Juvenile Arthritis

Submission is supported by data from the Phase 3 QUASAR program, which showed a significantly greater percentage of patients with moderately to severely active ulcerative colitis who received TREMFYA® achieved clinical remission at Week 44 compared with placebo SPRING HOUSE, Pa., March 11, 2024 /PRNewswire/ -- Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of TREMFYA® (guselkumab) for treatment of adults with moderately to severely active ulcerative colitis (UC). The submission is based on results from the Phase 3 QUASAR program evaluating the efficacy and safety of TREMFYA® in the treatment of individuals living with moderately to severely active UC who had an inadequate response or intolerance to conventional therapy, prior biologics and/or JAK inhibitors.1 The data show statistically significant and clinically meaningful improvements in symptoms, patient-reported outcomes such as fatigue and measures of disease activity including high bar endpoints such as endoscopic and histologic remission.2,3 The safety results were consistent with the known safety profile of TREMFYA® in approved indications.2,3,a "Despite advances in therapy, many people living with ulcerative colitis still experience inadequate response to or do not tolerate existing therapies," said David Lee, MD, PhD, Global Therapeutic Area Head Immunology. "TREMFYA has the potential to be a new treatment option for patients. We look forward to working with the FDA in review of this application and remain focused on developing new therapies for those living with chronic autoimmune conditions, such as ulcerative colitis, who are experiencing persistent and debilitating symptoms." TREMFYA® is a dual-acting IL-23i that blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23.4 IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including UC.5 TREMFYA® was first approved in the U.S. in July 2017 for the treatment of adult patients with moderate-to-severe plaque psoriasis and was subsequently also approved for adults with active psoriatic arthritis in July, 2020.4 Clinical data from the Phase 3 QUASAR induction study through 12 weeks were presented at the 2023 Digestive Disease Week (DDW) Annual Meeting2 and results from the Phase 3 QUASAR maintenance study through 44 weeks will be presented at an upcoming medical meeting. Editor's Notes: a. TREMFYA® is not approved to treat UC. ABOUT THE QUASAR STUDY ( NCT04033445 ) QUASAR is a randomized, double-blind, placebo-controlled, parallel group, multicenter, seamless Phase 2b/3 program designed to evaluate the efficacy and safety of TREMFYA®, a selective IL-23 inhibitor, in adult patients with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics and/or JAK inhibitors (i.e., tumor necrosis factor-alpha antagonists, vedolizumab, or tofacitinib).1 QUASAR included a Phase 2b dose-ranging induction study, a confirmatory Phase 3 induction study, and a Phase 3 maintenance study. Efficacy, safety, pharmacokinetics, immunogenicity, and biomarkers are assessed at specified time points.1 ABOUT ULCERATIVE COLITIS Ulcerative colitis (UC) is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus.6 It is the result of the immune system's overactive response.6 Symptoms vary, but may include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss and fatigue.6 ABOUT TREMFYA® (guselkumab) Developed by Johnson & Johnson, TREMFYA® is the first approved fully-human, dual-acting monoclonal antibody that blocks IL-23 by binding to the p19 subunit of IL-23 and binding to CD64, a receptor on cells that produce IL-23.4 IL-23 is an important driver of the pathogenesis of inflammatory diseases.5 Findings for dual acting are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known.7,8,9,10 TREMFYA® is approved in the U.S.,4 Canada,11 Japan12 and a number of other countries for the treatment of adults with moderate to severe plaque psoriasis (PsO) who are candidates for injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light) and for the treatment of adult patients with active psoriatic arthritis ( PsA).4 It is also approved in the EU for the treatment of moderate to severe plaque PsO in adults who are candidates for systemic therapy and for the treatment of active PsA in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy.13 Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®. IMPORTANT SAFETY INFORMATION3 What is the most important information I should know about TREMFYA® (guselkumab)? TREMFYA® is a prescription medicine that may cause serious side effects, including: Serious Allergic Reactions. Stop using TREMFYA® and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction: fainting, dizziness, feeling lightheaded (low blood pressure) swelling of your face, eyelids, lips, mouth, tongue or throat trouble breathing or throat tightness chest tightness skin rash, hives itching Infections. TREMFYA® may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA® and may treat you for TB before you begin treatment with TREMFYA® if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA®. