Description
ZymoGenetics discovers, develops, and commercializes therapeutic proteins to combat life-threatening illnesses. Its only approved product is Recothrom, a topical hemostatic agent used to control bleeding during surgical procedures, which is partnered with Bayer. Outside of Recothrom, ZymoGenetics' pipeline contains several compounds in various stages of development for the treatment of inflammatory and autoimmune diseases, cancer, and viral infections. ZymoGenetic is focused on the discovery, development and commercialization of protein therapeutics for the treatment of significant human diseases. The Company has generated a pipeline of proprietary product candidates and intends to commercialize them through internal development, collaborations with biopharmaceutical partners or out-licensing of patents. The first of these products, RECOTHROM(r), was approved by the U.S. Food and Drug Administration in January 2008. RECOTHROM, recombinant thrombin, is a topical hemostatic agent used for the control of moderate bleeding during surgical procedures, which was approved by the FDA on January 17, 2008. It is a recombinant version of a bloodclotting protein. Other thrombins are marketed in the United States in forms derived from bovine plasma or human plasma. The Company's product provides an effective and safe alternative to plasma-derived thrombin products. ZymoGenetic is marketing RECOTHROM in the United States using its own commercial infrastructure, which includes a dedicated field force of sales people and medical scientific liaisons. ZymoGenetic has retained all RECOTHROM rights in the United States. In June 2007, the Company entered into a license and collaboration agreement with Bayer Schering Pharma AG, under which Bayer Schering Pharma would develop and commercialize RECOTHROM outside of the United States. Simultaneously, the Company entered into a co-promotion agreement with Bayer HealthCare LLC, under which Bayer would co-promote RECOTHROM in the United States for up to four years following the RECOTHROM launch, ending in March 2012. In August 2008, Bayer Schering Pharma submitted the Marketing Authorization Application to the European Medicines Agency for approval to market RECOTHROM as a topical aid to control surgical bleeding. Interferon-l1 is a cytokine with potential applications for the treatment of viral infections and autoimmune diseases. ZymoGenetic's product candidate, PEG-IFN-l, is a pegylated version of the IFN-l1 protein. The Company is conducting a Phase 1b trial to evaluate the safety and anti-viral activity of PEG-IFN-l in patients with genotype 1 hepatitis C virus infection who relapsed after the combination treatment of interferon-a and ribavirin. ZymoGenetic's current focus is the continued commercialization of its first product, RECOTHROM, and the development of PEG-IFN-l in partnership with Bristol-Myers Squibb and other internal product candidates to treat a variety of serious diseases and medical con