STAINES-UPON-THAMES, United Kingdom, Oct. 31, 2019 /PRNewswire/ — Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced that UVADEX^® (methoxsalen) has received regulatory approval in Australia by the Therapeutic Goods Administration (TGA) for extracorporeal administration with the THERAKOS^® CELLEX^® Photopheresis System. The treatment is indicated for steroid-refractory and steroid-intolerant chronic graft versus host disease (cGvHD) in adults following allogeneic hematopoietic stem cell (HSC) transplantation. The TGA also approved Uvadex in conjunction with the THERAKOS CELLEX Photopheresis System for the palliative treatment of skin manifestations of cutaneous T-cell lymphoma (CTCL) that is unresponsive to other forms of treatment.

“The TGA approval of UVADEX with the Therakos ECP platform opens up new treatment options for patients with these challenging conditions,” said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer, Mallinckrodt. “The cGvHD indication is also an important milestone for Mallinckrodt, confirming the potential benefit of this therapeutic option for patients who are refractory to or intolerant of steroid treatments.”

About Chronic Graft Versus Host Disease (cGvHD)
Graft-versus-host-disease is a common complication of hematopoietic stem cell (HSC) transplantation resulting in significant morbidity and mortality.¹ It can be classified as acute or chronic based on the clinical presentation and the time of occurrence after the transplantation. Signs and symptoms of cGvHD nearly always occur within the first year post transplantation but can occasionally happen several years later.² In cGvHD, the skin is the most frequently affected organ with manifestations of itchy rash, hyper or hypopigmentation and changes in texture.  However, the disease can affect multiple sites, which may have a major impact upon a patient’s quality of life.^2,3  Chronic GvHD can lead to debilitating consequences, such as joint contractures, loss of sight, end-stage lung disease, or mortality resulting from profound chronic immune suppression leading to recurrent or life-threatening infections.¹

About Cutaneous T-Cell Lymphoma (CTCL)
Cutaneous T-cell lymphoma (CTCL) is an umbrella term for a group of non-Hodgkin lymphomas involving T lymphocytes that localize in the skin. It is a relatively rare cancer, with 2,500 to 3,000 new cases per year in the United States.⁴ The age of onset of the condition is typically greater than 50 years, with the incidence rising significantly in the later decades of life.⁵ CTCL causes visible skin symptoms ranging from a small rash to extensive redness, peeling, burning, soreness, and itchiness all over the body.⁶,⁷  CTCL falls into different categories based on the severity of the disease and symptoms.⁸

Minimum Product Information: UVADEX^® (methoxsalen) Concentrated Injection for extracorporeal circulation via photopheresis (ECP)

This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.

Indications in Australia: UVADEX (methoxsalen) is indicated for extracorporeal administration with the THERAKOS CELLEX Photopheresis System for the:

• treatment of steroid‑refractory and steroid‑intolerant chronic graft versus host disease (cGVHD) in adults following allogeneic HSC transplantation.
• palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) that is unresponsive to other forms of treatment.

