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 and should drive top-line growth, including Pfizer and Astellas, which market Cresemba in Europe (ex Nordics) and the US, respectively. In August, Basilea reported positive top-line data for Zevtera in the first cross-supportive Phase III study TARGET; top-line data from the ERADICATE study are expected H221, both are required for a US FDA submission. Basilea’s oncology pipeline is spearheaded by derazantinib (pan-FGFR inhibitor), which is in a Phase II registration study for intrahepatic cholangiocarcinoma. A Phase I/II study for derazantinib in patients with advanced urothelial cancer has now been initiated, 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.