Zevtera launches in the US

Basilea has announced that Zevtera (ceftobiprole) is now available in the US through its commercial partner Innoviva Specialty Therapeutics (IST). As an MRSA active antibiotic, the US is an important market for ceftobiprole, given the prevalence of resistant infections. We believe the US likely represents most of the available market (circa 85%) for ceftobiprole.

While there are other 5th-generation cephalosporins already available in the US, it is important to recognise that Zevtera is the only one with a specific approval for Staphylococcus aureus bacteraemia (SAB). The SAB indication represents the principal commercial opportunity for Zevtera, with approximately 120,000 patients per year, of whom approximately 50% involve MRSA infection. With only vancomycin and daptomycin approved for SAB, and with a growing threat of resistance, we believe there is a clear need for new effective treatment options, particularly one with the well-understood safety and tolerability profile associated with Zevtera. We currently forecast peak sales of $250m for Zevera in the SAB indication alone.

We have previously noted that we believe IST to be a good choice of partner for ceftobiprole with well-aligned priorities in the anti-infectives field. For example, the current anti-infective portfolio at IST comprises several hospital-based complementary antibiotics targeting important infectious diseases. Ultimately, Zevtera's US availability represents an important element of the company's growth story, complementing the ongoing US success of Cresemba (isavuconazole), sold there through Astellas. With Cresemba facing loss of exclusivity from Q4 2027 in the US and Europe, Zevtera revenues should help offset any decline in sales, hopefully until the availability of fosmanogepix, which is currently progressing through Phase 3 evaluation.

Given its profile, we believe that fosmanogepix remains key to the future success and longevity of the anti-infectives franchise at Basilea, with the potential to be an even larger commercial success than Cresemba. In particular, its activity against most of the fungi on the WHO critical list should ensure commercial success. Also, its activity against resistant strains and ability to penetrate important organs (particularly CNS) better than currently available antifungal classes should ultimately result in fosmanogepix featuring strongly in treatment guidelines. Our forecasts suggest peak sales of $1.2bn.

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