Generic Drug Repurposing for COVID-19 and Beyond

Generic Drug Repurposing for COVID-19 and Beyond

By
Susan Athey, Rena Conti, Richard Frank, Jonathan Gruber
Institute for Health System Innovation & Policy. July
2020

The novel disease caused by the SARS-CoV-2 virus (COVID-19) is both a shock to our health and our wealth, with more than 110,000 dead in the U.S., the sharpest reduction in economic activity since the Great Depression, and (thus far) $3 trillion in federal fiscal relief. These massive costs imply that there are enormous social returns to therapeutic development that would either prevent, or treat, COVID infections effectively.

Much of the attention of U.S. policy makers has been focused on scaling up manufacturing capacity for COVID-19 vaccines. There has been less policy attention paid to the development of therapeutics. For novel therapeutics, patent protection allows for innovators to charge monopoly prices far exceeding the costs of new drug discovery, development, and manufacturing, making these markets attractive for private company investment. But the private sector has little incentive to pursue another important avenue: drugs that have already been approved to treat another disease might be repurposed to prevent or treat COVID-19.

Repurposed drugs have been successfully developed to treat a wide range of diseases, including rare genetic disorders, cancer, and infections. They can be brought to market quicker and more cheaply than new drugs, because their safety is already established and manufacturing processes are well understood. In comparison to vaccines, repurposed drugs have the advantage of having low liability risk, and they are easily accepted into routine clinical practice. Scientists have already identified over 100 candidates for repurposing drugs that might be used alone or in combination to prevent or treat COVID-19.

However, in many cases repurposed drugs do not appeal to private sector innovators and financiers in the same fashion as new therapeutics, because they often lack the opportunity for the innovator to patent the intellectual property developed thereby limiting profits. Incorporating drug repurposing into the U.S. government’s COVID-19 response would remedy this market failure.

Developing any drug to treat COVID-19 faces another challenge: identifying enough patients to successfully enroll and complete the requisite clinical trial to establish the drug’s safety and effectiveness. Reports are already emerging of shortages in the number of new patients eligible for tests of drugs aimed at treating COVID-19. This is in part because so much attention has been placed on hydroxychloroquine – despite very limited evidence supporting its’ effectiveness in treating COVID-19. These trials have limited coordination among them, using up the limited pool of available patients and therefore limiting our ability to thoughtfully investigate a broader portfolio of promising candidate.

We propose a three-part plan for U.S. leadership. The objective of this plan is to advance a low cost, high impact response to fighting COVID-19 and future pandemics. The plan is built on current public agency infrastructure, employs public-private partnerships with established academic laboratories, clinical development networks, and drug manufacturers, and will pay prizes to innovators that successfully bring repurposed drugs to market. Public agencies will fund studies aimed at identifying promising drug repurposing targets and coordinate clinical trials of promising candidates alone and in combination with new therapeutics. Government will also contract for the manufacturing of promising candidates, paying costs plus a premium to ensure sufficient capacity for the exploration of new uses without undercutting the adequacy of supply for existing uses. We estimate the total cost per therapeutic successfully developed and produced from this effort would amount to on average $200M.