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20180813 Updated Pipeline HYR 2018 WEB

Basilea focuses on developing products that address the medical challenge of increasing resistance and non-response to current treatment options in the therapeutic areas of bacterial infections, fungal infections and cancer.

  • Isavuconazole is an intravenous (i.v.) and oral azole antifungal and the active agent of the prodrug isavuconazonium sulfate. It received marketing authorization in Europe for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate.1 It is approved in the United States for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis.2 In Switzerland, isavuconazole is approved for the treatment of adult patients with invasive aspergillosis and for the treatment of mucormycosis in adult patients who are resistant to or intolerant of amphotericin B and in adult patients with moderate to severe renal impairment.3

  • Ceftobiprole is a cephalosporin antibiotic for i.v. administration with rapid bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria, including methicillin-susceptible and resistant Staphylococcus aureus (MSSA, MRSA) and susceptible Pseudomonas spp. The drug is approved for sale in major European countries and several non-European countries for the treatment of adult patients with community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP).4

Basilea's pipeline includes three oncology drug candidates in different stages of development:

  • Derazantinib is an investigational, oral, multi-kinase inhibitor designed to preferentially inhibit the FGFR family of kinases, a key driver of cell proliferation, differentiation and migration. The drug candidate is currently in a clinical study for intrahepatic cholangiocarcinoma (iCCA), a form of biliary tract cancer for a potential registration. It has demonstrated favorable clinical data in a biomarker-driven Phase 1/2 study in iCCA patients. Both the FDA and EMA have granted orphan drug designation for this disease. Derazantinib is currently not approved in any jurisdiction.
  • BAL101553 is a clinical stage tumor checkpoint controller being developed as a potential therapy for diverse cancers, including tumor types unresponsive to standard therapeutics. BAL101553 is currently not approved in any jurisdiction. 
  • BAL3833 is a phase 1 orally available small-molecule drug candidate. It is a panRAF/SRC kinase inhibitor as it blocks BRAF and CRAF and also inhibits the SRC kinase family. BAL3833 is currently not approved in any jurisdiction. 



1.  European Public Assessment Report (EPAR) Cresemba

2. Cresemba U.S. prescribing information

3. Full indication in: Swissmedic-approved information for healthcare professionals as of August 2017

4. U.K. Summary of Product Characteristics (SPC)