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: fever, sweats, or chills muscle aches weight loss cough warm, red, or painful skin or sores on your body different from your psoriasis diarrhea or stomach pain shortness of breath blood in your phlegm (mucus) burning when you urinate or urinating more often than normal Do not use TREMFYA® if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA®. Before using TREMFYA®, tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed in the section "What is the most important information I should know about TREMFYA®?" have an infection that does not go away or that keeps coming back. have TB or have been in close contact with someone with TB. have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TREMFYA®. are pregnant or plan to become pregnant. It is not known if TREMFYA® can harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if TREMFYA® passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the possible side effects of TREMFYA®? TREMFYA® may cause serious side effects. See "What is the most important information I should know about TREMFYA®?" The most common side effects of TREMFYA® include: upper respiratory infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, and bronchitis. These are not all the possible side effects of TREMFYA®. Call your doctor for medical advice about side effects. Use TREMFYA® exactly as your healthcare provider tells you to use it. Please read the full Prescribing Information , including Medication Guide for TREMFYA®, and discuss any questions that you have with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1– 800– FDA– 1088. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding TREMFYA®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. ABOUT JOHNSON & JOHNSON At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at or at . Follow us at @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. are a Johnson & Johnson companies. National Institutes of Health: Clinicaltrials.gov. A study of guselkumab in participants with moderately to severely active ulcerative colitis (QUASAR). Identifier: NCT04033445. Available at: . Accessed February 2024. Allegretti, J, et al. The efficacy and safety of guselkumab induction therapy in patients with moderately to severely active ulcerative colitis: Results from the Phase 3 QUASAR induction study. Presented at Digestive Disease Week, May 6-9. Peyrin-Biroulet L, et al. Guselkumab in patients with moderately to severely active ulcerative colitis: QUASAR Phase 2b induction study. Gastroenterology. 2023 Dec;165(6):1443-1457. doi: 10.1053/j.gastro.2023.08.038. Epub 2023 Sep 1. PMID: 37659673. US Food and Drug Administration. TREMFYA® Prescribing Information. Available at: . Accessed February 2024. Schinocca, C. et al. Role of the IL-23/IL-17 pathway in rheumatic diseases: an overview. Frontiers in immunology. 2021 Feb 22;12:321. . Crohn's & Colitis Foundation. What is ulcerative colitis? Available at: . Accessed February 2024. Mehta H, et al. Differential Changes in inflammatory mononuclear phagocyte and T-Cell profiles within psoriatic skin during treatment with guselkumab vs. secukinumab. J Invest Dermatol 2021;141(7):1707-1718. Available at: . Accessed February 2024. Wang Y, et al. Monocytes/Macrophages play a pathogenic role in IL-23 mediated psoriasis-like skin inflammation. Sci Rep. 2019;9(1):5310. Available at: . Accessed February 2024. Matt P, et al. Up-regulation of CD64-expressing monocytes with impaired FcγR function reflects disease activity in polyarticular psoriatic arthritis. Scand J Rheumatol 2015; 44(6):464-473. Available at: . Accessed February 2024. McGonagle D, et al. Guselkumab, an IL-23p19 subunit–specific monoclonal antibody, binds CD64+ myeloid cells and potently neutralises IL-23 produced from the same cells. Presented at EULAR 2023, May 31-June 3. The Canadian Agency for Drugs & Technologies in Health. TREMFYA Prescribing Information. Available at: . Accessed February 2024. Japan Pharmaceuticals and Medical Devices Agency. Tremfya Report on the Deliberation Results. Available at: . Accessed February 2024. European Commission: Tremfya (guselkumab). Available at: . Accessed February 2024. SOURCE Johnson & Johnson

