DUBLIN, Nov. 14, 2024 /PRNewswire/ — Mallinckrodt plc, a global specialty pharmaceutical company, today announced the winner of the Extracorporeal Immunomodulation Award (EIA). The award recognizes a project aimed at identifying the optimal timing for extracorporeal photopheresis (ECP) initiation and assessing its effectiveness when combined with other graft versus host disease (GvHD) therapies. To recognize the occasion, Mallinckrodt, which provides immunomodulatory therapy via ECP, dedicated the $75,000 grant to this research. This year’s award holds special significance as it marks 30 years since clinicians first used ECP to successfully treat chronic graft versus host disease (cGvHD).1,2

The EIA-winning project was submitted by Dr Andrea Varkonyi, of the South-Pest Central Hospital, National Institute of Hematology and Infectiology’s Department of Hematology and Stem Cell Transplantation, in Budapest, Hungary. Her team will carry out a retrospective and prospective study, comparing ruxolitinib alone to ruxolitinib combined with ECP therapy in the treatment of acute and chronic GvHD. They will also evaluate the impact of ECP on the development of transplant-associated thrombotic microangiopathy (TA-TMA).

“Mallinckrodt is thrilled to recognize Dr. Andrea Varkonyi with this year’s the Extracorporeal Immunomodulation Award and continuing the research in chronic GvHD. As the manufacturer of the THERAKOS CELLEX Photopheresis System we are committed to supporting research that seeks to improve patient outcomes and tackle unmet needs in this important area of medicine.” said Peter Richardson, MRCP (UK), Executive Vice President & Chief Scientific Officer.

Dr. Varkonyi said, “Acute and chronic GvHD, along with TA-TMA, remain unresolved issues following allogeneic bone marrow transplantation. Despite the intent of the procedure, these complications often prevent patients from achieving complete recovery. We are grateful to be receiving this award to advance research in this area. Thank you, Mallinckrodt, for the opportunity to further our research.”

The study’s objective is to identify the optimal timing for introducing ECP and assess its effectiveness when combined with other therapies. It aims to address key areas of interest in allogeneic stem cell transplant-associated fundamental and clinical research.

Entries to the EIA award were invited from clinicians and scientists working on translational or outcomes-based research, as well as collaborative projects, in the field of GvHD-focused ECP. Submissions were assessed on a range of criteria, including scientific merit, originality, and feasibility.

The EIA award recognizes individuals and institutions whose research contributes to the continued advancement of knowledge in this area of medicine and is just one part of our ongoing commitment to the science of immunomodulation through ECP.

In June, the THERAKOS CELLEX System technology secured CE certification under the European Union Medical Device Regulation (EU MDR). It involved a robust quality management system audit, technical and microbiological reviews, and a thorough clinical assessment, demonstrating the organization’s ongoing commitment to ECP evidence generation, post approval.

About THERAKOS CELLEX Photopheresis System

The THERAKOS CELLEX Photopheresis System is the world’s only fully integrated and validated ECP system.3 THERAKOS performs ECP using patented technology that collects, separates and treats a small amount of white blood cells (immune cells) while the patient is connected to the instrument. The treated cells are then returned to the patient where they help to modify the immune response in a process called immunomodulation. It is used to treat a range of immune-mediated diseases. THERAKOS Systems are used by over 300 treatment centres in over 30 countries worldwide.4

About Extracorporeal Photopheresis (ECP)

Extracorporeal photopheresis (ECP) is an immunomodulatory therapy that has demonstrated efficacy in various T-cell and immune-mediated diseases.³ ECP is recommended by international and national guidelines for a spectrum of diseases, including cutaneous T-cell lymphoma (CTCL), acute and chronic graft-versus-host disease (aGvHD and cGvHD), chronic lung allograft dysfunction-bronchiolitis obliterans syndrome (CLAD-BOS) and after cardiac transplantation. 5,6,7,8,9,10,11,12,13,14,15, 16,17

EU INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE THERAKOS PHOTOPHERESIS PROCEDURE

Indications
The THERAKOS CELLEX Photopheresis System is indicated for patients older than 18 years of age for the administration of photopheresis in the following:

