Basilea Pharmaceutica Ltd. Logo
 

Corporate information

 
 
 

Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (SIX: BSLN). Through the integrated research, development and commercial operations of its Swiss subsidiary Basilea Pharmaceutica International Ltd., the company focuses on providing innovative pharmaceutical products in the therapeutic areas of bacterial infections, fungal infections and oncology, targeting the medical challenge of rising resistance and nonresponse to current treatment options.

Portfolio 

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

  • Isavuconazole is an intravenous (i.v.) and oral azole antifungal. The drug was approved in March 2015 by the United States Food and Drug Administration (FDA) for patients 18 years of age and older for the treatment of invasive aspergillosis and invasive mucormycosis. The European Commission granted marketing authorization1 in October 2015 to isavuconazole for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate. Isavuconazole has orphan drug designation for approved indications in Europe and the U.S. Basilea has licensed the U.S. rights to Astellas Pharma Inc. Isavuconazole is commercialized under the trade name CRESEMBA® by Basilea in certain European countries and by Astellas in the U.S. Outside the U.S. and the EU, isavuconazole is currently an investigational product and not approved for commercial use. The drug was co-developed by Basilea and its U.S. licensee Astellas.
  • Ceftobiprole is a broad-spectrum antibiotic 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.2 Ceftobiprole is approved for sale in 13 European countries3 and certain non-European countries for the treatment of adult patients with community-acquired pneumonia and hospital-acquired pneumonia (excluding ventilator-associated pneumonia).2 The drug has been launched in Germany, France, Italy, the United Kingdom and Austria. 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 a contract with BARDA4 for up to USD 100 million funding for a clinical phase 3 program to potentially gain regulatory approval in the U.S.

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 therapeutics. It is currently undergoing clinical phase 1/2a evaluation in patients with advanced solid tumors as a once-daily oral dose. It showed clinical anti-tumor activity in a previous phase 1/2a study with weekly 2-hour i.v. infusion. BAL101553 is currently not approved in any jurisdiction.
  • 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. BAL3833 is currently not approved in any jurisdiction.

    Alitretinoin is an oral dermatology drug for systemic use in adults with severe chronic hand eczema unresponsive to potent topical corticosteroids. Global rights to the drug were transferred to Stiefel, a GlaxoSmithKline (GSK) company, in July 2012. GSK is marketing the drug in several countries; in the U.S., alitretinoin is an investigational drug and not approved by the FDA. In January 2016, GSK informed Basilea that it had elected to discontinue its U.S. alitretinoin program. Basilea has initiated discussions with GSK for transferring the U.S. rights back to Basilea

 

Footnotes

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

2. UK Summary of Product Characteristics (SPC).

3. Ceftobiprole 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.

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

 

History 

Basilea was founded in 2000 and went public on the SIX Swiss Exchange in 2004.


 
Info