Iterum Therapeutics (ITRM)

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$ITRM >Iterum Therapeutics announces Issuance of Allowance for a U.S. Patent Covering Oral Sulopenem
December 15 2022 - 08:00AM
GlobeNewswire Inc.
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Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company” or “Iterum”), 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 that the United States Patent and Trademark Office (“USPTO”) has issued Iterum a Notice of Allowance for U.S. patent application number 16/372,075 entitled “Combinations of Beta-Lactam Compounds and Probenecid and Uses Thereof” that covers the use of Iterum's candidate combination of sulopenem etzadroxil and probenecid in treating multiple diseases, including uncomplicated urinary tract infections.
“Following on from the patent recently issued by the USPTO directed to the composition of the bilayer tablet of sulopenem etzadroxil and probenecid (“oral sulopenem”) and its related uses, we are very pleased to strengthen our oral sulopenem patent estate further with the addition of this new patent which, when issued, will afford protection until at least 2039 and further enhance its commercial opportunity. If approved, oral sulopenem will be the first oral penem available in the United States,” said Corey Fishman, Chief Executive Officer. “Enrollment in our pivotal Phase 3 clinical trial for oral sulopenem for the treatment of uncomplicated urinary tract infections is ongoing, and we expect to provide an update following an interim analysis at 50% patient enrollment.”

This Notice of Allowance concludes the substantive examination of the patent application and will result in the issuance of a U.S. patent after administrative processes are completed. The U.S. patent scheduled to issue from this application will expire April 1, 2039, absent any extensions. The recently issued U.S. patent for oral sulopenem entitled “Combinations of Beta-Lactam Compounds and Probenecid and Uses Thereof” also expires in 2039, absent any extensions.

The Company’s patent portfolio also contains pending patent applications outside the U.S. including Europe and China, submitted following receipt of the Written Opinion of the International Search Authority indicating that several claims directed to the composition of the bilayer tablet of oral sulopenem are novel and inventive.

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.