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news.MonoSol Rx and Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, have entered into an exclusive licensing agreement under which Strativa has acquired the US commercialization rights to the thin film formulation of ondansetron from MonoSol Rx.
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Under terms of the agreement, MonoSol Rx will receive milestone payments prior to commercial launch and sales-based milestones that could total $23.5 million as well as payments for purchase of product supply and royalties on net sales.
Based on the results of a recently completed pilot bio-equivalency study, MonoSol Rx is initiating pivotal trials immediately to enable application for drug approval in the US. Subject to favorable results, it is anticipated that Strativa could file an new drug application with the appropriate regulatory authorities within the next 12 months.
The ondansetron thin film formulation is a new oral formulation in development for the prevention of chemotherapy-induced nausea and vomiting, prevention of nausea and vomiting associated with radiotherapy, and post-operative nausea and vomiting.