PR87729

DUBLIN, Jan. 22, 2021 /PRNewswire=KYODO JBN/ --

Mallinckrodt plc (

https://c212.net/c/link/?t=0&l=en&o=3044095-1&h=4196795004&u=http%3A%2F%2Fwww.mallinckrodt.com%2F&a=Mallinckrodt+plc

), a global biopharmaceutical company, announced today that Japan's Ministry of

Health, Labour and Welfare (MHLW) approved the CELLEX(R) extracorporeal

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

chronic graft versus host disease (cGvHD) in adults.

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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.(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 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.(1)

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/mm(3).

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.

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 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.

CONTACT

Media Inquiries

Caren Begun

Green Room Communications

+1 201-396-8551

caren@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.

Kazuo Nishiyama

Sales & Marketing, Product Manager

+81 3 6234 1650

kazuo.nishiyama@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) 2021 Mallinckrodt. 1/21

REFERENCES

1       Filipovich, Biol Blood Marrow Transplant 2005; 11:945-956.

2       Jagasia 2015. Biol Blood Marrow Transplant. 2015; 21(3): 389-401.

3       Pavletic et al. Biol Blood Marrow Transplant. 2006;12:252-66.

SOURCE Mallinckrodt plc