• Cutaneous T Cell Lymphoma (CTCL)
• Solid Organ Transplant Rejection (SOT) (heart, lung)

The THERAKOS CELLEX Photopheresis System is indicated in patients older than 3 years of age for the management of:

• Acute and Chronic Graft versus Host Disease (aGvHD, cGvHD)

Contraindications
THERAKOS Photopheresis is contraindicated in:

• Patients possessing a specific history of a light sensitive disease
• Patients who cannot tolerate extracorporeal volume loss or who have white blood cell counts greater than 25,000 / mm3
• Patients who have coagulation disorders or who have previously had a splenectomy

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 readily available throughout the procedure.

• Do not expose the device to a magnetic resonance (MR) environment. The device may present a risk of projectile injury, and thermal injury and burns may occur. The device may generate artifacts in the MR image, or may not function properly.
• Thromboembolic events, including pulmonary embolism and deep vein thrombosis, have been reported in the treatment of Graft versus Host Disease (GvHD). Special attention to adequate anticoagulation is advised when treating patients with GvHD.
• When prescribing and administering THERAKOS Photopheresis for patients receiving concomitant therapy, exercise caution when changing treatment schedules to avoid increased disease activity that may be caused by abrupt withdrawal of previous therapy.

Adverse Events

• Hypotension may occur during any treatment involving extracorporeal circulation. Closely monitor the patient during the entire treatment for hypotension.
• Transient pyretic reactions, 37.7–38.9°C (100–102°F), have been observed in some patients within six to eight hours of reinfusion of the photoactivated leukocyte-enriched blood. A temporary increase in erythroderma may accompany the pyretic reaction.
• Treatment frequency exceeding labelling recommendations may result in anaemia.
• Venous access carries a small risk of infection and pain.

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

IMPORTANT SAFETY INFORMATION FOR METHOXSALEN USED IN CONJUNCTION WITH THERAKOS PHOTOPHERESIS

Consult the 8-methoxypsoralen (Methoxsalen (20 micrograms / mL)) professional leaflet or the oral 8-methoxypsoralen formulation package insert before prescribing or dispensing any medication.

Warnings and Precautions

• Patients exhibiting multiple basal cell carcinomas or having a history of basal cell carcinoma should be diligently observed and treated.
• Methoxsalen may cause fetal harm when given to a pregnant woman. Women undergoing photopheresis should be advised to avoid becoming pregnant.
• Special care should be exercised in treating patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents.
• Oral administration of methoxsalen followed by cutaneous UVA exposure (PUVA therapy) is carcinogenic.
• Patients should be told emphatically to wear UVA absorbing, wrap-around sunglasses for twenty-four (24) hours after methoxsalen treatment. They should wear these glasses any time they are exposed to direct or indirect sunlight, whether they are outdoors or exposed through a window.

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

ABOUT MALLINCKRODT
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; 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.

CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release contains forward-looking statements, including with regard to Therakos, 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 effects of Mallinckrodt’s recent emergence from bankruptcy; 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 THERAKOS; and other risks identified and described in more detail in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Mallinckrodt’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, 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.

Contact

Media Inquiries
Green Room Communications
908-577-4531
mediainquiries@grcomms.com

Investor Relations
Derek Belz
Vice President, Investor Relations
314-654-3950
derek.belz@mnk.com

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.

