Omrix: human thrombin demonstrates similar efficacy to bovine thrombin

By Jennifer Lanning Drey

Portland, Ore., Oct. 16 - Omrix Biopharmaceuticals, Inc. announced that its human thrombin product demonstrated equivalent efficacy, measured by time to hemostasis, when compared to bovine thrombin in a phase 3 clinical trial.

Omrix plans to file a Biologics License Application with the Food and Drug Administration for standalone human thrombin by Nov. 15 and launch the product in 2007, Dr. Peter Johnson, clinical professor of surgery at the University of North Caroline, said Monday. Johnson reviewed the Omrix study data during a company conference call.

The primary endpoint of Omrix's pivotal clinical trial evaluated the equivalence of topical human thrombin to bovine thrombin in terms of efficacy as determined by success in achieving hemostasis within 10 minutes of product application.

Omrix's human thrombin and the bovine thrombin each achieved hemostasis within 10 minutes more than 97% of the time in the pivotal trial, according to a company news release.

The company also said the human thrombin demonstrated a similar safety profile to bovine thrombin in the trial.

If the human thrombin is approved, Omrix will move forward with plans to introduce a kitted thrombin in combination with a gelatin-based hemostat, Johnson said.

The refrigerated kitted product would be ready to use within one minute and would not require mixing or reconstitution.

"The competitive advantage of such a paired product will be its ease of use, its safety and the marketing strength of Omrix's partner Johnson & Johnson," he said.

Bovine thrombin carries an FDA black box warning because it can cross-react with human thrombin to continuously activate or inhibit thrombin.

Omrix is a New York-based biopharmaceutical company.

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