Iterum Therapeutics Announces Partnership for Commercialization Services

Core Viewpoint - Iterum Therapeutics has entered into a Product Commercialization Agreement with EVERSANA to bring its oral antibiotic ORLYNVAH to the U.S. market by Q4 2025, targeting uncomplicated urinary tract infections (uUTIs) caused by multi-drug resistant pathogens [1][2]. Company Overview - Iterum Therapeutics focuses on developing next-generation oral and IV antibiotics to combat infections from multi-drug resistant pathogens in both community and hospital settings [1][5]. - The company has received FDA approval for ORLYNVAH (oral sulopenem) for treating uUTIs in adult women with limited or no alternative oral antibacterial treatment options [5][7]. Product Details - ORLYNVAH is a novel oral penem antibiotic effective against Enterobacterales species, including those resistant to third-generation cephalosporins [7]. - The treatment addresses a significant market need, as approximately 30% of uUTIs in the U.S. are caused by quinolone non-susceptible pathogens, and about 1% are resistant to all commonly available oral antibiotics [4]. Market Context - UTIs are among the most common bacterial infections, with around 15 million emergency room visits and over 40 million total prescriptions for uUTIs annually in the U.S. [4]. - Approximately two-thirds of uUTI prescriptions are for patients at elevated risk for treatment failure, highlighting the need for effective new treatments [4]. Partnership with EVERSANA - The partnership with EVERSANA aims to leverage their extensive commercial capabilities to ensure a swift market entry for ORLYNVAH [2][8]. - EVERSANA will provide a range of services including sales, marketing, logistics, and regulatory support for the commercialization of ORLYNVAH in the U.S. [1][2].