^©2024 Mallinckrodt. EU-2400258 10/24

References

1. Owsianowski M, et al. Bone Marrow Transplant. 1994;14(5), 845-848.
2. Solh M, et al. (2023). Bone Marrow Transplant. 2023;58(2), 168-174.
3. Knobler R, et al. J Eur Acad Dermatol Venereol. 2020;34(12):2693-2716.
4. Data on File – Ref-07615. Mallinckrodt Pharmaceuticals.
5. Hart JW, et al. Ther Adv Hematol. 2013;4:320-334.
6. Knobler R, et al. J Eur Acad Dermatol Venereol. 2020;34(12):2693-2716.
7. Trautinger F, et al. Eur J Cancer. 2017;77:57 74.
8. Padmanabhan A, et al. J Clin Apher. 2019;34(3):171-354.
9. Alfred A, et al. Br J Haematol. 2017;177:287-310.
10. Cho A, et al. Front Med (Lausanne). 2018;5:236.
11. Zeiser R. et al. Graft-versus-Host Erkrankung, akut. 2021. Available at: https://www.onkopedia.com/de/onkopedia/guidelines/graft-versus-host-erkrankung-akut/@@view/html/index.html. Accessed August 2024.
12. Bredeson C, et al. Curr Oncol. 2014;21(2):e310-325.
13. Pierelli L, et al. Transfusion. 2013;53(10):2340-2352.
14. Wolff D, et al. Biol Blood Marrow Transplant. 2011;17:1-17.
15. Dignan FL, et al. Br J Haematol. 2012;158(1):30-45; 46-61.
16. Knobler R, et al. J Eur Acad Dermatol Venereol. 2021;25(1):27-49.
17. Costanzo MR, et al. J Heart Lung Transplant. 2010;29(8):914-956.

Logo – https://mma.prnewswire.com/media/2385856/mallinckrodt_standard_color_v3_01_Logo.jpg

DUBLIN, April 14, 2024 /PRNewswire/ — Mallinckrodt plc, a global specialty pharmacy company, today announced that submissions for its 2024 Extracorporeal Immunomodulation Award (EIA) will open on 13 April 2024 during the 50^th Annual Meeting of the European Bone Marrow Transplant Meeting (EBMT), Europe’s largest annual congress in blood and bone marrow transplantation and cellular therapies. In recognition of 30 years since clinicians first used ECP to successfully treat chronic GvHD,¹ Mallinckrodt, provider of immunomodulatory therapy via Extracorporeal Photopheresis (ECP) and manufacturer of the world’s only fully integrated, validated, ECP system, is pleased to mark this important milestone by this year dedicating the award to the study of ECP for cGvHD.

All clinicians and scientists working on translational or outcomes-based research, as well as collaborative projects, in the EMEA region are invited to apply. Submissions will be assessed on a range of criteria, including scientific merit, originality, and feasibility, and the winning project will receive an educational grant of €75,000.

“Mallinckrodt has pioneered ECP immunomodulation through its THERAKOS^TM CELLEX^TM Photopheresis System and is pleased to support continued research that further contributes to this field of medicine,” said Peter Richardson, MRCP (UK), Executive Vice President & Chief Scientific Officer.

Part of Mallinckrodt’s ongoing commitment to the science of immunomodulation through ECP is to recognize individuals and institutions whose research contributes to the advancement of knowledge in this area of medicine.

Previous winners have included a collaboration between The RIGHT institute and University Hospital Besançon, in France. The team, led by Dr Etienne Daguindau, investigated the mechanisms of cell death generated through ECP, and its direct effects on the innate cells involved in the resolution of inflammation. In 2018, the prize went to a team from the Rotherham NHS Foundation Trust’s Department of Haematology. Led by Dr Nick Matthews, the study evaluated the effect of ECP on monocytes in the GvHD setting.

Entries to the 2024 EIA Award will close on 1 September 2024. For full details on how to enter, go to: https://therakos.eu/healthcare-professionals/research-opportunities-educational-grants/

The 2024 EIA is just part of Mallinckrodt’s celebration of 30 years of ECP in GvHD. We are also collaborating with our partners to bring you two symposia at the 2024 EBMT Annual Meeting:

• Symposium: 30 years of ECP in GvHD: Recommendations for the treatment of cGvHD. This event will be presented by the GvHD Hub, and supported through an unrestricted educational grant from Therakos, Mallinckrodt.
  Speakers: Mohamad Mohty, Bipin Savani, Florent Malard, and Zinaida Peric.
  Location: Hall 5
  Date and Time: Sunday, April 14, 4.30 p.m. – 6 p.m. British Summer Time (BST)
• Nurse Symposium: 30 Years of ECP – Patient-centered therapy using Therakos ECP technology, then, now and in the future.
  Speakers: Michelle Kenyon, Francesca Kinsella, Laura Dalling
  Location: Hall 1
  Date and Time: Monday, April 15, 4.30 p.m. – 6 p.m. British Summer Time (BST)

The sessions will be held in person at the meeting’s Glasgow venue. To register, go to the EBMT Annual Meeting website.

