– CELLEX ECP is now available for reimbursement in Japan for patients who are steroid-resistant
or -intolerant and suffering from cGvHD –
DUBLIN, March 9, 2023 /PRNewswire/ -- 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®
extracorporeal photopheresis (ECP) system for the treatment of
steroid-resistant or -intolerant chronic graft versus host disease
(cGvHD).
"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/mm3.
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.
© 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.
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