Bayer HealthCare entered into a "co-promotion agreement," with ZymoGenetics, Inc., a biopharmaceutical company headquartered in Seattle, to develop and commercialize rThrombin, a new drug candidate. The product, which is pending approval by the U.S. Food and Administration (FDA), is a recombinant form (engineered through DNA technology) of thrombin, a coagulation protein. Currently, the only thrombin therapy available in the U.S. is Thrombin-JMI®, manufactured by King Pharmaceuticals, a bovine-derived product made from cow blood.
Thrombin helps the blood clot by converting fibrinogen, a protein manufactured by the liver, to fibrin. Fibrin is an elastic protein that forms into a network of interlocking chains that make up the foundation of the clot. The new thrombin product is being developed "as an aid to controlling bleeding during surgery," according to the June 19, 2007 press release. Thrombin is used in more than one million surgeries in the U.S annually.
ZymoGenetics is positioning rThrombin as a safe, effective alternative to plasma-based thrombin, which can potentially cause the formation of inhibitory antibodies to bovine thrombin, and other safety concerns associated with an animal-derived blood product.
Bayer HealthCare will provide sales and marketing expertise for the first three years following the official launch of rThrombin. The Leverkusen, Germany-based company will be responsible for clinical trials and regulatory approvals necessary for product approval in all countries outside the U.S. Bayer will commercialize rThrombin in all non-U.S. countries.
Currently, Bayer manufactures two recombinant factor VIII products to treat hemophilia A: Kogenate® FS, sold by Bayer HealthCare Pharmaceuticals, and Helixate® FS, which is sold by CSL Behring.
ZymoGenetics stated in its press release that it has received notification of its biologics license application by the FDA, with an anticipated response by October 18, 2007.
Source: ZymoGenetics news release dated June 19, 2007