More companies join the leaders, yet progress on AMR is slow
The 2020 Antimicrobial Resistance Benchmark finds signs of improvement in how pharmaceutical companies are tackling antimicrobial resistance (AMR), particularly when it comes to stewardship. Disclosure, particularly among generic medicine manufacturers, has also improved.
More companies are taking steps to reduce the risk of overselling antibiotics and antifungal medicines to healthcare practitioners. Companies are also sharing what they know about resistance from their surveillance programmes, with Pfizer setting the pace by publicly sharing its raw data.
Environmental risk-management strategies for manufacturing go somewhat further than in 2018, with companies also publicly committing to a comprehensive list of defined discharge limits. More clinical-stage antibiotics than in 2018 are supported by plans to ensure better access and good stewardship soon after launch. However, the development of such plans remains patchy.
Good practices are overshadowed by slow pace of change
Examples of good or even best practice can be found in all areas. Nevertheless, the pace of change does not match the scale of the AMR challenge. A few companies deserve recognition for continuing to step up their efforts across multiple areas, yet others have rolled back good practice since 2018, or have taken steps to leave the market.
The R&D pipeline for priority bacteria and fungi remains small, despite rising rates of resistance, and includes few novel candidates. In most areas of R&D, the bulk of the activity is carried out by just a few companies, for example in vaccines R&D and antifungal R&D. One company, GSK, is developing almost a fifth of all projects identified. This concentration puts important candidates at risk – there are very few companies to develop them further and bring them to market, should the current asset owners withdraw from this space.
Almost all companies with antibiotics on the market are side-stepping or overlooking opportunities to improve the availability of such products in high-need countries,* as reflected by low numbers of registration filings for new products, and by a lack of efforts to supply older, still useful antibiotics to low- and middle-income countries.
External incentives effective at spurring action
Companies are more likely to take action in response to clear priorities or external incentives, such as those offered by civil society or public health agencies. For example, more than a third of R&D projects target pathogens in the highest threat category defined by WHO and CDC, and companies are sharing surveillance data and results with multi-partner, multinational programmes.
Research grants and other ‘push’ incentives for R&D have stimulated SMEs to become leaders in developing innovative antibacterial and antifungal medicines. Companies are responding differently to the lack of acquisition interest by larger companies for successful assets. For example, in October 2019, Melinta delayed the commercial launch of its antibacterial delafloxacin (Baxdela®) so additional sources of liquidity could be secured. In December 2019, it filed for bankruptcy. Achaogen filed for bankruptcy in 2019, despite launching an effective new antibiotic. Other small- and medium-sized companies in scope are currently at risk of going bankrupt. It is necessary to increase public and private investments to guarantee the global supply of any antibiotics emerging from the pipeline.
Generics companies expand their role
Leading generic medicine manufacturers continue to expand beyond their conventional role of major producers, with at least one company investing in R&D, and more companies now also taking steps such as strategies for affordability, licensing deals to improve availability, and measures to ensure reliable supplies. For example, Cipla acquired the rights to plazomycin from Achaogen, taking responsibility for making it available, including in LMICs.
*102 low- and middle-income countries where bacterial and fungal infectious diseases are endemic, and where populations are more likely to lack access to antibacterial and antifungal medicines.
The goal of the Antimicrobial Resistance Benchmark is to guide and incentivise pharmaceutical companies to do more to tackle drug-resistance. It identifies good ideas for limiting AMR and highlights where action is still required. To fairly compare the diverse companies, the Benchmark evaluated them only in those metrics that are relevant to their portfolio and pipelines, comparing them in three groups: large research-based pharmaceutical companies, generic medicine manufacturers and pharmaceutical SMEs (small- and medium-sized enterprises). Read more about the analytical framework here.