Debiopharm performs on average in Research & Development when compared to other small and medium-sized enterprises in scope.
Debiopharm has four antibacterial projects for priority pathogens in its pipeline, including one novel clinical-stage candidate, afabicin, for acute bacterial skin and skin structure infections (ABSSSI).
Sales & Operations
Therapeutic areas: Oncology; infectious diseases
Products on the market: Two non-antimicrobial medicines: oxaliplatin (Eloxatin®/Elplat®/Dacotin®/Dacplat®) used to treat colorectal cancer, and triptorelin (Decapeptyl®/Trelstar®/Pamorelin®/Triptodur®) a hormonal therapy drug used to treat prostate cancer.
R&D grants received since 2016: At least USD 4.7 million, awarded by one funder (CARB-X). Its latest award, worth USD 2.1 million, was granted by CARB-X in May 2019 to advance the development of its antibiotic programme Debio 1454, targeting multidrug-resistant A. baumannii. Debio 1454 compound inhibits bacterial fatty acid biosynthesis, an essential pathway in many bacterial species including Gram-negative, drug-resistant strains.
Financing and investment structure: Family-owned company
M&A since 2018: None in the antibacterial and/or antifungal sectors
for diseases in scope
Pipeline size: 4 projects for priority pathogens* (4 antibacterial medicines)
Development stages: 2 clinical projects, including afabicin, a Phase II clinical candidate for the treatment of acute bacterial skin and skin structure infections (ABSSSI), with an additional indication for bone and joint infections also in development, and 2 pre-clinical projects
Novelty: 1 novel project, afabicin, a Phase II clinical candidate for the treatment of acute bacterial skin and skin structure infections that belongs to a new chemical class of antibacterials and has a new drug target, mode of action and no known cross-resistance to other antibacterial classes
Regulatory approvals: 0 approvals for priority pathogens
Access plans: Neither of its 2 late-stage R&D projects have project-specific access plans.
Stewardship plans: Neither of its 2 late-stage R&D medicine projects have project-specific stewardship plans.
Opportunities for Debiopharm
Develop access and stewardship plans for afabicin. Debiopharm is developing one antibacterial candidate (afabicin) in late-stage clinical development. Debiopharm can develop plans to ensure that afabicin will be available and affordable in low- and middle-income countries and appropriately used globally after market approval. As examples of access plans, the company can commit to an equitable pricing strategy and/or look for out-licensing opportunities with multiple manufacturers in low- and middle-income countries. As examples of stewardship plans, the company can commit to decouple sales incentives from sales volumes and/or become involved in antibacterial surveillance activities.
Changes since 2018
This section lists notable changes in companies’ activities since the 2018 Benchmark. Since Debiopharm was not in scope for evaluation in 2018, no changes are reported.
Performance by research area
Evaluated: medicine & vaccine pipelines for priority* bacteria & fungi
A.1 R&D investments
As with all other SMEs evaluated, Debiopharm was not scored in this indicator.
A.2.1 Pipeline size of four projects
Debiopharm reports four projects targeting priority pathogens in its pipeline. The company focuses on antibacterial medicine development, and has two projects in clinical development (Phase II) and two in pre-clinical development.
A.2.2 One clinical-stage novel project
Debiopharm’s clinical-stage medicine pipeline for priority pathogens consists of both new and adapted R&D projects. Debiopharm has one clinical-stage antibacterial medicine project that is considered novel: afabicin, for acute bacterial skin and skin structure infections (ABSSSI). It meets all criteria set by WHO for innovativeness, including belonging to a new chemical class and having a new target, mode of action and no cross-resistance to other antibacterial classes.
A.2.3 Vaccines in the pipeline
Debiopharm is not eligible for this indicator as it is not active in vaccine development.
A.2.4 One candidate targeting critical and/or urgent priorities
Debiopharm has one pre-clinical candidate that targets N. gonorrhoeae, which is considered an urgent R&D priority for limiting AMR, as identified by the US Centers for Disease Control and Prevention (CDC). Further details were provided on the basis of confidentiality.
A.3 Intellectual capital sharing
As an SME, Debiopharm was not scored for this indicator, in line with the external stakeholder consensus defined by the Foundation.
A.4 No access or stewardship plans for late-stage R&D projects targeting priority pathogens
Debiopharm has two such R&D projects. It currently reports no plans that address either the stewardship of or appropriate access to the products, upon reaching the market.
Pipeline targeting priority pathogens: 4
As a small- to medium-sized enterprise (SME), Debiopharm is not evaluated in this Research Area. It has no antibacterial products on the market.
As a small- to medium-sized enterprise (SME), Debiopharm is not evaluated in this Research Area. It has no antibacterial and/or antifungal products on the market.
Activities in this area are not scored by the Benchmark. This information is provided given the importance of diagnostics, animal health and agriculture on the topic of AMR.
Debiopharm is developing an antimicrobial susceptibility testing (AST) device for its antibacterial afabicin, which is in Phase II of clinical development. It is also developing a sample preparation technology for direct blood testing, which could shorten the time to identify pathogens and enable appropriate use of antibacterials.
* Bacteria and fungi that have been identified as priority R&D targets for limiting AMR, by either the WHO and/or the Centers for Disease Control and Prevention (CDC).