OMRIX Biopharmaceuticals Announces U.S. Phase III Clinical Trial for Intravenous Immunoglobulin (IVIG) in Subjects with Primary Immune Deficiency Diseases.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 -- Supports Future Growth of Hyperimmune hyperimmune /hy·per·im·mune/ (hi?per-i-mun´) possessing very large quantities of specific antibodies in the serum. hyperimmune possessing very large quantities of specific antibodies in the serum. Business and Strategy to Geographically Expand Immunoglobulin Products 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, recently announced that pursuant to a supply and distribution agreement dated August 10, 2006, FFF (FreeForm Fabrication) See rapid manufacturing and 3D printing. Enterprises, Inc. ("FFF") will commence a United States Phase III open label, single arm, multi-center clinical trial for treatment of primary immune deficiency immune deficiency n. See immunodeficiency. with Omr-IgG-am(TM), the Company's intravenous immunoglobulin ("IVIG IVIG Intravenous immunoglobulin, see there ") currently marketed outside of the U.S. "Our agreement with FFF and the subsequent Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the for Omr-IgG-am in the US represents a stepping stone for OMRIX as we continue to develop our passive immunotherapy business and sets the foundation for all future hyperimmune regulatory processes," stated Robert Taub, OMRIX's President and Chief Executive Officer. "Our IVIG product, Omr-IgG-am, is currently approved and marketed in one country outside of the U.S. Gaining US approval would support our strategy to geographically expand our immunoglobulin (IG) products." Under the terms of the agreement FFF has agreed to take over sponsorship of the active Investigational New Drug application for Omr-IgG-am. Upon 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. approval of the biologics license application to market Omr-IgG-am in the United States, FFF will become the exclusive marketing agent and authorized distributor for Omr-IgG-am in the United States for five years. About IVIG IVIG is an antibody-based product that contains the spectrum of antibodies normally present in healthy adult human plasma. It can be used to provide ongoing treatment for primary and secondary immune deficiencies as well as replacement therapy by providing a broad selection of antibodies that mimic a healthy immune system. About Omr-IgG-am Omr-IgG-am is a highly purified IVIG solution containing over 95% IgG and only small traces of IgA. The physiological distribution of the IgG subclass In programming, to add custom processing to an existing function or subroutine by hooking into the routine at a predefined point and adding additional lines of code. subclass - derived class is maintained due to a highly effective production process. Two virus removal and/or inactivation inactivation /in·ac·ti·va·tion/ (in-ak?ti-va´shun) the destruction of biological activity, as of a virus, by the action of heat or other agent. steps ensure safety without altering efficiency. Omr-IgG -am does not contain sucrose or albumin. Omr-IgG-am 5% IV is available in 2.5gr (50ml), 5gr (100ml) and 10gr (200ml) intravenous solutions and is a ready-to-use liquid preparation that can be stored at room temperature. About OMRIX Biopharmaceuticals, Inc. OMRIX, a commercial-stage biopharmaceutical company, develops and markets innovative biosurgical and passive immunotherapy products, utilizing its proprietary protein purification technology and manufacturing know-how. As part of its business strategy, OMRIX commercializes certain of its biosurgical products through collaborations with companies whose marketing and sales expertise are a complement to OMRIX's own areas of specialty. OMRIX's novel and easy-to-use biological-device convergence products address 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 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 Prospectus as filed with the Securities and Exchange Commission on April 21, 2006. 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. OMRI-G |
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