PR99722

Mallinckrodt Announces Reimbursement Approval in Japan for the CELLEX(R) Extracorporeal Photopheresis (ECP) System for the Treatment of Chronic Graft Versus Host Disease (cGvHD)

DUBLIN, March 9, 2023 /PRNewswire=KYODO JBN/ --

– CELLEX ECP is now available for reimbursement in Japan for patients who are

steroid-resistant or -intolerant and suffering from cGvHD –

Mallinckrodt plc (

https://c212.net/c/link/?t=0&l=en&o=3801942-1&h=3085666488&u=http%3A%2F%2Fwww.mallinckrodt.com%2F&a=Mallinckrodt+plc

), (NYSE American: MNK) ("Mallinckrodt" or the "Company"), a global specialty

pharmaceutical company, today announced that Japan's National Health Insurance

(NHI) system has approved reimbursement for the CELLEX(R) extracorporeal

photopheresis (ECP) system for the treatment of steroid-resistant or

-intolerant chronic graft versus host disease (cGvHD).

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

"We are very pleased that we have received approval for reimbursement in Japan

for the CELLEX ECP System. 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, Mallinckrodt General Manager of Japan.

Following the approval of the CELLEX ECP System in Japan in late 2020, with the

reimbursement approval, healthcare providers in Japan can now begin to

prescribe the CELLEX ECP System and treat patients suffering from cGvHD who are

steroid-resistant or -intolerant.

The approved uses for the CELLEX ECP System differ depending upon the country.

Please refer to each country's Operator's Manuals and labeling for approved

uses.

"Chronic graft versus host disease is a highly debilitating disease with a

significant impact to 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 care providers, access to an important therapeutic

option where there has been a high unmet medical need," said Lisa French,

Executive Vice President and Chief Commercial Officer of Mallinckrodt

Pharmaceuticals.

About Chronic Graft Versus Host Disease (cGvHD)

Graft versus host-disease is a common complication of allogeneic hematopoietic

stem cell transplantation (HSCT) resulting in significant morbidity and

mortality.(1) 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 texture2. 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.(1)

IMPORTANT SAFETY INFORMATION FOR JAPAN

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/mm(3).

ABOUT THE THERAKOS CELLEX ECP SYSTEM FOR JAPAN

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 skin symptoms of 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.

APPROVED USES FOR THE THERAKOS CELLEX ECP SYSTEM

The approved uses for CELLEX ECP differ depending upon the country. Please

refer to each country's Operator's manuals and labeling for approved uses.

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; 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 channel of distribution of important company

information, such as press releases, investor presentations and other financial

information. It also uses its website to expedite public access to

time-critical information regarding the company in advance of or in lieu of

distributing a press release or a filing with the U.S. Securities and Exchange

Commission (SEC) disclosing the same information. Therefore, investors should

look to the Investor Relations page of the website for important and

time-critical information. Visitors to the website can also register to receive

automatic e-mail and other notifications alerting them when new information is

made available on the Investor Relations page of the website.

CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS

This release contains forward-looking statements, including 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.

CONTACT

Media Inquiries

Heather Guzzi

Green Room Communications

+1 973-524-4112

hguzzi@greenroompr.com

Investor Relations

Daniel J. Speciale, CPA

Vice President, Finance and Investor Relations Officer

+1 314-654-3638

daniel.speciale@mnk.com

Mallinckrodt Pharma K.K.

Junichi Yoshimura

Sales & Marketing, Product Manager

+81 3 6441 3604

junichi.yoshimura@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.

(C)2023 Mallinckrodt. JP-2300001 3/23

References

(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.

SOURCE  Mallinckrodt plc