Under the agreement, Menarini will buy the exclusive rights to commercialise cefepime-taniborbactam in 96 countries in return for a licensing fee, R&D payments, regulatory, sales-based milestone payments
Venatorx and Menarini Group partner on Cefepime-Taniborbactam commercialisation. (Credit: Myriams-Fotos from Pixabay)
US-based Venatorx Pharmaceuticals has signed an agreement to grant the exclusive rights of investigational cefepime-taniborbactam to Italian biopharmaceutical firm Menarini Group.
Venatorx’s lead asset cefepime-taniborbactam is an intravenous (IV) beta-lactam/beta-lactamase inhibitor (BL/BLI) antibiotic combination that completed a Phase 3 study.
It is being developed to treat complicated urinary tract infections (cUTIs), including pyelonephritis, hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
Under the commercial agreement, Menarini Group will buy the exclusive rights to commercialise cefepime-taniborbactam, subject to clearance from relevant health agencies, in 96 countries in Europe, Latin America, the Middle East, Turkey, North Africa, and the Commonwealth of Independent States (CIS).
The agreement states that the pharmaceutical company will get an upfront licensing fee and additional Research and development (R&D) payments.
Venatorx will also get regulatory, sales-based milestone payments, and potential royalty payments as per the net sales percentage.
Menarini Group CEO Elcin Barker Ergun said: “At Menarini, we believe that the addition of cefepime-taniborbactam expands our existing AMR anti-infectives portfolio and provides the opportunity to further strengthen our building of an important antibiotics portfolio focused on the critical pathogens responsible for the vast majority of antibiotic resistance.
“By leveraging our expertise and Menarini’s expansive commercial infrastructure, we will provide the resources needed to optimise the commercialisation, upon approval of relevant health authorities, of cefepime-taniborbactam and ensure patient access to this medicine across our global footprint.”
The antibiotic combination’s New Drug Application was accepted for review by the US Food and Drug Administration (FDA) for cUTI, including pyelonephritis with a Prescription Drug User Fee Act (PDUFA) date of 22 February 2024.
Cefepime-taniborbactam has also received US FDA Qualified Infectious Disease Product (QIDP) and Fast Track designations to treat cUTI and HABP/VABP.
In September 2018, Venatorx partnered with Everest Medicines to commercialise the combination in the People’s Republic of China, Macau, Hong Kong, Taiwan, South Korea, and select countries in Southeast Asia.
The company signed an agreement with Melinta Therapeutics in November 2023 to commercialise cefepime-taniborbactam in the US.
Venatorx CEO Christopher Burns said: “With its global commercial infrastructure and significant experience in commercialising infectious disease products, including antibiotics, Menarini is ideally positioned to bring cefepime-taniborbactam to key geographic markets.”