Most of us take for granted the ability to fight infections that, less than a century ago, could have caused severe illness, disfigurement or death. Before the discovery of antibiotics, anything that could lead to an infection – from surgery of any kind to a simple paper cut – could be fatal. If I were writing this column about the Evolving World of Pharma in 1928, I would certainly be writing about Alexander Fleming and his discovery of penicillin. Instead, we face a scenario today that no-one of that time would have imagined.
The world is facing a healthcare crisis in the form of antimicrobial resistance (AMR). As stated by the World Health Organization (WHO), “New resistance mechanisms are emerging and spreading globally, threatening our ability to treat common infectious diseases, resulting in prolonged illness, disability, and death.”
But why are we in this situation?
Why has science not kept up with the demand for novel antibiotics?
A big part of the problem, according to Peter Jackson, Executive Director of the AMR Centre is that, over the past 30 years, investment in antibiotic R&D has dropped below the critical level needed to support a sustainable pipeline that can stay on top of emerging superbugs.
Modern technologies such as artificial intelligence (AI) have been widely lauded as providing a potential solution to the high costs of drug development. For example, as we saw earlier this year in ‘AI is the breakthrough disruptor we’ve been waiting for’, AI is expected to make the hunt for new drugs quicker, cheaper and more effective. However, as more and more pharma giants abandon their antibiotic programs, we have to understand that, for many, the business model in antibiotics is too difficult. The market simply doesn’t provide a return on the investment required. Other therapeutic areas are ‘easier’ and more profitable.
With the realization that this is a crucial part of the problem underlying the dwindling supply of effective antibiotics, policy makers have started to take action. For example, in 2018, the UK government launched a £10 million research competition to encourage the development of novel approaches to combating AMR. Then in the USA earlier this year, the Re-Valuing Antimicrobial Products (REVAMP) Act was considered by the US House of Representatives. Under REVAMP, if a company were to have a novel antibiotic approved, that company could receive 12 months of additional market exclusivity that could be transferred to another high-value drug – potentially worth billions of dollars – to recoup their investment in antimicrobial development. REVAMP might not have been the perfect answer, and there are probably many good reasons that it was ultimately rejected by US politicians. However, the UK government’s competition and REVAMP were both – I think – brilliant ideas for incentivizing the industry. I hope that more ideas like these will be proposed and discussed.
At the time of writing this article, the list of new molecular entities (NMEs) approved by the FDA during 2019 numbers 41. Alongside new formulations of lefamulin (an existing treatment for community-acquired bacterial pneumonia) and triclabendazole (an existing treatment for fascioliasis), there is just one novel antibiotic compound – Pretomanid.
Pretomanid was approved by the FDA this year for the treatment of drug-resistant tuberculosis (TB). This would seem to be a huge step forward in addressing AMR, and I’m sure...
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