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Basilea Pharmaceutica

Zevtera FDA Approval


4 April 2024

The approval of Zevtera (ceftobiprole) represents the company's determination to bring this important treatment option to patients in the key US market. Zevtera has been approved by FDA for the treatment of Staphylococcus aureus bacteraemia (SAB), including those with right-sided infective endocarditis and acute bacterial skin and skin structure infections (ABSSSI) as well as adults and children with community-acquired bacterial pneumonia (CABP). We believe there is a real unmet need for patients with SAB, with approximately 120,000 cases in the US, and particularly where MRSA is involved.


Serving an acute unmet medical need

The presence of MRSA leads to poorer outcomes, with 15%-50% mortality rates in patients with MRSA bacteraemia. The glycopeptides vancomycin and daptomycin are first-line treatments in MRSA bacteraemia, requiring 4-6 weeks of intravenous therapy. Metastatic infections often require surgical intervention and can result in extended hospitalisation. However, both daptomycin and vancomycin have concerns over emerging resistance (and the potential for cross-resistance), as well as vancomycin's poor tissue distribution and risk of renal toxicity. Additionally, daptomycin is inactivated in the lung, rendering it useless for the treatment of respiratory infections. As a result, we believe there is a clear need for new, effective, and well-tolerated treatment options like Zevtera.

Management delivering

Our $400m peak sales forecast is based primarily on the need for effective treatment options for SAB, mainly where resistant bacteria (MRSA) are involved. Furthermore, the importance of ceftobiprole has been reflected in BARDA's provision of $112m (approximately 75%) of the funding for clinical development and regulatory activity. FDA approval of ceftobiprole is also important to the extent that it provides a product at the beginning of its product life cycle. The company has been very active recently, bolstering its antibacterial pipeline with the endolysin tonabacase, which could act synergistically with ceftobiprole. 

Substantial de-risking ongoing

The approval of ceftobiprole represents another element of the ongoing de-risking, along with the recent acquisition of the novel Phase 3-ready anti-fungal fosmanogepix. While the initial objective was to deliver a partner before FDA approval, we note commentary today that details the heightened interest received as Zevtera approached US approval. As such, we look forward to the attraction of a suitable commercial partner by mid-year 2024, which should allow Zevtera to reach its full commercial potential.

Basilea Income Statement (CHF 000s) 

Source: Calvine Partners Research

Basilea Cash Flow (CHF 000s) 

Source: Calvine Partners Research

Basilea Balance Sheet (CHF 000s) 

Source: Calvine Partners Research



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