Extracorporeal Photopheresis (ECP), Including Mallinckrodt's THERAKOS® ECP Immunomodulation, Receives Approval for Reimbursement by Swiss Federal Department of Home Affairs

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CHESTERFIELD, England, August 23, 2016 /PRNewswire/ --

- Approval granted for reimbursement of Extracorporeal Photopheresis (ECP) for Bronchiolitis Obliterans Syndrome (BOS) derived from lung transplantation. 

- First approval of a Health Technology Appraisal for ECP in BOS by a national governmental regulatory agency. 

Mallinckrodt plc (NYSE: MNK), a leading specialty pharmaceutical company, announced that Switzerland's Federal Department of Home Affairs (FDHA) has approved reimbursement of Extracorporeal Photopheresis (ECP) treatment for patients in Switzerland with Bronchiolitis Obliterans Syndrome (BOS) following lung transplantation. Mallinckrodt Pharmaceuticals provides ECP therapy through its THERAKOS^® therapeutic platforms, including the latest generation THERAKOS CELLEX^®Photopheresis System.

The FDHA's decision relates to the use of ECP in Switzerland as salvage therapy for patients with BOS already on augmented immunosuppression and macrolide antibiotics as immunomodulation. It represents the first approval of a Health Technology Appraisal for ECP in BOS by a national governmental regulatory agency.

The initial request for FDHA approval was submitted by the University Hospital of Zurich's Lung Transplant Program and supported by Mallinckrodt. It was followed in September 2015 by a Health Technology Appraisal that made a detailed evaluation of the scientific, health economics and value information on ECP in patients with BOS. The approval of reimbursement went into effect on 1 August 2016, and is subject to re-evaluation by the end of 2019, based on any new evidence generated at that point.

"The reimbursement approval makes an important immunotherapy treatment more widely available to Swiss patients who have exhausted other therapies in the treatment of this condition," said Mark Trudeau, President and Chief Executive Officer of Mallinckrodt. "It also demonstrates the underlying potential of this highly durable asset and the contribution we believe it can make to our growing Hospital business."

Approximately 50 lung transplants^[1] are conducted each year in Switzerland. About half of the surviving recipients will develop BOS after five years following lung transplantation according to international registry data.^[2]  This rate of BOS rises to 75% after more than ten years, despite lifelong immunosuppression.^[2] BOS is associated with progressive decline of lung function (forced expiratory volume in 1 sec, FEV₁) and, ultimately, death due to respiratory failure. BOS is the leading cause of death one year after lung transplantation and is the main reason for the inferior long-term outcomes in lung transplant recipients.^[3] Approximately 20% of lung transplant patients die of opportunistic infections and secondary malignancies.^[4]

Patients who develop BOS after receiving a lung transplant are most commonly treated with augmented/altered immunosuppression and a trial of macrolide antibiotics as immunomodulation. If lung function decline progresses, several salvage therapy options may be utilised. However, balancing the progressive decline of lung function and the attempt to keep the risk of infection at bay limits the use of the available immunosuppressive salvage therapies.^[5] ECP is an immunomodulatory therapy which does not act as additional immunosuppression, but rather it acts to generalize immunomodulation slowing or even to halt lung function decline generally without potential severe side effects of immunosuppression, including opportunistic infections.^[6]

Mallinckrodt is the world's only provider of integrated systems for the delivery of Extracorporeal Photopheresis (ECP), and its systems are used by academic medical centres, hospitals and treatment centres in more than 30 countries. THERAKOS Systems have been used to deliver over one million photopheresis treatments globally.

About Mallinckrodt plc 
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical and biopharmaceutical products and therapies, as well as nuclear imaging products. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and hemostasis products; and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing; and the Nuclear Imaging segment includes nuclear imaging agents. To learn more about Mallinckrodt, visit http://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.

