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news.Omrix Biopharmaceuticals has revealed that, in accordance with a recently signed agreement, FFF Enterprises will begin a phase III US clinical trial evaluating Omr-IgG-am for treatment of primary immune deficiency.
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Omr-IgG-am is a highly purified intravenous immunoglobulin (IVIG) solution that is currently marketed outside of the US.
Under the terms of the agreement FFF has agreed to take over sponsorship of the active investigational new drug (IND) application for Omr-IgG-am. Upon FDA approval of the biologics license application to market Omr-IgG-am in the US, FFF will become the exclusive marketing agent and authorized distributor for Omr-IgG-am in the US for five years.
“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’ president and CEO.
“Our IVIG product, Omr-IgG-am, is currently approved and marketed in one country outside of the US,” he continued. “Gaining US approval would support our strategy to geographically expand our immunoglobulin products.”