Contraindications: History of idiosyncratic or hypersensitivity reaction to methoxsalen, psoralen compounds or any excipients of UVADEX; co‑existing melanoma, basal cell or squamous cell skin carcinoma; lactation; aphakia. ECP procedure contra-indications: Photosensitive disease; inability to tolerate extracorporeal volume loss; WBC count > 25,000 mm³; previous splenectomy; coagulation disorders. Special warnings and precautions: Only physicians who have special competence in the diagnosis and treatment of cGVHD and CTCL who have special training and experience with the THERAKOS CELLEX Photopheresis System should use UVADEX. Men and women being treated with UVADEX should take adequate contraceptive precautions both during and after completion of photopheresis treatment. Exposure to large doses of UVA causes cataracts in animals, an effect enhanced by the administration of oral methoxsalen. The patient’s eyes should be protected from UVA light by wearing wrap‑around, UVA‑opaque sunglasses during the treatment cycle and during the following 24 hours. Exposure to sunlight or ultraviolet radiation (even through window glass) may result in serious burns and, in the long‑term, “premature aging” of the skin therefore patients should avoid exposure to sunlight during the 24 hours following photopheresis treatment. Thromboembolic events, such as pulmonary embolism and deep vein thrombosis, have been reported with UVADEX administration through photopheresis systems for treatment of patients with graft versus host disease. This product contains 4.1% w/v ethanol and each 1 mL of UVADEX contains 40.55 mg of ethanol. Caution is advised in patients with liver disease, alcoholism, epilepsy, brain injury or disease. No specific information is available for use in renal or hepatic impairment and there is no evidence for dose adjustment in the elderly. The safety and efficacy of UVADEX have not been established in children. Use in pregnancy: Category D. Use in Lactation: UVADEX is contra-indicated. Interactions with other medicines: Effects on P450 system metabolism may affect clearance / activation of other drugs (caffeine, paracetamol) or may extend the methoxsalen half-life leading to prolonged photosensitivity in patients. Methoxsalen binding to albumin may be displaced by dicoumarol, warfarin, promethazine and tolbutamide with potential for enhanced photosensitivity. Caution when treating with concomitant photosensitising agents. Adverse effects: In the clinical trials, published information and postmarketing surveillance of UVADEX/ECP, adverse events were usually mild and transient and in most cases, related to the underlying pathology. Very common: diarrhoea, anaemia, nausea, headache, hypertension, sinusitis, upper respiratory tract infection, fatigue, pain in extremity, pyrexia, cough, dyspnoea, cushingoid, dry eye, photophobia, toothache, anorexia. Common: depression, lacrimation increased, abdominal pain, hypokalaemia, paraesthesia oral, pharyngolaryngeal pain, tachycardia, conjunctivitis, eye pain, visual acuity reduced, dysphagia, chills, mucosal inflammation, nasopharyngitis, contusion, blood pressure diastolic decreased, haemoglobin decreased, hyperglycaemia, hypocalcaemia, neuropathy peripheral, tremor, rash, hypotension. Additional adverse effects seen in clinical trials include vomiting, infections. Adverse events related to the ECP/CELLEX procedure – thromboembolism and severe allergic reactions, vascular access complication, vasovagal spasm, hickman catheter infection/thrombosis, headache, hypercoagulability, haemolysis. Additional adverse events identified post-marketing: anaphylactic reaction, allergic reaction, dysgeusia, exacerbation of congestive heart failure, sepsis, endocarditis, and vomiting. Dosage and Administration: Chronic Graft versus Host Disease: Three ECP treatments in the first week then two ECP treatments per week for at least 12 weeks, or as clinically indicated. Cutaneous T-cell Lymphoma: ECP treatment on two successive days each month for six months. Patients who show an increase in skin scores after eight treatment sessions may have their treatment schedule increased to two successive days every two weeks for the next three months. Refer to full Product Information and THERAKOS CELLEX Operator’s Manual for information regarding administration.

Store below 25°C. Date of first approval: 16 September 2019. Date of revision: 11 October 2019.

Indications and Prescribing Information for Uvadex vary globally. Please refer to the individual country product label for complete information.

Before prescribing Uvadex, please refer to the full Product Information also available by calling + 1 800.778.7898.

ABOUT THERAKOS
Mallinckrodt is the world’s only provider of approved, fully-integrated systems for administering immunomodulatory therapy through ECP. Its Therakos ECP 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.

Terumo BCT is the exclusive distributor of the Therakos ECP platform in Australia, as well as Latin America and select countries in Europe. To learn more about Terumo BCT, visit www.terumobct.com.

UVADEX (methoxsalen) and THERAKOS CELLEX Photopheresis Systems are separately approved in a number of global markets. Please refer to your local approved labelling for Uvadex and the Operator’s Manual for CELLEX for more information on approved uses for specific indications.

Before administering therapy using the THERAKOS CELLEX Photopheresis System, please refer to the Operator’s Manual available at +61 2 9429 3600 or +1 (800)778-7898.   

ABOUT MALLINCKRODT
Mallinckrodt 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, nephrology, pulmonology and ophthalmology; 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.

