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Basilea - FDA orphan designation for lisavanbulin

Updated: Aug 7, 2021

The announcement this morning that the US FDA granted Orphan Drug Designation to Basilea's lisavanbulin highlights its growing importance as a potential treatment of glioblastoma (brain cancer). Orphan drug designation qualifies lisavanbulin for various development incentives, longer market exclusivity and likely premium pricing.

With lisavanbulin, Basilea has adopted a targeted approach to glioblastoma seeking to deliver a chemotherapy that combines strong efficacy with reduced resistance and an ability to cross the blood-brain barrier. Basilea is examining the presence of end-binding protein 1 (EB1) as a predictive biomarker that could improve the identification of patients suitable for lisavanbulin treatment across various types of cancer. Data so far suggest that the identification of EB1 in patients' tumour tissue significantly improves outcomes. The use of this biomarker has the potential to reduce the risk of treatment failure, and data presented at recent cancer conferences supports EB1 use. Data have been extremely encouraging so far, and its development has caught the attention of several media and medical publications.

Basilea is currently conducting a phase 1/2 study for lisavanbulin in patients with recurrent glioblastoma, using end-binding protein 1 (EB1) for patient selection, and interim results from the Phase 2 part of the study are expected in the second half of 2021.

Please see our recent publication for more details on lisavanbulin, where we explore recent data and the prospects for the drug.

We have calculated a discounted cash flow fair value of CHF120 for Basilea and further success with lisavanbulin will provide an important upside.

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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 contained in this publication should be considered as any form of advice.



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