Retrospective analysis suggests Acthar Gel treatment was associated with similar improvement in health status and overall symptom reduction in African Americans and non-African Americans with symptomatic sarcoidosis1 Findings on treatment response and physician-reported outcomes indicate that Acthar Gel may be a viable treatment option for both African American and non-African American sarcoidosis patients1 DUBLIN, March 11, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced the publication of findings from a retrospective chart review of Acthar® Gel (repository corticotropin injection) treatment outcomes for African American and non-African American patients with symptomatic sarcoidosis – including treatment patterns, co-medication use, and overall health outcomes.1 This analysis suggested that Acthar Gel treatment was associated with similar improvements in health outcomes, a reduction in symptoms, and reduced co-medication use in both African Americans and non-African Americans with symptomatic sarcoidosis.1 The manuscript was recently published online in Therapeutics & Clinical Risk Management. This research builds upon findings from a study investigating the clinical and real-world outcomes of Acthar Gel treatment in a subgroup of African Americans with symptomatic sarcoidosis, previously presented at the 2022 American Thoracic Society Annual International Conference in San Francisco, CA, and published in Therapeutic Advances in Respiratory Disease in 2019.2 Acthar is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides.3 Acthar Gel is approved by the U.S. Food and Drug Administration (FDA) for the treatment of several autoimmune disorders and medical conditions known to cause inflammation, including symptomatic sarcoidosis.3 Please see additional indications and Important Safety Information below. "The results of this retrospective medical chart review highlight unmet needs that exist for African American patients with symptomatic sarcoidosis, who are disproportionately affected by the disease, and reinforce Acthar Gel's potential to help improve health outcomes for appropriate patients,"1,4,5 said George Wan, Ph.D., M.P.H., Vice President, Evidence Generation and Data Sciences, Mallinckrodt. "This research reflects Mallinckrodt's commitment to collecting real-world data on the relationship between patient characteristics, treatment patterns, and outcomes to support clinicians' treatment decisions and address disparities in symptomatic sarcoidosis care."1 About the Study:1 In this retrospective analysis, a national database of Acthar Gel prescribers and the American Medical Association Physician Master were merged to obtain a sample of 98 physicians to provide data on the last 6 consecutive patients seen who met the study's eligibility criteria. The medical records were extracted for adult patients (≥18 years) with a diagnosis of advanced symptomatic sarcoidosis, who had ≥1 symptom, and who had either completed at least one course of Acthar Gel or had received Acthar Gel for at least 6 months during data collection. A total of 272 patients with symptomatic sarcoidosis were included in this analysis (African American (AA): n=168; non-African American (non-AA): n=104). Most patients in both race groups were diagnosed with stage 3 or 4 sarcoidosis based on chest imaging and biopsy (AA: 61.3%, n=103 vs. non-AA: 68.3%, n=71; p=0.2453). Per an assessment of patient characteristics and Acthar Gel treatment patterns, this analysis suggests that the average time since the first diagnosis of sarcoidosis was slightly longer among AA than non-AA (mean ± SD: 5.2 ± 7.6 years vs. 4.3 ± 5.1 years; p>0.05).1 Further, a lower proportion of AA vs. non-AA had completed a course of Acthar Gel therapy (44%, n=74 vs. 55.8%, n=58; p=0.0602) during the data collection period,1 and the duration of Acthar Gel treatment was slightly longer among AA vs. non-AA (mean ± SD: 31.7 ± 32 vs. 29 ± 27.4 weeks; p>0.05).1 "This research underscores the importance of conducting real-world studies to provide data that helps to recognize the disparities in symptomatic sarcoidosis care and address unmet needs to better support health outcomes for all appropriate patients," said Mary McGowan, Chief Executive Officer, Foundation for Sarcoidosis Research (FSR). FSR is the leading international organization dedicated to finding a cure for sarcoidosis and improving care for sarcoidosis patients through research, education, and support. Key Findings: Co-Medication Utilization Patterns1 Significantly fewer patients among both race groups were on any co-medication after Acthar Gel initiation (p<0.0001): AA before: 88.1%, n=148 vs. after: 20.2%, n=34 Non-AA before: 83.7%, n=87 vs. after: 24%, n=25 More AA had a reduction in any co-medication use after Acthar Gel initiation (AA: -77% vs. non-AA: -71%; p<0.0001). After Acthar Gel initiation, fewer AA (before: 59.5%, n=100 vs. after: 11.9%, n=20; p<0.0001) and non-AA (before: 65.4%, n=68 vs. after: 14.4%, n=15; p<0.0001) were on glucocorticoids. Overall, the mean prednisone dose reduced after Acthar Gel