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-Mallinckrodt Presents Data on Real-World Outcomes with THERAKOS™ CELLEX™ Photopheresis System Treatment at 2024 Tandem Meetings

– Analysis of published studies on extracorporeal photopheresis (ECP) treatment for steroid-resistant chronic graft-versus-host disease (SR-cGvHD) assessed that THERAKOS ECP may improve short- and long-term patient outcomes1 –

THIS INFORMATION IS INTENDED ONLY FOR THE EUROPEAN PUBLIC

DUBLIN, Feb. 22, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced a poster presentation of findings from a systematic literature review and meta-analysis of safety, efficacy and outcomes in the real world of extracorporeal photopheresis (ECP) treatment for patients with steroid-refractory chronic graft-versus-host disease (SR-cGvHD).1 An analysis of 47 studies reporting on the THERAKOS™ CELLEX™ photopheresis system showed that treatment of SR-cGvHD with DBS was associated with improvements in patients' overall survival (OS), failure-free survival (FFS), and overall response rate (ORR).1 Results will be shared in a poster presentation at the Meetings Tandem of 2024, the Transplantation combination

A systematic review of the literature available through October 19, 2022 was first conducted to identify and analyze studies of patients receiving DBS for SR-cGvHD that reported efficacy, safety, or health-related quality of life outcomes ( HRQoL).1 The literature review identified 47 studies that uniquely reported treatment with THERAKOS ECP with a sample size ≥ 10 patients, comprising a total of 2,361 patients.1 Lines of therapy were poorly reported (n=15) and ranged from 0 to ≥4 lines of prior treatment.1 Most clinical studies (n=27) used a retrospective case series design.1

Using the studies identified in the systematic literature review, random effects meta-analyses were performed for short- and long-term efficacy outcomes, including ORR and skin-specific response, and OS and FFS, respectively.1 Also Subgroup analysis was performed to explore the effect of National Institutes of Health (NIH) outcome assessment criteria versus non-NIH/unknown criteria.1 Safety and HRQoL outcomes were poorly reported in existing clinical literature and were therefore not suitable for meta-analysis.1

"We are pleased to share this important analysis of real-world data supporting the efficacy, safety, and associated improvements of THERAKOS ECP in short- and long-term outcomes, including overall survival, failure-free survival, and overall response rate. , for patients with steroid-refractory chronic graft-versus-host disease1," said Zachariah DeFilipp, MD, Hematopoietic Cell Transplant and Cellular Therapy Program, Massachusetts General Hospital, MA. "This analysis not only builds on the growing body of evidence supporting the usefulness of DBS in the treatment of patients with this condition, but also reflects the importance of supporting clinicians with treatment options for the management of patients who do not. respond to other types of therapy, such as steroids.1"

When evaluating the short-term effectiveness of THERAKOS ECP, this meta-analysis found1:

When evaluating the long-term effectiveness of THERAKOS ECP, this meta-analysis found1:

LimitationsData collected in systematic literature reviews and meta-analyses may have errors or omissions. The studies included in the analysis are heterogeneous, using different patient populations, endpoints, interventions, and doses.1 There was considerable heterogeneity across analyses, with I2 values ​​ranging from 65% to 91%.1 Most of the studies included in the meta-analysis were retrospective analyzes1 and these observations may require further investigation in prospective controlled trials. Statistical evaluations should be interpreted with caution. Results may be influenced by therapies not evaluated in the study and clinical/health economic outcomes may not be solely attributable to THERAKOS ECP.

This study was sponsored by Mallinckrodt Pharmaceuticals. Details of the presentation can be found below:

Abstract

IMPORTANT SAFETY INFORMATION FOR THE THERAKOS™ PHOTOPHERESIS PROCEDURE

IndicationsThe THERAKOS™ CELLEX™ Photopheresis System is indicated for the administration of photopheresis. Please refer to the applicable product label for a complete list of warnings and precautions.

ContraindicationsPhotopheresis THERAKOS™ is contraindicated in:

Warnings and Precautions THERAKOS™ photopheresis treatments should always be performed in locations where standard medical emergency equipment is available. Volume replacement fluids and/or volume expanders should be available throughout the procedure. Safety in children has not been established.

