Omrix Biopharmaceuticals Ltd. (Nasdaq:OMRI) has announced that the US Food and Drug Administration (FDA) has granted marketing clearance for its second generation fibrin sealant, Evicel, to control bleeding (hemostasis) during liver surgery. Evicel differs from Omrix's first generation fibrin sealant, Crosseal, in that Evicel does not contain a stabilizer, and therefore will not have the neurosurgical contraindication required of Crosseal.
Johnson & Johnson (NYSE:JNJ) subsidiary, Ethicon Inc., will market Evicel.
Omrix also announced that it submitted to the FDA additional results of a Phase III clinical trial, comparing the efficacy of Evicel to standard-of-care in peripheral vascular surgery.
Omrix president and CEO Robert Taub said, “To obtain approval for Evicel for use in all surgical procedures, we must show that it is effective in three pivotal clinical studies. We’ve already obtained one approval, we’ve completed trials in the second area, and we’re in the midst of the third trial, which means that we’re close to obtaining general approval.”
In it annual financial report for 2005, Omrix announced a number of milestones that it expected to achieve during 2006. One of these was the present approval. The company also expects to obtain the results of Phase II/III clinical trials for its Biological Hemostatic Dressing (BHD) for the management and rapid control of bleeding, including severe or brisk bleeding, and for use on active bleeding sites; and submit the results of Phase II clinical trials for human plasma-derived Thrombin hemostatis product for a gradual onset of clotting; and immunotherapies, one for the treatment of West Nile virus, now undergoing preclinical trials, and another for the treatment of smallpox.
In response to the FDA approval, CIBC Capital Markets said, “This approval is expected to lead to materially higher sales of Crosseal/Evicel in the US. We are reiterating our “Sector Outperform” rating and $21 price target.”
Published by Globes [online], Israel business news - www.globes.co.il - on July 11, 2006
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