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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. Basilea 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). 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 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, Japan, Latin America, the Middle East and North Africa (MENA) region, Canada, Russia, Turkey and Israel. In Europe, it is currently marketed in Germany, Italy, the United Kingdom, France, Austria and the Nordic countries. Pfizer is anticipated to assume the responsibility for commercializing the drug in Europe (excluding the Nordic countries) by the end of 2017. Basilea's license partner Astellas Pharma US markets the drug in the U.S. 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 13 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).3 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 distribution agreements for the drug in Latin America, the Middle East and North Africa (MENA) region, Canada and the Nordics. Basilea is preparing for the conduct of a clinical phase 3 program aiming at the regulatory approval of ceftobiprole in the United States. It consists of two cross-supportive phase 3 studies, one in the treatment of Staphylococcus aureus bacteremia (bloodstream infections) and the second one in ABSSSI. Basilea reached agreement with the FDA on Special Protocol Assessments for both studies. The program receives funding from the Biomedical Advanced Research and Development Authority (BARDA), the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, under contract number HHSO100201600002C. The total value of the contract, which was signed in 2016, could reach approximately USD 108 million over a period of 4.5 years if pre-defined milestones are met. Basilea's pipeline includes two early-stage oncology drug candidates: - 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. Basilea is exploring once-daily oral dosing of drug candidate BAL101553 (prodrug of BAL27862) in an open-label phase 1/2a study in adult patients with advanced solid tumors. This study was amended in late 2016 to include the enrollment of adult patients with recurrent or progressive glioblastoma (brain cancer) after prior radiotherapy with or without chemotherapy. In another phase 1/2a clinical study, Basilea is exploring weekly 48-hour continuous infusion of BAL101553 as an alternative dosing regimen for the treatment of solid tumors. Basilea entered into a clinical study agreement with the Adult Brain Tumor Consortium (ABTC) in the U.S., which will support a clinical phase 1 study with BAL101553 to determine the safety and tolerability of BAL101553 in combination with standard radiation. 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. 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. In March 2017, Basilea received the U.S. rights back from Stiefel.