Meitheal turns to Nabriva’s Contepo, aiming for third FDA approval

Meitheal Pharmaceuticals has obtained exclusive rights for North America to Nabriva Therapeutics' intravenous broad-spectrum antibiotic, Contepo (fosfomycin for injection). This antibiotic has faced regulatory challenges in the United States since 2020. However, there is an anticipated FDA decision on its use for treating complicated urinary tract infections (cUTIs) expected later this year.

Contepo is described as a novel therapeutic aimed at addressing the growing issue of antibiotic resistance. Tom Shea, the CEO of Meitheal, emphasized that the company is strategically positioned to guide Contepo through the final regulatory stages and deliver a high-quality antibiotic to both patients and healthcare providers.

Under the agreement, Meitheal will acquire the licensing rights, along with all related intellectual property, technology, and expertise for Contepo. In return, Nabriva will receive an undisclosed payment upon the deal's closing and will earn royalties from US sales of the drug.

The oral version of fosfomycin, marketed in the US by AbbVie as Monurol, was approved by the FDA in 1997 for the treatment of uncomplicated urinary tract infections (UTIs) in women. In contrast, Nabriva’s injectable version, Contepo, has faced setbacks, with the FDA issuing rejection letters in both 2019 and 2020. The rejections cited deficiencies in facility inspections and manufacturing processes at European contract manufacturing sites.

This acquisition adds a valuable asset to Meitheal’s specialty portfolio. Last year, the company acquired North American rights to XTMAB-16, an anti-TNFα antibody developed by Xentria. Meitheal’s recent acquisitions align with the strategic vision of its parent company, Nanjing King-Friend Biochemical Pharmaceutical, which aims to focus on branded biopharmaceuticals.