During R&D, five companies plan ahead to enhance access to future antibiotics while ensuring their responsible use

Companies:

Entasis, GSK, Johnson & Johnson, Pfizer, Tetraphase

Topic:

Access & stewardship planning

What:

Entasis, GSK, Johnson & Johnson, Pfizer and Tetraphase plan ahead to make antibiotic candidates accessible upon market entry, while also ensuring their prudent use, by having at least one late-stage project with both an access and stewardship plan.

Region:

Global

Rising antimicrobial resistance (AMR) poses twin challenges: excess and access. The rise of AMR is being accelerated by excessive or inappropriate antibacterial and antifungal use, while millions of people currently live without reliable access to such products. Both issues are closely interlinked as the need to enhance access where necessary must be balanced with that of ensuring optimal and appropriate use.

Why do access and stewardship plans matter?
When companies plan ahead during research and development, they help to ensure public health needs are considered and (where appropriate) are able to provide swifter access to new products at more affordable prices. To promote the likelihood of new products being used appropriately and remaining effective over time, companies must couple plans for access with plans for stewardship. With only a few antibiotics in development, and considering the scale of unmet need, five companies stand out for their access and stewardship plans: Entasis, GSK, Johnson & Johnson, Pfizer and Tetraphase. Together, they have eight projects in late-stage development that are supported by both an access and stewardship plan. 

What do access and stewardship plans look like?
The companies use various mechanisms to help ensure access to new medicines in low- and middle-income countries including licensing and affordability commitments, filing for registration in countries with a high disease burden, taking account of populations’ varying ability to pay in pricing strategies, and waiving or not enforcing patent rights. Stewardship measures include surveillance of resistance and disease, and the introduction of more appropriate marketing practices. This is particularly important in countries with high rates of drug resistance. In some cases, product development partners require such plans to be made during the development phase. This is the case for six of the eight projects supported by both access and stewardship plans in 2020.

Full breakdown of the late-stage antibiotics with both access and stewardship plans:

Entasis: Sulbactam/ durlobactam
  • Project type: a betalactam/beta-lactamase inhibitor (BL/BLI) combination where sulbactam is active against A.baumannii and durlobactam confers additional protection against betalactamases.
  • Access plan: responsible IP and licensing arrangements; equitable pricing strategy
  • Stewardship plan: surveillance
Entasis: Zoliflodacin
  • Project type: a novel candidate for the treatment of uncomplicated gonorrhoea, developed in partnership with the Global Antibiotic Research & Development Partnership (GARDP)
  • Access plan: responsible IP and licensing arrangements; equitable pricing strategy; tiered pricing model
  • Stewardship plan: surveillance
GSK: GSK-070
  • Project type: a novel candidate for the treatment of Mycobacterium tuberculosis
  • Access plan: registration plans; equitable pricing strategy
  • Stewardship plan: surveillance
GSK: Gepotidacin
  • Project type: a novel candidate for the treatment of bacterial infections including Neisseria gonorrhoeae
  • Access plan: registration plans; equitable pricing strategy
  • Stewardship plan: surveillance
Johnson & Johnson: Bedaquiline (Sirturo®)
  • Project type: a paediatric medicine for the treatment of drug resistant tuberculosis in adolescents
  • Access plan: registration plans; global compassionate Use programme
  • Stewardship plan: expansion of existing stewardship initiatives/activities to help broaden the treatment young children.
Pfizer: Ceftaroline fosamil (Zinforo™)
  • Project type: a treatment for MRSA as a new target indication to an expanded paediatric population
  • Access plan: equitable pricing strategy
  • Stewardship plan: surveillance
Pfizer: Aztreonam/ avibactam
  • Project type: a combination treatment for multidrug-resistant Enterobacteriaceae
  • Access plan: equitable pricing strategy; global compassionate use programme
  • Stewardship plan: surveillance
Tetraphase: Eravacycline (Xerava™)
  • Project type: a recently approved product for multidrug-resistant Gram-negative and Gram-positive infections
  • Access plan: responsible IP and licensing arrangements
  • Stewardship plan: surveillance

Learn more

View our detailed overview of each company’s performance

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