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 for Mallinckrodt 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.

Contact

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

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.  10/19. FR-1900004

References

1 Filipovich, Biol Blood Marrow Transplant 2005; 11:945‐956
2 Jagasia 2015. Biol Blood Marrow Transplant. 2015; 21(3): 389–401.
3 Pavletic et al. Biol Blood Marrow Transplant. 2006;12:252–66.
4 Agar NS, Wedgeworth E, Crichton S, et al. Survival outcomes and prognostic factors in mycosis fungoides/Sezary syndrome: validation of the revised International Society for Cutaneous Lymphomas/European Organisation for Research and Treatment of Cancer staging proposal. JCO. 2010;28:4730–4739
5 Kim YH, Liu HL, Mraz-Gernhard S, et al. Long-term outcome of 525 patients with mycosis fungoides and Sezary syndrome: clinical prognostic factors and risk for disease progression. Arch Dermatol. 2003;139:857–866.
6 Knobler R, et al. J Eur Acad Dermatol Venereol. 2014;28 Suppl 1:1-37.
7 Sokołowska-Wojdyło M, et al. Postepy Dermatol Alergol. 2015;32(5):368-383.
8 Trautinger F, et al. Eur J Cancer. 2006;42(8):1014-1030

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SOURCE Mallinckrodt Pharmaceuticals

STAINES-UPON-THAMES, United Kingdom, Oct. 22 2019 /PRNewswire/ — Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, has announced that its 2020 Advancing Extracorporeal Photopheresis (ECP) Immunomodulation Investigator Award is open for entries.

As in previous years, the award is intended to recognise and support the institutions of those individuals who are making a difference in advancing the knowledge around ECP Immunomodulation in the EMEA region. With the winning entry receiving an educational grant of €50,000, this year’s award programme supports research that investigates the overarching immunomodulatory role of ECP through inflammation control and resolution while specifically preserving immune function.

The award, now in its third year, was developed by Mallinckrodt to mark 30 years of its pioneering THERAKOS ECP Immunomodulation. The Investigator Award reflects the company’s ongoing commitment to the science of immunomodulation through ECP and its therapeutic applications. The call for entries is now open and will take submissions until the closing date of 31 January 2020.

“As a pioneer in ECP immunomodulation, Mallinckrodt established the ECP Immunomodulation Investigator Award to recognise the efforts of those working in this exciting field of medicine. I urge those involved in ECP Immunomodulation to submit an entry and so help further the understanding of immunomodulatory therapy through ECP”, said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer of Mallinckrodt.

Last year’s winning entry was submitted by Dr. Rachel Crossland of Newcastle University in the United Kingdom. Her team is investigating the impact of ECP Immunomodulation on extracellular vesicles and their profiles in response to therapy in patients with graft-versus-host disease (GvHD). A major complication affecting between 40-70% of Hematopoietic Stem Cell Transplant (HSCT) patients, severe GvHD carries a high mortality rate.¹

Full details on how to enter the 2020 ECP Immunomodulation Investigator Award can be found at https://www.therakosinstitute.eu/the-mallinckrodt-2020/

ABOUT THERAKOS
Mallinckrodt is the world’s only provider of fully-integrated and validated 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.

For important safety information related to the THERAKOS CELLEX Photopheresis System, please visit https://www.therakos.co.uk/important-safety-information-hp.

1. Jagasia M, Arora M, Flowers ME, et al. Risk factors for acute GVHD and survival after hematopoietic cell transplantation, Blood. 2012 Jan 5;119(1):296-307. doi: 10.1182/blood-2011-06-364265. Epub 2011 Oct 18.

ABOUT MALLINCKRODT
Mallinckrodt 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, nephrology, pulmonology and ophthalmology; 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.

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 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.

Contact

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. 9/19  EU-1900122

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.

Contact

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

STAINES-UPON-THAMES, England, March 26, 2019 /PRNewswire/ — Mallinckrodt plc (NYSE: MNK), a leading specialty pharmaceutical company, today announced the recipient of 2019’s Advancing Extracorporeal Photopheresis (ECP) Immunomodulation Investigator Award. The winning entry was submitted by co-investigator Dr. Rachel Crossland of Newcastle University in the United Kingdom.