initiation among AA (before: 18.5 mg/day vs. after: 10.1 mg/day) and non-AA (before: 17.6 mg/day vs. after: 10 mg/day). The proportion of patients on prednisone daily dose of <10 mg increased after Acthar Gel initiation among both race groups (AA before: 27.8%, n=27/97 vs. after: 31.6%, n=6/19; non-AA before: 13.6%, n=9/66 vs. after: 60%, n=9/15). Physicians' Assessment of Improvement1 The health status of 95.2% (n=160) of AA and 97.1% (n=101) of non-AA improved following treatment with Acthar Gel, based on physician-provided assessments of patient outcomes. Treatment response to overall symptoms was not statistically significantly different between both race groups (AA: 72.6%, n=122 vs. non-AA: 70.2%, n=73) The most frequently reported changes in symptoms following Acthar Gel treatment in both race groups were: Reduction in inflammation (AA: 33.9%, n=57 vs. non-AA: 32.7%, n=34) Improvement in quality of life (AA: 31.5%, n=53 vs. non-AA: 34.6%, n=36) Improvement in lung function (AA: 30.4%, n=51 vs. non-AA: 53.8%, n=56; p<0.05) Reduction in fatigue (AA: 27.4%, n=46 vs. non-AA: 35.6%, n=37) Limitations:1 Data retrospectively collected from medical charts of patients may have omissions and errors. Completeness of information was assessed to the extent possible to minimize bias resulting from any missing data. In addition, only data available in medical charts or known to be complete to the respondents were extracted. Additional limitations of this study include: Physicians' standards for the interpretation of change in each patient's health status vary which may result in bias due to over- or under-estimation of the effectiveness of Acthar Gel. This study was unable to quantify clinical data such as diagnostic and safety measures, clinical and sustained response after treatment, and reasons for discontinuation or dose adjustments related to Acthar Gel. Due to the exploratory nature of this analysis, data were not collected for other medications besides Acthar Gel. Data on adverse reactions in this population, drivers of the decision to use Acthar Gel, and detailed information on prior therapies were not captured. This study was sponsored by Mallinckrodt Pharmaceuticals. INDICATIONS Acthar Gel is indicated for: Inducing a diuresis or a remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus Monotherapy for the treatment of infantile spasms in infants and children under 2 years of age Treatment of acute exacerbations of multiple sclerosis in adults. Controlled clinical trials have shown Acthar to be effective in speeding the resolution of acute exacerbations of multiple sclerosis. However, there is no evidence that it affects the ultimate outcome or natural history of the disease Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation Symptomatic sarcoidosis Treatment during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus Treatment during an exacerbation or as maintenance therapy in selected cases of dermatomyositis (polymyositis) Adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis IMPORTANT SAFETY INFORMATION Contraindications Acthar is contraindicated: For intravenous administration In infants under 2 years of age who have suspected congenital infections With concomitant administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of Acthar In patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction, or sensitivity to proteins of porcine origin Warnings and Precautions The adverse effects of Acthar are related primarily to its steroidogenic effects Acthar may increase susceptibility to new infection or reactivation of latent infections Suppression of the hypothalamic-pituitary-adrenal (HPA) axis may occur following prolonged therapy with the potential for adrenal insufficiency after withdrawal of the medication. Adrenal insufficiency may be minimized by tapering of the dose when discontinuing treatment. During recovery of the adrenal gland patients should be protected from the stress (e.g., trauma or surgery) by the use of corticosteroids. Monitor patients for effects of HPA axis suppression after stopping treatment Cushing's syndrome may occur during therapy but generally resolves after therapy is stopped. Monitor patients for signs and symptoms Acthar can cause elevation of blood pressure, salt and water retention, and hypokalemia. Monitor blood pressure and sodium and potassium levels Acthar often acts by masking symptoms of other diseases/disorders. Monitor patients carefully during and for a period following discontinuation of therapy Acthar can cause gastrointestinal (GI) bleeding and gastric ulcer. There is also an increased risk for perforation in patients with certain GI disorders. Monitor for signs of perforation and bleeding Acthar may be associated with central nervous system effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, and severe depression to psychosis. Existing conditions may be aggravated Patients with comorbid disease may have that disease worsened. Caution should be used when prescribing Acthar in patients with diabetes and myasthenia gravis Prolonged use of Acthar may produce cataracts, glaucoma, and secondary ocular infections. Monitor for signs and symptoms Acthar is immunogenic and prolonged administration of Acthar may increase the risk of hypersensitivity reactions. Cases of anaphylaxis have been reported in the postmarketing setting. