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 with 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 in H221 and 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 potential registration study for intrahepatic cholangiocarcinoma and a Phase I/II study in patients with advanced urothelial cancer. Top-line data from a Phase IIa study investigating BAL101553 in glioblastoma and ovarian cancer patients can be expected before end-2019.
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.