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THERAKOS™ CELLEX™ Photopheresis System Receives CE Certificate Under the European Union Medical Device Regulation (EU MDR)

03 settembre 2024 | 09.45

LETTURA: 7 minuti

– THERAKOS, the world's only fully integrated and validated Extracorporeal Photopheresis (ECP) system,^¹ received this CE certificate under the EU's new and more rigorous certification process –

DUBLIN, Sept. 3, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, announced that the THERAKOS™ CELLEX™ Photopheresis System has obtained CE Certification under the updated European Union Medical Device Regulation (EU MDR) 2017/745.

The EU MDR 2017/745 is a rigorous regulatory certification program for medical devices intended to support innovation while maintaining safety. The process for THERAKOS to achieve this new CE certificate involved a quality management system audit of the Dublin site, a technical review, a microbiological review, and a thorough clinical assessment.

The EU MDR application for THERAKOS was submitted in September 2022. Along with addressing the new requirements for medical devices, this submission also included two important design enhancements:

THERAKOS is approved for use in patients who require the administration of photopheresis. This includes patients older than 18 with Cutaneous T Cell Lymphoma or Solid Organ Transplant Rejection (heart, lung), and patients older than 3 with Acute and Chronic Graft versus Host Disease.

"We are pleased THERAKOS has received the CE Certificate under the new EU MDR requirements that have been put in place to ensure the highest quality and safety standards for medical devices in the EU," said Christopher Hirt, MD, Vice President Hospital International. "Importantly, THERAKOS was granted this certificate after meeting the increased safety and performance requirements, which may give healthcare providers even greater confidence when treating patients."

About THERAKOS™ CELLEX™ Photopheresis SystemThe THERAKOS CELLEX Photopheresis System is the world's only fully integrated and validated ECP system.¹ THERAKOS performs ECP using patented technology that collects, separates and treats a small amount of white blood cells (immune cells) while the patient is connected to the instrument. The treated cells are then returned to the patient where they help to modify the immune response in a process called immunomodulation. It is used to treat a range of immune-mediated diseases. THERAKOS Systems are used by over 300 treatment centres in over 30 countries worldwide.²

About Extracorporeal Photopheresis (ECP)Extracorporeal photopheresis (ECP) is an immunomodulatory therapy that has demonstrated efficacy in various T-cell and immune-mediated diseases.³ ECP is recommended by international and national guidelines for a spectrum of diseases, including cutaneous T-cell lymphoma (CTCL), acute and chronic graft-versus-host disease (aGvHD and cGvHD), chronic lung allograft dysfunction-bronchiolitis obliterans syndrome (CLAD-BOS) and after cardiac transplantation.^{4,5,6,7,8,9,10,11,12,13,14,15}

IMPORTANT SAFETY INFORMATION FOR THE THERAKOS™ PHOTOPHERESIS PROCEDURE UNDER EU MDR

Indications under EU MDRThe THERAKOS™ CELLEX™ Photopheresis System is indicated for patients older than 18 years of age for the administration of photopheresis in the following:

The THERAKOS™ CELLEX™ Photopheresis System is indicated in patients older than 3 years of age for the management of:

ContraindicationsTHERAKOS™ Photopheresis is contraindicated in:

Warnings and Precautions

Adverse Events

Please refer to the THERAKOS™ CELLEX™ Photopheresis System Operator Manual for a complete list of warnings and precautions.

IMPORTANT SAFETY INFORMATION FOR METHOXSALEN USED IN CONJUNCTION WITH THERAKOS™ PHOTOPHERESIS

ContraindicationsMethoxsalen is contraindicated in:

Warnings and Precautions

Refer to the package insert for methoxsalen sterile solution (20 micrograms / mL) or the oral 8-methoxypsoralen dosage formulation for a list of all warnings and precautions.

Please refer to the THERAKOS™ CELLEX™ Photopheresis System Operator Manual for a complete list of warnings and precautions and adverse events.

ABOUT MALLINCKRODTMallinckrodt 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; 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.

CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTSThis release contains forward-looking statements, including with regard to THERAKOS, its potential to improve health and treatment outcomes, and its potential impact on patients. 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: the effects of Mallinckrodt's recent emergence from bankruptcy; satisfaction of, and compliance with, 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 or adverse side effects or adverse reactions associated with THERAKOS; and other risks identified and described in more detail in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Mallinckrodt's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, 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 InquiriesGreen Room Communications908-577-4531mediainquiries@grcomms.com

Investor RelationsDerek BelzVice President, Investor Relations314-654-3950derek.belz@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.

References

¹ Knobler R, et al. J Eur Acad Dermatol Venereol. 2020;34(12):2693-2716.² Data on File – Ref-07615. Mallinckrodt Pharmaceuticals.³Hart JW, et al. Ther Adv Hematol. 2013;4:320-334.⁴ Knobler R, et al. J Eur Acad Dermatol Venereol. 2020;34(12):2693-2716.⁵ Trautinger F, et al. Eur J Cancer. 2017;77:57 74.⁶ Padmanabhan A, et al. J Clin Apher. 2019;34(3):171-354.⁷ Alfred A, et al. Br J Haematol. 2017;177:287-310.⁸ Cho A, et al. Front Med (Lausanne). 2018;5:236.⁹ Zeiser R. et al. Graft-versus-Host Erkrankung, akut. 2021. Available at: https://www.onkopedia.com/de/onkopedia/guidelines/graft-versus-host-erkrankung-akut/@@view/html/index.html. Accessed August 2024.¹⁰ Bredeson C, et al. Curr Oncol. 2014;21(2):e310-325.¹¹ Pierelli L, et al. Transfusion. 2013;53(10):2340-2352.¹² Wolff D, et al. Biol Blood Marrow Transplant. 2011;17:1-17.¹³ Dignan FL, et al. Br J Haematol. 2012;158(1):30-45; 46-61.¹⁴ Knobler R, et al. J Eur Acad Dermatol Venereol. 2021;25(1):27-49.¹⁵ Costanzo MR, et al. J Heart Lung Transplant. 2010;29(8):914-956.