Commercialising drug repurposed products: what works and what doesn’t

Finding new drug repurposed opportunities is rarely a problem, but selecting the right ones is challenging and developing them to the market is in most cases a particularly difficult issue that needs to be overcome. While drug repurposing is increasingly recognised as a valuable strategy in pharmaceutical R&D, it is often associated in its ‘pure’ form with low value by the companies that need to invest in the commercialisation process. Modifications of the original drug product for its new indication can arbitrage regulatory jurisdiction, route of administration, dose, combinations with another drug or administration in specific medical contexts. Examples of each will be presented. Repurposing thrives in difficult or complex regulatory environments and withers in vanilla ones. Thus, merely taking the same existing marketed generic product for a different indication is rarely a successful strategy, but finding the ideal presentation and integrating it into medical practice in a way appropriate for the new use can be. Identifying and then focussing the development towards this new environment should be inherent in the repurposing concept from the start.