– A total of 11 scientific abstracts from Mallinckrodt's research for adults with HRS with rapid reduction in kidney function1 provide further insight into the clinical efficacy, safety, and real-world utility of TERLIVAZ treatment for appropriate patients –
– Mallinckrodt's presence to include three oral presentations and one AASLD Poster of Distinction –
Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/9111651-mallinckrodt-aasld-2023-liver-meeting/
Included among Mallinckrodt's breadth of data for adults with HRS with rapid reduction in kidney function1 are three oral presentations and one Poster of Distinction detailing research of clinical outcomes with TERLIVAZ2,3,4 and real-world health economics outcomes for TERLIVAZ-treated patients with comorbidities.5
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.6 HRS involving rapid reduction in kidney function1 is estimated to affect more than 35,000 Americans annually and rates of HRS hospitalizations are increasing.7,8
Please see Limitation of Use and Important Safety Information, including Boxed Warning, below.
"It is essential to continue research into the relationship between TERLIVAZ treatment and key factors impacting clinical outcomes, such as concomitant treatments, comorbidities, and real-world care environments, to provide further insights into the continued use of TERLIVAZ for patients with this critical condition," said
Highlights of Mallinckrodt's 11 scientific presentations at the AASLD 2023 Liver Meeting include:
Mallinckrodt will also be present at the meeting with an interactive Medical Affairs booth in the exhibit hall (Location D2825) throughout the duration of the meeting.
Data collected in retrospective, pooled, database, or post hoc analyses may have errors or omissions. Outcomes may be influenced by therapies not evaluated in the study and the clinical/health economic outcomes may not be solely attributable to TERLIVAZ.
INDICATION AND LIMITATION OF USE
TERLIVAZ® is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE
TERLIVAZ is contraindicated:
Warnings and Precautions
Please click here to see full Prescribing Information, including Boxed Warning.
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.6 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.6 HRS involving rapid reduction in kidney function1 is estimated to affect more than 35,000 Americans annually and rates of HRS hospitalizations are increasing.7,8 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.9,10
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. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release contains forward-looking statements, including with regard to TERLIVAZ®, its potential to improve health and treatment outcomes, and 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: the impact of Mallinckrodt's pending Chapter 11 cases; satisfaction of, and compliance with, 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 or adverse side effects or adverse reactions associated with TERLIVAZ; 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
Senior Vice President, Finance and Chief Financial Officer, Specialty Generics
Vice President, Investor Relations
Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners.
©2023 Mallinckrodt. US-2300796 11/23
1 TERLIVAZ® (terlipressin) for Injection. Prescribing Information.
2 Fricker ZP, et al. Improved Mean Arterial Pressure from Baseline to the End of Treatment with Terlipressin is Associated with Hepatorenal Syndrome Reversal: A Pooled Analysis of 3 Phase III Studies. Abstract to be presented in oral presentation at the
3 Wong F, et al. Albumin Dosing with Terlipressin for the Treatment of HRS-AKI: A Double-Edged Sword. Abstract to be presented in oral presentation at the
4 Cullaro G, et al. Understanding the Relationship Between Mean Arterial Pressure and Terlipressin in Hepatorenal Syndrome-Acute Kidney Injury Reversal: A Post Hoc Analysis of the CONFIRM, REVERSE, and OT-0401 Trials. Poster of Distinction to be presented in oral presentation at the
5 Mumtaz K, et al. Decision-Analytic Model to Project the Benefit of Terlipressin Treatment Among Patients with Alcohol-Related Cirrhosis and HRS. Abstract to be presented in oral presentation at the
7 Data on file – Ref-06931. Mallinckrodt Pharmaceuticals.
8 Singh J, Dahiya DS, Kichloo A, Singh G, Khoshbin K, Shaka H. Hepatorenal Syndrome: A Nationwide Trend Analysis from 2008 to 2018. Annals of Med. 2021;53:1. doi.org/10/1080/07853890
10 Boyer TD, et al. Terlipressin Plus Albumin Is More Effective Than Albumin Alone in Improving Renal Function in Patients With Cirrhosis and Hepatorenal Syndrome Type 1. Gastroenterology. 2016;150:1579-1589.
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