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H.P. Acthar® Gel (Repository Corticotropin Injection) Health Economic Data Presented at the American Society of Health-System Pharmacists Summer Meetings

-- Retrospective analyses evaluated healthcare resource utilization and costs with Acthar in dermatomyositis/polymyositis symptoms and rheumatoid arthritis --

CHESTERFIELD, United Kingdom – June 20, 2016 - Mallinckrodt plc (NYSE: MNK), a leading global specialty biopharmaceutical company, today announced the results from two Mallinckrodt-sponsored retrospective analyses of claims data providing health economic information regarding the use of H.P. Acthar® Gel (repository corticotropin injection) in two distinct patient populations: dermatomyositis and polymyositis (DM/PM), and as an adjunct therapy for short-term administration in select cases of rheumatoid arthritis (RA). The results of each study were presented in poster sessions at the American Society of Health-System Pharmacists Summer Meetings, held June 11-15, in Baltimore.

Both abstracts can be accessed at link (pages 70 and 145).

Dermatomyositis and Polymyositis (DM/PM) Retrospective Analysis

“Medical Resource Utilization in Dermatomyositis/Polymyositis Patients Treated with Repository Corticotropin Injection, Intravenous Immunoglobulin, and/or Rituximab” (Knight R, Bond C, Popelar B, Wang L, Philbin M, Poster 36-M), compared non-medication-related medical resource use between patients treated with Acthar and patients treated with intravenous immunoglobulin (IVIG) and/or rituximab for DM/PM. Claims data of DM/PM patients were analyzed from the combination of three commercial health insurance databases in the U.S. from July 1, 2009 to June 30, 2014.

Findings from this retrospective, observational study among DM/PM patients include:

• Very few patients had used Acthar (n=132), while use of IVIG (n=1,150) or rituximab (n=562) was more common
• Compared to IVIG: Acthar patients had fewer per patient per month (PPPM) hospitalizations (0.09 vs. 0.17; P=0.049); shorter length of stay (LOS) (3.24 days vs. 4.55 days; P=0.004); PPPM hospital outpatient department (HOPD) visits (0.60 vs. 1.39; P < 0.001); and PPPM physician office visits (2.01 vs. 2.33; P=0.035)
• Compared to rituximab, Acthar had fewer PPPM HOPD visits (0.56 vs. 0.92; P < 0.001)
• Compared to IVIG + rituximab, Acthar had shorter LOS (2.18 days vs. 5.15; P < 0.001) and less PPPM HOPD visits (0.53 vs. 1.26; P < 0.001)
• Total non-medication PPPM costs were lower for Acthar compared to IVIG ($2,126 vs. $3,964;
  P < 0.001), rituximab ($2,008 vs. $2,607; P=0.018) and IVIG+rituximab ($1,234 vs. $4,858;
  P < 0.001)

Limitations of the Study
This study examined only non-medication medical resource use and associated non-medication costs. Other endpoints such as indirect healthcare costs, patient experience and quality-of-life measures, and effectiveness were not examined. Propensity score matching was used to control for potential confounders; however, the use of propensity scores will not correct for biases from unmeasured variables.

About DM/PM
Dermatomyositis and polymyositis (DM/PM) are rare inflammatory diseases that cause progressive muscle weakness, usually in the neck, upper arms, hips, and thighs. Dermatomyositis also causes skin rashes. ^2,3 People of all ages can be affected, though it usually occurs between the ages of 40-50 and is more common in women. ^4,5,6 There is no cure for DM/PM, but certain treatments can improve muscle strength and function. ¹ Corticosteroids and corticosteroid-sparing agents are used early in the treatment paradigm to improve muscle function.1 Acthar is the only medication approved by the U.S. Food and Drug Administration (FDA) for DM/PM other than corticosteroids.¹

Rheumatoid Arthritis (RA) Retrospective Analysis

“Real-World Treatment Patterns and Demographic, Clinical and Economic Characteristics of Rheumatoid Arthritis Patients Initiating Repository Corticotropin Injection Therapy” (Wu B, Deshpande G, Popelar B, Wan G, Philbin M, Poster 33-T), describes the profile of adult patients with RA initiating Acthar treatment, including baseline characteristics, treatment patterns and healthcare costs. Patients age 18 and older with two or more diagnoses for RA between July 1, 2006 and April 30, 2015, were identified from a nationally representative HealthCore Integrated Research DatabaseSM.

Findings from this retrospective, cohort study among RA patients in a commercially insured population include:

• Acthar was only initiated in a very small proportion of patients with RA (0.1%, n=180). Acthar was started on average 7.1 months after the initial RA diagnosis
• After initiation of Acthar there were significant reductions in healthcare resource utilization, compared with the pre-initiation period, as follows:
• Hospitalization* (all-cause: 42 vs. 25, p <0.01; RA-related: 13 vs. 4, p <0.01)
• Emergency department visit* (all-cause: 43 vs. 23, p =0.04; RA-related: 8 vs. 1, p <0.01)
• Outpatient service+ (all-cause: 56 vs. 47, p <0.01; RA-related: 10 vs. 5, p <0.01)
• Biologic use* (1,137 vs. 474, 58.3% reduction, p <0.01)
• Corticosteroid use* (442 vs. 231, 47.7% reduction, p <0.01)
• Non-biologic DMARD use* (376 vs 137, 63.6% reduction, p <0.01)
• Medical cost offset was observed due to reduced costs for all types of medical services which offset the drug costs by 14%-30%

* Number of patients per 1,000 patient year
+ Number of encounters per patient year

Limitations of the Study
This study estimated costs from a commercial payer’s perspective, which may underestimate the overall cost burden of the disease. These results may have limited generalizability to a non-commercially insured population.

