ZymoGenetics Earns Milestone Payment for RECOTHROM(R) European Filing
Tuesday September 2, 6:00 am ET
SEATTLE--(BUSINESS WIRE)--ZymoGenetics, Inc. (NASDAQ:ZGEN - News) announced today that it will receive a $5 million milestone payment from Bayer HealthCare, which was triggered by the submission of the Marketing Authorization Application to the European Medicines Agency (EMEA) for approval to market RECOTHROM® Thrombin, topical (Recombinant). Bayer filed with the EMEA for authorization to market RECOTHROM as a topical aid to control surgical bleeding. RECOTHROM received United States Food and Drug Administration approval in January 2008.
“Bayer’s filing for approval in Europe demonstrates their commitment to RECOTHROM,” said Bruce L.A. Carter, Chief Executive Officer of ZymoGenetics. “Bayer has been a valued partner in selling RECOTHROM, the first and only plasma-free thrombin, in the US and in driving the ex-US program forward.”
RECOTHROM is being commercialized in a global collaboration between ZymoGenetics and Bayer which began in June 2007. Bayer acquired the rights to RECOTHROM in all markets outside the US and will commercialize RECOTHROM, leveraging the company’s strong commercial presence in global markets. Currently, stand-alone thrombin products are not widely available in the European Union (EU). However, in five of the largest member states of the EU there are in excess of 4 million surgical procedures performed annually where a hemostatic product is generally used. ZymoGenetics retains US market rights and Bayer provides its trained surgical sales force to support the first three years of the US market launch.
About RECOTHROM® Thrombin, topical (Recombinant)
RECOTHROM is a recombinant form of human thrombin that is structurally and functionally similar to human thrombin. It is not derived from animal or human blood. With thrombin being used in more than 1 million surgeries each year in the United States, RECOTHROM gives surgeons the opportunity to provide their patients with a plasma-free thrombin alternative for surgical hemostasis. The production of recombinant proteins is not dependent on the availability of blood from animals or human donors and can be scaled up to meet market demand.
RECOTHROM is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical. RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP.
surf's up......crikey
