STAINES-UPON-THAMES - 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

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

The multicenter, prospective, observational registry sought to characterize the adult patient population (18 years of age) being treated with Acthar Gel for acute MS relapse and describe treatment patterns, MS exacerbation recovery, and safety outcomes.

The primary endpoint was: change from baseline to Month 2 as measured by the MS Impact Scale, version 1 (MSIS-29v1) physical subscale score.

Patients were also assessed with the Expanded Disability Status Scale (EDSS) and Clinical Global Impression of Improvement (CGI-I) scale.

Patients were followed for up to 24 months, and a minimum of six months at 31 U.S. sites.

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

Interim baseline patient characteristics from 50 percent enrollment (n=32, 18 years of age) will be presented.

The study is an ongoing, randomized, double-blind, placebo-controlled parallel group pilot trial to assess the efficacy and safety of Acthar Gel in patients who continue to experience acute exacerbations of MS after treatment with high-dose intravenous or oral corticosteroids.

The study's primary objective is to generate an estimate of the response rate for Acthar Gel and to assess its safety and tolerability. The secondary objective is to assess the effect of treatment on quality-of-life measures.

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

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.

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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.

Contact:

Caren Begun

Tel: 201-396-8551

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