Collaborators on the winning project include Professor Anne Dickinson, Professor of Marrow Transplant Biology, Newcastle University, Professor Hildegard Greinix, Director of Haematology, Medical University Graz, Graz, Austria; and Dr. Aisling Flinn, Clinical Research Associate in Paediatric Immunology, Newcastle Hospitals NHS Foundation Trust.

Their 12-month study will investigate the impact of ECP Immunomodulation on extracellular vesicles and their profiles in response to therapy in patients with graft-versus-host disease (GvHD). A major complication affecting between 40-70% of Hematopoietic Stem Cell Transplant (HSCT) patients, severe GvHD carries a high mortality rate.¹

Along with the 2019 Investigator Award, Dr. Crossland’s team will receive an educational grant of €50,000 to support their research. The winner was first revealed at the THERAKOS ECP Immunomodulation symposium at the 45^th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) in Frankfurt, Germany.

On receiving the award, Dr. Crossland said: “We are honoured to receive the Investigator Award and thrilled that it allows us to look at a potential new pathway into how ECP impacts or modulates immune responses in patients.”

Mallinckrodt developed the Investigator Award to mark 30 years of its pioneering THERAKOS ECP Immunomodulation. The Investigator Award reflects the company’s ongoing commitment to the science of immunomodulation through ECP and its therapeutic applications. Now in its second year, the award recognises individuals and institutions whose research contributes to the advancement of knowledge in this area of medicine.

“As a pioneer in ECP immunomodulation, Mallinckrodt is proud to support the work of those who continue to investigate this exciting field of medicine. I congratulate Dr. Crossland and her team, and look forward to seeing the results of their work,” said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer of Mallinckrodt.

Entries were invited from clinicians and scientists working on translational or outcomes-based research, as well as collaborative projects. Submissions were assessed on a range of criteria, specifically scientific merit, originality and feasibility. The 2020 Advancing ECP Immunomodulation Investigator Award will be open for entries in September 2019. Full details on how to enter can be found at https://www.therakosinstitute.eu/.

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.

For important safety information related to the THERAKOS CELLEX Photopheresis System, please visit https://www.therakos.co.uk/important-safety-information-hp.

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.

1. Jagasia M, Arora M, Flowers ME, et al. Risk factors for acute GVHD and survival after hematopoietic cell transplantation, Blood. 2012 Jan 5;119(1):296-307. doi: 10.1182/blood-2011-06-364265. Epub 2011 Oct 18.

Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. ^© 2019 Mallinckrodt.  3/19

References

 View original content to download multimedia:http://www.prnewswire.com/news-releases/mallinckrodt-announces-2019-investigator-award-for-pioneering-efforts-in-ecp-immunomodulation-300818630.html

SOURCE Mallinckrodt

EMEA Media Inquiries: James Tate, The Henley Group, +44(0)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, +1-314-654-3638, daniel.speciale@mnk.com

BEDMINSTER, N.J., Feb. 25, 2019 /PRNewswire/ — Mallinckrodt Pharmaceuticals (NYSE:MNK), a leading global specialty pharmaceutical company, today announced it has entered into a research collaboration agreement with Transimmune AG, a company developing novel immunotherapies based on its unique understanding of the physiologic processes underlying the activation of antigen-presenting cells. THERAKOS UVAR XTS^®/CELLEX^® Photopheresis is a medical procedure that is administered using U.S. FDA-approved UVADEX^® (methoxsalen) Sterile Solution for the palliative treatment of skin manifestations associated with Cutaneous T-Cell Lymphoma (CTCL) in patients who are unresponsive to other forms of treatment. The companies will collaborate on translational research to further expand understanding of the underlying mechanism of action (MOA) for extracorporeal photopheresis, and its application toward the development of potential next-generation photopheresis technology, with plans to expand on Mallinckrodt’s current Therakos^® photopheresis platform through new clinical trials.

