Meitheal Pharmaceuticals has expanded its biopharmaceutical portfolio through the acquisition of rights to CONTEPO (fosfomycin for injection) from Nabriva Therapeutics for the North American region.
Meitheal gains access to the rights to CONTEPO, including development and regulatory works, intellectual property rights, technology and related know-how.
Nabriva will receive payment upon the agreement closing in addition to royalties on net sales of the injection in the US.
An intravenous broad-spectrum antibiotic, CONTEPO has shown activity against multi-drug resistant strains causing complicated urinary tract infections (cUTI).
Fosfomycin for intravenous administration is already marketed outside the US and has been approved for nine indications, including cUTI and other serious bacterial infections.
CONTEPO's new dosing approach aims to optimise the compound's pharmacokinetics and pharmacodynamics.
It met the primary endpoint in the ZEUS trial enrolling patients with cUTI.
Nabriva filed a new drug application with the US Food and Drug Administration (FDA) seeking approval for the injection to treat cUTI, including acute pyelonephritis.
A decision from the US regulator is expected in the second half of 2024.
Meitheal is preparing for the commercial launch by establishing a full commercial marketing and sales team, and a medical science liaison team to support clinicians.
Nanjing King-Friend Biochemical Pharmaceutical, the parent company of Meitheal, has made an investment of more than $300m in capital as well as research and development to support sustainable product supply in areas such as branded biopharmaceuticals.
Meitheal Pharmaceuticals CEO Tom Shea stated: “The strategic addition of CONTEPO to our robust product portfolio provides us with a novel therapeutic with the potential to address a significant unmet need around increasing antibiotic resistance.
“As a fully integrated biopharmaceutical company, Meitheal is uniquely positioned to advance CONTEPO through the final stages of the regulatory process and, if approved, deliver a consistent supply of this high-quality antibiotic to patients and providers in need of an innovative option for drug-resistant urinary tract infections.”
