Mallinckrodt Announces Publication of New Data on Acthar Gel (Repository Corticotropin Injection) in Rheumatoid Arthritis, Systemic Lupus…

Posted: March 4, 2020 at 6:45 pm

-- Retrospective chart review assessing Acthar Gel treatment utilization and patterns in 92 patients suggests improvement in symptoms across three disease states in a real-world setting --

STAINES-UPON-THAMES, United Kingdom, March 4, 2020 /PRNewswire/ --Mallinckrodt plc(NYSE: MNK), a global biopharmaceutical company, today announced findings from a retrospective medical record analysis to assess practice patterns and outcomes of Acthar Gel (repository corticotropin injection) in the treatment of the immune-mediated diseases rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) and dermatomyositis/polymyositis (DM/PM). Results of the study were recently published online in Open Access Rheumatology: Research and Reviews.

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), and for use during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis).1Please see Important Safety Information for Acthar Gel below.

The study, titled "Treatment with Repository Corticotropin Injection in Patients with Rheumatoid Arthritis, Systemic Lupus Erythematosus, and Dermatomyositis/Polymyositis," examined 92 adult patients (18 years of age) 54 with RA, 30 with SLE and 8 with DM/PM who were treated at 14 U.S. clinical sites with Acthar Gel between January 1, 2011 and February 15, 2016. Researchers collected data on patient demographics, disease and treatment history; Acthar Gel dosing, frequency and duration; concomitant medication use; and physicians' assessments of outcomes and adverse events. Results of the analysis showed that across all three patient populations, the most frequently reported reasons for initiating treatment with Acthar Gel were inadequate response to prior therapies, acute exacerbation or flare of disease, and need for an alternative therapy. The findings also suggest that patients' symptoms improved with Acthar Gel as reported by physicians' impression of overall change after treatment initiation and over the course of the study. Among 57 patients with data on physician impression of change, 78.1 percent of patients with RA, 94.7 percent of patients with SLE and 66.7 percent of patients with DM/PM had a rating of improved. Further, the mean time to best impression of change was 3.42.5 months for RA, 4.32.7 for SLE, and 3.41.6 for DM/PM.

"All three immune-mediated diseases examined in this study can be difficult to manage, and patients can often experience debilitating disease flares and exacerbations," said Tunde Otulana, M.D., Senior Vice President and Chief Medical Officer at Mallinckrodt. "The study suggests that Acthar Gel may have been associated with an improvement in disease exacerbations and symptoms, and it provides insights into real-world practice patterns and outcomes associated with Acthar Gel therapy that may help inform decision-making among clinicians in managing these conditions."

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Further, the study builds on the company's Phase 4 study of Acthar Gel in RA patients (open-label portion, n=259; randomized, placebo-controlled, blinded, withdrawal portion, n=154) presented at the European Congress of Rheumatology 2019 (EULAR), June 12-15 in Madrid. The randomized, placebo-controlled, double-blind two-part study demonstrated that significantly more patients with persistently active RA who met response criteria at week 12 (63 percent of patients in the open-label period who achieved low disease activity (LDA) as assessed by Disease Activity Score 28-joint count Erythrocyte Sedimentation Rate (DAS28-ESR) of <3.2 at 12 weeks) maintained LDA with Acthar Gel (62 percent) versus placebo (43 percent, P<0.05) at week 24. In the double-blind period of the study (weeks 12-24), adverse events (AEs) were reported in 33 percent of the Acthar Gel treatment group and 40 percent of the placebo group. In the open-label period of the study (weeks 0-12), AEs were reported in 38 percent of patients. Overall AEs observed in the study were consistent with previous trials of Acthar Gel. The study was subject to study limitations, including that the results may not be solely attributable to Acthar Gel.

Key Findings:2

Study Limitations:2

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.3 An estimated 1.5 million U.S. adults are living with RA.4 Treatment is aimed at stopping inflammation to put the disease in remission and relieve symptoms.5 Nonsteroidal anti-inflammatory drugs are used to ease symptoms whereas corticosteroids, disease-modifying anti-rheumatic drugs and biologics are used to slow down the disease activity.5

About Systemic Lupus ErythematosusSLE is an autoimmune disease in which the immune system produces antibodies to cells within the body leading to widespread inflammation and tissue damage.6 It is the most common form of lupus, a condition that impacts an estimated 1.5 million Americans.7 Ninety percent of those diagnosed with lupus are women, often between the ages of 15-44.8 Lupus is characterized by periods of illness "flares" and remissions and the disease can affect the joints, skin, brain, lungs, kidneys, and blood vessels. Symptoms and signs may include fatigue, pain or swelling in joints, skin rashes, and fevers.6

About Dermatomyositis/PolymyositisDM/PM are rare inflammatory diseases that cause progressive muscle weakness.9 For instance, muscle weakness associated with PM involves those in the hips, thighs, shoulders, upper arms and neck.10 DM also causes skin rashes.9 People of all ages can be affected, though it usually occurs in adults between the ages of 45-60 and is more common in women.11,[12]

ActharGel (repository corticotropin injection) 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 InquiriesJim HeinsH+K Strategies212-885-0463jim.heins@hkstrategies.com

Investor Relations Daniel 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-2000329 03/20

References

1 Acthar Gel (repository corticotropin injection) [prescribing information]. Mallinckrodt ARD LLC.2Ho-Mahler N, Turner B, Eaddy M, Hanke ML, Nelson WW. Treatment with repository corticotropin injection in patients with rheumatoid arthritis, systemic lupus erythematosus, and dermatomyositis/polymyositis. Open Access Rheumatology: Research and Reviews. 2020:12 21-29.3Mayo Clinic website. Rheumatoid Arthritis. Overview. Available at: https://www.mayoclinic.org/diseases-conditions/rheumatoid-arthritis/symptoms-causes/syc-20353648. Accessed November 5, 2019.4Arthritis Foundation. What is Rheumatoid Arthritis? Available at: http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/what-is-rheumatoid-arthritis.php. Accessed November 5, 2019.5Arthritis Foundation. Rheumatoid Arthritis Treatment. Available at: http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/treatment.php. Accessed November 5, 2019.6The Centers for Disease Control and Prevention. Systemic lupus erythematosus (SLE or lupus). Available at: https://www.cdc.gov/lupus/facts/detailed.html. Accessed March 21, 2019.7Kabadi S, Yeaw J, Bacani AK, Tafesse E, Bos K, Karkare S, et al. Healthcare resource utilization and costs associated with long-term corticosteroid exposure in patients with systemic lupus erythematosus. Lupus. 2018;27:1799-1809. doi: 10.1177/0961203318790675.8Pons-Estel GJ, Alarcon GS, Scofield L, Reinlib L, Cooper GS. Understanding the epidemiology and progression of systemic lupus erythematosus. Semin Arthritis Rheum. 2010; 39(4):257268.9Medline Plus. Myositis. https://medlineplus.gov/myositis.html. Accessed November 3, 2016.10 Mayo Clinic. Polymyositis. http://www.mayoclinic.org/diseases-conditions/polymyositis/basics/symptoms/con-20020710. Accessed November 3, 2016.11Bernatsky S, Joseph L, Pineau CA, et al. Estimating the prevalence of polymyositis and dermatomyositis from administrative data: age, sex and regional differences. Ann Rheum Dis. 2009;68:1192-1196.12Cheeti A, Panginikkod S. Dermatomyositis and Polymyositis. [Updated 2019 Nov 13]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK532860/.

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