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH and Acthar activity There may be an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver Long-term use may have negative effects on growth and physical development in children. Monitor pediatric patients Decrease in bone density may occur. Bone density should be monitored in patients on long-term therapy Adverse Reactions Commonly reported postmarketing adverse reactions for Acthar include injection site reaction, asthenic conditions (including fatigue, malaise, asthenia, and lethargy), fluid retention (including peripheral swelling), insomnia, headache, and blood glucose increased The most common adverse reactions for the treatment of infantile spasms (IS) are increased risk of infections, convulsions, hypertension, irritability, and pyrexia. Some patients with IS progress to other forms of seizures; IS sometimes masks these seizures, which may become visible once the clinical spasms from IS resolve Pregnancy Acthar may cause fetal harm when administered to a pregnant woman Please see full Prescribing Information for additional Important Safety Information. ABOUT SYMPTOMATIC SARCOIDOSIS Sarcoidosis is a challenging and rare multisystem disease.6 In some cases, the symptoms may come and go throughout a lifetime.6 This is referred to as symptomatic sarcoidosis.6 In people with sarcoidosis, the immune system overreacts, forming clumps of cells called granulomas that result in inflammation to the body's tissues.7 The disease can impact any organ, but it most often impacts the lungs, lymph nodes, eyes, liver, and skin.8 Nearly 90 percent of people with sarcoidosis will suffer lung problems.8 Concomitant involvement of organs outside of the lungs is common, occurring in more than half of all sarcoidosis cases, according to one study.2 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, hepatology, nephrology, pulmonology, ophthalmology, and oncology; 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 CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS This release contains forward-looking statements, including with regard to Acthar® Gel, its potential to improve health and treatment outcomes, its potential impact on patients. 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: the effects of Mallinckrodt's recent emergence from bankruptcy; satisfaction of, and compliance with, 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 or adverse side effects or adverse reactions associated with Acthar Gel; 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 Media Inquiries Green Room Communications 908-577-4531 mediainquiries@grcomms.com Investor Relations Derek Belz Vice President, Investor Relations 314-654-3950 derek.belz@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. ©2024 Mallinckrodt. US-2400042 03/24 References ___________________________________ 1 Bindra J, et al. Acthar Gel in African Americans versus Non-African Americans with Symptomatic Sarcoidosis: Physician Assessment of Patient Medical Records. Ther Clin Risk Manag. 2024;20:83-94 . 2Chopra I, et al. Repository Corticotropin Injection in Patients with Advanced Symptomatic Sarcoidosis: Retrospective Analysis of Medical Records. Ther Adv Res Dis. 2019(13);1-11. DOI: 10.1177/1753466619888127. 3 Acthar® Gel (repository corticotropin injection) [prescribing information]. Mallinckrodt ARD LLC. 2023. 4 Judson MA. Pulmonary Sarcoidosis: A Guide for the Practicing Clinician. Humana Press, New York, NY. 2014. 8;149-186. 5 Hena, K. M. Sarcoidosis Epidemiology: Race Matters. Front Immunol. 2020;11:1-5. 6 Sarcoidosis. American College of Chest Physicians. Available at: . Accessed February 2024. 7 Sarcoidosis Overview. 2019. Cleveland Clinic. Available at: . Accessed February 2024. 8 Judson MA, Boan AD, Lackland DT. The Clinical Course of Sarcoidosis: Presentation, Diagnosis, and Treatment in a Large White and Black Cohort in the United States. Sarcoidosis Vasc Diffuse Lung Dis. 2012. 29(2);119-127. View original content to download multimedia: SOURCE Mallinckrodt plc Company Codes: NYSE:MNK, OTC-BB:MCKPF, OTC-BB:MNKPF, OTC-PINK:MCKPF