About Rheumatoid Arthritis (RA)
Rheumatoid arthritis (RA) is an autoimmune disease. It is a chronic condition that causes pain, stiffness, and swelling of the joints-all symptoms caused by inflammation. An estimated 1.5 million U.S. adults are living with RA.⁷ Treatment is aimed at stopping inflammation to put the disease in remission and relieve symptoms.7 Nonsteroidal anti-inflammatory drugs (NSAIDs) are used to ease symptoms whereas corticosteroids, disease modifying anti-rheumatic drugs (DMARDs) and biologics are used to slow down the disease activity.⁸

About H.P. Acthar Gel (repository corticotropin injection)
H.P. Acthar Gel (repository corticotropin injection), is an injectable drug approved by the FDA for the treatment of 19 indications. Of these 19 indications, the following are currently promoted:

• Inducing a diuresis or a remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.
• 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.
• As monotherapy for the treatment of infantile spasms (“IS”) in infants and children under 2 years of age.
• Use during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus.
• Use during an exacerbation or as maintenance therapy in selected cases of systemic dermatomyositis (polymyositis).
• Use as adjunct therapy for short-term administration in select cases of rheumatoid arthritis.

For more information about Acthar, please visit www.acthar.com. Full prescribing information may be accessed here.

Important Safety Information

• Acthar should never be administered intravenously.
• Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of Acthar.
• Acthar is contraindicated where congenital infections are suspected in infants.
• Acthar is contraindicated in patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction or sensitivity to proteins of porcine origins.
• 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. Cushing's Syndrome may occur during therapy but generally resolves after therapy is stopped. Monitor patients for signs and symptoms.
• Monitor patients for elevation of blood pressure, salt and water retention, and hypokalemia.
• Acthar often acts by masking symptoms of other diseases/disorders. Monitor patients carefully during and following discontinuation.
• Acthar can cause gastrointestinal (GI) bleeding and gastric ulcer with an increased risk for perforation with certain GI disorders. Monitor for signs of bleeding.
• Acthar may be associated with central nervous system effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, depression, and psychosis. Existing conditions may be aggravated.
• Patients with comorbid disease may have that disease worsened. Caution should be used in patients with diabetes and myasthenia gravis.
• Prolonged use of Acthar may produce cataracts, glaucoma and secondary ocular infections.
• Acthar is immunogenic and prolonged use may increase the risk of hypersensitivity reactions.
• There is an enhanced effect in patients with hypothyroidism and those with cirrhosis of liver.
• Long-term use may have negative effects on growth and physical development in children. Monitor pediatric patients.
• Decrease in bone density may occur. Monitor during long-term therapy.
• Pregnancy Class C: Acthar has been shown to have an embryocidal effect and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
• Common adverse reactions include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain.
• Specific adverse reactions reported in IS clinical trials in infants and children under 2 years of age included: infection, hypertension, irritability, Cushingoid symptoms, constipation, diarrhea, vomiting, pyrexia, weight gain, increased appetite, decreased appetite, nasal congestion, acne, rash, and cardiac hypertrophy. Convulsions were also reported, but these may actually be occurring because some IS patients progress to other forms of seizures and IS sometimes mask other seizures, which become visible once the clinical spasms from IS resolve.

Please see full Prescribing Information here for additional important safety information. 

ABOUT MALLINCKRODT
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical and biopharmaceutical products and therapies, as well as nuclear imaging products. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; analgesics and hemostasis products; and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing; and the Nuclear Imaging segment includes nuclear imaging agents. To learn more about Mallinckrodt, visit 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.

CONTACTS

Media
Rhonda Sciarra
Senior Communications Manager
314-654-8618
rhonda.sciarra@mallinckrodt.com

Meredith Fischer
Senior Vice President, Communications and Public Affairs
314-654-3318
meredith.fischer@mallinckrodt.com

Investor Relations
Coleman N. Lannum, CFA
Senior Vice President, Investor Strategy and IRO
314-654-6649
cole.lannum@mallinckrodt.com

 

¹ The Myositis Association. Retrieved from: http://www.myositis.org. Last accessed: April 27, 2016.

² Medline Plus. Myositis. http://www.nih.gov/medlineplus/myositis.html. Accessed April 15, 2013.

³ Mayo Clinic. Polymyositis. http://www.mayoclinic.com/health/polymyositis/DS00334. Accessed April 15, 2013.

⁴ Bernatsky 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.

⁵ Miller ML. Clinical manifestations and diagnosis of adult dermatomyositis and polymyositis. UpToDate website. http://www.uptodate.com/contents/clinical-manifestations-and-diagnosis-of-adult-dermatomyositis-and-polymyositis?source=search_result&search=dermatomyositis&selectedTitle=1~124. Published September 23, 2010. Accessed March 6, 2014.

⁶ Pappu R, Seetharaman M. Polymyositis. Medscape Reference website. http://emedicine.medscape.com/article/335925-overview#a0156. Published February 20, 2013. Accessed April 15, 2013.

⁷ What is Rheumatoid Arthritis? Arthritis Foundation. Available at: http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/what-is-rheumatoid-arthritis.php. Accessed June 2, 2016.

⁸ Arthritis Foundation. Rheumatoid Arthritis Treatment. http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/treatment.php [Accessed on July 14, 2015].