-Post-hoc analyses showcase Mallinckrodt's commitment to patients with HRS involving rapid reduction in kidney function,1an acute and life-threatening condition2-
Terlipressin is an investigational agent being evaluated for the treatment of HRS involving rapid reduction in kidney function1 in the
These studies are sponsored by Mallinckrodt Pharmaceuticals and include:
Abstract 2952 Title: Early Treatment with Terlipressin in Patients with Hepatorenal Syndrome Yields Improved Clinical Outcomes in 3 Phase III North American Studies
Abstract 564 (Encore) Title: Gender Affects the Association Between Serum Creatinine Levels and Clinical Response to Terlipressin in Patients with Hepatorenal Syndrome Type of Acute Kidney Injury
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.3 It has been approved outside the
Hepatorenal syndrome (HRS) involving rapid reduction in kidney function1 is an acute and life-threatening syndrome involving acute kidney failure in people with advanced liver disease.2 HRS is classified into two distinct types – a rapidly progressive type that leads to acute renal failure and a more chronic type that progresses over weeks to months.2 HRS is estimated to affect between 30,000 and 40,000 Americans annually.7,8 If left untreated, the rapid reduction in kidney function associated with HRS1 has a median survival time of approximately two weeks and greater than 80 percent mortality within three months.9
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, 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.
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This release includes forward-looking statements with regard to terlipressin, including related to interactions with regulators, steps being taken related to its manufacturing, 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: 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.
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.
© 2022 Mallinckrodt. US-2200583 06/22
1 Data on File – Ref-05737. Mallinckrodt Pharmaceuticals.
3 Data on File – Ref-05488. Mallinckrodt Pharmaceuticals.
4 Data on File – Ref-05482. Mallinckrodt Pharmaceuticals.
7 C Pant, B S Jani, M Desai, A Deshpande,
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