The anti-fungal Cresemba has been an enduring and highly successful cornerstone of Basilea's long-established anti-infectives franchise. As we have suggested many times, this is due not only to its differentiated profile but also the attraction of highly relevant commercial partners (particularly Astellas in the US and Pfizer). Continued growth looks assured, with a combination of important new geographies (such as China) and continued underlying growth in existing markets.
Basilea's 5th generation cephalosporin antibiotic ceftobiprole has played a minor supporting role to date with its approval for community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP) outside the US. However, this looks set to change. The TARGET study has already delivered a positive result in severe skin infections, but it is ceftobiprole's potential in Staphylococcus aureus bacteraemia (SAB) which should drive commercial success. Top-line results for ERADICATE have previously been reported, and the recent IDWeek event in Washington DC provides further support and insight into ceftobiprole's potential here. For example, the successful primary endpoint result (versus daptomycin) was consistent in patients, irrespective of whether they were infected with MSSA or drug-resistant MRSA bloodstream infections at baseline. Also, the median time to Staph aureus bloodstream clearance was 3 days with ceftobiprole compared to four days with daptomycin and five days for MRSA with both antibiotics.
SAB is a leading cause of bloodstream infections, responsible for a broad variety of complications and has been associated with significant morbidity and a mortality of 20 to 40%.
Further data on secondary endpoints and populations were presented, which included overall success in the clinically evaluable population (77.9% ceftobiprole vs 77.8% daptomycin); microbiological eradication (82% ceftobiprole vs 77.3% daptomycin); all-cause mortality (5.8% ceftobiprole vs 5.6% daptomycin) at 70 days post randomisation in the mITT population. Together these data suggest that ERADICATE has delivered a highly competitive profile for ceftobiprole in the SAB setting.
One of the highlights of Cresemba's success has been the relevance of the commercial partners which Basilea has secured, we believe. In recent times, despite the apparent desire to address increasing antibiotic resistance, the antibiotic field has struggled in large part because of the current payment model - although this is changing. Given the unmet need in SAB and the limited choice available to physicians (daptomycin facing increased resistance) in the MRSA setting, combined with the quality of the data generated in ERADICATE, we now look forward to Basilea securing a commercial partner which can deliver success in the key US market for ceftobiprole.
Basilea is planning to submit a New Drug Application (NDA) for ceftobiprole to the FDA around year-end 2022.
We calculate a discounted cash flow fair value of CHF120 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 contained in this publication should be considered as any form of advice.