Healthcare Industry News: ETHICON
News Release - June 26, 2006
Enrollment in Phase III Clinical Trial for OMRIX's Thrombin Stand-Alone Product Has Been Completed
OMRIX's Thrombin Being Developed for Use in General SurgeryCompany on Track to File BLA in Q4 2006
NEW YORK--(HSMN NewsFeed)--June 26, 2006--OMRIX Biopharmaceuticals, Inc. (NASDAQ: OMRI ) announced today that patient enrollment in the multi-center, Phase III pivotal trial for the Company's Thrombin stand-alone product candidate has been completed. OMRIX's Thrombin stand-alone, which is derived from human plasma, is designed to provide effective hemostasis (control of bleeding) without the risk of adverse reactions associated with the use of bovine-sourced hemostats. OMRIX's Thrombin will be available in a frozen liquid form making it ready for immediate use without the need for re-constitution. While the product will have a two year stability, it can be stored liquid in the operating room refrigerator for 30 days. Currently, the only stand-alone thrombin product available in the U.S. is a bovine-based lyophilized product.
Robert Taub, President and CEO of OMRIX Biopharmaceuticals, Inc., stated, "Today's announcement is aligned with our strategy to build the most comprehensive and competitively differentiated franchise in biosurgery, particularly in the area of hemostasis. Together with, ETHICON, Inc., our distributor with whom we developed thrombin, we look forward to bolstering our leadership position in this growing area. Furthermore, we are pleased to be on track to file our BLA the fourth quarter of this year."
About the Study (A Comparative Evaluation of Human Thrombin versus Bovine Thrombin in Achieving Hemostasis in Patients Undergoing Cardiovascular, Neurologic (spine) and General Surgery Procedures)
The study is a Phase III pivotal, multi-center, prospective, randomized, controlled, double-blinded trial comparing thrombin topical (human) to bovine thrombin in achieving intra-operative hemostasis during cardiovascular, neurologic (spine) and general surgery procedures. A total of 304 patients were enrolled in the trial. The Company's target indication for this study is general hemostasis.
About OMRIX's Biosurgery Franchise: Defining the Marketplace
The Company's biosurgical franchise is comprised of three distinct commercial opportunities: liquid fibrin sealants (a type of surgical tissue adhesive whose ingredients interact during application to form a stable clot) used by surgeons as an adjunct to conventional surgical techniques; human thrombin (an enzyme that facilitates blood clotting by reacting with fibrinogen) often used by surgeons in combination with gelatin, such as ETHICON Surgiflo(TM) or other passive hemostat products in a tamponade fashion; and the Biological Hemostatic Dressing, BHD, (a convergence biological-device product that combines the efficacy of a biodegradable hemostatic mechanical barrier with the potency of human-derived biological components to promote the rapid formation of a clot at the site of a brisk bleeding wound).
About OMRIX Biopharmaceuticals, Inc.
OMRIX, a commercial-stage biopharmaceutical company, develops and markets innovative biosurgical and passive immunotherapy products, utilizing its proprietary protein purification technology and manufacturing know-how. As part of its business strategy, OMRIX commercializes certain of its biosurgical products through collaborations with companies whose marketing and sales expertise are a complement to OMRIX's own areas of specialty. OMRIX's novel and easy-to-use biological-device convergence products address unmet medical needs. For more information, please visit: www.omrix.com.
Forward-Looking Statements
This press 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. Words or phrases such as ''anticipate,'' ''believe,'' ''continue,'' ''ongoing,'' ''estimate,'' ''expect,'' ''intend,'' ''may,'' ''plan,'' ''potential,'' ''predict,'' ''project'' or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking.
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 sections entitled ''Risk factors'' and "Management's discussion and analysis of financial condition and results of operations" in the company's Prospectus as filed with the Securities and Exchange Commission on April 21, 2006. Accordingly, you should not unduly rely on these forward-looking statements, which speak only as of the date of this press release.
Unless required by law, the company undertakes no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this press release or to reflect the occurrence of unanticipated events. You should, however, review the factors and risks we describe in the reports the company will file from time to time with the Securities and Exchange Commission after the date of this press release.
Source: OMRIX Biopharmaceuticals
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