Mallinckrodt Announces Data Publication on the Treatment Effectiveness of Acthar Gel (Repository Corticotropin Injection) for Resolution of Multiple…

STAINES-UPON-THAMES, United Kingdom, Nov. 7, 2019 /PRNewswire/ --Mallinckrodt plc(NYSE: MNK), a global biopharmaceutical company, today announced the publication of "Treatment Effectiveness for Resolution of Multiple Sclerosis Relapse in a U.S. Health Plan Population" in an electronic publicationposted in advance of print publication in the peer-reviewed journal Neurology and Therapy. Results from the analysis showed that multiple sclerosis (MS) relapse patients taking Acthar Gel (repository corticotropin injection) had a higher relapse resolution rate than those taking intravenous immunoglobulin (IVIG) or plasmapheresis (PMP) treatment.

MS is a chronic, degenerative disease that can cause numerous impairments including fatigue, balance/coordination issues, numbness or tingling, vision problems, muscle spasms, tremors and emotional changes1, and some people with MS experience relapses while on standard disease-modifying therapies.2

Acthar Gel is U.S. Food and Drug Administration (FDA)-approved for the treatment of acute exacerbations of MS in adults. Controlled clinical trials have shown Acthar Gel to be effective in speeding the resolution of acute exacerbations of MS.However, there is no evidence that it affects the ultimate outcome or natural history of the disease.3Please see Important Safety Information for Acthar Gel below.

"The management of MS relapse is an ongoing challenge, in particular for those patients who need additional treatment options after first-line agents such as corticosteroids," said George Wan, Ph.D., Vice President and Global Head of Health Economics and Outcomes Research at Mallinckrodt. "We are committed to working toward a better understanding of the potential clinical and health economic outcomes associated with Acthar Gel and other late-line treatments for MS relapse to help guide clinical practice and potentially improve outcomes for patients. In addition, we look forward tothe results of Mallinckrodt'songoing, randomized, double-blind, placebo-controlled OPTIONS study, which we anticipate will provide data on some of the more difficult-to-treat MS patients in the future."

"Treatment Effectiveness for Resolution of Multiple Sclerosis Relapse in a US Health Plan Population"evaluated the rate of MS relapse occurrence, frequency of use of MS relapse treatments including corticosteroids, and relapse treatment effectiveness (or relapse resolution rates) for corticosteroid treatment alternatives Acthar Gel, IVIG, and PMP. No minimum health plan enrollment was required. The data were originally shared in a posterpresentation at MSParis2017, the joint ECTRIMS-ACTRIMS meeting.4

Key findings5

Methods5

Limitations6

The analysis was conducted by Mallinckrodt.

About Multiple SclerosisMS is a neurologic disorder that affects the central nervous system (i.e., the brain and spinal cord).7Symptoms can include fatigue, balance/coordination issues, numbness or tingling, vision problems, muscle spasms, tremors and emotional changes.1 More than eight in 10 people with MS will experience a relapse, or flare-up, that brings new or worsening symptoms.8

Acthar Gel (repository corticotropin injection)IndicationsActhar Gel is an injectable drug approved by theFDAfor the treatment of 19 indications. Of these, today the majority of Acthar use is in these indications:

IMPORTANT SAFETY INFORMATION

Contraindications

Warnings and Precautions

Adverse Reactions

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

Please see fullPrescribing Information.

ABOUTMALLINCKRODTMallinckrodt 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 expectations regarding related clinical trials, 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 InquiriesDaniel YungerKekst CNC212-521-4879mallinckrodt@kekstcnc.com

Investor Relations Daniel J. Speciale, CPAVice President, Investor Relations and IRO314-654-3638daniel.speciale@mnk.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-1901843 10/19

References

______________________________1 Multiple Sclerosis: Hope Through Research. National Institute of Neurological Disorders and Stroke. 2012. Available at https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Hope-Through-Research/Multiple-Sclerosis-Hope-Through-Research#3215_29.2 Coyle PK, Krieger S. Managing acute relapses in multiple sclerosis CME. Medscape Education Neurology & Neurosurgery. 2013. Available at: http://www.medscape.org/viewarticle/779270_print.3 ActharGel (repository corticotropin injection) (prescribing information).Mallinckrodt ARD LLC.4 Nazareth, T., Manasi,D., Sheer, R., Yu, T. & Schwab, P. (2017, October).MS Relapse Treatments and Relapse Resolution: Retrospective Study Results from a US Health Plan. Poster session presented atMSParis2017, the joint ECTRIMS-ACTRIMS meeting in Paris, France.5 Nazareth, T., Datar, M. & Yu, T. Treatment Effectiveness for Resolution of Multiple Sclerosis Relapse in A US Health Plan Population. Neurology and Therapy. 2019. Available at: https://www.ncbi.nlm.nih.gov/pubmed/31564036.6 Data on File, Mallinckrodt, 2019.7 Willis BMJ Best Practice Multiple Sclerosis.October 2018. p. 4.8Tillery EE, Clements JN, Howard Z. What's new in multiple sclerosis? The Mental Health Clinician. 2017; 7(5) 213-220.

SOURCE Mallinckrodt plc

http://www.mallinckrodt.com

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Mallinckrodt Announces Data Publication on the Treatment Effectiveness of Acthar Gel (Repository Corticotropin Injection) for Resolution of Multiple...