OMRIX Biopharmaceuticals Receives FDA Approval for Thrombin Stand Alone, EVITHROM* Thrombin, Topical (Human), with General Hemostasis in Surgery Indication
First and Only Bovine-Free Stand-Alone Topical Thrombin Approved by FDA
NEW YORK -- OMRIX Biopharmaceuticals, a commercial-stage biopharmaceutical company that develops and markets biosurgical and passive immunotherapy products, announced today that on August 27, 2007, the U.S. Food and Drug Administration, or FDA, approved its Biologics License Application, or BLA, to market its thrombin stand alone product, or Evithrom*, with a general hemostasis in surgery indication.
EVITHROM* was developed in collaboration with Johnson & Johnson Wound Management, a division of ETHICON, INC., a Johnson & Johnson Company. ETHICON will market EVITHROM* as both a stand-alone thrombin and in conjunction with an absorbable gelatin sponge such as SURGIFLO* Hemostatic Matrix with FlexTip. Johnson & Johnson Wound Management plans to make the product commercially available in the United States in Q4 2007.
“The offering of thrombin stand alone and thrombin in conjunction with an absorbable gelatin sponge such SURGIFLO are two additional building blocks to the one-stop-shop of biological hemostats Omrix and Ethicon are forming, stated Robert Taub, President and Chief Executive Officer of OMRIX Biopharmaceuticals, Inc. “This innovative concept of providing a one-stop-shop of biological hemostats will be getting closer to fruition once Evicel*, our fibrin sealant, will be approved with a general hemostasis indication. We anticipate this approval in January 2008 and the one-stop-shop concept will be further supplemented with the subsequent expected approval of our fibrin patch.â€
About EVITHROM* Thrombin Topical (Human)
EVITHROM* is a manufactured human plasma-derived alternative to the use of bovine protein-based thrombin, which is currently used to control bleeding in approximately one million surgical procedures each year in the United States. Exposure to bovine-derived thrombin has been shown to produce an immunogenic response in some patients. In patients who develop antibodies to bovine-derived thrombin there is an increased risk for complications including severe bleeding, thrombosis and anaphylactic shock. In addition, patients who develop antibodies to bovine-derived thrombin preparations are at a significantly higher risk of immunogenic response when re-exposed to these products.
EVITHROM* is shipped frozen and can be stored in the freezer for up to two years. EVITHROM* does not need to be reconstituted with a needle before use, as is the case with the current standard of care.
EVITHROM* is contraindicated in individuals known to have anaphylactic or severe systemic reaction to human blood products. As with all plasma-derived products, the risk of transmitting infectious agents cannot be completely eliminated. EVITHROM* should not be injected directly into the circulatory system and should not be used for the treatment of severe or brisk arterial bleeding.
*Trademark
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.