StemCell Therapy

-- The two-part multicenter study of 259 enrolled subjects showed >60 percent of patients achieved low disease activity (LDA) at week 12 with open-label therapy, an effect that was maintained in a proportion of patients with 12 additional weeks of treatment in the double-blind phase --

STAINES-UPON-THAMES, United Kingdom, April 15, 2020 /PRNewswire/ --Mallinckrodt plc(NYSE: MNK), a global biopharmaceutical company, today announced the publication of findings from its randomized, placebo-controlled, double-blind Phase 4 study to assess the safety and efficacy of Acthar Gel (repository corticotropin injection, or RCI) in patients with persistently active rheumatoid arthritis (RA) despite treatment with stable background disease-modifying antirheumatic drugs (DMARDs) and low-dose glucocorticoids. Results of the study were recently published online in Rheumatology and Therapy, an open access peer-review journal. Preliminary findings from the study were presented at the European Congress of Rheumatology 2019 (EULAR) held in June.

Acthar Gel is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides. Acthar Gel is approved by the U.S. Food and Drug Administration (FDA) as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in RA, including juvenile RA (selected cases may require low-dose maintenance therapy).1Please see Important Safety Information for Acthar Gel below.

The study, titled "Repository Corticotropin Injection for Active Rheumatoid Arthritis Despite Aggressive Treatment: A Randomized Controlled Withdrawal Trial," enrolled 259 adult patients (18 years of age) with RA who were treated at 60 centers in four countries between Nov. 7, 2016, and Feb. 13, 2019. Results of the study showed that Acthar Gel demonstrated the potential for effectiveness in achieving low disease activity (LDA) as assessed by DAS28-ESR2 in patients with active RA despite current treatment with low-dose glucocorticoids and one or two DMARDs.

"The results of this study suggest that there could be a reasonable risk-benefit for the short-term use of RCI over six months in appropriate patients with persistently active RA despite concurrent use of DMARDs and low-dose glucocorticoids. Many patients achieved LDA by three months with the response persisting for an additional three months in a majority of patients whether discontinuing or continuing RCI. The adverse event profile was similar in patients who continued and discontinued RCI,i" said Dr. Roy Fleischmann, Co-Medical Director of the Metroplex Clinical Research Center and Clinical Professor of Medicine at the University of Texas Southwestern Medical Center in Dallas and the study's lead author.

"Rheumatoid arthritis is a common autoimmune disease that can damage bone and joints and greatly impact daily functioning for patients. The goal of treatment is remission or low disease activity, but for a subset of underserved patients with debilitating RA who don't achieve remission or LDA with standard therapy, additional options are greatly needed," said Tunde Otulana, M.D., Senior Vice President and Chief Medical Officer at Mallinckrodt. "We are encouraged by the results of this study that demonstrate Acthar Gel can be considered for appropriate patients in this persistently active population, and we're grateful to the patients, their families and clinicians who participated in the study."

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Key Findings3:

Open-label Period

Randomized, Placebo-Controlled, Blinded, Withdrawal Period

Methods3:

Study Limitations3:

The study was funded by Mallinckrodt.

About Rheumatoid ArthritisRA is an autoimmune disease. It is a chronic condition that causes pain, stiffness, and swelling of the jointsall symptoms and signs caused by inflammation.4 An estimated 1.5 million U.S. adults are living with RA.5 Treatment is aimed at stopping inflammation to put the disease in remission and relieve symptoms.6 Nonsteroidal anti-inflammatory drugs are used to ease symptoms whereas glucocorticoids, and non-biologic and biologic DMARDs are used to slow down the disease activity.6

INDICATIONS

Acthar Gel (repository corticotropin injection) is indicated for:

IMPORTANT SAFETY INFORMATION

Contraindications

Warnings and Precautions

Adverse Reactions

Other adverse events reported are included in the full Prescribing Information.

Please see fullPrescribing Informationfor additional Important Safety Information.

ABOUT MALLINCKRODTMallinckrodt 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 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.

CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTSThis release includes forward-looking statements concerning Acthar Gel including its potential impact on patients and anticipated 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.

CONTACTSFor Trade Media InquiriesCaren BegunGreen Room Communications201-396-8551caren@greenroompr.com

For Financial/Dailies Media InquiriesRon BartlettH+K StrategiesSenior Vice PresidentM: +1 813 545 2399ron.bartlett@hkstrategies.com

Investor RelationsDaniel J. Speciale, CPAVice President, Investor Relations and IRO314-654-3638daniel.speciale@mnk.com

Mallinckrodt, the "M" brand mark and theMallinckrodt Pharmaceuticalslogo are trademarks of aMallinckrodtcompany. Other brands are trademarks of aMallinckrodtcompany or their respective owners.2020Mallinckrodt.US-2000523 04/20

References

i AEs reported in 1.5% of patients in part 1 or in either group in part 2.ii ACR20=American College of Rheumatology 20% improvement; ACR50=American College of Rheumatology 50% improvement; ACR70=American College of Rheumatology 70% improvement

1 Acthar Gel (repository corticotropin injection) [prescribing information]. Mallinckrodt ARD LLC.2Disease Activity Score 28-joint count Erythrocyte Sedimentation Rate.3Fleischmann R, Furst DE, Connolly-Strong E, Liu J, Zhu J, Brasington R. Rheumatol Ther (2020). https://doi.org/10.1007/s40744-020-00199-3.4Mayo Clinic website. Rheumatoid Arthritis. Overview. Available at: https://www.mayoclinic.org/diseases-conditions/rheumatoid-arthritis/symptoms-causes/syc-20353648. Accessed April 1, 2020.5Arthritis Foundation. What is Rheumatoid Arthritis? Available at: http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/what-is-rheumatoid-arthritis.php. Accessed April 1, 2020.6Arthritis Foundation. Rheumatoid Arthritis Treatment. Available at: http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/treatment.php. Accessed April 1, 2020.

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Mallinckrodt Announces Publication of Data on Acthar Gel (Repository Corticotropin Injection) from its Randomized, Double-Blind, Placebo-Controlled...

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