Iterum Therapeutics plc

Iterum Therapeutics plc is a pharmaceutical company focused on developing and commercializing ORLYNVAH™, an oral branded penem antibiotic. The company aims to make ORLYNVAH™ the first oral branded penem available in the United States and potentially the first and only oral and intravenous (IV) branded penem globally. Penems, including thiopenems and carbapenems, are a class of ß-lactam antibiotics. The company's primary product, sulopenem, is a potent thiopenem antibiotic delivered intravenously. It is active against gram-negative bacteria that cause urinary tract and intra-abdominal infections. Iterum Therapeutics has also developed an oral tablet formulation, sulopenem etzadroxil-probenecid, referred to as oral sulopenem or ORLYNVAH™. The combination of intravenous sulopenem and oral sulopenem/ORLYNVAH™ constitutes the company's sulopenem program. Iterum Therapeutics believes sulopenem and ORLYNVAH™ can offer new treatment options for antibacterial resistance without the toxicities associated with some widely used antibiotics, such as fluoroquinolones. The company exclusively licenses two U.S. patents and three foreign patents from Pfizer Inc. (Pfizer). One U.S. patent covers the composition of matter of sulopenem etzadroxil, projected to expire in 2029, with a potential extension to 2034 under the Hatch-Waxman Act. The company also owns four U.S. patents, one Japanese patent, one Korean patent, and one Australian patent. These include one U.S. patent, the Japanese patent, the Korean patent, and the Australian patent, all directed to the composition of the bilayer tablet of oral sulopenem and its related preparations and/or uses. Two U.S. patents cover the method of use of oral sulopenem in treating multiple diseases, including uUTIs. One U.S. patent is directed to the method of use of sulopenem etzadroxil, probenecid, and valproic acid in treating multiple diseases.