Lu Rahman looks at the drug repurposing market. How attractive a proposition is it financially?
More than ever the world is watching drug development and is aware of the time it takes to get a drug to market. The 10-15 years that this can involve is costly, so unsurprisingly, drug repurposing has become a credible and core aspect of the drug development process. Identifying new therapeutics from existing drugs is an appealing proposition for an industry where the average spend on taking a drug from research to shelf is $1.3 billion.1 Of course, the cost varies according to disease type – cancer having the highest development costs.
Repurposing drugs has several benefits for drug companies – a shortened timeline means reduced discovery and development costs plus potentially decreased financials associated with the safety, pharmacokinetics and toxicology of the product. In a sector where costs are so high, finding new ways to make money out of products, particularly ones for which you own the IP, is appealing. The prospect of making savings and efficiencies explains why an industry has been created out of finding new indications for de-risked compounds or biologics.
Developing a drug involves considerable investment. It’s estimated that over $4 billion a year is spent on drug candidates that may prove non-viable.2 It stands to reason then that at whatever stage a drug has passed safety approvals, repurposing it could be financially beneficial.
According to Market Watch, the global drug repurposing market is projected to grow from $24,560 million this year (2020) to $25,330 million by 2026. The sector has found particular strength where rare or neglected diseases are concerned. The World Health Organization estimates that there are between 5000 and 8000 rare diseases globally so meeting these needs could prove profitable.
As we have seen with the COVID-19 pandemic, there are times when the world cannot wait for lengthy drug development times giving technology a key role to play. And while the hunt for a vaccine continues, looking at existing drugs to treat this virus is a logical step.
In a short space of time AI has become a valuable tool in drug discovery and development helping to identify biological entities for target identification and validation and fast-tracking the process even further. The current pandemic has highlighted not only the benefits repurposing but also of incorporating machine learning in the process.
Earlier this year Pharnext and the University Hospital Institute (UHI) Méditerranée Infection teamed up to evaluate repurposed drugs for potential use against COVID-19. This biopharmaceutical company is developing innovative drug combinations based on big genomic data and artificial intelligence, and in a joint effort with the UHI Méditerranée Infection, is researching potential drug candidates for fighting the COVID-19 virus.
The activities focus on rapidly testing in vitro a number of already approved drugs that were previously identified by Pharnext as potential candidates for fighting COVID-19 using its PLEOTHERAPYTM AI platform. The testing also includes several high priority drug combination candidates, also identified by Pharnext using its technology.
One of the most prominent repurposed drugs of late has to be dexamethasone. Earlier this year, the RECOVERY (Randomised Evaluation of COVid-19 thERapY) trial in the UK was established as a randomised clinical trial to test potential treatments for COVID-19, including low-dose dexamethasone (a steroid treatment). Over 11,500 patients enrolled from over 175 NHS hospitals in the UK.
It was found that dexamethasone reduced deaths by one-third in ventilated patients and by one fifth in other patients receiving oxygen. There was no benefit among those patients who did not require respiratory support. Based on these results, one death would be prevented by treatment of around eight ventilated patients or around 25 patients requiring oxygen alone.3 The fact that dexamethasone is cheap and widely available, makes this a real success story.
Other recent examples also include the findings that a PARP inhibitor, currently used to treat breast and ovarian cancer, may be useful in treating children with high-risk neuroblastoma. Meanwhile, a research programme at Edinburgh University not only discovered what has been described as a ‘Holy Grail’ molecular target to protect nerves from damage in multiple sclerosis (MS) but also suggested that a common diabetes drug could help enhance this new-found natural mechanism – and prevent disability progression in the neurological condition.
Dr Don Mahad, Lead Author and Senior Clinical Lecturer at the University of Edinburgh, said: “Disability in MS is caused by a loss of nerve fibres following damage to the myelin that protects them. Although our understanding of MS has vastly improved over the last two decades, new therapies still do not protect nerve fibres. Such protection is the Holy Grail in MS treatment – not only for the relapsing form of MS, which has various options available, but for progressive forms too, where treatment continues to lag behind.
“Our discovery shows that nerves respond to myelin damage by increasing the movement of mitochondria (the cell powerhouse, which produces energy) to the area of damage – a response we’re calling ‘ARMD’. Remarkably, we were able to enhance ARMD and protect these vulnerable nerves using the readily available diabetes drug pioglitazone.”
Clearly opportunities exist but the drug repurposing market is not without its challenges. A recent study, Minimum costs to manufacture new treatments for COVID-194 highlighted that: “‘Repurposing’ existing drugs to treat COVID-19 is vital to reducing mortality and controlling the pandemic. Several promising drugs have been identified and are in various stages of clinical trials globally” However, the authors note that: “ If efficacy of these drugs is demonstrated, rapid, mass availability at an affordable cost would be essential to ensuring equity and access especially amongst low- and middle-income economies”. While the development costs may be lowered in the race to find new uses for old drugs, the question exists of how much profit can be gained from these products? While a drug may present a new and patentable new use, this does not guarantee its developer or manufacturer can charge more money for that new indication.
So while drug repurposing may be a less risky proposition, it is also not without its challenges.
Volume 21, Issue 4 – Fall 2020