A life science industry report representing 36 key businesses and organisations concerned about the growing impact of anti-microbial resistance (AMR) on human health is calling on the UK government to help address a £500m research funding gap and take action to counter the chronic shortage of scientists working on new antibiotics.
The authors, Bionow, LifeArc, OneNucleus, and The AMR Centre, highlight the issues in a wide-ranging new report – New Drugs for Anti-Microbial Resistance: Maximising the AMR Opportunity for the UK.
The Government’s five-year AMR strategy (2013-2018) focused on creating a supply of safe and effective antimicrobial drugs. It is due to be revamped in the New Year and the group says the new strategy needs to recognise the reality that small businesses are now shouldering the research burden. Along with greater funding support, it says further market incentives are urgently required.
The report also calls for an effective work group to be formed across SMEs, pharmaceutical companies, government departments, investors, philanthropy and academia to build sustainable funding initiatives across the AMR drug development pipeline, using focused government interventions to maximise private sector leverage.
Dr Peter Jackson, executive director of the AMR Centre, based at Alderley Park in Cheshire, said: “There’s some great new science and technologies emerging from academic research to begin addressing this grave threat to our society. Crucially, many of these are being held back by a shortage of funding to the biotech companies engaged in the testing stages of their development as new treatments.
“We have looked at the strengths and weaknesses of the UK’s current position, including mapping this pipeline of new drugs to treat AMR. We estimate there are fewer than 150 scientists working on new antibiotics in the UK – this for a problem that threatens to undermine all of modern medicine. SMEs are at the forefront of current activity in the UK, with 23 companies progressing 47 new drug programs. Whilst this shows exciting potential, the UK’s current translational capability is under invested, and not yet adequately powered to provide a sustainable pipeline of life-saving medicines to treat AMR.
“Alongside industry, the Government has a key role to catalyse private investment into the SMEs in the sector. It can provide cornerstone funding for investment in R&D and introduce new market payment schemes that properly recognise the value that a new pipeline of antibiotics will bring for patients suffering from life-threatening infections caused by drug-resistant superbugs.”
The report says the AMR pipeline has the potential to make a global contribution but is significantly under-invested. According to Companies House financial records, SMEs have less than £50m cash reserves on their balance sheets, with one company having more than half of this total. Eleven companies have significantly less than £1m in cash, and most companies report having less than 12 months of cash available to support programs.
All reporting companies stated that existing programs have been delayed and new projects not started due to the lack of funding. Importantly, companies report that in some cases they do not have sufficient cash reserves to meet matched funding commitments, preventing or delaying successful applications for international AMR grant funding initiatives. Companies also report the lack of availability of skilled and experienced staff is an issue, particularly in microbiology.
Along with the SMEs, the UK industrial AMR therapeutics landscape comprises two major pharma companies, the AMR Centre, the Medicines Discovery Catapult, the drug discovery company and contract research organisation Evotec, a number of academic-based industrial ‘accelerators’ and major charities such as the Wellcome Trust and LifeArc. GlaxoSmithKline is the UK’s only major pharma company with antibiotic products on the market. Their R&D activities are based in the USA, and the company has two new products in clinical development for TB and Gonorrhoea. AstraZeneca has two new antibody therapeutics in clinical development through its US-based Medimmune R&D centre.
Dr Jackson said only 16 of programs currently underway in the UK target World Health Organisation “critical priority” Gram-negative pathogens, such as drug-resistant E. coli, whilst a further 16 are focused on Gram-positive pathogens, such as MRSA and C. difficile. A further 15 programs are early stage platform technologies with the potential to treat both types of pathogen.
The group evaluated the UK’s AMR pipeline and estimate the likely funding requirement for the next five years to progress the existing programs to their next major developmental milestones. Taking into account the projected scientific success rates and costs to develop new drugs, it estimates that at least £200m will be required to progress the current UK pipeline over the next five years, substantially more than the £47m that companies currently have at their disposal on their balance sheets.
Furthermore, to capitalise on our underpinning scientific strengths and deliver an expanded UK pipeline, potentially trebling the number of SMEs and pre-clinical projects, delivering five new clinical assets and at least one new Gram-negative drug for patients, would require investment of over £500m from 2019 to 2023.
This report recommends three actions:
- An effective work group should be formed across SMEs, pharmaceutical companies, government departments, investors, philanthropy and academia to build funding initiatives across the AMR drug development pipeline, using focused government interventions to maximise private sector leverage.
- The Government’s next five-year AMR strategy should acknowledge the importance of SMEs as well as the strengths and gaps in the UK’s AMR drug development capability and recommend cross-departmental support for focused investments in AMR.
- The Government should make rapid progress in implementing market reward mechanisms for the UK, to address the broken antibiotics reimbursement model and re-incentivising innovators and private sector finance to deliver new antibiotics for patients with life-threatening drug-resistant infections.