About THERAKOS ECP Immunomodulation
THERAKOS ECP Immunomodulation is delivered through the CELLEX and UVAR XTS^® extracorporeal photopheresis (ECP) systems. THERAKOS Immunotherapy harnesses the power of each individual patient's immune system to fight disease and is used by academic medical centres, hospitals, and treatment centres in more than 30 countries. THERAKOS Photopheresis systems are fully integrated and CE marked for the administration of photopheresis. For more information, please visit http://www.therakos.co.uk . 

About Bronchiolitis Obliterans Syndrome (BOS)  

Lung transplantation is an established therapeutic option for selected patients with end-stage lung disease^[7] and the number of transplants per year has steadily increased over the last few decades. However, 50% of lung transplant recipients will develop BOS after five years, rising to 75% after more than ten years, despite lifelong immunosuppression.^[8] BOS is associated with progressive decline of lung function (FEV₁) and, ultimately, death due to respiratory failure. BOS is the leading cause of death one year after lung transplantation and is the main reason for the unfavourable long-term outcomes of lung transplant procedures.^[9]

Sources  

1. Swiss Transplant, Swiss National Foundation for Organ Donation and Transplantation. Organ Donation and Transplantation Activity Report: 2014. Available at http://www.swisstransplant.org/en/information-material/statistics/annual-figures/  Accessed September 14, 2015. 

2. Yusen RD, Edwards LB, Kucheryavaya AY, et al. The registry of the International Society for Heart and Lung Transplantation: thirty-first adult lung and heart-lung transplant report--2014; focus theme: retransplantation. J Heart Lung Transplant. 2014;33(10):1009-1024. 

3. Sources: 

Finlen Copeland CA, Snyder LD, Zaas DW, Turbyfill WJ, Davis WA, Palmer SM. Survival after bronchiolitis obliterans syndrome among bilateral lung transplant recipients. Am J Respir Crit Care Med. 2010;182(6):784-789. 

Sato M, Hwang DM, Waddell TK, Singer LG, Keshavjee S. Progression pattern of restrictive allograft syndrome after lung transplantation. J Heart Lung Transplant. 2013;32(1):23-30. 

4. Yusen RD, Edwards LB, Kucheryavaya AY, et al. The registry of the International Society for Heart and Lung Transplantation: thirty-first adult lung and heart-lung transplant report--2014; focus theme: retransplantation. J Heart Lung Transplant. 2014;33(10):1009-1024. 

5. Meyer KC, Raghu G, Verleden GM, et al. An international ISHLT/ATS/ERS clinical practice guideline: diagnosis and management of bronchiolitis obliterans syndrome. Eur Respir J. 2014;44(6):1479-1503. 

6. Knobler R, Berlin G, Calzavara-Pinton P, et al. Guidelines on the use of extracorporeal photopheresis. J Eur Acad Dermatol Venereol. 2014;28(suppl 1):1-37. 

7. Christie JD, Edwards LB, Kucheryavaya AY, et al. The Registry of the International Society for Heart and Lung Transplantation: 29th adult lung and heart-lung transplant report-2012. J Heart Lung Transplant. 2012;31(10):1073-1086. 

8. Yusen RD, Edwards LB, Kucheryavaya AY, et al. The registry of the International Society for Heart and Lung Transplantation: thirty-first adult lung and heart-lung transplant report--2014; focus theme: retransplantation. J Heart Lung Transplant. 2014;33(10):1009-1024. 

9. Sources: 

Finlen Copeland CA, Snyder LD, Zaas DW, Turbyfill WJ, Davis WA, Palmer SM. Survival after bronchiolitis obliterans syndrome among bilateral lung transplant recipients. Am J Respir Crit Care Med. 2010;182(6):784-789. 

Sato M, Hwang DM, Waddell TK, Singer LG, Keshavjee S. Progression pattern of restrictive allograft syndrome after lung transplantation. J Heart Lung Transplant. 2013;32(1):23-30.

SOURCE Mallinckrodt