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STAINES-UPON-THAMES, England, July 31, 2017 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, announced the publication of a company-initiated literature review of clinical and economic data on H.P. Acthar® Gel (repository corticotropin injection) across seven autoimmune and inflammatory disorders – all approved indications for the product. The evidence supported the use of H.P. Acthar Gel across the indications reviewed, pointing to a reduced need for background medications and lower post-therapy healthcare utilization and medical costs.
The analysis, which summarizes data from the Academy of Managed Care Pharmacy (AMCP) Formulary dossier for H.P. Acthar Gel and includes studies from 1956 to 2016, was published online in the June 28, 2017 issue of Advances in Therapy and titled "Clinical and Economic Evaluation of Repository Corticotropin Injection: A Narrative Literature Review of Treatment Efficacy and Healthcare Resource Utilization for Seven Key Indications." The full article is available here.
The article cites data demonstrating the impact of the product – both clinical and healthcare resource utilization (HCRU) – and includes evidence summarized from 16 published clinical investigations and six HCRU studies performed across the seven indications.
"Mallinckrodt's ongoing commitment to conducting studies of patients who receive H.P. Acthar Gel continues to improve understanding and treatment of autoimmune and inflammatory diseases," said Tunde Otulana, MD, Chief Medical Officer at Mallinckrodt. "The extensive body of clinical and economic data in this important review supports the impact that Acthar has had across the seven evaluated indications for patients, the healthcare system and society for many years."
The indications addressed in the study are:
H.P. Acthar Gel is U.S. Food and Drug Administration (FDA)-approved for the treatment of 19 autoimmune and inflammatory disorders.1 In 2010 the label was updated to its current form and approved by the FDA to refine the number of indications, and to recognize inclusion of the approved IS indication.
H.P. Acthar Gel has a wealth of clinical experience in the marketplace. Across the 10 currently promoted indications, data demonstrating the impact of the product has been generated by company-sponsored trials, patient registries, investigator-initiated studies, and health economics and outcomes research (HEOR). Mallinckrodt continues to invest in ongoing data generation, including support for additional company-sponsored and independent clinical trials in marketed and potential new indications, HEOR studies and further investigation to support its mechanism of action.
Over two dozen ongoing clinical trials of H.P. Acthar Gel in the treatment of the approved indications and potential new indications are currently registered in the National Institutes of Health clinical trials database (www.ClinicalTrials.gov). A bibliography of existing H.P. Acthar Gel publications by indication can be found on the company's website.
DM/PM are rare inflammatory diseases that cause progressive muscle weakness2, usually in the muscles closest to the trunk of the body.3 For instance, muscle weakness associated with PM involves those in the hips, thighs, shoulders, upper arms and neck.4 DM also causes skin rashes.5 People of all ages can be affected, though it usually occurs between the ages of 40-50 and is more common in women.5,6
ABOUT INFANTILE SPASMS IS is a rare seizure disorder that affects approximately 2,500 children in the U.S. every year.7 It most commonly occurs between four and eight months of age.8 Sometimes called West syndrome, IS demands early identification, diagnosis, and treatment to help limit lasting effects.7 Children with IS generally have one or more of the following symptoms: a certain type of seizure (called "spasms"), a disorganized and chaotic brain-wave pattern called hypsarrhythmia as recorded on an EEG (electroencephalogram).8
ABOUT MULTIPLE SCLEROSIS MS is a neurologic disorder that affects the central nervous system (i.e., the brain and spinal cord).9 Symptoms can include fatigue, balance/coordination issues, numbness or tingling, vision problems, muscle spasms, tremors and emotional changes. More than eight in 10 people with MS will experience a relapse, or flare-up, that brings new or worsening symptoms.10
ABOUT PROTEINURIA IN NEPHROTIC SYNDROME NS is a collection of symptoms that occur when the blood vessels in the kidney begin to leak excess protein in the urine, a condition called proteinuria. A variety of diseases and underlying disorders damage the kidneys and cause proteinuria in people with NS. These etiologies can include glomerular diseases such as: idiopathic membranous nephropathy, focal segmental glomerulosclerosis, minimal change disease, membranoproliferative glomerulonephritis, lupus nephritis, and IgA nephropathy. In these and other related disorders, the glomeruli, or small blood vessels that work as the kidney's filtering system, are damaged.
