The UK Government has highlighted the need to improve the commercial viability of new antibiotics as part of its strategy to address the growing problem of antimicrobial resistance.
The five-year strategy, which is based on recommendations made by chief medical officer Dame Sally Davies in March, acknowledged that the return on investment for companies working in antibiotic research is very low, and there should be both an improvement in the regulatory pathway for these medicines as well as incentives for companies working in the area.
The threat of antimicrobial resistance is one of the biggest healthcare challenges the world currently faces, with many infections now developing that cannot be treated.
Despite this, research by life sciences companies into new treatments is hampered by several factors, including the difficulty of finding new agents; the limited duration a new drug can be use; and concerns about the regulatory environment.
This has led to such initiatives as the New Drugs for Bad Bugs (ND4BB) programme, involving several pharma companies working together to research new antibiotics as part of the EU-backed Innovative Medicines Initiative, as well as the US government funding research from GlaxoSmithKline.
The strategy published by the Department of Health covers the UK’s role in this area, and was broadly welcomed by the country’s industry.
Stephen Whitehead, chief executive of the Association of the British Pharmaceutical Industry (ABPI), commented that the strategy “rightly acknowledges that the commercial environment for antibiotic development needs to be addressed”.
He added: “It is vitally important that a realistic plan of action is agreed so that all partners can work together to deliver upon the strategic objectives that are outlined within the strategy.”
Steve Bates, Whitehead’s counterpart at UK biotech trade body the BioIndustry Association (BIA), also saw the plans as a move in the right direction, but said the type of incentives needed to be appropriate.
“We need incentives for pharmaceutical companies to develop drugs that will only be used infrequently and sparingly rather than paid for every pill used,” he said.
UK companies trying to develop new antibiotic treatments include Redx Pharma, which has received backing from the Government’s regional growth fund to create an anti-infectives subsidiary to be based at AstraZeneca’s (AZ) research site in Cheshire, UK after AZ moves the bulk of its R&D operations to Cambridge.
“The World Health Organization (WHO) has launched a major initiative to urge governments and the pharmaceutical industry to promote new R&D efforts to develop new anti-infective medicines,” said Dr Neil Murray, CEO of Redx.
“Redx is playing an active part in this effort and we welcome the fact our own government has not only recognised the seriousness of the situation, but is seeking to provide leadership on the issue.”
AZ, which is one of the companies involved in the IMI project, was also positive about the strategy, with Catriona McMahon, director, UK medical and healthcare affairs, telling PMLiVE that it recognised the problem of antimicrobial resistance as a “global issue”.
McMahon also agreed that greater research incentives were needed, suggested this could come in several forms, including an option to share the risk of investment; a simpler R&D pathway; or appropriate pricing for any drug that reaches market.
“In truth, there’s probably no one simple solution,” she said, acknowledging that any change would be driven by a combination of these options.
In addition to its plans to improve research into new medicines, the antimicrobial resistance strategy includes other key areas to improve, including the prevention and management infections through better hygiene and monitoring of bacteria.
There should also be better education and training around the prescribing of antibiotics to reduce inappropriate usage, while better data on the resistance of bugs needs to be collected to find the most resistant bacteria.
To support all these efforts, the UK will provide funding of up to £4m to set up a new National Institute of Health Research (NIHR) Health Protection Research Unit to focus on antimicrobial resistance strategy and healthcare associated infections.