Mallinckrodt to Present Data on Terlipressin in Adult Patients with Hepatorenal Syndrome (HRS) at the European Association for the Study of the Liver (EASL) 2022 International Liver Congress

-Post-hoc analyses showcase Mallinckrodt's commitment to patients with HRS involving rapid reduction in kidney function,¹an acute and life-threatening condition²-

DUBLIN, June 23, 2022 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKPF), a global biopharmaceutical company, today announced two scientific posters to be presented on the disease progression and treatment paradigms for patients with hepatorenal syndrome (HRS) involving rapid reduction in kidney function¹ at the European Association for the Study of the Liver (EASL) 2022 International Liver Congress, taking place June 22 – 26 in London, UK. The full list of Mallinckrodt's presentations is below. For more information, please visit the EASL website here.

Terlipressin is an investigational agent being evaluated for the treatment of HRS involving rapid reduction in kidney function¹ in the U.S., and its safety and effectiveness have not yet been established by the FDA.

Khurram Jamil, Vice President, Hepatology, Clinical Development & Critical Care, said, "It is our hope that this research may help inform clinicians on the early identification and management of adult patients with HRS with rapid reduction in kidney function.¹ We look forward to sharing new data from a retrospective analysis that uncovers the influence of baseline serum creatinine (SCr) levels on clinical outcomes for patients with HRS involving rapid reduction in kidney function,¹ and resharing the findings of our subgroup analysis examining HRS gender differences and response to treatment – recently presented at the 2022 American Transplant Congress."

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

• Presenter: Michael Curry, MD
• Presentation Date: June 24, 2022; 9AM – 6PM BST
• Poster #: FRI537

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

• Presenter: Khurram Jamil, MD
• Presentation Date: June 24, 2022; 9AM – 6PM BST
• Poster #: FRI490

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 U.S. for more than 30 years and is available on five continents for its two indications in the countries where it is approved.^4,5,6

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.

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.

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.

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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

References

¹ Data on File – Ref-05737. Mallinckrodt Pharmaceuticals.
² National Organization for Rare Disorders. Hepatorenal Syndrome. Available at: https://rarediseases.org/rare-diseases/hepatorenal-syndrome/. Accessed June 16, 2022.
³ Data on File – Ref-05488. Mallinckrodt Pharmaceuticals.
⁴ Data on File – Ref-05482. Mallinckrodt Pharmaceuticals.
⁵ FDA Cardiovascular and Renal Drugs Advisory Committee. Mallinckrodt Pharmaceuticals Terlipressin Advisory Committee Briefing Document NDA #022231. July 2020.
⁶ European Association for the Study of the Liver (EASL). Clinical practice guidelines for the management of patients with decompensated cirrhosis. J Hepatol. 2018;69(2):406-460.
⁷ C Pant, B S Jani, M Desai, A Deshpande, Prashant Pandya, Ryan Taylor, R Gilroy, M Olyaee. Hepatorenal syndrome in hospitalized patients with chronic liver disease: results from the Nationwide Inpatient Sample 2002–2012. J of Investig Med. 2016; 64:33–38.
⁸ United States Census Bureau: Quick Facts. Available at: https://www.census.gov/quickfacts/fact/table/US/PST045218. Accessed June 16, 2022.
⁹ Flamm, S.L., Brown, K., Wadei, H.M., et al. The Current Management of Hepatorenal Syndrome–Acute Kidney Injury in the United States and the Potential of Terlipressin. Liver Transpl, 2021; 27: 1191-1202. https://doi.org/10.1002/lt.26072.

SOURCE Mallinckrodt plc