Iterum Therapeutics Announces Filing of US Patent Application Based on Favorable Written Opinion of the International Search Authority

Bilayer tablet patent application could provide U.S. patent coverage for Iterum’s commercial formulation through 2039, if granted

DUBLIN, Ireland and CHICAGO, Dec. 07, 2020 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the Company), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced the filing of a U.S. national phase patent application directed to the composition of the bilayer tablet of sulopenem etzadroxil and probenecid and its related uses with the U.S. Patent and Trademark Office (“USPTO”).

“If approved, this U.S. patent application related to the bilayer tablet, which includes both sulopenem etzadroxil as well as probenecid, could provide U.S. patent coverage for Iterum’s commercial formulation out to 2039, excluding any additional term for patent term adjustment or patent term extension, thereby extending the current patent protection afforded by the existing sulopenem etzadroxil patent estate,” said Corey Fishman, Chief Executive Officer. “We are encouraged by the Written Opinion of the International Search Authority, which indicates that several claims directed to the composition of the tablet are novel and inventive. We anticipate additional patent filings in countries outside the U.S., including Europe and China, which should help facilitate partnering discussions in those regions.”

The sulopenem bilayer tablet contains sulopenem etzadroxil, a prodrug of sulopenem that enables oral bioavailability, and probenecid, a renal tubular transport blocking agent, which together enhance the exposure of sulopenem to the bacterial pathogen responsible for the infection. These claims encompass the oral formulation used in the Phase 3 registration studies to support the safety and efficacy of sulopenem etzadroxil and probenecid. An extension of the life of the patent estate would enable pursuit of claims related to our previously granted QIDP indications such as pneumonia.

About Iterum Therapeutics plc

Iterum Therapeutics plc is a clinical-stage pharmaceutical company dedicated to developing differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications. The licensed U.S. patent claim for a composition of matter patent for sulopenem etzadroxil is due to expire in 2029, subject to potential extension of up to 2034 under the Drug Price Competition and Patent Term Restoration Act of 1984 (referred to as the Hatch-Waxman Act).