Beyond enhancing MOA understanding and advancing the technology platform, it is also anticipated that the insights gained through the joint research endeavor with the Transimmune experts can expand potential clinical applicability across diverse immune-mediated disease states. If clinical evidence is shown, these conditions may include CTCL, graft-versus-host disease, organ transplant rejection and all autoimmune diseases – all exclusively licensed to Mallinckrodt under the agreement.

Transimmune was founded by Richard Edelson, M.D., Lerner Professor of Dermatology, Chair and Professor, Department of Dermatology, Yale University School of Medicine, and a photopheresis pioneer. Dr. Edelson has spent decades studying the photopheresis mechanism of action and founded Transimmune to translate those insights into improving photopheresis therapy.

“Mallinckrodt invests in assets and technologies to further their application in conditions with few or limited therapeutic options, and for the treatment of underserved patients with severe and critical conditions,” said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer, Mallinckrodt. “This agreement is an example of our model of collaboration and partnership with experts in both basic and clinical research – similar to the recent collaborative research partnership announced with Washington University School of Medicine in St. Louis – to expand our access to innovative science and technology in areas of mutual interest.”

Mallinckrodt and Transimmune will establish a joint governance committee consisting of representatives from both companies to oversee, review and coordinate the activities under the agreement.

The companies intend to explore a joint commercial collaboration arrangement related to a next-generation Mallinckrodt photopheresis system. Mallinckrodt is the only provider of an integrated closed loop photopheresis therapy, which is delivered through its latest generation THERAKOS^® CELLEX^® Photopheresis System.

About Therakos Immunotherapy
Therakos immunotherapy is delivered through CELLEX systems to harness the power of the patient’s immune system to treat the skin manifestations of CTCL, and is used by academic medical centers, hospitals, and treatment centers in more than 25 countries. Therakos photopheresis systems are fully integrated closed systems and U.S. Food and Drug Administration (FDA)-approved for the palliative treatment of the skin manifestations of CTCL in persons who have not been responsive to other forms of treatment.

About UVADEX (methoxsalen) Sterile Solution

INDICATIONS AND USAGE
UVADEX^® (methoxsalen) Sterile Solution is indicated for extracorporeal administration with the THERAKOS^® UVAR XTS^® or THERAKOS CELLEX^® Photopheresis System in the palliative treatment of the skin manifestations of Cutaneous T-Cell Lymphoma (CTCL) that is unresponsive to other forms of treatment.

IMPORTANT SAFETY INFORMATION

CAUTION: READ THE THERAKOS UVAR XTS or THERAKOS CELLEX PHOTOPHERESIS SYSTEMS’ OPERATOR’S MANUAL PRIOR TO PRESCRIBING OR DISPENSING THIS MEDICATION.

CONTRAINDICATIONS
UVADEX is contraindicated in patients exhibiting idiosyncratic or hypersensitivity reactions to methoxsalen, other psoralen compounds, or any of the excipients. Patients possessing a specific history of a light-sensitive disease state should not initiate methoxsalen therapy.

Diseases associated with photosensitivity include lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum, and albinism. UVADEX is contraindicated in patients with aphakia because of the significantly increased risk of retinal damage due to the absence of lenses.

Patients should not receive UVADEX if they have any contraindications to the photopheresis procedure.

