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FDA accepts ceftobiprole's NDA

The US FDA has accepted the New Drug Application (NDA) for Basilea's antibiotic ceftobiprole and set 3 April 2024 as the Prescription Drug User Fee Act (PDUFA) date - the day by which a final decision on drug approval should be given. Basilea is seeking approval for ceftobiprole in three indications: Staphylococcus aureus bacteraemia (SAB), acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).

Of the circa $400m peak sales we forecast, we believe the SAB indication is the largest commercial opportunity, given the unmet need and the limited treatment options for patients suffering from resistant infections such as MRSA.


Ceftobiprole has been designated as a Qualified Infectious Disease Product (QIDP), and so from the approval date, it should receive ten years of market exclusivity in the US. Basilea is planning to commercialize ceftobiprole in the US through a partner and intends to enter such a partnership prior to the PDUFA goal date in April. We believe successful execution here should represent a key de-risking event for Basilea.


Basilea’s strong revenue growth and anti-infectives franchise are currently dominated by the anti-fungal Cresemba. Cresemba is facing the loss of exclusivity in the US and Europe from 2027, and therefore ceftobiprole is an important product to bolster growth further out. However, it should be noted that Cresemba sales should still be supported by revenue from recently launched markets such as China and Japan.


We calculate a discounted cash flow fair value of CHF 91 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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