Healthcare Industry News: thrombin
News Release - June 26, 2006
Enrollment in Phase III Clinical Trial for OMRIX's Thrombin Stand-Alone Product Has Been CompletedOMRIX's thrombin Being Developed for Use in General Surgery
Company 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.
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Source: OMRIX Biopharmaceuticals
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