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Pipeline analysis

Pipeline: Which companies are developing new treatments for the most threatening bacteria and fungi?

Pathogens are becoming increasingly resistant to common antibiotics, which drives an urgent need for new and novel treatment options. To reveal which promising new products are being developed, the 2020 Antimicrobial Resistance Benchmark has analysed the size and contents of 21 pharmaceutical pipelines. 

The Benchmark has identified the companies with the largest pipelines targeting the biggest bacterial and fungal threats from antimicrobial resistance (AMR), referred to as ‘priority pathogens’. It breaks the pipelines down into medicine and vaccines projects and identifies the medicine candidates that qualify as ‘novel’. It also identifies which pathogens are most frequently targeted by the companies in scope. 

Priority pathogen R&D - what you need to know:
  • New medicines for priority pathogens are urgently needed: New medicines are needed to replace the ones that are no longer effective. In Brazil, Indonesia and Russia, 40%-60% of infections are caused by drug-resistant bacteria. In India, this reaches more than 70% for several common bacteria. In the US, 90% of Candida auris isolates are resistant to one antifungal (fluconazole).
  • What are 'priority pathogens'? To highlight the top R&D priorities, the WHO and the US Centers for Disease Control and Prevention (CDC) have compiled a list of certain pathogens that pose a greater threat of resistance than others.
  • How the Benchmark defines 'novelty':  To determine whether a medicine is novel, the Benchmark uses four WHO-defined criteria: (1) new chemical class (or structure); (2) new target; (3) new mode of action; and (4) absence of cross-resistance.

How many projects are in the pipeline?
The Benchmark examined the R&D pipelines of eight large R&D-based pharmaceutical companies, and 13 pharmaceutical small and medium-sized enterprises (SMEs). They include companies with large R&D divisions and market presence, and those with leading expertise in developing critically needed antibiotics and antifungals.

In 2020 a total of 138 R&D projects in development were identified from 21 companies. This includes everything from the preliminary and discovery stages of R&D, as well as potential products that are working their way through clinical trials. Exactly 80% of these are medicines, with vaccines making up the remainder of the pipeline. Most projects target bacterial rather than fungal priority pathogens (128 out of 138). Just over 20% of the projects target tuberculosis. 

138 priority R&D projects 1521 antibacterial and antifungal medicines and vaccines
A total of 138 R&D projects are being developed by 21 companies, 54% are in clinical development or beyond.

Which large R&D-based companies develop the most R&D projects?
In 2020, the Benchmark finds that the eight large R&D-based pharmaceutical companies have a combined total of 77 projects, including three novel candidates, in their R&D pipelines targeting priority bacteria and fungi. GSK has the largest R&D pipeline, with 27 projects: 15 vaccines and 12 medicines. Among its medicine candidates, two are considered novel.

Large R&D-based companies are developing 77 R&D projects
The figure compares R&D pipelines targeting priority bacteria and fungi from eight large research-based pharmaceutical companies, including those with the biggest presence in anti-infectives markets.

What do the pipelines of the SMEs look like?
Pharmaceutical SMEs have a total 61 projects in their R&D pipelines: including 36 new medicine candidates and 25 adapted medicine candidates. The 13 SMEs in scope of the Benchmark are not engaged in vaccine R&D.  Almost all SMEs (12 companies) target pathogens that pose a ‘critical’ or ‘urgent’ threat level.

Pharmaceutical SMEs are developing 61 R&D projects
The figure compares R&D pipelines targeting priority bacteria and fungi from 13 pharmaceutical SMEs focused on such R&D.

Which pathogens are targeted most?
Breaking down the pipeline further, most projects specifically target the scientifically challenging Gram-negative bacteria (GNB) that can cause severe infections and high mortality. Due to their cell wall structure and diverse resistance mechanisms it is more difficult for antibacterials to enter the cell of a GNB compared to Gram-positive bacteria (GPB) and many GNB species have now become resistant to multiple antibacterials.

There are 54 projects in the pipeline for GNB, 29 for GPB, and 16 that target both GNB and GPB. The GNB most frequently targeted are Enterobacteriaceae (including carbapenem-resistant Enterobacteriaceae, or CRE and extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae) (36 projects) followed by P. aeruginosa (18 projects) and A. baumannii (12 project). The GPB most frequently targeted include S. aureus (25 projects) and S. pneumoniae (12 projects). 

Most projects target Gram-negative bacteria
Most projects target Gram-negative bacteria. The bacteria receiving the most attention include Enterobacteriaceae and M. tuberculosis.

How has the pipeline changed since 2018?
With resistance building and medicines becoming less effective, promising clinical candidates are closely watched to see when and whether they are likely to become available. The 2020 Benchmark looked at how the number of R&D projects targeting priority pathogens has changed since 2018, when the first Benchmark report was published. It examined projects in the 2018 pipeline that have moved between phases of development or were discontinued and the number of new projects that were newly added to the pipeline in 2020. It looked only at companies and pathogens that were in scope in both years. 

From the 112 projects in 2018, almost one-third of projects progressed from one stage of development to another between 2018 and 2020. Since 2018, in the discovery stage/preclincial stage about the same number of projects have been discontinued (25) as have been newly added (27) to the pipeline.

The pipeline* has grown only marginally since 2018. One third of projects advanced.
* Showing only those projects that meet criteria used in both 2018 and 2020.

1. Bodie M., et al. Addressing the rising rates of gonorrhea and drug-resistant gonorrhea: There is no time like the present. Can Commun Dis Rep. 2019;45(2-3):54–62. Published 2019 Feb 7. doi:10.14745/ccdr.v45i23a02
2. The World Bank. Pulling Together to Beat Superbugs.;2019. https://www.worldbank.org/Accessed January 07,2020.
3. CDDEP. Antibiotic Resistance of Escherichia coli in India; https:// resistancemap.cddep.org/. Assessed 
January 07, 2020.

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