Last close As at 05/08/2026
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CHF681m
Research: Healthcare
Basilea has announced that the results from its Phase III trial (ERADICATE) for ceftobiprole have been published the New England Journal of Medicine, a high-impact peer-reviewed medical journal. While these trial results were first shared in July 2022, we believe that the publication highlights positive data from the study as management awaits a regulatory decision on US approval. Basilea filed its new drug application (NDA) with the FDA for ceftobiprole in August 2023, and the ERADICATE study evaluated its application for Staphylococcus aureus bacteraemia (SAB), one of the three indications Basilea is seeking approval for. Management expects a decision from the FDA by Q224, potentially representing a significant catalyst for the company.
Written by
Basilea Pharmaceutica |
Zevtera (ceftobiprole) clinical data published |
Company update |
Pharma and biotech |
29 September 2023 |
Share price performance
Business description
Analysts
Basilea Pharmaceutica is a research client of Edison Investment Research Limited |
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Basilea has announced that the results from its Phase III trial (ERADICATE) for ceftobiprole have been published the New England Journal of Medicine, a high-impact peer-reviewed medical journal. While these trial results were first shared in July 2022, we believe that the publication highlights positive data from the study as management awaits a regulatory decision on US approval. Basilea filed its new drug application (NDA) with the FDA for ceftobiprole in August 2023, and the ERADICATE study evaluated its application for Staphylococcus aureus bacteraemia (SAB), one of the three indications Basilea is seeking approval for. Management expects a decision from the FDA by Q224, potentially representing a significant catalyst for the company.
Year |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/21 |
148.1 |
(6.6) |
(56.9) |
0.0 |
N/A |
N/A |
12/22 |
147.8 |
12.3 |
104.1 |
0.0 |
41.6 |
N/A |
12/23e |
158.2 |
43.5 |
332.2 |
0.0 |
13.9 |
N/A |
12/24e |
180.7 |
63.2 |
482.3 |
0.0 |
9.1 |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
Basilea has announced that the New England Journal of Medicine has published data from the Phase III ERADICATE clinical trial, the results for which were initially reported in July 2022. This was a double-blind, non-inferiority study (n=390) to assess ceftobiprole for the treatment of bacterial bloodstream infections caused by Staphylococcus aureus, also referred to as SAB, compared to daptomycin (plus optional aztreonam) as the standard of care. The primary endpoint was the demonstration of non-inferiority (15% non-inferiority margin) compared to the comparator arm. At 70 days post-randomisation in the modified intent-to-treat population, the results showed that the ceftobiprole arm had a 69.8% overall treatment success rate (vs 68.7% with daptomycin), indicating that the primary non-inferiority endpoint had been reached. Further, bloodstream clearance of methicillin-resistant Staphylococcus aureus (MRSA) bacteria was achieved in 93.3% of patients with ceftobiprole (vs 87.8% with daptomycin) after a median of five treatment days. Additionally, clearance of methicillin-susceptible Staphylococcus aureus bacteria was achieved in 94.3% of patients with ceftobiprole after a median of three treatment days (vs 95.2% with daptomycin after a median of four treatment days). Ceftobiprole also showed a desirable safety and tolerability profile.
As a reminder, Zevtera (ceftobiprole) is an intravenous beta-lactam antibiotic medication. In August 2023, Basilea announced that it had submitted an NDA application to the FDA, seeking approval for three indications: SAB, acute bacterial skin and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP). Approval of Zevtera in the US is a key strategic priority for Basilea, and a decision from the FDA is expected in Q224, potentially representing a major catalyst for investor attention. We also note that the FDA previously granted qualified infectious disease product (QIDP) designation to Zevtera, allowing up to 10 years of market exclusivity in the US, if successful with regulatory approval.
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Research: TMT
The Competition and Markets Authority (CMA) has given final approval to the takeover of EMIS by UnitedHealth. Subject to the scheme receiving the approval of the court at the sanction hearing on 25 October, the takeover is expected to complete on 27 October. On 23 October EMIS will pay the recently proposed interim dividend to shareholders on the register on 6 October without reducing the acquisition cash consideration.