“Repurposing” Medicines: A Case for Low- and Middle-Income Countries with Developing Healthcare Systems.
Medicine developers are looking to medicine “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.
A book chapter by Warren Kaplan in Pharmaceutical Policy in Countries with Developing Healthcare Systems discusses whether low- and middle-income countries (LMICs) could potentially benefit from such repurposing. In particular, the chapter investigates the possibility of developing new uses for generic and/or failed medicines.
The author concentrates on repurposing anti-infective medicines, rather than those for chronic conditions. There is a relative paucity of anti-infectives in Food and Drug Association withdrawn clinical trials and repurposing new uses for medicines withdrawn from clinical trials would seem very risky. 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. A sufficiently large number of patients is needed to make a drug profitable, so repurposing medicines for ‘neglected’ or even more common diseases in LMICs is a challenge. The author determines that successful repurposing of medicines for LMICs will not happen without policy alignment and synergies of expertise 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.Read the Book