“Repurposing” medicines: A case for low- and middle-income countries with developing healthcare systems

Abstract

Medicine developers are looking to medicine repositioning (also referred to in this chapter as as ‘repurposing’) as a cost effective, reduced-risk strategy for developing new medicines. Repurposing refers to the concept or process of taking a medicine developed for one indication and applying it to another. This chapter discusses whether low and middle countries could potentially benefit from such repurposing. In particular, the chapter investigates the possibility of developing new uses for generic and/or failed medicines. The chapter concentrates on repurposing anti-infective medicines, rather than those for chronic conditions. There is a relative paucity of anti-infectives in FDA withdrawn clinicial trials . Repurposing new uses for medicines withdrawn from clinical trials would seem very risky indeed. Furthermore, repurposing a new indication for some already-approved generics is possible but has other challenges. If a repurposed generic medicine works in a new disease indication using its existing formulation and doses, it may be controversial for the company to charge a higher price for the new disease indication, while patients continue to pay a lower price for the same medicine for the old disease indication. Typically, what is needed is a sufficiently large number of patients to make a drug profitable so, in this regard, repurposing medicines for ‘neglected’ or even more common diseases in LMICs are clearly a challenge where the market may exists but patients are not insulated from the cost of medicines. Successful repurposing of medicines for LMICs will not happen without policy alignment and synergies of expertise that are created through collaborations between academia and industry. Unlike use of failed medicines, the investigation of new targets and mechanisms for existing drugs with known safety profiles may add value to the business model and bring more therapies to market for patients in LMICs.