WARNINGS AND PRECAUTIONS

• Patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents such as anthralin, coal tar or coal tar derivatives, griseofulvin,
• phenothiazines, nalidixic acid, halogenated salicylanilides (bacteriostatic soaps), sulfonamides,
• tetracyclines, thiazides, and certain organic staining dyes such as methylene blue, toluidine blue, rose bengal, and methyl orange may be at greater risk for photosensitivity reactions with UVADEX
• Oral administration of methoxsalen followed by cutaneous UVA exposure (PUVA therapy) is carcinogenic. Methoxsalen also causes DNA damage, interstrand cross-links and errors in DNA repair
• Methoxsalen may cause fetal harm when given to a pregnant woman. There are no adequate and well-controlled studies of methoxsalen in pregnant women. If UVADEX is used during pregnancy, or if the patient becomes pregnant while receiving UVADEX, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant. It is not known whether this drug is excreted in human milk
• After methoxsalen administration, exposure to sunlight and/or ultraviolet radiation may result in “premature aging” of the skin
• Since oral psoralens may increase the risk of skin cancers, monitor closely those patients who exhibit multiple basal cell carcinomas or who have a history of basal cell carcinomas
• Serious burns from either UVA or sunlight (even through window glass) can result if the recommended dosage of methoxsalen is exceeded or precautions are not followed
• Patients should be advised to avoid all exposure to sunlight during the 24 hours following
• photopheresis treatment
• Exposure to large doses of UVA light causes cataracts in animals. Oral methoxsalen exacerbates this toxicity. Serum methoxsalen concentrations are substantially lower after extracorporeal UVADEX treatment than after oral methoxsalen treatment. Nevertheless, if the lens is exposed to UVA light while methoxsalen is present, photoactivation of the drug may cause adducts to bind to biomolecules within the lens
• Instruct patients emphatically to wear UVA-absorbing, wrap-around sunglasses for 24 hours after
• UVADEX treatment
• Safety in children has not been established
• Thromboembolic events, such as pulmonary embolism and deep vein thrombosis, have been reported with UVADEX administration through photopheresis systems for treatment of patients with graft-versus-host disease, a disease for which UVADEX is not approved.

ADVERSE REACTIONS
Side effects of photopheresis (UVADEX used with the THERAKOS Photopheresis System) were primarily related to hypotension secondary to changes in extracorporeal volume (>1%).

For the THERAKOS^® UVAR XTS^®/CELLEX^® Photopheresis Procedure:

INDICATIONS
The THERAKOS UVAR XTS Photopheresis System/THERAKOS CELLEX Photopheresis System is indicated for use in the ultraviolet-A (UVA) irradiation, in the presence of the photoactive drug 8-methoxypsoralen (8-MOP^®), of extracorporeally circulating leukocyte-enriched blood, in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL), in persons who have not been responsive to other forms of treatment.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
The THERAKOS UVAR XTS or THERAKOS CELLEX Photopheresis Systems are not designated, sold, or intended for use except as indicated.

Certain underlying medical conditions contraindicate THERAKOS Photopheresis, including patients:

• who cannot tolerate extracorporeal volume loss during the leukocyte-enrichment phase
• exhibiting idiosyncratic or hypersensitivity reactions to 8-methoxypsoralen/psoralen compounds
• with coagulation disorders
• who have had previous 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
• Patients who may not be able to tolerate the fluid changes associated with extracorporeal photopheresis should be monitored carefully
• Procedures, such as renal dialysis, which might cause significant fluid changes (and expose the patient to additional anticoagulation) should not be performed on the same day as extracorporeal photopheresis
• Individual patients may require a heparin dosage that varies from the recommended dose to prevent post-treatment bleeding or clotting during a treatment

ADVERSE REACTIONS

• 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 labeling recommendations may result in anemia
• Venous access carries a small risk of infection and pain

Please see Full Prescribing Information, including the BOXED WARNING for UVADEX, and see the appropriate THERAKOS Photopheresis System Operator’s Manual.

ABOUT MALLINCKRODT
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies. 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 gastrointestinal products. 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 the collaboration with Transimmune AG, including expectations regarding future research and clinical trial plans, potential commercial arrangements and the 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: clinical trial results, uncertainties inherent in research and development; 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.

Contact

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

Media
Daniel Yunger
Kekst CNC
212-521-4879
mallinckrodt@kekstcnc.com

Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. ^© 2019 US-1900007 02/19

References

 View original content to download multimedia:http://www.prnewswire.com/news-releases/mallinckrodt-announces-extracorporeal-photopheresis-research-collaboration-agreement-with-transimmune-ag-300800571.html

SOURCE Mallinckrodt Pharmaceuticals

BEDMINSTER, N.J., Feb. 20, 2019 /PRNewswire/ — Mallinckrodt Pharmaceuticals (NYSE:MNK), a leading global specialty pharmaceutical company, today announced interim analysis results of its company-sponsored, Phase 3, single-arm, open-label, multi-center study assessing the efficacy of treating steroid-refractory, acute Graft-versus-Host Disease (aGvHD) pediatric patients with UVADEX^® (methoxsalen) Sterile Solution in conjunction with the THERAKOS^® CELLEX^® Photopheresis system. Given the overall response rate exceeded the specified target at the study midpoint, the company is electing not to proceed with further enrollment of additional patients in the clinical trial.

