A Research & Development

Reporting on companies’ R&D activities to develop new medicines and vaccines that target pathogens posing the greatest threat to human health. This Research Area maps R&D pipelines, highlights areas of focus and where gaps remain, and looks at how companies plan ahead to ensure new products can be rapidly made available for people in need.

Large research-based pharmaceutical companies
Biopharmaceutical companies

Context

As AMR increases, there is a pressing need for novel products to be developed to replace ineffective treatment options. Major scientific hurdles, along with technical and regulatory complexities, form significant disincentives to investing in such R&D. Nevertheless, investment is needed, including from those pharmaceutical companies that have resolved to remain in this sector. Certain pathogens pose a greater threat of resistance than others; the WHO and the US Centers for Disease Control and Prevention have both identified pathogens that are priorities for R&D into new medicines, vaccines and diagnostics. Once a new antimicrobial medicine is approved, the challenge is to introduce it in a way that (a) ensures its rapid and appropriate accessibility for patients in need while (b) conserving its use more broadly to slow the inevitable emergence of resistance. Pharmaceutical companies are encouraged to engage with others to plan ahead, during the development process, to achieve these twin 


The leaders

In Research & Development, GSK is the leader amongst large research-based pharmaceutical companies, followed by Johnson & Johnson and Sanofi. GSK is the largest investor in the space of antimicrobial R&D and has a promising pipeline in terms of size as well as the number of vaccines and novel antimicrobial candidates. Among biopharmaceutical companies, Entasis leads. It has a novel antibiotic candidate in its pipeline, for which it has an access provision in place through its agreement with GARDP. All leaders in this Research Area have novel antimicrobial candidates in their pipelines.


In summary

Majority of R&D projects for infectious diseases target priority pathogens 
Of the 30 companies in scope,* the Benchmark has identified 24 companies carrying out a total of 276 R&D projects that target infectious diseases. Of these, the majority (175) target pathogens identified as priorities for further R&D by the WHO and/or the CDC (referred to by the Benchmark as priority pathogens). Of the 175 R&D projects, 88 are in the preclinical development, and 87 are in the clinical stage. Almost one third (54 out of 175) targets gram-negative bacteria, a critical target for AMR: over half of these are in the preclinical stages of development.

GSK has the fullest pipeline, with a large proportion of projects focusing on priority pathogens. It also has the highest number of vaccines in development that target priority pathogens. The pipelines of biopharmaceutical companies are comparatively smaller, as would be expected for companies of this type. These companies focus on R&D for priority areas.

Figure 23: Antimicrobial pipelines contain 276 R&D projects 

The companies in scope are developing 276 antimicrobial R&D projects. Of these, 136 are in clinical stages of development. Gram-negative bacteria (GNB) receive the most attention. Projects shown in this figure include adaptations.

Over half of R&D projects targeting priority pathogens are conducted through partnerships
More than 50% of the 130 new R&D projects (excluding adaptations) are now being conducted in partnership. In 58 partnership-based projects, companies are working with public- or non-profit-sector partners only. In eight projects, companies’ partners include both public- or non-profit- and private-sector entities. In the remaining seven projects, companies are working with other private-sector partners only.

Open collaborations, including PDPs, comprise a third of the overall number of project partnerships analysed by the Benchmark. Only one PDP (GARDP) is involved with the discovery and development of antibiotics against gram-negative (GNB) and/or gram-positive bacteria (GPB). Sanofi is developing half of the 16 new candidates targeting priority pathogens in its pipeline through open collaborations, which is comparatively high versus other companies assessed in this Research Area.

Figure 30: Half of new R&D projects involve partnerships with public or nonprofit partners.

66 out of 130 R&D projects involving new medicines or vaccines targeting priority pathogens are carried out in partnerships with public or non-profit partners. These involve 27 PDPs or open collaborations, of which only two focus on new antibiotics for GNB and/or GPB – these are managed by GARDP and IMI. The remaining PDP projects are focused on HIV/AIDS, malaria and tuberculosis.

Out of 28 antibiotics in late stages of clinical development, only two have both access and stewardship provisions in place
The Benchmark identified 56 R&D projects in late stages of clinical development targeting priority pathogens (out of 175 projects), including 28 antibiotics and 14 vaccines for bacterial infections (the other 14 candidates focus on HIV/AIDS and malaria). Of these 28 antibiotics, only two meet the standard of having plans in place to ensure both rapid access where needed and stewardship of the successful candidate: eravacycline, being developed by Tetraphase, targets a group of priority pathogens that cause complicated intra-abdominal and urinary tract infections; and paediatric bedaquiline for the treatment of tuberculosis, in development by Johnson & Johnson. Two other antibiotics – being developed by GSK for gonorrhoea and Pfizer for multidrug-resistant gram-negative bacterial infections – have stewardship provisions but no access plan, while three other antibiotics in the clinical pipeline have an access plan in place but no stewardship provisions, being developed by GSK, Entasis and Melinta. 

Access provisions for late-stage candidates are varied
The most common access provisions for medicines and vaccines in late stages of development are: plans to register these products in countries where there is a high need (upon approval), plans for equitable and/or tiered pricing, and commitments to license IP to partners based in need-based geographic areas. GSK, Johnson & Johnson, Pfizer and Sanofi have the most access provisions in place. The most predominant stewardship provision is the development of a surveillance programme for monitoring resistance.

Common access provisions include voluntary licensing, needs-based registration and equitable pricing. Stewardship provisions are focused on surveillance programmes for monitoring resistance.

Figure 32: Almost half of the companies have at least one access and/or stewardship provision in place for a late-stage clinical candidate.

Enlarge

In this Research Area, the Benchmark assesses pharmaceutical companies engaged in antimicrobial R&D (i.e., in new antimicrobial drug development and/or the adapting of existing antimicrobial medicines and vaccines, including those in preclinical and clinical development, e.g., to develop new formulations or label extensions). It looks at the size of companies’ pipelines, whether they are targeting priority pathogens identified by WHO and/or CDC, their R&D investments and how they plan ahead to ensure successful candidates are both accessible and used conservatively.



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