Fosfomycin Tromethamine

Meitheal Pharmaceuticals has secured North America rights to Nabriva Therapeutics’ intravenous broad-spectrum antibiotic Contepo (fosfomycin for injection), which has been stuck in regulatory limbo in the US since 2020. However, an FDA decision on the injectable for treating complicated urinary tract infections (cUTIs) is expected later this year. Dubbing it a “novel therapeutic with the potential to address a significant unmet need around increasing antibiotic resistance,” Tom Shea, chief executive of Meitheal, said the company is “uniquely positioned to advance Contepo through the final stages of the regulatory process and…deliver a…high-quality antibiotic to patients and providers.”As part of the deal, Meitheal gains licensing rights and all associated intellectual property, technology and know-how for Contepo, while Nabriva stands to receive an undisclosed payment at closing and royalties on US sales.While the oral form of fosfomycin – marketed as Monurol in the US by AbbVie – was cleared by the FDA in 1997 to treat uncomplicated UTIs in women, Nabriva’s injectable version has been rejected twice by the US regulator in 2019 and 2020. Both complete response letters cited deficiencies related to facility inspections and manufacturing processes at contract manufacturing sites in Europe.With this acquisition, Meitheal has added a second asset to its specialty portfolio, after bagging North America rights to Xentria’s anti-TNFα antibody XTMAB-16 last year. Meitheal’s buyouts align with the broader vision of its parent company Nanjing King-Friend Biochemical Pharmaceutical to focus on branded biopharmaceuticals.