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– Mallinckrodt Announces Reimbursement Approval in Japan for the CELLEX® Extracorporeal Photopheresis (ECP) System for the Treatment of Chronic Graft-versus-Host Disease (cGvHD)

– CELLEX ECP Now Available for Reimbursement in Japan for Steroid-Resistant/Intolerant Patients with cGvHD –

DUBLIN, March 9, 2023 /PRNewswire/ — Mallinckrodt plc, (NYSE American: MNK) (“Mallinckrodt” or the “Company”), a global specialist pharmaceutical company, today announced that the National Health Insurance system (NHI) of Japan has approved reimbursement for the CELLEX® extracorporeal photopheresis (ECP) system for the treatment of steroid-resistant or intolerant chronic graft-versus-host disease (cGvHD).

“We are very pleased to have received reimbursement approval for the CELLEX ECP System in Japan. As a pharmaceutical company focused on improving outcomes for neglected patients with serious and critical conditions, we strive to develop treatment options that address unmet medical needs. “, declared Masatoyo Gunji, general manager of Mallinckrodt in Japan.

Following the approval of the CELLEX ECP System in Japan at the end of 2020, with reimbursement approval, healthcare providers in Japan can now start prescribing the CELLEX ECP System and treating patients suffering from cGvHD who are resistant or intolerant to the steroids.

The approved uses for the CELLEX ECP System differ by country. Consult user manuals and country labeling for approved uses.

“Chronic graft-versus-host disease is a highly debilitating disease with a significant impact on the health of these patients with limited treatment options in Japan. The reimbursement approval and subsequent launch of the CELLEX ECP System in Japan represents a crucial milestone that will provide these patients, and their caregivers, with access to an important therapeutic option where there has been a great unmet medical need,” said Lisa French, Executive Vice President and Chief Commercial Officer, Mallinckrodt Pharmaceuticals.

About Chronic Graft-versus-Host Disease (cGvHD) Graft-versus-host disease is a common complication of allogeneic hematopoietic stem cell transplantation (HSCT) causing significant morbidity and mortality.1 It can be classified as acute or chronic based on clinical presentation and time of onset after transplantation. Signs and symptoms of cGvHD almost always appear within the first year post-transplant, but can occasionally appear several years later.2 In cGvHD, the skin is the most frequently affected organ, with manifestations of an itchy rash, hyper- or hypopigmentation, and texture changes 2. However, the disease can affect multiple sites, which can have a major impact on the patient’s quality of life.2,3 Chronic GvHD can have debilitating consequences, such as joint contractures, vision loss, end-stage lung disease, or mortality. as a result of profound chronic immunosuppression leading to recurrent or life-threatening infections.1


Intended Use or Efficacy This system is used as extracorporeal photopheresis therapy in chronic steroid resistant or intolerant graft-versus-host disease.

WarningsInstructions for use:

Contraindications / Prohibitions Instructions for use:

Applicable subject (patient)Do not use for the following population.

ABOUT THE THERAKOS CELLEX ECP SYSTEM FOR JAPAN The CELLEX System offers extracorporeal photopheresis (ECP) and consists of an instrument, procedure kit, methoxalene solution, and UVA lamp. DBS was initially developed as a therapy for patients with cutaneous symptoms of cutaneous T-cell lymphoma (CTCL).

The CELLEX system was designated as an early introduction medical device in Japan by the 15th Study Panel on the Early Introduction of Highly Needed Medical Devices. This meeting was organized by the MHLW and was held on February 17, 2011.

CELLEX was also designated an Orphan Medical Device by the MHLW on January 18, 2017.

APPROVED USES OF THE THERAKOS CELLEX ECP SYSTEM Approved uses of CELLEX ECP differ by country. Consult operator’s manuals and country labeling for approved uses.

ABOUT MALLINCKRODT Mallinckrodt is a global company made up of multiple subsidiaries that develop, manufacture, market and distribute pharmaceutical products and specialty therapies. The company’s Specialty Brands segment focuses on autoimmune and rare 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 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 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 time-sensitive company-related information before or instead of distributing a press release or filing with the US Securities and Exchange Commission (SEC) disclosing the same information. . Therefore, investors should refer to the Investor Relations page of the website for important and time-sensitive information. Website visitors can also sign up to receive automatic email and other notifications that alert them when new information is posted on the Investor Relations page of the website.

CAUTIONARY STATEMENTS REGARDING FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements, including statements regarding the use of the CELLEX system, including the potential benefits associated with its use. 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: 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 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. Forward-looking statements made herein are valid only as of today, and Mallinckrodt does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events and developments, or for any other reason. , except as required by law.


Consultas para MediosHeather GuzziGreen Room Communications 1 973-524-4112hguzzi@greenroompr.com

Investor RelationsDaniel J. Speciale, CPAVice President, Finance and Investor Relations 1 314-654-3638daniel.speciale@mnk.com

Mallinckrodt Pharma K.K.Junichi YoshimuraDirector, ventas y marketing 81 3 6441 3604junichi.yoshimura@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. JP-2300001 3/23


1 Filipovich. Biol Blood Marrow Transplant. 2005; 11:945–956.2 Jagasia. Biol Blood Marrow Transplant. 2015; 21(3): 389–401.3 Pavletic, et al. Biol Blood Marrow Transplant. 2006;12:252–66.

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