OMRIX Biopharmaceuticals Receives FDA Approval For General Hemostasis In Surgery Indication For EVICEL Liquid Fibrin Sealant (Human)

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Dermatology;  Blood / Hematology
Article Date: 11 Jan 2008 - 9:00 PDT

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OMRIX Biopharmaceuticals, Inc. ("OMRIX" or the "Company") (NASDAQ: OMRI) announced that the U.S. Food and Drug Administration has granted an expanded indication for general hemostasis in surgery for EVICEL Liquid Fibrin Sealant (Human). EVICEL is the first liquid fibrin sealant to be indicated as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques is ineffective or impractical.

"Although Fibrin Sealants have been commercially available in the U.S. since 1999, their potential remains largely unexplored. FDA approval of the clinical supplement and general hemostasis in surgery indication for EVICEL are important developments as they significantly expand the market potential for this product and bring us closer to our stated objective of creating a one-stop-shop for biological hemostats," stated Robert Taub, President and Chief Executive Officer of OMRIX Biopharmaceuticals, Inc. "Ethicon, Inc., our marketing partner, will now actively promote EVICEL for a wide range of surgeries."

The approval of the general hemostasis in surgery indication is based on the submission of clinical data related to three pivotal studies conducted in three different surgical procedures with challenging bleeding. The pivotal study included in the last submitted clinical supplement is entitled: A Prospective, Randomized, Controlled Evaluation of Fibrin Sealant 2 (FS2) as an Adjunct to Hemostasis for Soft Tissue Bleeding during Retroperitoneal or Intra-abdominal Surgery.

In this clinical study, EVICEL was shown to be superior to the control product (Surgicel®, oxidized regenerated cellulose) in achieving hemostasis in less than 10 minutes. Superiority was also established at the secondary efficacy endpoints of 7 and 4 minutes.

About EVICEL

EVICEL is the only all human plasma-derived liquid fibrin sealant commercially available in the U.S. It does not contain aprotinin, which has been associated with adverse health effects. EVICEL is easy to use and readily available for time-sensitive needs in the operating room. The product is sold as a frozen liquid and requires less than one minute preparation time after thawing. It can be stored for 30 days as a ready-to-use liquid preparation at refrigerator temperature, a significant competitive advantage.

Important Safety Information

EVICEL is contraindicated in individuals known to have anaphylactic or severe systemic reaction to human blood products. As with all plasma-derived products, the risk of transmitting infectious agents cannot be completely eliminated. EVICEL should not be injected directly into the circulatory system or used for the treatment of severe or brisk arterial bleeding. Anaphylactic reactions may occur. No adverse events of this type were reported during the conduct of the clinical trials.

About OMRIX Biopharmaceuticals, Inc.

OMRIX Biopharmaceuticals, Inc. ("OMRIX") is a fully integrated biopharmaceutical company developing and marketing protein-based biosurgery and passive immunotherapy products. OMRIX's biosurgery product line includes products and product candidates that are used for the control of bleeding, or hemostasis, and other surgical applications. OMRIX's novel Fibrin Patch, a biological-device convergence product candidate, addresses an unmet medical need. The Company's passive immunotherapy product line includes antibody-rich products and product candidates for the treatment of immune deficiencies, infectious diseases and potential biodefense applications. For more information, please visit http://www.omrix.com.

Safe Harbor Statement

This news release contains forward-looking statements. Forward-looking statements provide the Company's current expectations or forecasts of future events. Forward-looking statements include statements about the Company's expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. The Company's actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the Company's filings with the Securities and Exchange Commission (SEC), including sections entitled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's Form 10-K as filed with the SEC on March 13, 2007, and the Company's most recent quarterly reports on Form 10-Q and its current reports on Form 8-K. Unless required by law, the Company undertakes no obligation to publicly update or revise any forward-looking statement to reflect circumstances or events after the date of this news release.

OMRIX Biopharmaceuticals, Inc.