The U.S. Food and Drug Administration on Tuesdayapproved Israeli biotech Omrix‘s human thrombin product Evithrom for surgical use. It is the first approval of a human thrombin product since 1954, the agency said.
Evithrom, derived from human plasma, is designed to control bleeding during surgery.
It competes directly with Seattle biotech ZymoGenetics’ genetically-engineered thrombin. The Zymo drug’s launch — originally scheduled for October — last week was delayed by three months as the FDA required more time to review information about manufacturing operations. rThrombin, as the local company’s recombinant thrombin is known, will be the first product to come out of ZymoGenetics’ pipeline since it became a public company.
ZymoGenetics stock closed 3.45 percent lower at $11.77. In a conference call following the FDA’s decision to delay rThrombin’s approval, company executives maintained that they were confident that their product would dominate the thrombin market despite being beaten to the street by its rival by several months. rThrombin would also compete with King Pharmaceuticals’ bovine thrombin product, which is used in about 1 million surgeries annually, according to Bloomberg.
Zymogenetics says that recombinant thrombin is less risky and a better platform to provide a more consistent supply than human or bovine-derived thrombin.
King Pharmaceuticals corporate affairs executive vice president James Greene said his company is able to manufacture twice as much thrombin as is currently consumed in the market. He also said that the bovine thrombin product, which has been used in 11 million procedures in over 12 years, is safe and “very well understood” by physicians.
UPDATE: McAdams Wright Ragen analyst Paul Latta says that recombinant thrombin “is a compelling marketing story.”
“There is no fear associated with viruses, or fear of the bloodbank in general,” unlike products derived from human blood, he said. Bovine-derived products raise concerns about anti-bodies, he said.
Nevertheless, Omrix will have “a first mover advantage, which will be a challenge,” Latta said. But he dismissed the fact that ZymoGenetics’ stock downturn has much to do with the FDA announcement, as the stock market saw a general downturn. “I’m sure it was a factor, but it probably wasn’t the prime factor,” he said.