Meitheal Pharmaceuticals Expands Specialty Biopharmaceuticals Portfolio with Acquisition of CONTEPO™ (Fosfomycin for Injection) from Nabriva Therapeutics

• CONTEPO™ offers a unique mechanism of action and has the potential to address increasing antibiotic resistance and gaps in the current antibiotic treatment landscape
• NDA for CONTEPO™ is pending
• Agreement adds a second branded biopharmaceutical to Meitheal’s portfolio following the commercial licensing agreement for XTMAB-16 in 2023

Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company based in Chicago and focused on the development and commercialization of generic injectables, fertility, biologic, and branded products, today announced it has acquired North America rights to CONTEPO™ (fosfomycin for injection) from Nabriva Therapeutics. CONTEPO™ is a novel, intravenous (IV), broad spectrum antibiotic with demonstrated activity against most multi-drug resistant (MDR) strains that cause complicated urinary tract infections (cUTI).

“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,” said Tom Shea, Chief Executive Officer of Meitheal. “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.”

Under the Asset Purchase Agreement, Meitheal acquires North America rights to CONTEPO™, including any results of development and regulatory activities, and all intellectual property (IP) rights, technology, and know-how related to CONTEPO™. In exchange, Nabriva will receive payment upon closing and a royalty on net U.S. sales of CONTEPO™.

Fosfomycin for intravenous (IV) administration is marketed outside the U.S. where it has been approved across nine indications, including cUTI and other serious bacterial infections. CONTEPO™ utilizes a new dosing approach to optimize the compound’s pharmacokinetics and pharmacodynamics and has demonstrated efficacy by meeting the primary endpoint in the pivotal ZEUS™ trial for patients with cUTI, including acute pyelonephritis.

“The treatment paradigm for complicated infections in the U.S. is fragmented and inefficient with increasing antibiotic resistance rendering many traditional treatment options obsolete,” said Brett Novak, Meitheal Senior Vice President of Commercial Operations. “CONTEPO™, with demonstrated efficacy against most contemporary multi-drug resistant strains and a differentiated mechanism of action, has the potential to serve as the alternative antibiotic treatment of choice in appropriate patients, and provide them with the right spectrum of coverage for complicated UTIs.”

Nabriva submitted the New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for the approval of CONTEPO™ (fosfomycin for injection) for the treatment of cUTI, including acute pyelonephritis. A decision is expected from the FDA later this year. In preparation for commercial launch, Meitheal will establish a full commercial marketing and sales organization in addition to a medical science liaison (MSL) team to support clinician needs.

Meitheal’s parent company, Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (NKF), has invested over $300 million in capital and research and development in recent years to support sustainable product supply across the Company’s focus areas including branded biopharmaceuticals.

ABOUT COMPLICATED URINARY TRACT INFECTION

Complicated urinary tract infections (cUTI) represent a serious infection in patients with underlying functional or structural abnormality of the urinary tract or in the presence of catheterization, and includes patients with acute pyelonephritis, regardless of underlying abnormalities of the urinary tract. An estimated three million cases of Gram-negative cUTIs are treated in the U.S. hospital setting annually, where approximately 40 percent of cases are suspected to be caused by resistant strains. Ineffectively managed cUTIs can lead to increased treatment failure rates, which in turn, can result in prolonged hospital stays, recurrence, re-hospitalization, and mortality – each of which poses a substantial resource and economic burden on the healthcare and payer systems.

Among the causes of cUTI is Enterobacteriaceae, which is a multi-drug resistant (MDR) strain of Gram-negative bacteria. Enterobacteriaceae produces extended spectrum beta-lactamases (ESBL), a chemical that can cause some antibiotics to be ineffective in treating bacterial infections such as cUTI. As a result, cUTI poses a serious and rapidly emerging health threat for hospitalized patients, especially those in intensive care units.

ABOUT CONTEPO™

CONTEPO™ (fosfomycin for injection) is a novel, potentially first-in-class in the U.S., intravenous investigational antibiotic with a broad spectrum of Gram-negative and Gram-positive activity, including activity against most contemporary multi-drug resistant (MDR) strains such as extended spectrum β-lactamase (ESBL)-producing Enterobacteriaceae. IV fosfomycin has been approved for a number of indications and utilized for over 45 years outside the U.S. to treat a variety of infections, including cUTIs and other serious bacterial infections.

ABOUT MEITHEAL PHARMACEUTICALS

Founded in 2017 and based in Chicago, Meitheal Pharmaceuticals is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 55 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of the end of May 2024, Meitheal, directly or through its partners, has over 20 products in the research and development phase, 14 products planned for launch in 2024, and an additional 19 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked among the top 100 Crain’s Best Places to Work in Chicago, Meitheal emulates the traditional Irish guiding principle we are named for — Meitheal (Mee·hall): working together toward a common goal, for the greater good.

Learn more about who we are and what we do at www.meithealpharma.com.

ABOUT NANJING KING-FRIEND BIOPHARMACEUTICAL COMPANY (NKF)

Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (NKF) is a China-based company principally engaged in the research and development, production and sales of Active Pharmaceutical Ingredients (API) and Finished Dosage Form (FDF). Established in 1986 as one of world leading manufacturers of heparin related APIs, NKF has grown into a fully integrated API and FDF manufacturer in multiple therapeutic areas including critical care and oncology. With three U.S. FDA approved manufacturing sites in China and more than 500 employees, including more than 100 dedicated research and development experts, NKF strives to meet patient needs globally with market presence in the U.S., China, EU and across the world. The Company is publicly listed on Shanghai Stock Exchange with a market capitalization over U.S. $3.0 billion.

ABOUT NABRIVA THERAPEUTICS PLC

Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA^® (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics also developed CONTEPO™ (fosfomycin for injection), a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis.

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