Pfizer makes significant strides to become joint leader alongside GSK

• These eight companies represent the bulk of the large research-based pharmaceutical companies currently active in infectious diseases R&D.

• Although all three leaders perform well across the board, Pfizer made significant improvements in the scale and scope of its efforts to address AMR, and signalled a clear boost to its infectious diseases R&D.

GSK and Pfizer are joint leaders of the large research-based companies in 2021. They are followed by Johnson & Johnson. Although all three leaders perform well across the board, Pfizer made significant improvements in the scale and scope of its efforts to address AMR, and signalled a clear boost to its infectious diseases R&D. 

GSK is the clear leader in Research & Development, with 31 R&D projects. About half of its pipeline comprises vaccines projects, the largest number of any company in scope. One third of its projects (11) target pathogens classed as posing a critical and/or urgent threat from AMR, more than any other company. GSK reports access and/or stewardship planning for all of its late-stage projects, and the detail of its reported plans has increased following the implementation of its process for developing such plans in Phase III for all projects.

GSK is one of only four companies to report that 100% of its manufacturing sites are in compliance with the discharge limits that it has set. Further, GSK reports that 93% of its suppliers’ sites are compliant with discharge limits. It performs less well in stewardship than the other leaders, as it only partly decouples performance incentives for its sales agents from the volumes of sales they can secure.

Pfizer has expanded its R&D pipeline to 13 projects, up from eight in 2020, including those from its acquisitions of the biotechnology companies Arixa Pharmaceuticals and Amplyx Pharmaceuticals. These moves added innovative antibacterial and antifungal projects to its pipeline. Of the companies evaluated, Pfizer has the most late-stage projects that are already covered by plans for ensuring access, including registration commitments and equitable pricing strategies, as well as measures to strengthen supply and ensure stewardship. Pfizer stands out for filing its on-patent antibacterial and antifungal medicines across a total of 33 of the 102 low- and middle-income countries in scope for access metrics. This includes a move to file one medicine (ceftazidime/avibactam) in 18 further countries since 2020. Pfizer leads in Stewardship overall, and is the only company that publicly shares raw data from its AMR surveillance programme. It misses out on the top spot as it picks up a smaller proportion of the points available to it than GSK. Nevertheless, Pfizer has demonstrated strong progress in each Research Area. 

Johnson & Johnson follows Pfizer. It performs well in all three Research Areas, particularly in Responsible Manufacturing. It reports a comprehensive environmental risk-management strategy for limiting the impact of its manufacturing practices on drug resistance. The company extends the limits it sets at its own sites to its third-party suppliers, proactively reviewing the discharge levels they report. It has a mid-sized R&D pipeline of 14 projects; three more than in 2020. This includes two antibacterial vaccines, including the only vaccine candidate identified that targets E. coli. Both WHO and the CDC place resistant E. coli in their highest risk categories. Johnson & Johnson employs a range of access strategies to expand access to its on-patent medicine, bedaquiline, in all 30 countries that face a high-burden of multi-drug resistant TB identified by WHO. Yet it provides limited information on access strategies for off-patent/generic medicines.  

Novartis performs strongly in Responsible Manufacturing and Appropriate Access, yet has fully retreated from antimicrobial R&D with no projects that target priority pathogens in its clinical pipeline. As a result, it sits in fourth place. It is progressing in access to its off-patent/generic medicines, for example by registering its amoxicillin/clavulanic acid antibacterial in 70 of the countries in scope for the access metrics. Novartis also runs two broad initiatives that aim to expand access to its off-patent/generic medicines, namely the Novartis Access programme and the Novartis Sub-Saharan African (SSA) Unit. In a change since 2020, it now also supports an AMR surveillance programme, running in Poland, which publishes its aggregated results.

Although not in the leadership group, Sanofi, Shionogi and Otsuka each show good practice in specific areas. Sanofi, for example, is taking steps to ensure a continuous supply of its products, including by carrying out technology transfer initiatives in countries such as India, Nigeria, and Vietnam, with the transfer in Nigeria having been supported since 2008. Compared to the other companies evaluated,

Shionogi continues to invest the highest proportion of its revenues in antibacterial and antifungal R&D, and is one of only two companies to publish detailed information on which sites, including those operated by third-party suppliers, meet set limits on the concentration of antibacterials in wastewaters. Otsuka, as well as Johnson & Johnson, does not deploy sales agents for its anti-tuberculosis medicine.

MSD has gained the most approvals of new antibacterials since 2020, but performs less well than its peers as it remains unwilling to share data beyond what is already in the public domain. MSD has published a general commitment to expanding access to its products, but provides little insight into where specifically it has filed its products for registration, or into its strategies to expand access. 

What next?

These eight companies represent the bulk of the large research-based pharmaceutical companies currently active in infectious diseases R&D. Most of the R&D into antibacterial and antifungal pathogens depends on smaller biotech companies. Nevertheless, the companies evaluated here are conducting R&D that targets pathogens in the highest AMR threat category. The effectiveness of any successful new product must be preserved for as long as possible, which depends on comprehensive access and stewardship plans, but also on growing the pipeline of replacement medicines. As some of the largest producers of antibacterial and antifungal medicines and vaccines, these companies have significant capacity to improve access to their products in the countries with highest need and risk of resistance. Access in low- and middle-income countries can be provided via a range of actions from registering medicines and vaccines to building up the skills, knowledge and expertise needed for local manufacturing, and strengthening supply chains to prevent shortages, while taking each populations’ ability to pay into account in pricing policies.

*Merck & Co., Inc (Kenilworth, NJ, United States).