UPDATE 1-ZymoGenetics says FDA oks solution to control bleeding
(Adds details, FDA statement, share movement)
Jan 17 (Reuters) - ZymoGenetics Inc (ZGEN.O) said U.S. health regulators approved its solution to stop bleeding from small blood vessels after surgery, sending its shares up 11 percent.
The product, Recothrom, is a protein produced via recombinant DNA technology and is similar to human thrombin, which helps in the clotting of blood. It is not derived from animal or human blood, the company said.
In a separate statement, the U.S. Food and Drug Administration said Recothrom was the first approved clotting solution using recombinant DNA techniques.
In a study of 411 patients undergoing various surgical procedures, Recothrom met the primary indicator of effectiveness, which was control of bleeding within 10 minutes, the regulator said.
The drug maker said the approval triggered a $40 million milestone payment from Bayer HealthCare Pharmaceuticals, a unit of Bayer BAYG.DE, to ZymoGenetics.
Bayer will support the launch of Recothrom in the United States for three years, the company said in a statement.
In June 2007, Bayer HealthCare acquired the rights to Recothrom in all markets outside the United States, it said.
Shares of the company were up $1.35 at $13.35 in afternoon trade on the Nasdaq. (Reporting by Manish Gupta in Bangalore, Jennifer Robin Raj; Editing by Vinu Pilakkott)
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