Positive Opinion From Committee For Medicinal Products For Human Use (CHMP) For Evicel™ Liquid Fibrin Sealant (Human)

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Blood / Hematology
Article Date: 28 Jul 2008 - 3:00 PDT

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OMRIX Biopharmaceuticals, Inc. ("Omrix" or the "Company") (NASDAQ: OMRI), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, announced today that it has received a positive opinion 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 quality, safety and efficacy. The CHMP's positive opinion for Evicel will now be forwarded to the European Commission for marketing authorization, which is expected by the end of the third quarter of 2008 (3Q08). The CHMP's opinion also stated that the approved indication for EVICEL would read as follows, "Evicel is used as supportive treatment in surgery where standard surgical techniques are insufficient, 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 general hemostasis in surgery indication.

Upon its anticipated approval, EVICEL will be licensed for marketing in the 27 countries of the European Union, or EU. Per the terms of Omrix and ETHICON's supply and distribution agreement, ETHICON has the marketing rights for the EU.

About EVICEL

EVICEL™ is an all-human, plasma-derived fibrin sealant currently indicated in the US as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques is ineffective or impractical. It does not contain 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 liquid and requires less than one minute preparation time after thawing.

About Omrix Biopharmaceuticals, Inc.

Omrix is a fully integrated biopharmaceutical company that develops, manufactures and markets 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. The Company's passive immunotherapy product line includes antibody-rich products and product candidates for the treatment of immune deficiencies, infectious diseases and potential biodefense applications. For more information, please visit http://www.omrix.com.

Safe Harbor Statement

This news 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 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 forward-looking statement to reflect circumstances or events after the date of this news release.

Omrix Biopharmaceuticals, Inc.