Mallinckrodt to Present New Data from two Studies on Acthar Gel (Repository Corticotropin Injection) Therapy in Multiple Sclerosis (MS) Relapse at…

STAINES-UPON-THAMES, United Kingdom, Feb. 27, 2020 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, announced today that it will present new data from two studies of Acthar Gel (repository corticotropin injection) in multiple sclerosis (MS) relapse. The data will be highlighted in poster presentations at the Fifth Annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2020, held Feb. 27-29 in West Palm Beach, Florida.

"These studies underscore our commitment to patients with difficult-to-treat MS relapse who continue to have symptoms and disease exacerbations that don't resolve with standard therapy," said Tunde Otulana, M.D., Senior Vice President and Chief Medical Officer at Mallinckrodt. "We look forward to sharing data in MS relapse from two studies that seek to better understand this patient population and Acthar Gel's potential role in MS relapse."

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.1 Please see Important Safety Information for Acthar Gel below.

These studies are sponsored by Mallinckrodt Pharmaceuticals and include:

Top-line Results of a Prospective Observational Registry of Repository Corticotropin Injection for the Treatment of Multiple Sclerosis Relapse2

Study Design of the Randomized, Double-blind, Placebo-Controlled OPTIONS Study of Repository Corticotropin Injection for Acute Exacerbations of MS3

About Multiple Sclerosis

MS is a neurologic disorder that affects the central nervous system (i.e., the brain and spinal cord).4 Symptoms can include fatigue, balance/coordination issues, numbness or tingling, vision problems, muscle spasms, tremors and emotional changes.5 More than eight in 10 people with MS will experience a relapse, also known as a flare-up, exacerbation or attack, that brings new or worsening symptoms.5,6

ActharGel (repository corticotropin injection) Indications

ActharGel (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 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 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 STATEMENTS

This release includes forward-looking statements concerning Acthar Gel including expectations with regard to the studies described in this release, as well as 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.

CONTACTS For Trade Media Inquiries Caren Begun Green Room Communications 201-396-8551 caren@greenroompr.com

For Financial/Dailies Media Inquiries Jim Heins H+K Strategies 212-885-0463 jim.heins@hkstrategies.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 theMallinckrodt Pharmaceuticalslogo are trademarks of aMallinckrodtcompany. Other brands are trademarks of aMallinckrodtcompany or their respective owners.2020Mallinckrodt.US-2000279 02/20

References

1 ActharGel (repository corticotropin injection) [prescribing information].Mallinckrodt ARD LLC.

2 Data on file. Mallinckrodt ARD, LLC, 2020. Kaplan J, Miller T, Baker M, Due B, Zhao E. Topline results of a prospective observational registry of repository corticotropin injection for the treatment of multiple sclerosis relapse. Poster to be presented at:The fifth annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2020;February 27-29, 2020; West Palm Beach, FL.

3 Data on file. Mallinckrodt ARD, LLC, 2020. Goldstick L, Miller A, Due B, Bauer W, Zhao E, Cohen J, Robertson D, Wynn D. Study design of the randomized, double blind, placebo-controlled options study of repository corticotropin injection for acute exacerbations of RRMS. Poster to be presented at:The fifth annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2020;February 27-29, 2020; West Palm Beach, FL.

4 Willis BMJ Best Practice Multiple Sclerosis. October 2018. p. 4.

5 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. Accessed February 13, 2020.

6 Tillery EE, Clements JN, Howard Z. What's new in multiple sclerosis? The Mental Health Clinician. 2017; 7(5) 213-220.

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SOURCE Mallinckrodt Pharmaceuticals

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Mallinckrodt to Present New Data from two Studies on Acthar Gel (Repository Corticotropin Injection) Therapy in Multiple Sclerosis (MS) Relapse at...