– CELLEX ECP is now available for reimbursement in Japan for patients who are steroid-resistant or -intolerant and suffering from cGvHD –

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.