top of page
shutterstock_2330386787.jpg

Basilea Pharmaceutica

Zevtera FDA Approval

Basilea_logo_edited.png

4 April 2024

The approval of Zevtera (ceftobiprole) represents the company's determination to bring this important treatment option to patients in the key US market. Zevtera has been approved by FDA for the treatment of Staphylococcus aureus bacteraemia (SAB), including those with right-sided infective endocarditis and acute bacterial skin and skin structure infections (ABSSSI) as well as adults and children with community-acquired bacterial pneumonia (CABP). We believe there is a real unmet need for patients with SAB, with approximately 120,000 cases in the US, and particularly where MRSA is involved.

 

Serving an acute unmet medical need

​

The presence of MRSA leads to poorer outcomes, with 15%-50% mortality rates in patients with MRSA bacteraemia. The glycopeptides vancomycin and daptomycin are first-line treatments in MRSA bacteraemia, requiring 4-6 weeks of intravenous therapy. Metastatic infections often require surgical intervention and can result in extended hospitalisation. However, both daptomycin and vancomycin have concerns over emerging resistance (and the potential for cross-resistance), as well as vancomycin's poor tissue distribution and risk of renal toxicity. Additionally, daptomycin is inactivated in the lung, rendering it useless for the treatment of respiratory infections. As a result, we believe there is a clear need for new, effective, and well-tolerated treatment options like Zevtera.

​

Management delivering

​

Our $400m peak sales forecast is based primarily on the need for effective treatment options for SAB, mainly where resistant bacteria (MRSA) are involved. Furthermore, the importance of ceftobiprole has been reflected in BARDA's provision of $112m (approximately 75%) of the funding for clinical development and regulatory activity. FDA approval of ceftobiprole is also important to the extent that it provides a product at the beginning of its product life cycle. The company has been very active recently, bolstering its antibacterial pipeline with the endolysin tonabacase, which could act synergistically with ceftobiprole. 

​

Substantial de-risking ongoing

​

The approval of ceftobiprole represents another element of the ongoing de-risking, along with the recent acquisition of the novel Phase 3-ready anti-fungal fosmanogepix. While the initial objective was to deliver a partner before FDA approval, we note commentary today that details the heightened interest received as Zevtera approached US approval. As such, we look forward to the attraction of a suitable commercial partner by mid-year 2024, which should allow Zevtera to reach its full commercial potential.

Disclosures

 

Calvine Partners LLP is authorised and regulated by the Financial Conduct Authority for UK investment advisory and arranging activities.

 

This publication has been commissioned and paid for by Basilea Pharmaceutica and as defined by the FCA is not independent research. This report is considered a marketing communication under FCA Rules. It has not been prepared under the laws and requirements established to promote the independence of investment research. It is not subject to any prohibition on dealing ahead of the dissemination of investment research. This information is widely available to the public.

 

This report in the United Kingdom is directed at investment professionals, certified high net worth individuals, high net worth entities, self-certified sophisticated investors, and eligible counterparties as defined by the Financial Services and Markets Act 2000 (Financial Promotion) Order 2000. The report may also be distributed and made available to persons to whom Calvine Partners is lawfully permitted. This publication is not intended for use by any individual or entity in any jurisdiction or country where that use would breach law or regulations or which would subject Calvine Partners or its affiliates to any registration requirement within such jurisdiction or country.

 

Calvine Partners may provide, or seek to provide, services to other companies mentioned in this report. Partners, employees, or related parties may hold positions in the companies mentioned in the report subject to Calvine Partners' personal account dealing rules.

 

Calvine Partners has only used publicly available information believed to be reliable at the time of this publication and made its best efforts to ensure that the facts and opinions stated are fair, accurate, timely and complete at the publication date. However, Calvine Partners provides no guarantee concerning the accuracy or completeness of the report or the information or opinions within. This publication is not intended to be an investment recommendation, personal or otherwise, and it is not intended to be advice and should not be treated in any way as such. Any valuation estimates, such as those derived from a discounted cash flow, price multiple, or peer group comparison, do not represent estimates or forecasts of a future company share price. In no circumstances should the report be relied on or acted upon by non-qualified individuals. Personal or otherwise, it is not intended to be advice and should not be relied on in any way as such. 

 

This report's forward-looking statements, information, estimates and assumptions are not yet known, and uncertainties may cause the actual results, performance or achievements to significantly differ from expectations.

 

This report does not constitute an offer, invitation or inducement to engage in a purchase or sale of any securities in the companies mentioned. The information provided is for educational purposes only, and this publication should not be relied upon when making an investment decision or entering into a commercial contract. The past performance of any security mentioned is not a reliable indicator of future results. Readers should seek appropriate, independent advice before acting on any of the information contained herein. This report should not be considered investment advice, and Calvine Partners will not be liable for any losses, costs or damages arising from the use of this report. The information provided in this report should not be considered personalised advice.

 

Calvine Partners LLP, its affiliates, officers or employees do not accept any liability or responsibility with regard to the information in this publication. None of the information or opinions in this publication has been independently verified. Information and opinions are subject to change after the publication of this report, possibly rendering them inaccurate and/or incomplete.

 

Any unauthorised copying, alteration, distribution, transmission, performance, or display of this report is prohibited.

Basilea Income Statement (CHF 000s) 

Source: Calvine Partners Research

Basilea Cash Flow (CHF 000s) 

Source: Calvine Partners Research

Basilea Balance Sheet (CHF 000s) 

Source: Calvine Partners Research
bottom of page