Mallinckrodt Announces Study Demonstrating Effectiveness of ECP Immunomodulation, as an adjunct to local standard therapy, in Treatment of Lung T

-- 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, April 5, 2019 /PRNewswire/ -- Mallinckrodt plc , 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).

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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 39(th) 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((TM) )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 [https://c212.net/c/link/?t=0&l=en&o=2425686-1&h=2635961569&u=https%3A%2F%2Fabstractsonline.com%2Fpp8%2F%23!%2F5770%2Fpresentation%2F14875&a=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((TM)) CELLEX((TM)) 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 [https://c212.net/c/link/?t=0&l=en&o=2425686-1&h=34174159&u=http%3A%2F%2Fwww.therakos.co.uk%2F&a=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 THERAKOS(TM) 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 mm(3). 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 [https://c212.net/c/link/?t=0&l=en&o=2425686-1&h=1978267644&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D2391967-1%26h%3D2548136291%26u%3Dhttp%253A%252F%252Fwww.mallinckrodt.com%252F%26a%3Dwww.mallinckrodt.com&a=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 [mailto:james@henley.co.uk]

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

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

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

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Web site: http://www.mallinckrodt.com/

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