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 mold infections) and Zevtera (bacterial infections). Multiple licensing/distribution agreements are in place for Cresemba and Zevtera, which should drive top-line growth; revenues from these anti-infectives were up 56% y-o-y (FY18 CHF82m) and in February a $5m milestone was triggered from Pfizer. which markets Cresemba in Europe (ex Nordics), Russia, Turkey, Israel, China and Asia-Pacific. US Phase III registration trials have initiated 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 for intrahepatic cholangiocarcinoma that reported promising interim data in January. A Phase I/II study combing derazantinib with Roche’s PD-L1 antibody atezolizumab (Tecentriq) in patients with advanced urothelial cancer is expected to initiate mid-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.