– Two scientific abstracts spanning clinical and health economic outcomes research will be presented at the 2023 NKF SCM, showcasing the breadth of Mallinckrodt's commitment to HRS patients with rapid reduction in kidney function –
TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function, an acute and life-threatening condition requiring hospitalization.
Please see Limitation of Use and Important Safety Information, including Boxed Warning, below.
The findings from one of the abstracts, presented by
Additional information on these studies and the full list of Mallinckrodt's presentations can be found below.
"We look forward to sharing our new data highlighting our commitment to continued clinical investigation with treatment options for patients with HRS, like TERLIVAZ, as well as addressing the real-world impact that HRS and current treatment plans impart upon patients and healthcare systems from a cost and outcomes perspective,[3,4]" said
These studies are sponsored by Mallinckrodt Pharmaceuticals and include:
Poster #10: Treatment-Related Cost Analysis for Adults with Hepatorenal Syndrome with Rapid Reduction in Kidney Function
Poster #20: A Reduction in Serum Creatinine of at Least 30% Leads to Meaningful Clinical Outcomes in Patients with Hepatorenal Syndrome Type 1: A Pooled Analysis of 3 Phase III Studies
Find more information on the
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
Manage intravascular volume overload by reducing or discontinuing the administration of albumin and/or other fluids and through judicious use of diuretics. Temporarily interrupt, reduce, or discontinue TERLIVAZ treatment until patient volume status improves. Avoid use in patients with ACLF Grade 3 because they are at significant risk for respiratory failure.
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.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.[5,6] 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.
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 includes forward-looking statements, including with regard to TERLIVAZ, 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
Senior Vice President,
Global Corporate Controller & Chief Investor Relations Officer
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-2300159 04/23
 TERLIVAZ® (terlipressin) for injection. [Prescribing Information].
 National Organization for Rare Disorders. Hepatorenal Syndrome. Available at: https://rarediseases.org/rare-diseases/hepatorenal-syndrome/. Accessed March 28, 2023.
 Huang X, Bindra J, Chopra I, Niewoehner J, Wan GJ. Treatment-Related Cost Analysis for Adults with Hepatorenal Syndrome with Rapid Reduction in Kidney Function. Abstract to be presented at the
 Mujtaba MA, Zafar Z, Jamil K. A Reduction in Serum Creatinine of at Least 30% Leads to Meaningful Clinical Outcomes in Patients with Hepatorenal Syndrome Type 1: A Pooled Analysis of 3 Phase III Studies. Abstract to be presented at the
 C Pant, B S Jani, M Desai, A Deshpande,
 United States Census Bureau: Quick Facts. Available at: https://www.census.gov/quickfacts/fact/table/US/PST045218. Accessed March 28, 2023.
 Flamm, S.L., Brown, K., Wadei, H.M., et al. The Current Management of Hepatorenal Syndrome–Acute Kidney Injury in
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