OMRIX Biopharmaceuticals Announces Positive Phase I Results With Fibrin Patch

Main Category: Blood / Hematology
Also Included In: Pharma Industry / Biotech Industry;  Clinical Trials / Drug Trials
Article Date: 18 Oct 2007 - 4:00 PDT

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OMRIX Biopharmaceuticals, Inc. ("OMRIX" or "the Company") (NASDAQ: OMRI), a biopharmaceutical Company that develops and markets biosurgical and passive immunotherapy products, announced the results of its prospective, open label, Phase I study of its novel Fibrin Patch. The results show that the Fibrin Patch appears to be safe as an adjunct to hemostasis.

The fully absorbable Fibrin Patch, developed together with ETHICON, INC., contains proprietary biologics which form an instant clot when they come in contact with blood. It is intended to rapidly manage the whole spectrum of bleeding, from mild to potentially life threatening severe bleeding.

"We are pleased with the results of this Phase I safety study and anticipate initiating a pivotal clinical study in the U.S. during the first quarter of 2008 pending FDA's clearance of our IND to be filed later this quarter," stated Robert Taub, President and Chief Executive Officer of OMRIX Biopharmaceuticals, Inc. "Our Fibrin Patch addresses a significant unmet medical need and we look forward to completing clinical development, obtaining the necessary regulatory approvals, and commercializing the product in partnership with ETHICON, INC., a Johnson & Johnson Company."

The Phase I study was conducted in Israel and enrolled 10 eligible patients undergoing elective partial nephrectomy. The Fibrin Patch was used in this study as an adjunct to hemostasis after attempts to control bleeding with conventional surgical techniques had been made. Patients were followed up for eight weeks post-operatively. During the study, no adverse reactions attributable to the product were observed.

About The Fibrin Patch

Severe bleeding (arterial or venous or mixed) is an unmet market need. It is a serious concern in surgical patients and requires rapid control to prevent hemodynamic consequences (e.g., hypovolemia, tachycardia, or hypotension). Currently, there is no marketed hemostat for the management and control of severe bleeding because the volume and pressure of the bleeding in these situations displaces the clot formed with traditional hemostats including fibrin sealants.

The Fibrin Patch is designed to combine the functions of mechanical sealing and biological hemostasis by providing a unique biodegradable device that causes a clot to be rapidly formed and maintained to stop bleeding without any other action. It serves both the unmet need of controlling severe bleeding while also facilitating the process of controlling the full spectrum of bleeding events from mild to severe.

About OMRIX Biopharmaceuticals, Inc.

OMRIX Biopharmaceuticals 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 severe bleeding, 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 bio-defense 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 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 Securities and Exchange Commission 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.

http://www.omrix.com