Product AGI-350
AGI-350 is a novel presentation of an existing marketed drug which AGI is developing to treat a significant unmet medical need in the critical care setting. AGI-350 is specifically formulated to allow effective and efficient delivery of the drug directly to the lung, to treat a life-threatening, lung-related, condition. There are currently no formulations of the drug available for inhaled delivery, and AGI believes that AGI-350 will represent the first such approved use of the drug to treat the target critical care population.
AGI-350 has the potential to significantly improve therapy for the target patient population compared to current standard of care and represents a highly attractive market opportunity. We expect that AGI-350 will qualify for Orphan Drug status, which, if granted, should provide 10 years of market exclusivity in Europe, Japan and other selected markets, and 7 years exclusivity in the US, following regulatory approval.