The US market, particularly for MRSA therapies, is pivotal for the overall commercial success of new antibiotics, and the Swiss biotech, Basilea Pharmaceutica Ltd., needs good results from both ongoing Phase III studies of its rapid-acting broad-spectrum intravenous cephalasporin, ceftobiprole, to launch in that market, an event penciled in for 2022.
Ceftobiprole is already marketed in the EU and other ex-US markets by licensees and distributors, as Zevtera, and has just achieved positive top-line results in the Phase III TARGET study in patients with acute bacterial skin and skin structure infections (ABSSSI), the first of two-Phase III studies conducted under a special protocol assessment (SPA) agreement