OMRIX Biopharmaceuticals Receives Food and Drug Administration (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 thrombin: see blood clotting. Approved by FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. NEW YORK New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of -- OMRIX Biopharmaceuticals, Inc. ("OMRIX" or "The Company") (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : OMRI), 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 BLA abbr. Bachelor of Liberal Arts , to market its thrombin stand alone product, or Evithrom*, with a general hemostasis hemostasis /he·mo·sta·sis/ (he?mo-sta´sis) (he-mos´tah-sis) 1. the arrest of bleeding by the physiological properties of vasoconstriction and coagulation or by surgical means. 2. 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 absorbable gelatin sponge, n brand name: Gelfoam; drug class: hemostatic; action: absorbs blood and provides area for clot formation; uses: hemostasis during and following surgery. such as SURGIFLO* Hemostatic hemostatic /he·mo·stat·ic/ (he?mo-stat´ik) 1. causing hemostasis, or an agent that so acts. 2. due to or characterized by stasis of the blood. he·mo·stat·ic adj. 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 hemostats Surgery A hand-held surgical instrument with flattened opposing surfaces used to occlude blood vessels for hemostasis 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 fibrin: see blood clotting. patch." 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 im·mu·no·gen·ic adj. Producing an immune response. immunogenic producing immunity; evoking an immune response. 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 anaphylactic /ana·phy·lac·tic/ (an?ah-fi-lak´tik) pertaining to anaphylaxis. anaphylactic (an´ 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 Management's discussion and analysis (MD&A) A report from management to shareholders that accompanies the firm's financial statements in the annual report. It explains the period's financial results and enables management to discuss topics that may not be apparent in the financial 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. |
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