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Basilea focuses on the development of antibiotics, antifungals and oncology drugs, targeting the medical challenge of resistance and non-response to current treatment options.


Pipeline_2017

  • Isavuconazole is an intravenous (i.v.) and oral azole antifungal and the active agent of the prodrug isavuconazonium sulfate. It is approved in the United States for patients 18 years of age and older for the treatment of invasive aspergillosis and invasive mucormycosis.1 In Europe, isavuconazole holds marketing authorization for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate.2 Isavuconazole has orphan drug designation for the approved indications in Europe and the US. Basilea commercializes isavuconazole as CRESEMBA® in Germany, Italy, the UK and Austria, and is seeking national pricing and reimbursement in additional EU countries. In the US, the drug is commercialized by Basilea's license partner Astellas Pharma US. Outside the US and the EU, isavuconazole is currently not approved for commercial use. 

  • Ceftobiprole is a broad-spectrum antibiotic from the cephalosporin class for i.v. administration with bactericidal activity against certain Gram-positive and Gram-negative bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and susceptible Pseudomonas spp.3 Ceftobiprole is approved for sale in 13 European countries4 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).3 The drug is currently commercialized in Germany, Italy, the United Kingdom France, Austria and Switzerland. Ceftobiprole received Qualified Infectious Disease Product (QIDP) designation from the FDA for the potential treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Ceftobiprole is not approved in the United States. In April 2016, Basilea signed an agreement with BARDA5 to support a clinical phase 3 program to potentially gain regulatory approval in the US.

Basilea's pipeline includes two early-stage oncology drug candidates:

  • BAL101553 is a clinical stage tumor checkpoint controller being developed as a potential therapy for diverse cancers, including tumor types unresponsive to standard therapies. It is currently undergoing clinical phase 1/2a studies (oral and continuous infusion) in patients with advanced solid tumors. A phase 1/2a study with i.v. BAL101553 has been completed. 
  • BAL3833 is a phase 1 oral anti-cancer drug candidate (panRAF/SRC kinase inhibitor) targeting cell proliferation signaling pathways that are associated with tumor growth and the development of resistance to current therapies. It is the lead compound of a series of kinase inhibitors in-licensed by Basilea under an agreement with The Institute of Cancer Research, London, Cancer Research Technology, the Wellcome Trust and The University of Manchester. A phase 1 study of BAL3833 in adult patients with advanced solid tumors including metastatic melanoma is ongoing. 

 

Footnotes

1.  CRESEMBA® US prescribing information

2. The marketing authorization for isavuconazole is valid in all 28 European Union (EU) member states as well as in Iceland, Liechtenstein and Norway.

3. UK Summary of Product Characteristics (SPC) for Zevtera®)

4. Ceftobiprole (European trade name Zevtera® or Mabelio®, depending on the country) has received national licenses for the treatment of adult patients with community- and hospital-acquired pneumonia, excluding ventilator-associated pneumonia, in Austria, Belgium, Denmark, Finland, France, Germany, Italy, Luxembourg, Norway, Spain, Sweden, Switzerland and the United Kingdom. Ceftobiprole is not approved in the United States.

5. Biomedical Advanced Research and Development Authority (BARDA), a division within the US Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response. Contract No. HSO100201600002C

 
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