Interchangeability study for HADLIMA (adalimumab-bwwd) was conducted in accordance with the FDA’s Guidance for Industry; primary pharmacokinetics (PK) endpoints as well as efficacy, safety and immunogenicity profiles were comparable between switching group and continuous reference product Humira group 52-week results from SB17 Phase 3 study demonstrated long-term efficacy, safety, and immunogenicity of SB17 compared to reference ustekinumab, including switching from ustekinumab to SB17 INCHEON, Korea, March 09, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. presented two new study results for its immunology portfolio – SB5, a biosimilar to Humira1 (adalimumab), and SB17, a proposed biosimilar to Stelara2 (ustekinumab) – at the 2024 American Academy of Dermatology (AAD) Annual Meeting being held from March 8 to 12 in San Diego, California, United States. “We are excited to present new clinical data for our immunology portfolio at AAD Annual Meeting. We will continue to work towards generating robust scientific evidence that demonstrate comparable efficacy and safety of biosimilars to reference products, including data for switching from reference products to biosimilars,” said Ilsun Hong, Vice President, Production Evaluation Team Leader of Samsung Bioepis. SB5, approved by the U.S. Food and Drug Administration (FDA) under the brand name HADLIMA™ (adalimumab-bwwd) as a biosimilar to Humira, is being reviewed by the FDA as an interchangeable biosimilar to Humira based on the Phase 4 study results. The Phase 4 randomized, double-blind, parallel-group, multiple-dose, active comparator, multicenter study (NCT05510063) assessed pharmacokinetics (PK), efficacy, safety, and immunogenicity in two treatment groups of adult patients with moderate to severe plaque psoriasis: patients who switched between reference product Humira and the high-concentration formulation SB5 (40 mg/0.4 mL) versus those receiving reference product continuously. The interchangeability study met primary endpoints of AUCtau (week 23-25) and Cmax (week 23-25), demonstrating comparability between the switching group and continuous reference product treatment group. Other endpoints including efficacy, safety, and immunogenicity were also comparable. SB5 was first approved by the FDA in July 2019 under the brand name HADLIMA (adalimumab-bwwd) as a low-concentration (40 mg/0.8 mL) formulation of prefilled syringe and prefilled autoinjector. The high-concentration (40 mg/0.4 mL) formulation of prefilled syringe and prefilled autoinjector of HADLIMA was approved in August 2022. HADLIMA was introduced into the U.S. commercial market on July 1, 2023 and is marketed by Organon. In addition, Samsung Bioepis presented the final 52-week results from the Phase 3 study for SB17, comparing the long-term efficacy, safety, and immunogenicity between three treatment groups: SB17-treated group, reference ustekinumab-treated group, and switched group from reference ustekinumab to SB17 at Week 28. The study showed that efficacy, safety, and immunogenicity between the three arms were comparable up to Week 52. SB17 was recommended for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in February 2024 under the brand name PYZCHIVA™. In the United States, the Biologics License Application (BLA) for SB17 is under review by the FDA. If approved, SB17 will be commercialized by Sandoz in Europe and the U.S. Details of the Samsung Bioepis’ abstracts are as follows: Presentation TitlePresentation DetailsInterchangeability of SB5 and Adalimumab Reference Product in Patients with Moderate to Severe Chronic Plaque PsoriasisSession: PosterExhibit Date/Time: March 8-9th, 2024, 8:30 AM – 5:00 PMAbstract Number: 50522Authors: Steven R. Feldman, Skaidra Valiukevičienė, Grazyna Pulka, Elzbieta Krolikowska, Pawel Brzewski, Malgorzata Janczylo-Jankowska, Bartlomiej Kwiek, Lidia Rajzer, Soyeon Kim, Yumin Baek, Hyuna LeeClinical Similarity of SB17 (Proposed Ustekinumab Biosimilar) to Reference Ustekinumab in Patients with Moderate to Severe Plaque Psoriasis: Randomized, Double-blind, Phase III, 52-Week ResultsSession: PosterExhibit Date/Time: March 8-9th, 2024, 8:30 AM – 5:00 PMAbstract Number: 49140Authors: Steven R. Feldman, Joanna Narbutt, Giampiero Girolomoni, Jan Brzezicki, Nataliya Reznichenko, Maria Agnieszka Zegadlo-Mylik, Grazyna Pulka, Magdalena Dmowska-Stecewicz, Jiyoon Lee, Minkyung Lee, Young Hee Rho About HADLIMA (adalimumab-bwwd) Injection 40 mg/0.4 mL and 40 mg/0.8mL HADLIMA is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis: HADLIMA is indicated, alone or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs), for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. Juvenile Idiopathic Arthritis: HADLIMA is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Psoriatic Arthritis: HADLIMA is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Ankylosing Spondylitis: