31 October 2023
The anti-infectives franchise at Basilea has long been dominated by the anti-fungal Cresemba (isavuconazole). In the medium term, the ongoing success of Cresemba looks assured, and we were greatly encouraged by the recent in-licensing of a novel clinical-stage anti-fungal to help populate the development pipeline and potentially provide longevity to the anti-fungal franchise. The announcement this morning that the company has secured access to the novel antibacterial agent tonabacase through an exclusive license and option agreement with the South Korean company iNtRON Biotechnology reflects the company’s determination to possess a broad anti-infective platform, encompassing both fungal and bacterial infections.
Progressing the strategy
Tonabacase is a recombinant endolysin and potentially represents a first-in-class antibacterial approach. Endolysins are derived from bacteriophage which infect and kill bacteria. It is fair to say that while interest in the use of phage as antibacterial agents has been around for decades, their development has been overshadowed by the development of (usually) broad-spectrum antibiotics. However, mounting antibiotic resistance has led to re-evaluating the potential of phage, particularly recombinant endolysins, given their potential specificity and, perhaps more importantly, their lack of bacterial resistance mechanisms. Furthermore, they have shown activity against resistant bacteria (such as MRSA), coagulase-negative staphylococci, as well as intractable biofilms. The endolysins have also demonstrated synergy with existing antibiotic classes. Tonabacase is a clinical-stage endolysin (a peptidoglycan hydrolase) that kills Gram-positive bacteria by lysing the cell wall. Encouragingly, tonabacase has completed Phase 1 studies and has been shown to be well tolerated.
Licensing and option agreement provides choice
Although the antibiotic franchise at Basilea provides only a modest contribution to sales, currently through sales of the 5th generation cephalosporin Zevtera (ceftobiprole), outside the US, ceftobiprole is approaching approval and commercialisation in the key US market (PDUFA 3rd April 2024). This approval will come with 10 years of exclusivity, and as our peak sales forecast approaches $400m (largely the bacteraemia indication), we expect a relevant commercial partner to be secured. As a result, the importance of the antibacterial franchise at Basilea should significantly increase, and the potential addition of tonabacase, if it satisfactorily completes Basilea’s exacting preclinical evaluation, should help bolster the pipeline. We note that Basilea suggests that a successful outcome could result in tonabacase directly entering Phase 2 studies in 2025.
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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