DUBLIN - Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, today announced that three scientific abstracts evaluating treatment with TERLIVAZ (terlipressin) for injection for adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function1 including its impact on patient care, key HRS endpoints and patient comorbidity will be presented at the American Society of Nephrology (ASN) Kidney Week 2023 Scientific Meeting in Philadelphia, Pennsylvania, taking place November 2-5, 2023.

TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with HRS with rapid reduction in kidney function,1 an acute and life-threatening condition requiring hospitalization.

Mallinckrodt's three scientific abstracts at ASN's Kidney Week 2023 Scientific Meeting, two of which will take place on November 2 and one on November 4, will be presented by Juan Carlos Q. Velez, MD, and Hani M. Wadei, MD.

Juan Carlos Q. Velez, MD, will present findings from a post hoc analysis of the Phase III CONFIRM clinical trial exploring the incidence of HRS reversal in patients treated with TERLIVAZ plus albumin versus placebo plus albumin to determine if an improvement in serum creatinine of >30% was associated with improved clinical outcomes.3 The study evaluated the magnitude of improvement in serum creatinine level from baseline to the end of treatment, and its potential relationship with patient's length of intensive care unit stay and the incidence of renal replacement therapy, among other clinical measures.3

A pooled analysis of the results from the three largest prospective, randomized, placebo-controlled clinical studies in patients with HRS (OT-0401, REVERSE, and CONFIRM) will be presented by Hani M. Wadei, MD.4 The analysis assessed the role of TERLIVAZ plus albumin versus placebo plus albumin on HRS reversal in the subpopulation of patients with comorbidities of alcoholic hepatitis, mean arterial pressure of

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