Menarini will obtain the sole rights for the marketing of the antibiotic. Credit: fizkes / Shutterstock.com.

Venatorx Pharmaceuticals and the Menarini Group have signed an agreement for the commercialisation of the antibiotic cefepime-taniborbactam in 96 countries, contingent upon regulatory approvals.

Menarini will obtain the sole rights for the marketing of the antibiotic in the Commonwealth of Independent States, Europe, Latin America, the Middle East, North Africa and Turkiye.

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Cefepime-taniborbactam is an investigational intravenous beta-lactam/beta-lactamase inhibitor antibiotic combination to treat complicated urinary tract infections (cUTIs).

Venatorx is eligible for an upfront licensing fee, additional payments for research and development, regulatory and sales-based milestone payments and royalties on net product sales.

The FDA has accepted the new drug application for the antibiotic to treat cUTIs, including pyelonephritis, for review.

It set a Prescription Drug User Fee Act date of 22 February 2024.

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The antibiotic has also received Qualified Infectious Disease Product and fast track designations from the FDA for treating cUTIs, hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.

Venatorx and Everest Medicines made a licence deal in September 2018 to support cefepime-taniborbactam’s development, registration and marketing in several territories.

In April 2020, Venatorx and the Global Antibiotic Research and Development Partnership collaborated to expedite the development and accessibility of the antibiotic for both adults and children.

In November 2023, Venatorx signed an exclusive licence deal with Melinta Therapeutics for the commercialisation of the drug in the US market.

Venatorx CEO Christopher Burns stated: “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.

“Development of novel antibiotics with comprehensive resistance coverage is necessary to address critical global unmet medical needs and provide hope for patients and healthcare providers alike to effectively treat the rapidly growing number of drug-resistant gram-negative infections.”