Investment in later stage clinical development is needed to back up recent improvements in the discovery of new antibiotics, and to ensure the use of novel products is managed to maintain their effectiveness
Alarm over the rise of antimicrobial resistance has prompted an increase in early stage research and led to the discovery of a number of new antibiotics, but for the pharmaceutical industry public investment overall remains at “concerning levels”, and more money needs to be invested in late stage R&D.
Low levels of investment for later and more costly stages of clinical development may mean that many promising early-stage compounds will never reach patients. Governments need to put in place new mechanisms and incentives for antibiotic development.
In a report published today, the AMR Industry Alliance, representing companies responsible for one third of the global antibiotics supply, calls for governments in Europe and beyond, to step in and compensate for the R&D funding deficit.
According to the report, the existing funding cannot cover R&D costs for advanced clinical trials for all the promising compounds in companies’ pre-clinical pipeline. “Policy action is needed to ensure these compounds reach patients,” the report says.
In 2018 alone, companies in the alliance invested $1.6 billion in AMR-relevant R&D, while the public sector is spending roughly $500 million annually.
Thomas Cueni, chair of the alliance, who also is director general of the International Federation of Pharmaceutical Manufacturers, said the current levels of funding are “likely insufficient to sustain a viable pipeline.”
A large majority of companies surveyed for the Alliance’s report said they are likely to decrease investments in AMR “if no new incentives were established and commercial models remained the same.”
Companies are looking for new reimbursement mechanisms and incentives to address the market failure which means that new antibiotics should be used as little as possible, to preserve their effectiveness. The UK currently is planning a trial of market entry awards, under which companies would receive a lump sum payment when a new antibiotic is approved, but have responsibility for stewardship of the product, to maintain its effectiveness for as long as possible.
In the EU, 33,000 people die each year due to infections caused by resistant bacteria.
The European Commission has made AMR R&D funding available from its Horizon research and innovation programme and established a research prize for the better use of antibiotics. At the same time, the commission monitors national AMR plans in all member states.