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– Venatorx Pharmaceuticals and Menarini Group sign commercial agreement for cefepime-taniborbactam in 96 countries

MALVERN, Pa. and FLORENCE, Italy, Jan. 10, 2024 /PRNewswire/ — Venatorx Pharmaceuticals, a privately held pre-commercial pharmaceutical company focused on improving health outcomes for patients with multidrug-resistant bacterial infections and difficult-to-treat viral infections, and Menarini Group , an Italian biopharmaceutical group, announced today that they have signed an agreement under which Menarini will acquire the exclusive rights to market, subject to approval by the relevant health authorities, cefepime-taniborbactam in 96 countries in Europe, Latin America, the Middle East, Turkey and the North of Africa and the Commonwealth of Independent States (CIS). Under the terms of the agreement, Venatorx will receive an initial licensing fee, additional research and development payments, sales-based and regulatory milestone payments, and potential royalty payments based on a percentage of net sales.

“With its global commercial infrastructure and significant experience in commercializing infectious disease products, including antibiotics, Menarini is ideally positioned to bring cefepime-taniborbactam to key geographic markets,” said Christopher J. Burns, Ph.D., CEO of Venatorx. “The development of new antibiotics with comprehensive resistance coverage is necessary to address critical unmet global medical needs and provide hope to both patients and healthcare providers to effectively treat the rapidly increasing number of gram-negative infections.” resistant to drugs.

“At Menarini, we believe that the addition of cefepime-taniborbactam expands our anti-infectives portfolio against existing antimicrobial resistance and provides the opportunity to further strengthen our construction of a significant antibiotic portfolio focused on the critical pathogens responsible for the vast majority of antibiotic resistance,” said Elcin Barker Ergun, CEO of Menarini Group. “By leveraging our experience and Menarini’s extensive commercial infrastructure, we will provide the necessary resources to optimize the commercialization, subject to approval by the relevant health authorities, of cefepime-taniborbactam and ensure patient access to this medicine throughout our global presence” .

About Cefepime-Taniborbactam

Cefepime-taniborbactam is an investigational beta-lactam/beta-lactamase inhibitor (BL/BLI) intravenous (IV) antibiotic combination that is being developed for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis and bacterial pneumonia. hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP). The US FDA accepted for review a new drug application for cefepime-taniborbactam for cutaneous urinary tract infections, including pyelonephritis, with a PDUFA date of February 22, 2024.

Cefepime, a fourth-generation cephalosporin, is a widely used beta-lactam (BL) antibiotic with more than two decades of proven safety and clinical utility against susceptible gram-negative and gram-positive bacteria. Taniborbactam is a beta-lactamase inhibitor (BLI) that, in combination with cefepime, is being studied as a potential treatment option for patients with severe bacterial infections caused by antibiotic-resistant gram-negative bacteria, particularly extended-spectrum beta-lactamase ( ESBL), which express Enterobacterales, carbapenem-resistant Enterobacterales (CRE), and multidrug-resistant (MDR) Pseudomonas aeruginosa (MDR-PA), which may include carbapenem-resistant P. aeruginosa (CRPA).

Cefepime-taniborbactam has received Qualified Infectious Diseases Product (QIDP) and Fast Track designations from the US Food and Drug Administration (FDA) for the treatment of cUTI and HABP/VABP.

Funding partners and collaborators

Development of cefepime-taniborbactam began with federal funding from the National Institute of Allergy and Infectious Diseases, the National Institutes of Health, the U.S. Department of Health and Human Services under contract number HHSN272201300019C, and the Wellcome Trust under award number 360G. -Wellcome-101999/Z/ 13/Z, and continues with federal funding from the Biomedical Advanced Research and Development Authority (BARDA), Strategic Preparedness and Response Administration, Department of Health and Human Services under contract numbers HHSO100201900007C and 75A50122C00080 .

In September 2018, Venatorx entered into an exclusive licensing agreement with Everest Medicines to support the development, registration and commercialization of cefepime-taniborbactam in the People’s Republic of China, Macau, Hong Kong, Taiwan, South Korea and select Southeast Asian countries ( “the territory”).

In April 2020, Venatorx and GARDP announced a collaboration to accelerate the development and access of cefepime-taniborbactam for adult and pediatric populations. Venatorx has granted GARDP exclusive rights to distribute and subdistribute cefepime-taniborbactam, once approved for clinical use, in certain low- and lower-middle-income countries.

In November 2023, Venatorx entered into an exclusive licensing agreement with Melinta Therapeutics to commercialize cefepime-taniborbactam in the United States.

About Venatorx Pharmaceuticals, Inc.

Venatorx is a privately held pre-commercial pharmaceutical company focused on improving health outcomes for patients with difficult-to-treat drug-resistant gram-negative bacterial and viral infections. Venatorx’s main active ingredient, cefepime-taniborbactam, is an investigational antibiotic that has completed a Phase 3 study (NCT03840148) in adults with complicated urinary tract infections (cUTI), including pyelonephritis, and an NDA is under FDA review with a PDUFA action date of February 22, 2024. In October 2022, BARDA awarded a Project Bioshield contract of up to $318 million to Venatorx for the development and procurement of cefepime-taniborbactam for the treatment of resistant gram-negative infections, including melioidosis. As part of its broader portfolio, Venatorx is also developing a BL/BLI oral antibacterial, ceftibuten-ledaborbactam etzadroxil, which will advance directly to a global Phase 3 cUTI clinical trial under a new recently announced BARDA contract. For more information about Venatorx and its anti-infective portfolio, visit www.venatorx.com.

About Menarini Group

Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of more than $4.4 billion and more than 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pulmonology, gastroenterology, infectious diseases, diabetes, inflammation and analgesia. With 18 production sites and 9 research and development centers, Menarini products are available in 140 countries worldwide. For more information, visit www.menarini.com.

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, among others, statements regarding the potential, safety, efficacy, and regulatory and clinical development of Venatorx Pharmaceuticals’ product candidates.

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