Mallinckrodt plc (NYSE American: MNK), a global specialty pharmaceutical company, today announced that three scientific abstracts on clinical research on treatment with TERLIVAZ (terlipressin) for adult patients with hepatorenal syndrome (HRS) involving rapid reduction in kidney function,1 will be presented at the American Society of Nephrology (ASN) Kidney Week 2022 Scientific Meeting in Orlando, Florida, from November 3-6.

TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) involving rapid reduction in kidney function,1 an acute and life-threatening condition requiring hospitalization.2

The findings from a pooled analysis across the OT-0401, REVERSE, and CONFIRM clinical trials, presented by Dr. Juan Carlos Q. Velez, MD, Ochsner Health Network LLC, New Orleans, Louisiana, suggest that initiating treatment with terlipressin plus albumin in patients with HRS Type 1 (HRS-1) at lower serum creatinine (SCr) levels and Model for End-stage Liver Disease (MELD) scores is associated with greater probability of avoiding renal replacement therapy (RRT) through 90 days of treatment.3 Additional information on Dr. Velez' study and the full list of Mallinckrodt's presentations can be found below.

'We are eager to share data from our latest studies assessing treatment paradigms in the management of HRS and examining the clinical benefits of patients treated with terlipressin among the broader healthcare professional community. These findings provide critical insight into the importance of patient characteristics at baseline and reducing the time to therapeutic intervention in potentially improving long-term outcomes and the avoidance of renal replacement therapy, such as dialysis, in adults with HRS,' said Khurram Jamil, Vice President, Hepatology, Clinical Development & Critical Care. 'Following the recent FDA approval of TERLIVAZ, we are encouraged by the growing body of evidence that continues to support Mallinckrodt's commitment to improving the care for critically ill patients with unmet needs.'

These studies are sponsored by Mallinckrodt Pharmaceuticals and include:

Abstract TH-PO034: Initiation of Terlipressin at Lower Serum Creatinine Levels Is Associated With Avoidance of Dialysis in Patients With Hepatorenal Syndrome Type 13

Presenter: Juan Carlos Q. Velez, MD

Presentation Date: November 3, 2022; 10AM - 12PM ET

Location: Exhibit Hall, Orange County Convention Center, West Building

Abstract TH-PO035: Impact of Terlipressin on Serum Sodium Levels in Patients with HRS - the North American Experience4

Presenter: Shehzad Nawaz Merwat, MD

Presentation Date: November 3, 2022; 10AM - 12PM ET

Location: Exhibit Hall, Orange County Convention Center, West Building

Abstract TH-PO037: Impact of HRS Reversal on the Need for Renal Replacement Therapy - Analysis from 3 Phase III Terlipressin Studies5

Presenter: Muhammad Ahmad Mujtaba, MD

Presentation Date: November 3, 2022; 10AM - 12PM ET

Location: Exhibit Hall, Orange County Convention Center, West Building

Find more information on the American Society of Nephrology (ASN) Kidney Week 2022 website.

Terlipressin is one of the most studied pharmacological agents in HRS with more than 70 published manuscripts and presented abstracts on clinical data to date.6 It has been approved outside the U.S. for more than 30 years and is available on five continents for its indications in the countries where it is approved.7,8

About Hepatorenal Syndrome (HRS)

Hepatorenal syndrome (HRS) involving rapid reduction in kidney function1 is an acute and life-threatening condition that occurs in people with advanced liver disease.2 HRS is classified into two distinct types - a rapidly progressive type that leads to acute renal failure where patients are typically hospitalized for their care and a more chronic type that progresses over weeks to months.2 HRS involving rapid reduction in kidney function1 is estimated to affect between 30,000 and 40,000 Americans annually.9,10 If left untreated, HRS with rapid reduction in kidney function1 has a median survival time of approximately two weeks and greater than 80 percent mortality within three months.11

ABOUT MALLINCKRODT

Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology, and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; cultured skin substitutes and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients.

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CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS

This release includes forward-looking statements with regard to TERLIVAZ, including its potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues and other risks identified and described in more detail in the 'Risk Factors' section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.

Contact:

Heather Guzzi

Tel: 973-524-4112

Email: hguzzi@greenroompr.com

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