Repurposed drugs move through late-stage trials at up to 90% lower cost

Universities and hospitals are repurposing existing drugs through late-stage trials with funded costs up to 90% lower than those in the pharmaceutical industry. This “hidden” research system, which operates outside the patent system, has huge potential to regularly provide society with affordable treatments.

Examples include using a cancer drug to treat a leading cause of blindness, changing a drug from treating breast cancer to preventing it, and using an old anti-inflammatory drug to treat COVID.

The new research led by King’s College London and published in the Cambridge Law Journal explores the parallel drug innovation system operating outside pharmaceutical companies.

The research shows that hospitals and universities are conducting substantial numbers of late-stage clinical trials funded at less than 10% of pharmaceutical companies’ reported costs.

This is partly because universities and hospitals are able to carry out these trials with fewer resources than industry.

In drug research and development, there are three main barriers to innovation: expertise, risk and capital. These barriers are high for organizations that develop new drugs. However, the barriers are lower when repurposing generic drugs.

The expertise required when repurposing drugs is lower because the drug is well studied and already manufactured, investigators select projects based on their expertise, and the trials are approved by grant and ethics bodies. Risk is lower because no organization’s financial viability depends on the authorization and sales of the drug.

The research also explores how clinicians and scientists have different motivations for repurposing generic drugs than the incentives the patent system offers. These include helping patients recover more quickly and publishing studies to advance their careers.

Dr. Johnathon Liddicoat, reader in law at King’s College London, said, “This alternative research system offers enormous potential to help patients at a fraction of the cost, and governments around the world are starting programs to formally recognize the research in the system. The drugs are already cheap because they are generic, and the programs will ensure patients have access.”

The process of finding new uses for already authorized drugs is commonly known as “repurposing.” Early in a drug’s life cycle, companies are interested in repurposing, and recent data indicates that, on average, they obtain regulatory authorizations for 32 new uses annually.

These approvals permit the drugs to be marketed for those new uses in addition to the original use. However, once generic drugs enter the market, companies lose interest in repurposing because of competition. Yet it is also at this moment that the new system flourishes, with hospitals and universities using cheap, generic versions of the drugs in their research.

Who’s behind this story?

Sadie Harley

BSc Life Sciences & Ecology. Microbiology lab background with pharmaceutical news experience in oil, gas, and renewable industries.

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Robert Egan

Bachelor’s in mathematical biology, Master’s in creative writing. Well-traveled with unique perspectives on science and language.

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