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Basilea - Fleshing out Zevtera

With the recent FDA approval of Zevtera (ceftobiprole) for Staphylococcus aureus bacteraemia (SAB), severe skin infections (SSSI), and community-acquired pneumonia (CABP), the next step for commercial de-risking is to attract a suitable partner to ensure that it reaches its maximum commercial potential. Given the heightened interest as Zevtera moved towards FDA approval, this event is expected by mid-year 2024.


In the meantime, Basilea has taken the opportunity to further showcase the profile of Zevtera, presenting new details from ERADICATE at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) meeting in Barcelona. This presentation builds on additional detail from ERADICATE presented at IDWeek in the US in 2022 which showed that the primary endpoint result was achieved irrespective of whether patients were infected with MSSA or MRSA bloodstream infections at baseline.


As a reminder, 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 comparator daptomycin (68.7%). With a NI delta of +2% (-7.1%-11.1%), the result of ERADICATE was clearly well within the predefined 15% NI margin for the primary endpoint.


In the three posters presented at ESCMID, the focus was largely on the relevance of patients included in the ERADICATE study. One poster demonstrated the efficacy and safety of ceftobiprole in patients with a compromised kidney function (renal impairment,) while another detailed the broad and complex infection types at baseline, which included 30% of patients with more than one underlying infectious condition, foci or complications. These included dialysis, soft tissue infections, abdominal and thoracic abscesses, osteoarticular infections and right-sided endocarditis. The final poster demonstrated the rapid action of ceftobiprole in SAB patients with systemic clearance at four days (median) in both the ceftobiprole and comparator groups. Reassuringly, fewer patients in the ceftobiprole group had positive blood cultures for S. aureus at 10 days compared to the comparator group.


Additionally, an oral presentation detailed the results of an analysis of the data supporting the approval of ceftobiprole in CABP. Given that a positive result from both TARGET (SSSI) and ERADICATE (SAB) was required for FDA approval as part of the Special Protocol Assessment, perhaps the addition of the CABP indication was overlooked as an important element of the prescribing label. Nevertheless, Basilea has undertaken a reanalysis of the data under the auspices of the current FDA guidance for the development of drugs for CABP, and using a primary endpoint of early clinical success at day 3, ceftobiprole met the primary endpoint of non-inferiority to ceftriaxone +/- linezolid.


All told, we believe that the data accumulated throughout the development of ceftobiprole supports our peak sales estimate of approximately $400m. We look forward to Basilea securing a suitable commercial partner to finally de-risk this element of the Basilea investment case.


We calculate a discounted cash flow fair value of CHF 105 per share for Basilea.


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IMPORTANT:


Calvine Partners LLP is authorised and regulated by the Financial Conduct Authority.

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.




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