Basilea reported encouraging interim data for the derazantinib registrational Phase II trial in intrahepatic cholangiocarcinoma ("iCCA"), a few months earlier than we had anticipated. The overall response rate ("ORR") of 21% is in line with the efficacy observed in a previous Phase I/II trial and clinically relevant given the poor prognosis of the disease and the lack of 2nd line therapies, thus paving the way for a potential accelerated approval upon completion of the study in mid-2020E. The data supports clinical development of derazantinib in other fibroblast growth factor receptor ("FGFR") driven solid tumour indications, and one new trial is expected to start in mid-2019E. We conservatively forecast approval and launch in Q4/2023E based on Phase III data and peak sales of c.$70m in iCCA alone, with Basilea paying partner ArQule single-digit milestones related to iCCA. We maintain our OUTPERFORM recommendation and CHF112 target price ("TP"), of which derazantinib accounts for c.CHF1 per share, based on a 25% chance of success in iCCA.
10 Jan 2019
Derazantinib interim data in line with expectations
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Derazantinib interim data in line with expectations
Basilea Pharmaceutica AG (0QNA:LON) | 0 0 0.0% | Mkt Cap: 605.3m
- Published:
10 Jan 2019 -
Author:
Brigitte de Lima, PHD CFA -
Pages:
5
Basilea reported encouraging interim data for the derazantinib registrational Phase II trial in intrahepatic cholangiocarcinoma ("iCCA"), a few months earlier than we had anticipated. The overall response rate ("ORR") of 21% is in line with the efficacy observed in a previous Phase I/II trial and clinically relevant given the poor prognosis of the disease and the lack of 2nd line therapies, thus paving the way for a potential accelerated approval upon completion of the study in mid-2020E. The data supports clinical development of derazantinib in other fibroblast growth factor receptor ("FGFR") driven solid tumour indications, and one new trial is expected to start in mid-2019E. We conservatively forecast approval and launch in Q4/2023E based on Phase III data and peak sales of c.$70m in iCCA alone, with Basilea paying partner ArQule single-digit milestones related to iCCA. We maintain our OUTPERFORM recommendation and CHF112 target price ("TP"), of which derazantinib accounts for c.CHF1 per share, based on a 25% chance of success in iCCA.