Basilea announced today that the data from the ceftobiprole Phase 3 trial in patients with Staphylococcus aureus (S. aureus) bacteraemia (SAB) have been published in the prestigious peer-reviewed New England Journal of Medicine (NEJM). The publication should help raise awareness of the key attributes of ceftobiprole for both physicians and potential commercial partners ahead of its expected approval in the important US market in H2 2024.
As a reminder, ceftobiprole has been evaluated in two Phase 3 studies, largely funded by BARDA, and is under FDA review for SAB, severe skin infections (ABSSSI), and community-acquired bacterial pneumonia (CABP). Of the approximately $400m peak sales we forecast, we believe it is the SAB indication which presents the largest commercial opportunity given the unmet need and the limited treatment options for patients suffering from resistant infections (MRSA).
The NEJM publication details the results of the Phase 3 ERADICATE study in patients with SAB. ERADICATE was designed as a double-blind, non-inferiority (NI) study in 390 patients with complicated SAB, including right-sided infective endocarditis. Patients received ceftobiprole or standard-of-care daptomycin (plus optional aztreonam) for up to 42 days. Overall, patients receiving ceftobiprole showed a similar clinical benefit to those administered daptomycin, suggesting that ceftobiprole is an effective treatment option. This is important, given increasing concerns regarding the threat of emerging daptomycin resistance.
The primary endpoint of ERADICATE evaluated overall success at post-treatment evaluation (day 70 post-randomisation +/-5 days). Ceftobiprole was associated with an overall success rate of 69.8% in the mITT population at 70 days, which compared favourably to that of daptomycin (68.7%). With a NI delta of +2% (-7.1%-11.1%), the result of ERADICATE was well within the predefined 15% NI margin for the primary endpoint.
Importantly, the results obtained for the primary endpoint were replicated in key subgroups, including patients with resistant infections (MRSA). Effective treatment of MRSA is important given that MRSA bacteraemia leads to poorer outcomes, with 15%-50% mortality rates. Clearance of MRSA bacteria from the bloodstream was achieved in 93.3% of patients treated with ceftobiprole in ERADICATE compared with 87.8% in those receiving daptomycin after a median of 5 days of treatment.
Once approved and launched, Basilea has previously suggested a commercial strategy starting with SAB and subsequently involving other complications such as SAB-associated bone and joint infections, bacteraemia caused by ABSSSI, and other related indications.
Ceftobiprole is particularly important for Basilea as it seeks to build on its already successful anti-infectives franchise, which is currently dominated by the anti-fungal Cresemba. While Cresemba is facing the loss of exclusivity in the US and Europe from 2027, ceftobiprole should help bridge the gap, recognising that Cresemba will be supported by revenue from recently launched important markets such as China and Japan. Basilea is seeking to attract a suitable partner for ceftobiprole ahead of US approval. We believe successful execution should represent a key de-risking event for Basilea.
We calculate a discounted cash flow fair value of CHF 91 per share for Basilea.
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Basilea Pharmaceutica is a client of Calvine Partners, and as such, this publication is not independent and should be considered a marketing communication under FCA Rules. None of the information in this publication should be considered as any form of advice.