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Iterum Therapeutics Files Petition to Wind Up in High Court of Ireland
Iterum Therapeutics announced that it has filed a petition in the High Court in Ireland to wind up the company. An order was made appointing Damien Murran and Jennifer McMahon, each of Teneo Restructuring, as joint provisional liquidators to the company. The petition is due to be heard on April 13. If a winding up order is made by the High Court, the joint provisional liquidators will be confirmed as joint liquidators of the company, and this will result in the winding up and, in due course, the ultimate dissolution of the company. The joint provisional liquidators were also appointed to the company's Irish subsidiary, Iterum Therapeutics International. Although the company engaged in transaction discussions with two potential counterparties on proposed terms for the acquisition of sulopenem as part of the company's evaluation of strategic alternatives, neither of the counterparties were able to finalize a definitive agreement and consummate such a transaction on the required timeline and terms, given the limited cash runway for the company. Therefore, the board determined that continuing to pursue either transaction was not in the best interests of the company's creditors and shareholders and the company has determined that there are no further reasonable avenues available at this time for an alternative strategic transaction outside the context of a liquidation. It is intended that the joint provisional liquidators will oversee a wind down of the company's other subsidiaries. It is likely that the joint provisional liquidators may decide to manage a withdrawal of Orlynvah from the U.S. commercial market. Any such withdrawal would be done in accordance with FDA procedures and in consultation with the relevant third-party service providers including Eversana Life Science Services and clinicians, as appropriate.
Iterum Therapeutics Provides Business Update
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.
ORLYNVAH Expands Payor Reimbursement with Major PBM Agreement Covering 24 Million Lives
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."
Iterum Therapeutics Signs Major PBM Contract, Covering Over 40 Million Lives
Iterum Therapeutics provided a business update. Payor Reimbursement and Contracting Expands with Major PBM Agreement: ORLYNVAH's market access continues to accelerate. Iterum have finalized a 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 40 million lives starting in early 2026. This milestone underscores. Beginning in Q1 2026, Iterum plans to launch targeted pull-through campaigns focused on prescribers in high-coverage geographies, while Iterum awaits approval of additional Commercial and Medicare Part D agreements currently pending execution. Expansion of Patent Estate: The Japanese Patent Office has issued a Decision to Grant in Japanese Patent Application No. 2022-554381, entitled "Combinations of Beta-Lactam Compounds, Probenecid, and Valproic Acid and Uses Thereof". The allowed claims cover a combination of sulopenem etzadroxil, probenecid, and valproic acid for treating specified diseases. Upon issuance, this Japanese Patent will be projected to expire in March 2041, absent any extensions, and assuming timely payments of all maintenance fees during the lifetime of the patent.
Iterum Announces ORLYNVAH Reimbursement Coverage Near 25%
The company said, "Market Access Update: Expanding Reimbursement Footprint: ORLYNVAH's access continues to grow-both with and without prior authorization or medical exception pathways, allowing coverage approval for many of the ORLYNVAH prescriptions written to date. Current coverage now reaches nearly 25% of insured lives in the U.S., with increasing adoption by employer groups and payer formularies integrating ORLYNVAH into standard benefit designs on a weekly basis. Based on publicly available data sources, more than 60 million insured lives now have reimbursement access to ORLYNVAH through a variety of health plan benefit designs. This includes coverage under California and New York State Medicaid programs, certain Veterans Affairs/Tricare affiliates, and lines of business within Blue Cross Blue Shield plans, Aetna and others. Medicare Part D Milestone: We are pleased to announce a 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 expected to begin as early as Q1 2026. Key Pharmacy Benefit Manager Status: Iterum has submitted bids at the major Pharmacy Benefit Manager organizations across commercial, Medicare and Government plans, and is aiming to secure long term formulary positioning this year and into Q1 2026. Additional Specialty Distributor Now Stocked: In addition to ORLYNVAH being stocked at McKesson, ORLYNVAH is now available at Cencora. Having product available at these distributors will allow certain physicians to procure the product directly through these channels, as it fits within their practice preferences. Expansion of Patent Estate: The European Patent Office has issued a Communication under Rule 71(3) EPC indicating its intention to grant a patent from European Patent Application No. 19832143.2, entitled "combinations of beta-lactam compounds and probenecid and uses thereof", that covers a bilayer tablet of sulopenem etzadroxil and probenecid, methods of preparing the bilayer tablet, and the bilayer tablet for use in treating specified diseases. Upon issuance, the patent will be projected to expire in December 2039, absent any extensions, and assuming timely payments of all maintenance fees during the lifetime of the patent."
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