Basilea Pharmaceutica AG

Performance in the 2026 Benchmark

Performs well. With four antibacterial and antifungal candidates in development, Basilea has one of the most diverse pipelines among SMEs. All projects target ‘critical’ priority pathogens, and it demonstrates Best Practice for innovation, with all clinical-stage candidates classified as innovative, meeting at least one of WHO’s innovation criteria. In addition, two candidates have oral formulations that meet the Benchmark’s ‘other’ innovation criterion, which assesses real-world utility in LMICs. Both offer added clinical utility and can help overcome access barriers associated with intravenous-only options. It lacks efforts in access and stewardship planning because, as a development-only company, Basilea does not develop access plans for its projects, though it does participate in surveillance efforts. 

Opportunities for Basilea

Diversify pipeline to address additional pathogens with high burdens in LMICs. Basilea’s pipeline has a dual focus on antifungal and antibacterial medicines. The four projects in development cover a broad spectrum of WHO-listed critical-priority bacterial and fungal pathogens. As a development-only company, Basilea currently leads small- and medium-sized enterprises in the number of innovative medicines in its pipeline. The company has an opportunity to further expand and diversify its portfolio by addressing critical pathogens associated with high disease burdens in LMICs. 

Sales & Operations

• Therapeutic areas: Anti-infectives   

• Financial stage: Public (IPO completed in March 2004) 

• Products on the market: Cresemba®, Zevtera®   

• Commercial partners: As part of Basilea’s business model, it does not directly market its developed products. To commercialise its products, Basilea collaborates with licensing partners Asahi Kasei, Astellas, CR Gosun, Innoviva Specialty Therapeutics and Pfizer, while it distributes its products through Advanz Pharma, AVIR Pharma, Hikma, Knight, Lancet and Unimedic Pharma. Basilea acquired the rights to fosmanogepix, a clinical-stage broad-spectrum antifungal candidate, from Pfizer in November 2023 and to ceftibuten-ledaborbactam etzadroxil, a clinical-stage oral antibiotic from Venatorx in August 2025. 

• Funding partners:  Fosmanogepix, BAL2062, and the Phase III programme for Zevtera® were funded in part by the US Department of Health and Human Services (HHS), through the Administration for Strategic Preparedness and Response (ASPR) and BARDA. BAL2420 received funding from CARB‑X, with support also provided in part by HHS, ASPR, and BARDA. Furthermore, BARDA novated a contract from Venatorx to Basilea to support the development of ceftibuten-ledaborbactam etzadroxil in September 2025. 

Sample of pipeline assessed by the Benchmark

Pipeline for diseases in scope

Research & Development

Pipeline of both antibacterial and antifungal medicines, with 3 innovative medicines. Basilea has 4 projects in its pipeline targeting pathogens in scope. Its 2 antifungal projects include BAL2062, which targets invasive mould infections, and fosmanogepix, which targets candidemia and invasive mould infections. Its antibacterial projects, BAL2420 and ceftibuten-ledaborbactam etzadroxil, both target Gram-negative Enterobacterales. Its 4 projects target pathogens that are classified as ‘high’ or ‘critical’ on either WHO’s fungal or bacterial priority pathogen list. For example, Aspergillosis fumigatus (BAL2062) and Candida spp. (Fosmanogepix) and Enterobacterales. (See figure above for Basilea’s full pipeline breakdown, including development phases and disease targets). Three projects – Fosmanogepix, BAL2062 and Ceftibuten-ledaborbactam – are classified as innovative, meeting at least 1 of WHO’s 4 innovation criteria. Fosmanogepix meets all 4 criteria: it has no known cross-resistance, belongs to a new chemical class, and has both a new target and a new mode of action. BAL2062 meets 2 criteria (no cross resistance and new chemical class); ceftibuten-ledaborbactam meets one criterium (new chemical class). Ceftibuten–ledaborbactam and fosmanogepix also meet the Benchmark’s ‘other’ criterion for innovativeness, as their oral formulations provide added clinical utility and address access barriers associated with intravenous-only options. The company’s active in-house discovery programme focuses on novel antibiotic and antifungal compounds targeting WHO priority pathogens. 

No access plan in place, but engaged in surveillance for its sole late-stage project. As a development-only company, Basilea focuses on bringing medicines through approval, leaving access programmes to commercial partners. As such, it did not report an access plan for its late-stage antifungal project, fosmanogepix. Clinical trials were conducted in Brazil, South Africa and Thailand. It does, however, have a stewardship plan for fosmanogepix. This involves global surveillance activities embedded in the SENTRY programme, an initiative that monitors AMR trends. Beyond surveillance, no further stewardship commitments were identified.  

Active in 1 multinational AMR surveillance programme.  While Basilea is not assessed for its activities in AMR surveillance as an SME, its involvement in 1 AMR surveillance programme was identified during the period of analysis. Like 5 other companies in scope, Basilea is involved in the 'SENTRY Antimicrobial Surveillance Programme', which is run by JMI Laboratories, covering 88 and 43 genera of bacterial and fungal pathogens, 45 antibacterial and 8 antifungal medicines and 55 countries. Under the umbrella of SENTRY, Basilea has initiated global surveillance for its antibacterial and antifungal medicines, including its own products fosmanogepix and cefepime-taniborbactam; BAL2062 will be included starting 2026. SENTRY's antibacterial data can be accessed via its website; antifungal data is accessible via Pfizer's ATLAS website. The methods used to collect surveillance data for SENTRY are largely clear, including: the type of surveillance; where the analysis is conducted and which breakpoints are used; and how deduplication is considered. 

^{*Basilea acquired the global rights to ceftibuten-ledaborbactam etzadroxil from Venatorx during the period of analysis.}