-Mallinckrodt announces the publication of real-world data on the use of extracorporeal photopheresis (ECP) in heart transplant patients

- Results from Europe's largest multicenter, retrospective, observational chart review study investigating the actual use of ECP in heart transplant patients reinforce its use as a treatment for heart transplant rejection and rejection prevention1 -

DUBLIN, June 13, 2023/PRNewswire/ -- Mallinckrodt plc (NYSE American: MNK), a global specialty pharmaceutical company, today announced the publication of the findings of a retrospective, observational, single-arm, chart review study. Evaluating the actual use of extracorporeal photopheresis (ECP) and its impact on clinical outcomes in the modern era of heart transplantation.1 An online version of the data manuscript, the largest known study of ECP in transplant patients of heart, is currently published on the Journal of Heart and Lung Transplantation website ahead of print publication in the second half of 2023.

The interim results of this study were presented at a late-breaking session at the 20th Congress of the European Society for Organ Transplantation (ESOT) in 2021 in Milan, Italy. 2

The study, titled "European multicenter study on the real-world use and clinical impact of extracorporeal photopheresis after heart transplantation," examined data from the medical records of 105 patients who received ECP after heart transplantation in seven medical centers in Austria, Germany and France. , Hungary and Italy between 2015 and 2021. At the time of data extraction, 58 patients (55.2%) had completed their DBS treatment and 47 patients (44.8%) were on DBS treatment.1

"These findings from the first, largest European multicenter study investigating the actual use of ECP in heart transplant patients support ECP as a treatment for various types of graft rejection and in the prevention of graft rejection with varied treatment schedules1," said Markus. Barten, M.D., Surgical Director of the Heart Failure Clinic, University Heart and Vascular Center Hamburg. "These data are not only based on the growing body of real-world evidence supporting the use of ECP in heart transplant patients, but also reflect the importance of supporting clinicians with treatment modalities for rejection and stabilization." transplant.1"

About the study1

The mean age of patients at the onset of DBS was 47, Jun 13 (SD 14.4) - years (min 16 years to max 74 years), and the majority of patients (70.5%) they were men. They were followed for a mean time of 25.1 (SD 16.8) months from the start of ECP treatment to the last visit to the transplant center (follow-up time for overall survival outcome). The median time from the start of ECP treatment to the last visit at 2 years after ending ECP treatment was 22.5 (SD 13.7) months (follow-up time for graft function outcomes, response and complications).

Cardiomyopathy was the main reason for heart transplantation (n=81 patients; 77.1%), followed by coronary artery disease (n=11 patients; 10.5%), heart valve disease (n=5 patients; 4.8%) and myocarditis (n=5 patients; 4.8%). The main reason for starting ECP treatment was acute cellular rejection (ACR; n=37 patients; 35.2%), followed by rejection prevention (n=34 patients; 32.4%), mixed rejection (n=19 patients ; 18.1%), and antibody-mediated rejection (AMR; n=15 patients; 14.3%).

The rejection prevention subgroup included patients starting ECP without biopsy-proven rejection and on standard or reduced immunosuppressive therapy.

Key 1 results

Limitations1

The efficacy of DBS compared to other treatment options was not evaluated due to the descriptive, single-arm design of this study. Study limitations include that data generation for this observational study was not standardized. Patient examination schedules varied and not all data were available at all centers. No source data verification was performed and therefore transmission errors cannot be excluded. Not all of the demonstrated benefits can be attributed solely to ECP treatment, as transplant patients may have received multiple therapies at the time of ECP treatment. In patients with AMR or mixed rejection, DBS is commonly used in combination with other treatments.

This study was funded by Mallinckrodt.

IMPORTANT SAFETY INFORMATION FOR THE THERAKOS™ PHOTOPHERESIS PROCEDURE

IndicationsThe THERAKOS™ CELLEX™ Photopheresis System is indicated for the administration of photopheresis. Consult the appropriate product label for a complete list of warnings and precautions.

Contraindications THERAKOS™ Photopheresis is contraindicated in:

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

Adverse events

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

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

Contraindications Metoxsalen is contraindicated in:

Warnings and Cautions

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

See 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 over 30 years ago, is recommended by the International Society for Heart-Lung Transplantation (ISHLT)3 and other clinical societies4,5,6 as a adjuvant therapy for the prevention and treatment of ACR after heart transplantation. In addition, ECP may be considered to treat AMR with or without donor-specific antibodies.7,8 In countries where it is approved, ECP is used to treat a variety of immune-mediated diseases, including cutaneous manifestations of cutaneous cell lymphoma. T (CTCL), graft-versus-host disease (GvHD), solid organ transplant rejection, and other autoimmune diseases. During ECP treatment, a small number of white blood cells are collected and treated with a medication that is activated by ultraviolet light.

ABOUT MALLINCKRODT Mallinckrodt is a global company comprised of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceuticals and therapies. The company's Specialty Brands reportable segment areas of interest include rare and autoimmune diseases in specialty areas such as 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 segment includes specialty generic drugs and active pharmaceutical ingredients. For more information on Mallinckrodt, visit www.mallinckrodt.com.

Mallinckrodt uses its website as a distribution channel for important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to critical information about the company before or instead of distributing a press release or filing with the US Securities and Exchange Commission (SEC) that discloses the same information. Therefore, investors should refer to the Investor Relations page of the website for important and time-critical information. Website visitors can also sign up to receive automated emails and other notifications that alert them when new information is available on the Investor Relations page of the website.

FORWARD-LOOKING STATEMENTS This release contains forward-looking statements, including with respect to ECP and its potential impact on patients. Statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in forward-looking statements: satisfaction of 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 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 SEC filings, all of which are available on its website. Forward-looking statements made in this document speak only as of the present date and Mallinckrodt does not undertake 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 the law.

CONTACTS

Inquiries for MediosHeather GuzziSenior Vice President, Green Room Communications973-524-4112hguzzi@grcomms.com

Investor RelationsDaniel J. SpecialeGlobal Corporate Controller and Director of Investor Relations314-654-3638daniel.speciale@mnk.com

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

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

©2023 Mallinckrodt. EU-2300168 06/23

1 Barten, MJ et al. European multi-center study on the real-world use and clinical impact of extracorporeal photopheresis after heart transplantation. J Heart Lung Transplant. 2023. https://doi.org/10.1016/j.healun.2023.03....2 Barten, MJ. et al. Real World Use and Clinical Impact of Extracorporeal Photopheresis in Heart Transplant Patients – Results From a European Multi-Centre Study. Abstractpresented at: European Society for Organ Transplantation (ESOT) Congress 2021. Agosto/septiembre 2021.3 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);914–956.4 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):287-310.5 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;34:171–354.6 Knobler et al. European dermatology forum - updated guidelines on the use of extracorporeal photopheresis 2020 - part 2. Eur Acad Dermatol Venereol. 2021;35(1):27-49.7 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):1608-1639.8 Barten et al. Transplant Rev (Orlando). The clinical impact of donor-specific antibodies in heart transplantation. 2018;32(4):207-217.

Logo - https://mma.prnewswire.com/media/167103/mallinckrodt_plc_logo.jpg

View original content: https://www.prnewswire.com/es/comunicados-de-prensa/mallinckrodt-anuncia-datos-sobre-el-uso-de-fotoferesis-extracorporea-en-pacientes-con-trasplante-de-corazon-301849546.html