Basilea focuses on anti-infectives and oncology. Lead products are Cresemba (an antifungal), which is approved in the US and Europe, and Zevtera (an anti-MRSA broad-spectrum antibiotic), approved in many European and non-European countries for pneumonia.
Basilea has two approved hospital-based products: Cresemba (severe mould infections) and Zevtera (bacterial infections). Multiple licensing/distribution agreements are in place for Cresemba and Zevtera which should drive top-line growth: including Pfizer, which markets Cresemba in Europe (ex Nordics) and other territories, and Astellas, which markets Cresemba in the US. Phase III registration trials in the US are ongoing for Zevtera in ABSSSI (top line H219) and in SAB (top line H221), both are required for a US FDA submission. Basilea’s oncology pipeline is spearheaded by in-licensed asset derazantinib (pan-FGFR inhibitor), which is in a Phase II registration study (FIDES-01) for intrahepatic cholangiocarcinoma that recently enrolled the first patient into an additional cohort of the study. A Phase I/II study for derazantinib in patients with advanced urothelial cancer is expected to initiate mid-2019, using both a monotherapy and combination approach with Roche’s PD-L1 antibody atezolizumab (Tecentriq).
There is an ever-increasing need for therapeutic agents that are efficacious against drug-resistant strains of bacteria (eg MRSA), fungus or cancer. Hence, the opportunities for Zevtera, Cresemba and Basilea’s oncology pipeline could be significant.