�OMRIX Biopharmaceuticals, Inc. ("Omrix" or the "Company") (NASDAQ: OMRI), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, proclaimed today that it has received a positive thought for EVICEL� Fibrin Sealant (Human) from the Committee for Medicinal Products for Human Use (CHMP). Omrix is seeking approval to market Evicel in Europe for the improvement of hemostasis in surgery.
CHMP is the scientific committee of the European Medicines Agency (EMEA) and is responsible for reviewing medicinal product applications for tone, safety and efficacy. The CHMP's electropositive opinion for Evicel will now be forwarded to the European Commission for marketing authority, which is expected by the end of the third quarter of 2008 (3Q08). The CHMP's feeling also stated that the approved indication for EVICEL would read as follows, "Evicel is used as supportive handling in operation where standard surgical techniques are deficient, for improvement of hemostasis. Evicel is also indicated as suture support for hemostasis in vascular surgery."
EVICEL is currently marketed in the US by Johnson & Johnson Wound Management, a division of ETHICON, INC., a Johnson & Johnson company, with a worldwide hemostasis in surgery reading.
Upon its anticipated approval, EVICEL will be licenced for marketing in the 27 countries of the European Union, or EU. Per the terms of Omrix and ETHICON's append and statistical distribution agreement, ETHICON has the marketing rights for the EU.
About EVICEL
EVICEL� is an all-human, plasma-derived fibrin sealer currently indicated in the US as an adjunct to haemostasis for role in patients undergoing surgery, when control of bleeding by standard surgical techniques is inefficient or airy. It does not take aprotinin, which has been associated with adverse health effects. EVICEL� is easy to use and readily available for time-sensitive needs in the operating room. The product is sold as a frozen limpid and requires less than one moment preparation time after thawing.
About Omrix Biopharmaceuticals, Inc.
Omrix is a in full integrated biopharmaceutical company that develops, manufactures and markets protein-based biosurgery and passive immunotherapy products. Omrix' biosurgery product contrast includes products and product candidates that are used for the control of bleeding, or hemostasis, and other surgical applications. The Company's inactive immunotherapy product line includes antibody-rich products and cartesian product candidates for the discourse of immune deficiencies, infectious diseases and potential biodefence applications. For more information, please visit http://www.omrix.com.
Safe Harbor Statement
This news vent contains modern statements. Forward-looking statements render the Company's current expectations or forecasts of succeeding events. Forward-looking statements include statements about the Company's expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are non historical facts. Forward-looking statements are depicted object 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 modern 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 Securities and Exchange Commission (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 SEC on March 17, 2008, 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 advanced statement to reflect circumstances or events after the date of this news release.
Omrix Biopharmaceuticals, Inc.
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