Otsuka and Pfizer set consistent standard for stewardship and access plans

Antimicrobial resistance poses opposing challenges: access and excess. Millions of people live without reliable access to effective antibacterial and antifungal products, yet excessive or inappropriate use of these products can render them ineffective. The need to enhance access goes hand in hand with that of ensuring appropriate use to keep medicines working.

When companies plan for these challenges during R&D, they take account of public health needs and can ensure more rapid access to new medicines and vaccines at more affordable prices following their entry to markets. Companies are expected to have plans in place for pipeline projects in Phase II and beyond. The Benchmark assesses the extent to which companies create and disclose plans to make new products swiftly accessible upon market entry, and to ensure they are used appropriately thereafter. For medicines, plans for access must be coupled with plans for stewardship.

Specifically, the Benchmark looks at the late-stage antibacterial and antifungal R&D projects targeting priority pathogens for which companies have plans in place for access (in countries in scope and where burden of disease is higher) and for stewardship on a global basis.

Otsuka and Pfizer lead

All but two of 20 medicine projects in late-stage clinical development (from all companies in scope) have in place both an access and stewardship plan. Otsuka and Pfizer stand out, both reporting comprehensive access and stewardship plans for all late-stage projects in their pipelines. Access strategies include WHO prequalification, managed access programmes, equitable pricing, provisions for sustainable manufacturing and supply, registration, responsible IP and licensing and other provisions, some stipulated in partner agreements with organisations such as the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) and the Bill & Melinda Gates Foundation. 

Otsuka has plans for two late-stage candidates, both to combat tuberculosis. For its version of delamanid to treat children with drug-resistant TB, it works with the Pediatric Drug Resistant-TB Initiative launched by the Stop TB Partnership’s Global Drug Facility (GDF), national TB programmes and other stakeholders to ensure global access; it plans to complete a technology transfer shortly after receiving the first stringent regulatory authority approval of this child-friendly formulation. Otsuka is developing its second candidate (OPC-167832), a highly innovative agent in Phase II of clinical development, in partnership with the Bill & Melinda Gates Foundation, and aligns its access and stewardship plans with that foundation’s global access requirements.

Pfizer does not enforce its patents in Least Developed Countries (from May 2020). It has comprehensive access and stewardship plans for most candidates, including one in Phase III (aztreonam/avibactam) to treat serious gram-negative bacterial infections in adults, for which it plans a global pre-registration compassionate use programme. It also has robust, multifaceted plans for its vaccines to prevent C. difficile (for which no vaccine is yet on the market) and Group B Streptococcus (which causes around 90,000 infant deaths annually, co-funded by the Bill & Melinda Gates Foundation). 

GSK, Shionogi and Sanofi: examples of good practice 

GSK deploys company-wide policies to ensure access and stewardship plans are in place for its five late-stage projects, but it does not tailor plans to specific products as much as Pfizer and Otsuka do for theirs. Shionogi has progressed by actively seeking out partners to improve access and stewardship to its antibiotic candidate (cefiderocol). 

Sanofi has developed Shan6™ vaccine specifically for children in low- and middle-income countries. Shan6™ was approved in May 2021 in India. There, Sanofi has a dedicated manufacturing facility where it applies supply-chain best practices including buffer and safety stocks. Additional countries in scope for registration include Thailand and Kenya. For Shan6™, Sanofi applied for WHO prequalification to ensure access to the vaccine in all countries eligible for support from Gavi, the Vaccine Alliance. Pooled demand through UNICEF and Gavi tenders ensures quality of supply and affordability. In addition, Sanofi has developed equitable pricing strategies, conducted a payer pricing survey in nine countries, and takes account of affordability by market type. 

Next Steps

When pharmaceutical companies work with funders such as Wellcome Trust, the Bill & Melinda Gates Foundation or CARB-X, provisions attached to funding may require them to put in place strong access and stewardship plans. Some companies go the extra mile and develop their own plans internally. Pfizer leads the field, matching the quality of its internally developed plans with that of those it develops for co-funded projects.