Chicago-based Meitheal Pharmaceuticals has announced the acquisition of the North American rights to Contepo (fosfomycin for injection) from Nabriva Therapeutics.

Contepo is an intravenous antibiotic that shows broad-spectrum activity against many multi-drug resistant (MDR) strains that are responsible for complicated urinary tract infections (cUTI).

The acquisition is expected to expand the speciality biopharmaceuticals portfolio of Meitheal Pharmaceuticals, which is focused on generic injectables, fertility treatments, biologics, and branded products.

Under the asset purchase agreement, Meitheal Pharmaceuticals will receive all results of development and regulatory activities, along with all related intellectual property (IP) rights, technology, and expertise in North America.

In return, Nabriva Therapeutics will get a payment upon the agreement’s closure and a royalty based on the net sales of Contepo in the US.

Fosfomycin for intravenous administration has gained approval outside of the US for nine indications, including cUTI and other severe bacterial infections.

Contepo incorporates a dosing strategy designed to optimise its pharmacokinetics and pharmacodynamics.

It has demonstrated efficacy by meeting the primary endpoint in the ZEUS trial for patients suffering from cUTI, which includes acute pyelonephritis.

Nabriva Therapeutics has submitted the new drug application (NDA) for Contepo to the US Food and Drug Administration (FDA), seeking approval for the treatment of cUTI.

The FDA’s decision is anticipated later this year.

To support the drug’s commercial launch, Meitheal Pharmaceuticals will establish a comprehensive marketing and sales infrastructure, along with a medical science liaison (MSL) team.

Meitheal Pharmaceuticals CEO Tom Shea said: “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.”

According to Meitheal Pharmaceuticals, its parent company, Nanjing King-Friend Biochemical Pharmaceutical (NKF), has invested more than $300m in capital and research and development in recent years.

Last month, Meitheal Pharmaceuticals licensed Yusimry (adalimumab-aqvh), a biosimilar of Humira, from HKF for the US market.