UVADEX solution is U.S. Food and Drug Administration (FDA)-approved for extracorporeal administration with the THERAKOS UVAR XTS^® or CELLEX Photopheresis System in the palliative treatment of the skin manifestations of Cutaneous T-Cell Lymphoma (CTCL) that is unresponsive to other forms of treatment.

The planned interim analysis occurred at the midway point of enrollment (n=25) when pediatric patients (ages 1-21 years) reached four weeks of therapy to assess response rates. The analysis found an overall response rate of 74%. The company also performed an ad hoc 12-week analysis showing an overall response rate of 48%. The study protocol allows for discontinuation of the study if the treatment overall response rate at the four-week interim analysis is at least 48%. Eleven serious adverse events were reported, leading to two subject withdrawals and two deaths; none were considered related to the UVADEX photopheresis therapy. The safety and effectiveness of THERAKOS CELLEX Photopheresis System for use in treating pediatric patients with steroid-refractory aGvHD has not been evaluated by the FDA or any international regulatory body.

“Mallinckrodt is pleased to have been able to partner with the pediatric transplant community concerning this fragile patient population,” said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer, Mallinckrodt. “We believe the full details from the study’s interim analysis – which will be made public – will make a meaningful contribution to the body of data related to this critical condition.”

More details on the study (NCT02524847) can be found here on www.clinicaltrials.gov.

About Therakos Immunotherapy
Therakos immunotherapy is delivered through CELLEX systems to harness the power of the patient’s immune system to treat the skin manifestations of CTCL, and is used by academic medical centers, hospitals, and treatment centers in more than 25 countries. Therakos photopheresis systems are fully integrated closed systems and FDA-approved for the palliative treatment of the skin manifestations of CTCL in persons who have not been responsive to other forms of treatment.

About UVADEX (methoxsalen) Sterile Solution

INDICATIONS AND USAGE
UVADEX (methoxsalen) Sterile Solution is indicated for extracorporeal administration with the THERAKOS UVAR XTS or THERAKOS CELLEX Photopheresis System in the palliative treatment of the skin manifestations of Cutaneous T-Cell Lymphoma (CTCL) that is unresponsive to other forms of treatment.

IMPORTANT SAFETY INFORMATION

CAUTION: READ THE THERAKOS UVAR XTS or THERAKOS CELLEX PHOTOPHERESIS SYSTEMS’ OPERATOR’S MANUAL PRIOR TO PRESCRIBING OR DISPENSING THIS MEDICATION.

CONTRAINDICATIONS
UVADEX is contraindicated in patients exhibiting idiosyncratic or hypersensitivity reactions to methoxsalen, other psoralen compounds, or any of the excipients. Patients possessing a specific history of a light-sensitive disease state should not initiate methoxsalen therapy.

Diseases associated with photosensitivity include lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum, and albinism. UVADEX is contraindicated in patients with aphakia because of the significantly increased risk of retinal damage due to the absence of lenses.

Patients should not receive UVADEX if they have any contraindications to the photopheresis procedure.