ABOUT THERAKOS

Mallinckrodt’s Therakos therapeutic platforms, including the latest generation THERAKOS^TM CELLEX^TM Photopheresis System, are used by academic medical centers, hospitals, and treatment centers in more than 30 countries and have delivered more than 1 million treatments globally.² For more information, please visit www.therakos.eu.

Please see the Indications and Important Safety Information available at therakos.eu.

ABOUT MALLINCKRODT

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; and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit https://www.mallinckrodt.com.

CONTACT

Investor Relations
Derek Belz
Vice President, Investor Relations
314-654-3950
derek.belz@mnk.com

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.

^©2024 Mallinckrodt. EU-2400078 04/24

References

¹ Owsianowski, M., Gollnick, H., Siegert, W., Schwerdtfeger, R., & Orfanos, C. E. (1994). Successful treatment of chronic graft-versus-host disease with extracorporeal photopheresis. Bone marrow transplantation, 14(5), 845-848. 2 Data on File ref-05174.

THIS INFORMATION IS INTENDED FOR EUROPEAN AUDIENCES ONLY

DUBLIN, Feb. 21, 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 the safety, efficacy, and real-world outcomes 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 ECP was associated with improvements in patients’ overall survival (OS), failure-free survival (FFS), and overall response rate (ORR).¹ The results will be shared in a poster presentation at the 2024 Tandem Meetings, the combined Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood and Marrow Transplant Research (CIBMTR) taking place February 21-24, 2024 in San Antonio, TX.

A systematic review of literature available through October 19, 2022 was first conducted to identify and analyze studies of patients receiving ECP for SR-cGvHD that reported on efficacy, safety, or health-related quality of life (HRQoL) outcomes.¹ The literature review identified 47 studies which uniquely reported on THERAKOS ECP treatment 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-≥4 lines of previous treatment.¹ Most clinical studies (n=27) used a retrospective case series design.¹

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

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

In assessing the short-term efficacy of THERAKOS ECP, this meta-analysis found¹:

• The ORR (7 studies; 293 patients) at Months 3-4 and at Months 6-8 (13 studies; 540 patients) were 45.34% (95% CI: 26.64 – 65.45) and 58.23% (95% CI: 45.04-70.35), respectively.
• No significant difference in ORR between studies utilizing NIH criteria vs. non-NIH criteria, per the subgroup analysis.
• Skin-specific response at Months 2-3 and at Months 4-6 were 34.86% (95% CI: 13.26-65.21) and 54.22% (95% CI: 35.67-71.67), respectively.

In assessing the long-term efficacy of THERAKOS ECP, this meta-analysis found¹:

• The pooled OS rate (14 studies; 704 patients) at Month 12 was 83.97% (95% CI: 77.33-88.94).
• The OS rate (8 studies; 431 patients) at Month 60 was 57.96% (95% CI: 35.48-77.56).
• The FFS rate (4 studies; 169 patients) at Month 12 was 60.79% (95% CI: 38.94-79.03).

Limitations
Data collected in systematic literature reviews and meta-analyses may have errors or omissions. The studies included in the analysis are heterogeneous and use different patient populations, endpoints, interventions, and dosing.¹ There was considerable heterogeneity across analyses with I² values ranging from 65% to 91%.¹ Most studies included in the meta-analysis were retrospective analyses¹ and these observations may require further investigation in prospective, controlled trials. Statistical evaluations should be interpreted with caution. Outcomes may be influenced by therapies not evaluated in the study and the clinical/health economics outcomes may not be solely attributable to THERAKOS ECP.

This study was sponsored by Mallinckrodt Pharmaceuticals. Presentation details can be found below:

Abstract #340: Systematic Review and Meta-Analysis of Extracorporeal Photopheresis for the Treatment of Steroid-Refractory Chronic Graft-Versus-Host Disease¹

• Presenter: Zachariah DeFilipp, MD, Hematopoietic Cell Transplant and Cellular Therapy Program, Massachusetts General Hospital, MA
• Presentation Date: Thursday, February 22, 2024; 6:45 – 7:45 p.m. CST
• Location: Exhibit Hall 4a (Street Level)

IMPORTANT SAFETY INFORMATION FOR THE THERAKOS PHOTOPHERESIS PROCEDURE

Indications
The THERAKOS CELLEX Photopheresis System is indicated for the administration of photopheresis. Please refer to the appropriate product labelling for a complete list of warnings and precautions.

