Basilea has announced this morning that Astellas, the US partner for its antifungal Cresemba has received a paediatric extension from FDA. This paediatric approval extends the current adult label for the treatment of invasive aspergillosis and invasive mucormycosis to patients one year of age and older for the injectable formulation, and from six years of age for Cresemba capsules.
The paediatric population is an important market for Cresemba and generally includes children with haematological malignancies as well as other immunocompromised patients. Paediatric approval is also important to the extent that it brings six months of additional exclusivity, taking the US Cresemba exclusivity to September 2027, as anticipated. Our forecasts suggest that exclusivity in both the US and Europe extends to Q4 2027, assuming that Cresemba is also granted a paediatric extension in Europe which would add a further two years, taking market exclusivity to October 2027. Basilea expects a decision regarding the EU in H1 2024.
While sales of Cresemba will continue in important markets like China and Japan, Basilea has been keen to add longevity to its antifungal franchise, principally through the in-licensing route. We believe that the recent acquisition of the novel antifungal fosmanogepix should significantly boost the anti-infective franchise at Basilea, and we look forward to the commencement of Phase 3 evaluation in both candidaemia/invasive candidiasis and invasive mould infections starting in mid-2024 and end 2024 respectively. Phase 2 data have been highly supportive of the profile of fosmanogepix with a broad spectrum of activity, including coverage of all of the fungal pathogens highlighted in the critical group detailed for the first time by WHO in 2022. Additionally, as a novel first-in-class antifungal, fosmanogepix has activity against many fungal pathogens resistant to existing antifungal classes (including azole-resistant aspergillus). It is also available in both oral and intravenous formulations and provides wide tissue distribution, including the brain, neatly addressing many of the limitations of existing antifungal classes.
Following the recent fosmanogepix acquisition, our previous discounted cash flow fair value of CHF91 is under review.
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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 in this publication should be considered as any form of advice.