Adverse effects

Please refer to the THERAKOS™ CELLEX™ Photopheresis System Operator's Manual for a complete list of warnings and precautions.

IMPORTANT SAFETY INFORMATION FOR METHOXSALENE USED IN CONJUNCTION WITH THERAKOS™ PHOTOPHERESIS

ContraindicationsMetoxsalen is contraindicated in:

Warnings and precautions

Please refer to the package insert for methoxsalen sterile solution (20 micrograms/mL) or 8-methoxpsoralen oral dosage formulation for a list of all warnings and precautions.

Please refer to the THERAKOS™ CELLEX™ Photopheresis System Operator's Manual for a complete list of warnings, precautions and adverse events.

About extracorporeal photopheresis (ECP)ECP, a blood-based immunomodulatory therapy developed more than 30 years ago, is recommended by the International Society of Heart and Lung Transplantation (ISHLT)2 and other clinical societies3,4,5 as an adjunctive therapy for the prevention and treatment of ACR after heart transplantation. Additionally, ECP may be considered to treat AMR with or without donor-specific antibodies.6,7 In countries where it is approved, ECP is used to treat a variety of immune-mediated diseases, including the cutaneous manifestations of cutaneous T-cell lymphoma ( CTCL), graft versus host disease (GvHD), solid organ transplant rejection, and other autoimmune diseases. During DBS treatment, a small number of white blood cells are collected and treated with a medication that is activated by ultraviolet light.

ABOUT MALLINCKRODTMallinckrodt is a global company consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. Focus areas of the company's Specialty Brands reportable segment include autoimmune and rare diseases in specialty areas such as neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology and oncology; immunotherapy and neonatal respiratory intensive care therapies; analgesics; and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. For more information about Mallinckrodt, visit www.mallinckrodt.com.

CAUTIONARY STATEMENTS REGARDING FORWARD-LOOKING STATEMENTSThis release contains forward-looking statements, including with respect to THERAKOS ECP, its potential to improve health and treatment outcomes, its potential impact on patients, and the planned presentation regarding the results of the THERAKOS ECP study. . 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 effects of Mallinckrodt's recent emergence from bankruptcy; satisfaction and compliance with regulatory and other requirements; actions of regulatory bodies and other government authorities; changes in laws and regulations; problems with product quality, manufacturing or supply, or patient safety problems or adverse side effects or adverse reactions associated with THERAKOS ECP; 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 today's date and Mallinckrodt undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events and developments or otherwise, except as required by law. .

CONTACT

Media InquiriesGreen Room Communications908-577-4531mediainquiries@grcomms.com

Investor RelationsDaniel J. SpecialeSenior Vice President of Finance and Chief Financial Officer, Specialty Generics314-654-3638daniel.speciale@mnk.com

Derek BelzVice President, Investor Relations314-654-3950derek.belz@mnk.com

Mallinckrodt, the "M" mark, and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners.

©2024 Mallinckrodt. EU-2400019 02/24

References

1 Data on File – Ref-07190. Mallinckrodt Pharmaceuticals.2 Costanzo MR, et al. The International Society of Heart and Lung Transplantation Guidelines for the care of heart transplant recipients. J Heart Lung Trans. 2010:29(8);914–956.3 Alfred et al. The role of extracorporeal photopheresis in the management of cutaneous T-cell lymphoma, graft-versus-host disease and organ transplant rejection: a consensus statement update from the UK Photopheresis Society. Br J Haematol. 2017;177(2):287-310.4 Padmanabhan et al. Guidelines on the Use of Therapeutic Apheresis in Clinical Practice - Evidence-Based Approach from the Writing Committee of the American Society for Apheresis: The Eighth Special Issue. J Clin Apher. 2019;34:171–354.5 Knobler et al. European dermatology forum - updated guidelines on the use of extracorporeal photopheresis 2020 - part 2. Eur Acad Dermatol Venereol. 2021;35(1):27-49.6 Colvin et al. Antibody-mediated rejection in cardiac transplantation: emerging knowledge in diagnosis and management: a scientific statement from the American Heart Association. Circulation. 2015;131(18):1608-1639.7 Barten et al. The clinical impact of donor-specific antibodies in heart transplantation. Transplant Rev (Orlando). 2018;32(4):207-217.

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