Swiss biopharma Basilea Pharmaceutica has been awarded an additional $54.8 million under its existing Biomedical Advanced Research and Development Authority (BARDA) contract for Phase III development of its broad-spectrum cephalosporin antibiotic ceftobiprole, for supporting future regulatory filing in the U.S. The additional funding relates to BARDA’s exercise of two options, and takes the total potential value of the 4.5-year contract to $108 million, to support two cross-supportive Phase III studies evaluating ceftobiprole in the treatment of Staphylococcus aureus bloodstream infections and acute bacterial skin and skin structure infections (ABSSSI).
Basilea has already received $20 million under the original ceftobiprole development contract with BARDA, which was announced back in April 2016. Commenting on the additional funding, Basilea’s CMO Achim Kaufhold, M.D., stated, “Basilea has recently achieved important milestones, including the agreement with the FDA on Special Protocol Assessments for the two clinical Phase III studies in Staphylococcus aureus bacteremia and skin infections. BARDA has therefore exercised options under our agreement releasing the funding to support the next stage of the program. We anticipate initiating these studies within the next three to six months. If successful, our Phase III studies may allow for regulatory submission of ceftobiprole in the U.S. as well as support label extensions in other parts of the world.”
Ceftobiprole is an intravenously administered, broad-spectrum cephalosporin antibiotic that is active against certain Gram-positive and Gram-negative bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and susceptible Pseudomonas species. The drug is not approved in the U.S. for any indication, but has been awarded Qualified Infectious Disease Product (QIDP) designation by the FDA for the potential treatment of community-acquired bacterial pneumonia and ABSSSI. Ceftobiprole (Zevtera®/Mabelio®) is approved in 13 European countries and a number of non-European countries for the treatment of adult patients with community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP). Basilea has distribution agreements for the drug with several partners in more than forty countries.
Basilea’s antifungal agent isavuconazole (Cresemba®) was approved in the U.S. and Europe in 2015 for the treatment of invasive aspergillosis and invasive mucormycosis in adult patients. The drug is commercialized in the U.S. by Basilea’s licensee Astellas Pharma.
Basilea’s pipeline includes two early-clinical-stage oncology drug candidates. BAL101553 is an oral/intravenously administered tumor checkpoint controller undergoing Phase I/IIa studies in patients with advanced solid tumors. Earlier this month, the firm reported establishing a clinical study agreement with the Adult Brain Tumor Consortium to carry out a Phase I study evaluating BAL101553 combined with standard radiation therapy in newly diagnosed patients with glioblastoma that is resistant to standard chemotherapy due to an unmethylated O6-methylguanine-DNA-methyltransferase (MGMT) promoter.
Basilia’s second clinical candidate BAL3833 is an oral pan-RAF/SRC kinase inhibitor that is undergoing Phase I testing in adult patients with advanced solid tumors. BAL3833 is the lead compound in a series of kinase inhibitors licensed to Basiliea under an agreement with the U.K.’s Institute of Cancer Research, Cancer Research Technology, The Wellcome Trust, and the University of Manchester.