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Antibiotics

Clinical pipeline of new antibiotics remains small, global report highlights

The Access to Medicine Foundation’s report says, with such a small pipeline of antibiotics for priority infections, the need for access and stewardship plans is “more acute”.

Antibiotic blister packs

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Currently, 32 antibiotics are in late-stage clinical development

A quarter (25%) of clinical-stage antibiotics are supported by plans to ensure better access and good stewardship after launch compared to 7% in 2018, but the clinical pipeline of antibiotics for priority infections remains small, according to a report published by the Access to Medicine Foundation.

The 2020 ‘antimicrobial resistance benchmark’ report evaluates how the 30 most active pharmaceutical companies in antimicrobial research and development (R&D) across the world are limiting drug resistance.

It shows that currently 32 antibiotics are in late-stage clinical development, of which 8 have plans in place to accelerate access to antibiotics and stewardship after launch.

However, it adds that, with such a small pipeline, the need for access and stewardship plans is “more acute”, particularly as the 17 candidates currently without plans include antibiotics needed to “combat superbugs, such as Clostridium difficile, Neisseria gonorrhoeae and MRSA”.

According to the report, three pharmaceutical companies — GSK, Entasis and Cipla — are the current leaders in the field, with GSK having the biggest pipeline and developing the bulk of new vaccines. However, since 2018 two major pharmaceutical companies, Novartis and Sanofi, have retreated from new R&D into antibiotics. 

“The low profitability of antibiotics is leaving the world precariously reliant on just a handful of pharmaceutical companies to develop and manufacture them,” the report says. 

The report adds that many antibiotics remain unavailable in low- and middle-income countries.

“Such ‘access gaps’ can lead people to misuse antibiotics,” said Jayasree Iyer, executive director of the Access to Medicine Foundation.

“Pharma companies must address access to protect the effectiveness of their medicines.”

Philip Howard, a consultant antimicrobial pharmacist at Leeds Teaching Hospitals NHS Trust, said the benchmark report was a “timely reminder” that too little was happening to improve the antibiotic pipeline.

“Worryingly, older antibiotics [that are still clinically useful] are not being marketed to low- and middle-income countries, and the newer agents are often unaffordable.

“In addition, two start-up companies [that were developing new antibiotic products] filed for bankruptcy, with one being bought for a fraction of the funding they received,” he said.  

But Howard said that the Department of Health and Social Care was working with the National Institute for Health and Care Excellence to establish a model for funding new antibiotics. 

“They have committed £20m for two antibiotics in a pilot. This will move from paying for individual vials to a regular payment structure to [ensure that] the antibiotic is available, so [it would work] a bit like the fire service — you don’t want to use it [on a regular basis], but are happy to pay your taxes to have them available whenever they are needed.” 

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2020.20207592

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