Saturday, August 05, 2023
Basilea Pharmaceutica Ltd, a publicly traded biopharmaceutical company listed on the SIX Swiss Exchange (SIX: BSLN), has recently disclosed the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA). This NDA is for their antibiotic ceftobiprole, intended to treat patients in three specific indications: Staphylococcus aureus bacteremia (SAB), including right-sided infective endocarditis, acute bacterial skin and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP).
Dr. Marc Engelhardt, serving as the Chief Medical Officer at Basilea, stated that Staphylococcus aureus bacteremia is a common and serious bloodstream infection with a significant impact on patients' health. The phase 3 clinical program completed by Basilea demonstrates the efficacy of ceftobiprole in treating this complex infection. Additionally, the successful phase 3 studies conducted for ABSSSI and CABP further support the broad potential of ceftobiprole in treating severe bacterial infections in the US, especially when dealing with methicillin-resistant Staphylococcus aureus (MRSA) bacteria.
The NDA submission includes comprehensive clinical efficacy and safety data from the phase 3 studies, namely ERADICATE (SAB), TARGET (ABSSSI), and a phase 3 study focusing on CABP. Notably, the ERADICATE study was the largest double-blind randomized registrational study ever conducted for a new antibiotic treatment targeting SAB.
Ceftobiprole has received a Qualified Infectious Disease Product (QIDP) designation under the US Generating Antibiotic Incentives Now (GAIN) Act, which qualifies it for Priority Review within eight months of submission. Assuming the NDA submission is accepted, Basilea anticipates a decision from the FDA in the second quarter of 2024. The company's strategy involves partnering with a commercialization partner for the US market, and discussions are likely to take place before the FDA's decision on the NDA.
Basilea's ceftobiprole phase 3 program has been supported in part by funding from the US Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), through contract number HHSO100201600002C. Basilea has received around USD 112 million, covering approximately 75 percent of the costs related to the SAB and ABSSSI phase 3 studies, regulatory activities, and non-clinical work.
Ceftobiprole, administered intravenously as ceftobiprole medocaril, is a cephalosporin antibiotic known for its rapid bactericidal activity against a broad spectrum of Gram-positive bacteria, including methicillin-resistant strains of Staphylococcus aureus (MRSA), as well as Gram-negative bacteria. The drug is currently approved and marketed under the brand names Zevtera® and Mabelio® in multiple countries outside the US, specifically for treating adult patients with hospital-acquired bacterial pneumonia (HABP) and community-acquired bacterial pneumonia (CABP), excluding ventilator-associated bacterial pneumonia (VABP). However, ceftobiprole is not yet approved or partnered in the United States.
