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Basilea Pharmaceutica Ltd. is a commercial stage biopharmaceutical company 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. With two commercialized drugs, the company is committed to discovering, developing and commercializing innovative pharmaceutical products to meet the medical needs of patients with serious and life-threatening conditions. Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed on the SIX Swiss Exchange (SIX: BSLN).

Portfolio 

Basilea has currently two products on the market.

  • 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 Isavuconazole has orphan drug designation for the approved indications in Europe and the U.S. and was designated a Qualified Infectious Disease Product (QIDP) by the U.S. Food and Drug Administration (FDA) under the Generating Antibiotics Incentives Now (GAIN) Act. Basilea has entered into license and distribution agreements for isavuconazole in the U.S., Europe, China, Japan, Latin America, Asia-Pacific, the Middle East and North Africa region, Canada, Russia, Turkey and Israel. Outside the U.S. and the EU, isavuconazole is currently not approved for commercial use.
  • 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 It received Qualified Infectious Disease Product (QIDP) designation from the FDA for the potential treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Ceftobiprole is currently marketed in Germany, Italy, the United Kingdom, France, Austria and Switzerland. Basilea has entered into license and distribution agreements for the drug in Europe, Latin America, China, the Middle East and North Africa (MENA) region, Canada and Israel. Basilea has started a clinical phase 3 study in ABSSSI, which is the first of two cross-supportive phase 3 studies aiming at regulatory approval of ceftobiprole in the United States. The second study will be in Staphylococcus aureus bacteremia (SAB). Both studies will be conducted under a Special Protocol Assessment with the FDA. The phase 3 program is funded in part (up to USD 118 million, which is approximately 70% of the total estimated program costs) with Federal funds from the U.S. Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201600002C.

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

  • 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 small-molecule tumor checkpoint controller being developed as a potential therapy for diverse cancers, including tumor types unresponsive to standard therapeutics. The drug candidate is currently in phase 1/2a clinical evaluation. One study has two separate arms and evaluates once-daily oral BAL101553 in advanced solid tumors (dose-escalation completed) and recurrent glioblastoma (ongoing). A second study (phase 2a expansion) is evaluating BAL101553 as a weekly 48-hour i.v. infusion in recurrent glioblastoma and in platinum-resistant or refractory ovarian cancer. An additional phase 1 study is evaluating oral BAL101553 in combination with standard radiotherapy in patients with newly-diagnosed glioblastoma which have a reduced sensitivity to standard chemotherapy. 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. The compound originates from The Institute of Cancer Research in London where it was developed by scientists funded by Cancer Research UK and the Wellcome Trust. It is currently being explored as a daily oral administration in a clinical phase 1 dose-escalation study in adult patients with advanced solid tumors, including metastatic melanoma. BAL3833 is currently not approved in any jurisdiction.

 

Footnotes

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)

 

History 

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


 
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