Although attention has been focused on the use of genetically modified bacteriophages
to fight a highly resistant infection in a young girl, the antibiotic pipeline is not just drying up…but dying. This isn’t news though; in fact, we’ve known about it for a while. It’s been decades since a novel antibiotic hit the market and, as antimicrobial resistance surges, the treatment options are becoming increasingly scarce.
Recent attention has been focused on the bankruptcy of the biotech company Achaogen. It’s likely you haven’t even heard of them, let alone know that they filed for bankruptcy a few weeks ago. The reason this bankruptcy is worrisome is that Achaogen’s antibiotic, plazomicin, was actually approved
by the US Food and Drug Administration in June 2018 and, despite its efficacy against multidrug-resistant Enterobacteriaceae, it failed to keep the company afloat. The cost-prohibitive nature of antimicrobial research and development is all but ensuring that the pipeline for development is drying up. Not only does the Achaogen bankruptcy highlight the costly nature of antimicrobial development, but it’s even more worrisome that a company that was solely focused on such efforts couldn’t stay in business even with the financial push and support from the National Institutes of Health, the Biomedical Advanced Research and Development Authority (BARDA), and the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) .
Pew Charitable Trusts notes
that more than 90% of antibacterial products currently in development are by small companies and of these companies, more than 60% have no other pharmaceutical products on the market, meaning they’re solely focused on antibiotics. In most cases, it’s expected that bringing a new drug to market will take 10-15 years and cost approximately $1 billion. Antimicrobial resistance expert Maryn McKenna recently wrote that
“it’s time to talk about other, more controversial enticements to get more antibiotics on the market. These so-called ‘pull’ incentives (the alternative to push) don’t pay R&D costs up front; instead, they reward R&D done well. Short version: They gift pharma companies huge wads of cash.” Within these recommendations, they noted the importance of accelerating progress in countries, but also calling on public and private donors to help invest in innovation in antimicrobials. This continued focus on encouraging research and development underscores that this problem is on a global scale. As Pew Charitable Trusts points out, “Approximately 1 in 4 drugs in the pipeline represent a novel drug class or mechanism of action. Only one is potentially active against Gram-negative ESKAPE pathogens or WHO critical threat pathogens, and around a third of the novel products are in development for C difficile.
With 2 million Americans acquiring a drug-resistant infection each year, the roadblocks to developing innovative treatment and antimicrobials are something we need to focus on. The lack of incentive for companies to invest in the development is deeply worrisome, as are the challenges that those small companies who do go the road less traveled face. As the news constantly underscores the spread of these resistant infections and challenges of antimicrobial stewardship, we must also discuss how the perilous the road to antimicrobial development has become.