HADLIMA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. Crohn’s Disease: HADLIMA is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. Ulcerative Colitis: HADLIMA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.Limitations of Use:The effectiveness of HADLIMA has not been established in patients who have lost response to or were intolerant to tumor necrosis factor (TNF) blockers. Plaque Psoriasis: HADLIMA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HADLIMA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. Hidradenitis Suppurativa: HADLIMA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. Uveitis: HADLIMA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. SELECTED SAFETY INFORMATION SERIOUS INFECTIONS Patients treated with adalimumab products, including HADLIMA, are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue HADLIMA if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before HADLIMA use and during therapy. Initiate treatment for latent TB prior to HADLIMA use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with HADLIMA prior to initiating therapy in patients: with chronic or recurrent infection who have been exposed to TB with a history of opportunistic infection who resided in or traveled in regions where mycoses are endemic with underlying conditions that may predispose them to infection Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HADLIMA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Do not start HADLIMA during an active infection, including localized infections. Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection. If an infection develops, monitor carefully and initiate appropriate therapy. Drug interactions with biologic products: A higher rate of serious infections has been observed in rheumatoid arthritis (RA) patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of HADLIMA with other biologic DMARDs (eg, anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants. Consider the risks and benefits of HADLIMA treatment prior to initiating or continuing therapy in a patient with known malignancy. In clinical trials, more cases of malignancies were observed among adalimumab-treated patients compared to control patients. Non-melanoma skin cancer (NMSC) was reported during clinical trials for adalimumab-treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or psoralen and ultraviolet A (PUVA) therapy, for the presence of NMSC prior to and during treatment with HADLIMA. In adalimumab clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers. Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents. HYPERSENSITIVITY Anaphylaxis and angioneurotic edema have been reported following adalimumab administration. If a serious allergic reaction occurs, stop HADLIMA and institute appropriate therapy. HEPATITIS B VIRUS REACTIVATION Use of TNF blockers, including HADLIMA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal. Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy. Exercise caution in patients who are carriers of HBV and monitor them during and after HADLIMA treatment. Discontinue HADLIMA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming HADLIMA after HBV treatment. NEUROLOGIC REACTIONS TNF blockers, including adalimumab products, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome. Exercise caution when considering HADLIMA for patients with these disorders; discontinuation of HADLIMA should be considered if any of these disorders develop. HEMATOLOGIC REACTIONS Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with adalimumab products. Consider stopping HADLIMA if significant hematologic abnormalities occur. CONGESTIVE HEART FAILURE Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with adalimumab products; exercise caution and monitor carefully. AUTOIMMUNITY Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop. IMMUNIZATIONS Patients on HADLIMA should not receive live vaccines. Pediatric patients, if possible, should be brought up to date with all immunizations before initiating HADLIMA therapy. Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero-exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab products in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. ADVERSE REACTIONS The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (eg, upper respiratory, sinusitis), injection site reactions, headache, and rash. Before prescribing HADLIMA, please read the accompanying Full Prescribing Information, including the Boxed Warning about serious infections and malignancies, Medication Guide and Instructions for Use. About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X, LinkedIn. _________________________ 1 Humira is a trademark registered in the US by AbbVie Biotechnology Ltd. 2 Stelara is a trademark of Johnson & Johnson.