Healthcare Industry News: ETHICON
News Release - July 30, 2007
OMRIX Biopharmaceuticals Submits Market Authorization Application (MAA) to European Medicines Agency (EMEA) for Approval to Market Evicel(TM) with General Hemostasis Indication
NEW YORK--(HSMN NewsFeed)--OMRIX Biopharmaceuticals, Inc. ("OMRIX" or the "Company") (NASDAQ: OMRI ), a fully-integrated biopharmaceutical company that develops and markets protein-based biosurgery and passive immunotherapy products, announced today that it has submitted a Market Authorization Application (MAA) to the European Medicines Agency (EMEA) for approval to market EVICEL* Fibrin Sealant (Human), or Evicel, the Company's second generation liquid fibrin sealant, with an expanded indication of General Hemostasis in surgery."The expected EMEA approval for Evicel is an important milestone for OMRIX and ETHICON, a Johnson & Johnson company, and our strategy to expand the indication of our commercialized products," stated Robert Taub, President and Chief Executive Officer of OMRIX Biopharmaceuticals, Inc. "We believe that a General Hemostasis indication in surgery will provide us access to an additional 25% of the European market for liquid fibrin sealants."
The MAA contains the results of two prospective, randomized multi-center Phase III controlled studies: the first compared the hemostatic efficacy of Evicel to the standard-of-care in vascular surgery in 147 patients, and the second compared the hemostatic efficacy of Evicel to the standard-of-care in retroperitoneal or intra-abdominal surgery in 135 patients. The first study supported an additional indication in the U.S. for Evicel(TM) in vascular surgery (approved May 9, 2007) and the second study is under review by the Food and Drug Administration (FDA) for the expanded indication of General Hemostasis in surgery in the U.S. These two studies, together with supportive data obtained from the first generation Fibrin Sealant, Quixil®, are expected to meet the European requirements necessary for a general hemostasis indication.
Evicel differs from OMRIX's first generation fibrin sealant, Quixil®, in that Evicel does not contain the stabilizer, tranexamic acid, and therefore will not have the neurosurgical contraindication required of Quixil®.
EVICEL* Fibrin Sealant (Human)
Evicel has the advantage of its ease of use, immediate availability to the surgeon and its bovine- and aprotinin-free formulation. It provides for important hemostasis support when conventional surgical techniques prove to be inefficient, ineffective or impractical.
About OMRIX Biopharmaceuticals, Inc.
OMRIX Biopharmaceuticals is a fully-integrated biopharmaceutical company developing and marketing protein-based biosurgery and passive immunotherapy products. OMRIX' biosurgery product line includes products and product candidates that are used for the control of bleeding, or hemostasis, and other surgical applications. OMRIX' 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: www.omrix.com.
Safe Harbor Statement
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. 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 press release.
Source: OMRIX Biopharmaceuticals
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