Buying Time: The AMR Action Fund and the State of Antibiotic Development in the United States 2020

Abstract

Antimicrobial resistance is a pressing global threat, but companies developing antibiotics are failing. Large pharmaceuticals recently created the AMR Action Fund, which will invest $1 billion in small antibiotic development companies. To understand the state of antibiotic development in the United States, we conducted a case study of new agents against carbapenem resistant Gram-negative bacteria. Factors contributing to market failures were slow clinical uptake of drugs despite their effectiveness and safety, relatively small numbers of target infections that are insufficient to support existing drugs economically, and an excess of recently approved and pipeline agents with redundant spectra of activity. The AMR Action Fund will provide an immediate lifeline to companies in danger of failing due to an inability to secure investment, but it will not address issues identified in the case study or fix the antibiotic development model or marketplace. The Fund buys time for reforms to salvage antibiotic development.

Analysis of the Clinical Pipeline of Treatments for Drug-Resistant Bacterial Infections: Despite Progress, More Action Is Needed

“…The discovery of new antibacterial drugs with activity against MDR bacteria is very challenging due to difficulties in designing products with suitable physicochemical properties (leading to desirable pharmacokinetics/pharmacodynamics properties) and acceptable toxicity profiles. Another major challenge is the lack of a suitable economic model that can provide long-term support for biotech and small companies developing new antibacterial agents ( 14 – 17 ). Factors underlying the lack of support include (i) the fact that antibacterial treatments are available for most bacterial infections, with most available as inexpensive generics, (ii) the typical short treatment duration of acute bacterial infections ( 18 ), (iii) the time and cost associated with traditional research and development (R&D) models, (iv) stewardship measures that—aiming at preserving new antibiotics efficacy—appropriately encourage prescribers to reserve new antibiotics and place them in the bottom of clinical guidelines as last-resort treatments, and (v) a lack of funding for phase 2 and 3 trials ( 19 ).…”

“…All these elements have led to a market environment that is only marginally, if at all, profitable for most antibacterial drug developers. For example, the highest revenue for a patent protected antimicrobial in the United States in 2018 was US$138 million for the cephalosporin ceftaroline ( 17 ). The top 10 antimicrobials by sales in the United States in 2018, which included nine antibacterial drugs and the antifungal isavuconazole, had a total revenue of US$644 million.…”

Impact of novel microbial secondary metabolites on the pharma industry

“…In 2018, the market of approved antimicrobials was around 647 million dollars only in US (Fig. 1), and it is predicted to expand at a compound annual growth rate of 3.4% (Clancy and Nguyen 2020;Carr and Stringer 2019).…”

Structural Dynamics and Perspectives of Vitamin B6 Biosynthesis Enzymes in Plasmodium: Advances and Open Questions

“…700,000 deaths annually worldwide, with an estimated increase of up to 10 million by the year 2050 ( IACG, 2019 ). Concerning the severity of this situation, a forum of over 20 world’s leading pharmaceutical companies launched the establishment of the “AMR Action Fund” in 2020, with an investment goal to bring 2-4 new drugs into the market by the year 2030 ( Clancy and Nguyen, 2020 ). Altogether, there has been an enormous effort from the scientific community for the identification of new molecular targets and, possibly, for the proposition of novel drug candidates that could be used in malaria-endemic areas.…”