WARNINGS AND PRECAUTIONS

• Patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents such as anthralin, coal tar or coal tar derivatives, griseofulvin,
• phenothiazines, nalidixic acid, halogenated salicylanilides (bacteriostatic soaps), sulfonamides,
• tetracyclines, thiazides, and certain organic staining dyes such as methylene blue, toluidine blue, rose bengal, and methyl orange may be at greater risk for photosensitivity reactions with UVADEX
• Oral administration of methoxsalen followed by cutaneous UVA exposure (PUVA therapy) is carcinogenic. Methoxsalen also causes DNA damage, interstrand cross-links and errors in DNA repair
• Methoxsalen may cause fetal harm when given to a pregnant woman. There are no adequate and well-controlled studies of methoxsalen in pregnant women. If UVADEX is used during pregnancy, or if the patient becomes pregnant while receiving UVADEX, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant. It is not known whether this drug is excreted in human milk
• After methoxsalen administration, exposure to sunlight and/or ultraviolet radiation may result in “premature aging” of the skin
• Since oral psoralens may increase the risk of skin cancers, monitor closely those patients who exhibit multiple basal cell carcinomas or who have a history of basal cell carcinomas
• Serious burns from either UVA or sunlight (even through window glass) can result if the recommended dosage of methoxsalen is exceeded or precautions are not followed
• Patients should be advised to avoid all exposure to sunlight during the 24 hours following
• photopheresis treatment
• Exposure to large doses of UVA light causes cataracts in animals. Oral methoxsalen exacerbates this toxicity. Serum methoxsalen concentrations are substantially lower after extracorporeal UVADEX treatment than after oral methoxsalen treatment. Nevertheless, if the lens is exposed to UVA light while methoxsalen is present, photoactivation of the drug may cause adducts to bind to biomolecules within the lens
• Instruct patients emphatically to wear UVA-absorbing, wrap-around sunglasses for 24 hours after
• UVADEX treatment
• Safety in children has not been established
• Thromboembolic events, such as pulmonary embolism and deep vein thrombosis, have been reported with UVADEX administration through photopheresis systems for treatment of patients with graft-versus-host disease, a disease for which UVADEX is not approved.

ADVERSE REACTIONS
Side effects of photopheresis (UVADEX used with the THERAKOS Photopheresis System) were primarily related to hypotension secondary to changes in extracorporeal volume (>1%)

For the THERAKOS^® UVAR XTS^®/CELLEX^® Photopheresis Procedure:

INDICATIONS
The THERAKOS UVAR XTS Photopheresis System/THERAKOS CELLEX Photopheresis System is indicated for use in the ultraviolet-A (UVA) irradiation, in the presence of the photoactive drug 8-methoxypsoralen (8-MOP^®), of extracorporeally circulating leukocyte-enriched blood, in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL), in persons who have not been responsive to other forms of treatment.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
The THERAKOS UVAR XTS or THERAKOS CELLEX Photopheresis Systems are not designated, sold, or intended for use except as indicated.

Certain underlying medical conditions contraindicate THERAKOS Photopheresis, including patients:

• who cannot tolerate extracorporeal volume loss during the leukocyte-enrichment phase
• exhibiting idiosyncratic or hypersensitivity reactions to 8-methoxypsoralen/psoralen compounds
• with coagulation disorders
• who have had previous 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
• Patients who may not be able to tolerate the fluid changes associated with extracorporeal photopheresis should be monitored carefully
• Procedures, such as renal dialysis, which might cause significant fluid changes (and expose the patient to additional anticoagulation) should not be performed on the same day as extracorporeal photopheresis
• Individual patients may require a heparin dosage that varies from the recommended dose to prevent post-treatment bleeding or clotting during a treatment

ADVERSE REACTIONS

• 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 labeling recommendations may result in anemia
• Venous access carries a small risk of infection and pain

Please see Full Prescribing Information, including the BOXED WARNING for UVADEX, and see the appropriate THERAKOS Photopheresis System Operator’s Manual.

ABOUT MALLINCKRODT
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies. 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 gastrointestinal products. 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 including expectations with regard to the study described in this release. 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.

Contact

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

Media
Daniel Yunger
Kekst CNC
212-521-4879
mallinckrodt@kekstcnc.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. ^© 2019 Mallinckrodt. US-1900187 02/19

References

 View original content to download multimedia:http://www.prnewswire.com/news-releases/mallinckrodt-announces-interim-analysis-results-for-therakos-platform-phase-3-clinical-trial-in-treatment-of-pediatric-patients-with-steroid-refractory-acute-graft-versus-host-disease-300798392.html