Contraindications
THERAKOS Photopheresis is contraindicated in:

• Patients possessing a specific history of light sensitive disease
• Patients who cannot tolerate extracorporeal volume loss or who have white blood cell counts greater than 25,000 / mm³
• Patients who have coagulation disorders or who have previously had a splenectomy

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 readily available throughout the procedure. Safety in children has not been established.

• Do not expose the device to a magnetic resonance (MR) environment. The device may present a risk of protective injury, and thermal injury and burns may occur. The device may generate artifacts in the MR image, or may not function properly.
• Thromboembolic events, including pulmonary embolism and deep vein thrombosis, have been reported in the treatment of Graft versus Host Disease (GvHD). Special attention to adequate anticoagulation is advised when treating patients with GvHD.
• When prescribing and administering THERAKOS Photopheresis for patients receiving concomitant therapy, exercise caution when changing treatment schedules to avoid increased disease activity that may be caused by abrupt withdrawal of previous therapy.

Adverse Events

• Hypotension may occur during any treatment involving extracorporeal circulation. Closely monitor the patient during the entire treatment for hypotension.
• Transient pyretic reactions, 37.7–38.9 ᵒC (100–102 ᵒF), have been observed in some patients within six to eight hours of reinfusion of the photoactivated leukocyte-enriched blood. A temporary increase in erythroderma may accompany the pyretic reaction.
• Treatment frequency exceeding labelling recommendations may result in anaemia.
• Venous access carries a small risk of infection and pain.

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

IMPORTANT SAFETY INFORMATION FOR METHOXSALEN USED IN CONJUNCTION WITH THERAKOS PHOTOPHERESIS

Contraindications
Methoxsalen is contraindicated in:

• Patients exhibiting idiosyncratic or hypersensitivity reactions to methoxsalen, psoralen compounds, or any of the excipients
• Patients with co-existing melanoma, basal cell or squamous cell skin carcinoma
• Patients who are pregnant, and sexually active men and women of childbearing potential unless adequate contraception is used during treatment
• Patients with aphakia because of the significantly increased risk of retinal damage to the absence of a lens

Warnings and Precautions

• Special care should be exercised in treating patients who are receiving concomitant therapy (either topically or systemically) with known photosynthesizing agents.
• Oral administration of methoxsalen followed by cutaneous UVA exposure (PUVA therapy) is carcinogenic.
• Patients should be told emphatically to wear UVA absorbing, wrap-around sunglasses for twenty-four (24) hours after methoxsalen treatment. They should wear these glasses anytime they are exposed to direct or indirect sunlight, whether they are outdoors or exposed through a window.
• Safety in children has not been established.

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

Please refer to the THERAKOS CELLEX Photopheresis System Operator Manual for a complete list of warnings and 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 for Heart and Lung Transplantation (ISHLT)² and other clinical societies^3,4,5 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 range of immune-mediated diseases, including skin manifestations of cutaneous T-cell lymphoma (CTCL), graft-versus-host disease (GvHD), solid organ transplant rejection and other autoimmune diseases. During ECP treatment, a small amount of white blood cells is collected and treated with a drug that is activated by ultraviolet light.

ABOUT MALLINCKRODT
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; 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.

CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release contains forward-looking statements, including with regard to THERAKOS ECP, its potential to improve health and treatment outcomes, its potential impact on patients, and the planned presentation regarding the THERAKOS ECP study results. 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 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 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 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.

CONTACT

Media Inquiries
Green Room Communications
908-577-4531
mediainquiries@grcomms.com

Investor Relations
Daniel J. Speciale
Senior Vice President, Finance and Chief Financial Officer, Specialty Generics
314-654-3638
daniel.speciale@mnk.com

Derek Belz
Vice President, Investor Relations
314-654-3950
derek.belz@mnk.com

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.

^©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.