• New data examining fosfomycin for injection’s ability to treat acute pyelonephritis (AP) and complicated urinary tract infections (cUTIs) to be presented in three poster sessions
• Additional analyses from Phase 2/3 ZEUS clinical trial of fosfomycin for injection for cUTI to be shared
• Breadth of data presented demonstrates fosfomycin for injection’s effectiveness in combatting infections and Meitheal’s commitment to addressing the ongoing threat of antibiotic resistance

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 will share new antibiotic data at the 14^th annual IDWeek in Atlanta, GA, from October 19-22, 2025. Meitheal’s presentations will include clinical trial data updates on the safety and effectiveness of fosfomycin for injection for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis (AP).

Two of the three poster sessions at IDWeek will feature subsequent analysis from the Phase 2/3 ZEUS clinical trial of fosfomycin for injection including a subgroup analysis of patients with a high burden of chronic illness and severe acute disease, and a post-hoc analysis of the clinical pathogens and microbiological outcomes following treatment. Additionally, Meitheal will present findings from an additional assessment of fosfomycin for injection’s disk diffusion against resistant Enterobacterales.

“We are extremely excited about the data being presented at IDWeek 2025. The escalating public health issue of antimicrobial resistance and emergence of highly resistant organisms demands immediate attention and innovative therapeutic solutions,” said Dr. Keith Robinson, Chief Medical Officer of Meitheal Pharmaceuticals. “The clinical evidence highlights fosfomycin for injection’s therapeutic potential to address infectious diseases, make a difference for patients, and address an unmet need in the current antibiotic treatment landscape.”

Poster Presentations during IDWeek 2025:

Meitheal previously acquired United States rights to fosfomycin for injection from Nabriva Therapeutics in July 2024. A decision from the U.S. Food & Drug Administration on a New Drug Application for fosfomycin for injection is expected this year.

ABOUT FOSFOMYCIN FOR INJECTION

Fosfomycin for injection is the only antibiotic in the phosphonics class of antibiotics. This class is bactericidal, uniquely inhibiting the first step in bacterial cell wall synthesis with activity against antimicrobial resistant (AMR) pathogens. This results in low resistance rates and no known cross-resistance to other antibiotic classes. Supported by over 40 years of global use, fosfomycin for injection has proven clinical efficacy and safety for the treatment of adult patients with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP).

ABOUT MEITHEAL PHARMACEUTICALS, INC.

Founded in 2017 and based in Chicago, Meitheal 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 70 U.S. FDA-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of October 2025, Meitheal, directly or through its partners, has 46 products in the research and development phase, 9 additional products planned for launch in 2025, 4 products in clinical trial phases, and 23 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 regularly as one of Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2025, Meitheal emulates the traditional Irish guiding principle we are named for—working together toward a common goal, for the greater good.

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

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