Newsroom

Mallinckrodt Announces Study Demonstrating Effectiveness of ECP Immunomodulation, as an adjunct to local standard therapy, in Treatment of Lung Transplant Patients with Bronchiolitis Obliterans Syndrome (BOS)

-- Retrospective study  shows that ECP when added to standard local therapy improves survival probability  by approximately 30% in lung transplant patients diagnosed with BOS compared to  matched controls --

-- Adjunct ECP  therapy also shown to lower hospital-related expenses for BOS patients --

STAINES-UPON-THAMES, United Kingdom, 5 April 2019 --  Mallinckrodt plc (NYSE: MNK), a leading specialty pharmaceutical company, announces  the presentation of a retrospective study that demonstrates the effectiveness  of Extracorporeal Photopheresis (ECP), as an adjunct to local standard therapy,  in lung transplant recipients with Bronchiolitis Obliterans Syndrome (BOS)¹.

The study, led by Dr. Christian Joukhadar of  J&P Medical Study Ltd., will be delivered in an oral presentation on  Friday, 5 April, 2019 at the 39th Annual Meeting and Scientific  Sessions of the International Society for Heart and Lung Transplantation  (ISHLT) in Orlando, Florida, USA. Mallinckrodt supported the publication of the  study.

Dr. Joukhadar's work addressed the use of ECP  at the Medical University of Vienna as an empiric treatment option for lung  transplant recipients suffering from BOS. The study sought to evaluate  hospital-related costs and the clinical value of ECP when applied as an adjunct  to the local standard therapy of BOS compared to standard treatment alone.  UVAR XTS™ was the ECP technology  used in this study.

The retrospective study reveals that,  compared to standard BOS-directed therapies alone, the addition of ECP significantly  improves survival probability in double-lung transplant patients diagnosed with  BOS. Over the observation period of up to 15.5 years, survival probability was  improved by approximately 30% in the ECP-treated patients as compared to  matched controls.²

In addition, it was found the addition of ECP  to standard therapy exerts a substantially positive impact on the number of  total re-admissions to the hospital, the total days of care, and the total  patient days, as compared to treatment with standard therapy alone. The study concludes  "ECP has proved highly effective and cost saving in the treatment of lung  transplant patients presenting with BOS." ³

"Mallinckrodt,  a pioneer in the development and delivery of ECP immunomodulation, is pleased  to see this study's evidence of the clinical efficacy in lung transplant recipients with BOS,  and the notable cost savings this therapy can provide for hospitals,"  said Steven Romano, M.D., Executive Vice President and Chief Scientific  Officer of Mallinckrodt. "We are proud to support efforts to evaluate ECP  in this critical area of patient care.

The presentation abstract can be viewed here.

Mallinckrodt is the world's only provider of approved,  fully-integrated systems for administering immunomodulatory therapy through  ECP. Its Therakos therapeutic platforms, including the latest generation  THERAKOS™ CELLEX™ Photopheresis System, are used by  academic medical centres, hospitals, and treatment centres in nearly 40  countries and have delivered more than 1 million treatments globally. For  more information, please visit www.therakos.co.uk.

UVAR XTS and THERAKOS CELLEX Photopheresis Systems are  approved in a number of global markets, including Europe, for the  administration of photopheresis. Please refer to your local approved labelling  for more information on approved uses for specific therapeutic areas.

Important Safety Information for the THERAKOSTM  Photopheresis Procedure
   
  Indications
  The THERAKOS UVAR XTS and THERAKOS CELLEX  Photopheresis Systems are indicated for the administration of photopheresis.  Please refer to the appropriate product labelling for a complete list of  warnings and precautions.

Contraindications
  THERAKOS Photopheresis is contraindicated in patients  possessing a specific history of a light sensitive disease. THERAKOS  Photopheresis is contraindicated in patients who cannot tolerate extracorporeal  volume loss or who have white blood cell counts greater than 25,000 mm3.  THERAKOS Photopheresis is contraindicated in patients who have coagulation  disorders or who have previously had a splenectomy.

Warnings and Precautions
  THERAKOS Photopheresis treatments should always be  performed in locations where standard medical emergency equipment is available.  Volume replacement fluids and/or volume expanders should be readily available  throughout the procedure. Safety in children has not been established.

Both men and women should take adequate contraceptive  precautions both during and after completion of photopheresis therapy.

Adverse Events

  
• Hypotension may occur during any treatment involving  extracorporeal circulation. Closely monitor the patient during the entire  treatment for hypotension.

 
• Transient pyretic reactions, 37.7–38.9°C  (100–102°F), have been observed in some patients within six to eight hours of  reinfusion of the photoactivated leukocyte-enriched blood. A temporary increase  in erythroderma may accompany the pyretic reaction.


• Treatment frequency exceeding labelling  recommendations may result in anaemia.


• Venous access carries a small risk of infection and  pain.

Please refer to the appropriate product labelling for  a complete list of warnings and precautions.

1. Joukhadar C, Knobler  R, Cho A, et al. Extracorporeal Photopheresis Improves Survival Probability and  Lowers Hospital-Related Expenses In Lung Transplant Recipients With  Bronchiolitis Obliterans Syndrome, The Journal of Heart and Lung  Transplantation. Volume 38, Issue 4, S1-S526. doi: 10.1016/j.healun.2019.01.287
    2. ibid
    3. ibid

ABOUT MALLINCKRODT
  Mallinckrodt is a global business consisting of  multiple wholly owned subsidiaries that develops, manufactures, markets and  distributes 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, nephrology,  pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical  care therapies; and analgesics. Its Specialty Generics and Amitiza reportable segment  includes specialty generic drugs, active pharmaceutical ingredients and AMITIZA® (lubiprostone).  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 THERAKOS Photopheresis 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.

CONTACTS
  EMEA Media Inquiries
    James Tate
    The  Henley Group
    +1  44 1491 570 971
    james@henley.co.uk

US  Media Inquiries
    Daniel Yunger
    Kekst CNC
    +1 212 521 4879
    mallinckrodt@kekstcnc.com

Investor  Relations
    Daniel J. Speciale, CPA
    Vice President, Investor Relations and IRO
    314-654-3638
    daniel.speciale@mnk.com

Mallinckrodt, the "M" brand mark and  the Mallinckrodt Pharmaceuticals logo are trademarks of  a Mallinckrodt company.
    © 2019 Mallinckrodt.  4/19