The value of drug repositioning in the current pharmaceutical market.

Abstract

Drug repositioning is the process of developing new indications for existing drugs or biologics. Increasing interest in drug repositioning has occurred due to sustained high failure rates and costs involved in attempts to bring new drugs to market. It has been estimated that it may cost more than USD 800 million to develop a new drug de novo. In addition, due to regulatory requirements regarding safety, efficacy and quality, the time required to develop a new drug de novo has been estimated to be 10 to 17 years. De novo drug discovery has failed to efficiently supply pharmaceutical company pipelines. A rational approach to drug repositioning may include a cross-disciplinary focus on the elucidation of the mechanisms of disease, allowing matching of disease pathways with appropriately targeted therapeutic agents. Repurposed drugs or biologics have the advantage of decreased development costs and decreased time to launch due to previously collected pharmacokinetic, toxicology and safety data. For these reasons, repurposing should be a primary strategy in drug discovery for every broadly focused, research-based pharmaceutical company.