DUBLIN – January 27, 2021 – Mallinckrodt plc, a global biopharmaceutical company, announced today that Japan's Ministry of Health, Labour and Welfare (MHLW) approved the CELLEX? extracorporeal photopheresis (ECP) system for the treatment of steroid-resistant or intolerant chronic graft versus host disease (cGvHD) in adults.

The approval was based on an open-label study conducted in patients with steroid-resistant or intolerant cGvHD after allogeneic hematopoietic stem cell transplantation at three institutions in Japan. The efficacy rate following evaluation of response and changes in steroid dose 24-weeks after ECP initiation was 66.7 percent (8/12 patients), the primary endpoint of the study. Adverse events were observed in all patients (n=15, 106 events). Most of the adverse events observed were considered as those of the primary disease or associated with long-term treatment with steroids. There were no adverse events unique to this treatment.

“We are very pleased that the CELLEX ECP System has been approved. As a pharmaceutical company focused on improving outcomes for under-served patients with severe and critical conditions, we strive to develop treatment options that address unmet medical needs,” said Masatoyo Gunji, the President of Mallinckrodt Pharma K.K. “Treatment for patients with cGvHD who do not respond to steroids has long been a challenge and is one of the more difficult aspects in treatment of cGvHD. As a new treatment option, we expect the CELLEX ECP System to play an important role in treatment of patients with cGvHD.”

About Chronic Graft Versus Host Disease (cGvHD)

Graft versus host-disease is a common complication of hematopoietic stem cell transplantation (HSCT) resulting in significant morbidity and mortality. It can be classified as acute or chronic based on the clinical presentation and the time of occurrence after the transplantation. Signs and symptoms of cGvHD nearly always occur within the first year post transplantation but can occasionally happen several years later.2 In cGvHD, the skin is the most frequently affected organ with manifestations of itchy rash, hyper or hypopigmentation and changes in texture. However, the disease can affect multiple sites, which may have a major impact upon a patient's quality of life.2,3 Chronic GvHD can lead to debilitating consequences, such as joint contractures, loss of sight, end-stage lung disease, or mortality resulting from profound chronic immune suppression leading to recurrent or life-threatening infections.

IMPORTANT SAFETY INFORMATION

Intended Use or Efficacy

This system is used as extracorporeal photopheresis therapy in steroid resistant or intolerant, chronic graft versus host disease.

Warnings

Directions for Use:

1. When conducting extracorporeal photopheresis therapy for patients receiving other therapy, exercise caution when changing treatment schedules to avoid increased disease activity that may be caused by abrupt withdrawal of previous therapy.

2. Taking into account the condition of the patient, administer an appropriate amount of anticoagulant through the CELLEX device, as thromboembolic events may occur.

Contraindications / Prohibitions

Directions for Use:

1. Do not re-use (Procedural Kit and Methoxsalen Solution).

2. Do not operate the instrument in the presence of flammable anesthetic gases, external radio or electromagnetic disturbances that may interfere with proper performance of the device. There is the risk of ignition and malfunction.

Applicable subject (patient)

Do not use for the following population.

? Patients who cannot tolerate extracorporeal volume loss as the patient has possibility of hypotension and shock disease.

? Patients exhibiting idiosyncratic reactions to psoralen compounds including methoxsalen, or possessing a specific history of a light-sensitive disease state.

? Patients with aphakia because of the significantly increased risk of retinal damage due to the absence of a lens.

? Patients possessing a specific history of a disordered coagulation or patients who have had previous splenectomy as anticoagulants is used during therapy.

? Patients during pregnancy and lactation as it is likely to cause harm to the unborn child or suckling infant.

? Patients who have white blood cell counts greater than 25,000/mm3.

ABOUT THE THERAKOS CELLEX ECP SYSTEM

The CELLEX System delivers extracorporeal photopheresis (ECP), and consists of an instrument, procedural kit, methoxsalen solution and a UVA lamp. ECP was initially developed as a therapy for patients with Cutaneous T-Cell Lymphoma (CTCL).

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

CELLEX was also designated as an orphan medical device by the MHLW on January 18 2017.

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 and ophthalmology; 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.

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CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS

This release includes forward-looking statements concerning the use of the CELLEX System including potential benefits associated with its use. 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.