delay

Shares of ZymoGenetics Inc. dipped Tuesday after the company said additional studies are likely needed to gain European regulatory approval of its only marketed product, Recothrom.
Sales of the drug, which is used to control bleeding during surgical procedures, climbed to $8.5 million from $1.8 million during the third quarter. While approved in the U.S., it is not yet approved in Europe. Seattle-based ZymoGenetics licensed all rights outside of the U.S. to Germany-based Bayer in 2007.
In a Securities and Exchange Commission filing Monday, ZymoGenetics said Bayer pulled its application with European regulators as a response to indications that the drug candidate would take an additional study to gain approval.
The Committee for Medicinal Products for Human Use said Bayer's submission did not meet the necessary standards.
The stock fell 13 cents, or just under 2 percent, to $6.61 in afternoon trading. ZymoGenetics shares have traded between $2.55 and $7.31 over the last 52 weeks.

Bayer Submits Recombinant Human Thrombin for European Approval

2 Sep 2008 , 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.

Marketing of Trasylol Suspended

Bayer AG suspended worldwide sales of Trasylol, a clotting drug using during heart surgery to prevent bleeding, on Monday following a request from the U.S. Food and Drug Administration to remove the drug from the American market for safety reasons.