Healthcare Industry News: ETHICON
News Release - March 8, 2007
OMRIX Biopharmaceuticals Submits Supplemental Biologics License Application (sBLA) to Market Evicel With General Hemostasis in Surgery 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 Supplemental Biologics License Application, or sBLA, to the U.S. Food and Drug Administration (FDA) for approval to market Evicel, the Company's second generation liquid fibrin sealant, with an expanded indication of General Hemostasis in surgery.The sBLA contains the results of a prospective, randomized, multi-center Phase 3 controlled study comparing the hemostatic efficacy of Evicel to standard-of-care in retroperitoneal or intra-abdominal surgery in 135 patients. This clinical trial represents the third pivotal study performed with EVICEL and meets the requirements necessary for a general hemostasis indication. The first subject was randomized on February 28, 2006 and the last subject completed the study on December 27, 2006.
"With the expected approval of this sBLA, OMRIX will have the only fibrin sealant in the US with a General Hemostasis indication in surgery," stated Robert Taub, President and Chief Executive Officer of OMRIX Biopharmaceuticals, Inc. "Our investment to complete the development process with our partner, ETHICON, is a testament to our long-term commitment to bring safe and efficacious active hemostats to the market. When approved, this expanded indication will allow our marketing partner to exploit the full potential of this product."
About Evicel (Liquid Fibrin Sealant)
Evicel has the advantage of its ease of use, immediate availability to the surgeon and in its bovine-free formulation. It provides for important hemostasis support when conventional surgical techniques prove to be inefficient, ineffective or impractical.
About OMRIX Biopharmaceuticals, Inc.
OMRIX, a commercial-stage biopharmaceutical company, develops and markets innovative biosurgical and antibody-based products, utilizing its proprietary protein purification technology and manufacturing know-how. As part of its business strategy, OMRIX commercializes certain biosurgical products through collaborations with companies whose marketing and sales expertise are a complement to OMRIX's own areas of specialty. OMRIX' novel and easy-to-use Fibrin Patch, a biological-device convergence product candidate, addresses unmet medical needs. 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 prospectus as filed with the Securities and Exchange Commission on December 15, 2006 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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