OMRIX Biopharmaceuticals Announces U.S. Phase III Clinical Trial for Intravenous Immunoglobulin (IVIG) in Subjects with Primary Immune Deficiency Diseases.
OMRIX Biopharmaceuticals Inc. ("OMRIX" or "The Company") (NASDAQ: 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 Enterprises, Inc. ("FFF") will commence a United States Phase III open label, single arm, multi-center clinical trial for treatment of primary immune deficiency with Omr-IgG-am(TM), the Company's intravenous immunoglobulin ("IVIG") currently marketed outside of the U.S.
"Our agreement with FFF and the subsequent Phase III clinical trial 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 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.
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.
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 is maintained due to a highly effective production process. Two virus removal and/or inactivation 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
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