ITRM News & Events

Iterum Therapeutics provided a business update. Market Access Update: Medicare Part D Milestone: The company announces another signed rebate agreement with one of the top three Medicare Part D Pharmacy Benefit Managers. This agreement positions Orlynvah for inclusion on their Medicare Advantage Prescription Drug and Medicare Prescription Drug formularies. Patent Portfolio: Iterum has been granted a patent in the United States as patent number 12,544,337, entitled "Combinations of Beta-Lactam Compounds and Probenecid and Uses Thereof", that covers a bilayer tablet comprising sulopenem etzadroxil and probenecid, a method of making the bilayer tablet, and methods of treating diseases, including uncomplicated urinary tract infection. This US patent is projected to expire in December 2039, absent any patent term extensions, and assuming timely payments of all maintenance fees during the lifetime of the patent. FDA: The US Food and Drug Administration has responded to Iterum's request to discuss the use of Orlynvah as step-down therapy and the collection of real world data to support the proposed claim. The FDA has determined that Iterum would need to provide substantial evidence of effectiveness from an adequate and well-designed clinical trial in a supplemental new drug application to support the proposed indication for Orlynvah as step-down treatment of complicated urinary tract infections. The FDA recommends that Iterum request a Type C meeting to discuss the design and endpoints of any proposed clinical investigation to support the proposed indication.

The company said, "Payor Reimbursement and Contracting Expands with Major PBM Agreement: ORLYNVAH's market access continues to accelerate. We have finalized another commercial contract with a Group Purchasing Organization that collaborates with manufacturers on behalf of one of the largest Pharmacy Benefit Managers in the United States, adding coverage opportunities for more than 24 million lives starting in early 2026. This milestone underscores ORLYNVAH's growing acceptance across the payor landscape. The Company expects the final top three PBM in the United States to execute a contract for their commercial lives in the first quarter of 2026. Medicare Part D Milestone: We are pleased to announce another signed rebate agreement with one of the top three Medicare Part D Pharmacy Benefit Managers. This agreement positions ORLYNVAH for inclusion on their Medicare Advantage Prescription Drug and Medicare Prescription Drug formularies, with coverage of more than 10 million lives expected to begin as early as Q1 2026. FDA: The Company has requested a meeting from the U.S. Food & Drug Administration to discuss a claim for the use of ORLYNVAH as step-down therapy and the collection of real-world data to support the proposed claim. The FDA has determined that written responses to the Company's questions would be the most appropriate means for responding to this meeting request. A goal date of January 24, 2026 has been set for the FDA to provide their written responses."