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Oct 8 (Reuters) - Omrix Biopharmaceuticals Inc OMRI.O said an interim analysis of its experimental anti-bleeding product Fibrin Pad showed it was superior to an already approved product in stopping mild to moderate bleeding in a U.S. mid-stage trial.
Interim analysis of the trial showed Fibrin Pad was superior to Surgicel in achieving the main goal of haemostasis at four minutes after randomization with no re-bleeding requiring treatment during a subsequent six-minute observation period.
Surgicel is a haemostat made by Ethicon, a Johnson & Johnson (JNJ.N) unit.
However, Omrix said there was one serious adverse event of post-operative bleeding among four patients in a separate mid-stage study in Israel, where the product is being tested for severe bleeding.
Omrix said it also submitted a clinical trial application in the United Kingdom to study the safety and efficacy of Fibrin Pad in treating soft tissue severe bleeding.
The company expects UK’s Medicines and Healthcare Products Regulatory Agency to approve the application by the end of 2008 or early 2009.
Shares of Omrix were up 78 cents at $18.08 in morning trade on Nasdaq. (Reporting by Vidya L Nathan in Bangalore; Editing by Deepak Kannan)