ABOUT 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.11 An estimated 1.5 million U.S. adults are living with RA.12
ABOUT SYSTEMIC LUPUS ERYTHEMATOSUSSLE is an autoimmune disease in which the immune system produces antibodies to cells within the body leading to possible inflammation and tissue damage.13 It is the most common form of lupus, a condition that impacts an estimated 1.5 million Americans.14 Ninety percent of those diagnosed with lupus are women, often between the ages of 15-44.14 Lupus is characterized by periods of illness "flares" and remissions and the disease can affect the joints, skin, brain, lungs, kidneys, and blood vessels.13 Symptoms may include fatigue, pain or swelling in joints, skin rashes, and fevers.13
ABOUT SYMPTOMATIC SARCOIDOSIS
Sarcoidosis is a challenging, yet treatable, rare multisystem disease. In some cases the symptoms may come and go throughout a lifetime. This is referred to as symptomatic sarcoidosis.15 In people with sarcoidosis the immune system overreacts, forming clumps of cells called granulomas that result in inflammation to the body's tissues.15 The disease can impact any organ, but it most often impacts the lungs, lymph nodes, eyes, and skin.15 Over 90 percent of people with sarcoidosis will suffer lung problems.15 Concomitant involvement of organs outside of the lungs is common, occurring in as many as half of all sarcoidosis cases.16
About H.P. Acthar Gel (repository corticotropin injection) IndicationsH.P. Acthar Gel is an injectable drug approved by the FDA for the treatment of 19 indications. Of these, today the majority of Acthar use is in these indications:
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
ABOUT MALLINCKRODT Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies. 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; and analgesics and hemostasis products. 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 and its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing. 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.
Investor Relations Coleman N. Lannum, CFA
Senior Vice President, Investor Strategy and IRO
Daniel J. Speciale, CPA
Director, Investor Relations
Media Rhonda Sciarra
Senior Communications Manager
Chief Public Affairs Officer
1 H.P. Acthar® Gel (repository corticotropin injection) [prescribing information]. Mallinckrodt ARD, Inc.
2 Types of Myositis. The Myositis Association. Available at: http://www.myositis.org./learn-about-myositis/types-of-myositis. Accessed July 19, 2017.
3 Medline Plus. Myositis. Available at: https://medlineplus.gov/myositis.html. Accessed July 19, 2017.
4 Mayo Clinic. Polymyositis. Available at: http://www.mayoclinic.org/diseases-conditions/polymyositis/basics/symptoms/con-20020710. Accessed July 19, 2017.
5 Rheumatology Center. About Dermatomyositis and Polymyositis. Available at: https://www.actharrheumatology.com/dermatomyositis-and-polymyositis/about-dermatomyositis-and-polymyositis. Accessed July 19, 2017.
6 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.
7 Understanding Infantile Spasms. Acthar IS Website. Available at: https://www.actharis.com/what-are-infantile-spasms. Accessed July 19, 2017.
8 Parent and Caregiver Brochure - Acthar for Infantile Spasms: Commonly asked questions about treatment, Mallinckrodt Website, p. 2. Available at: https://www.actharis.com/docs/acthar-infantile-spasms-brochure.pdf. Accessed July 19, 2017.
9 Multiple Sclerosis Foundation. Get Educated-Common Questions-Multiple Sclerosis. Available at: https://msfocus.org/Get-Educated/Common-Questions#What is Multiple Sclerosis. Accessed July 21, 2017.
10 National Multiple Sclerosis Society. Relapsing-remitting MS (RRMS). Available at: http://www.nationalmssociety.org/What-is-MS/Types-of-MS/Relapsing-remitting-MS. Accessed July 19, 2017.
11 What is RA? ActharRA Web site. Available at: https://www.actharra.com/learn-about-acthar/what-is-ra. Accessed July 19, 2017.
12 What is Rheumatoid Arthritis? Arthritis Foundation. Available at: http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/what-is-rheumatoid-arthritis.php. Accessed November 3, 2016.
13 Systemic lupus erythematosus (SLE or lupus), The Centers for Disease Control and Prevention, Available at: http://www.cdc.gov/arthritis/basics/lupus.html. Accessed November 3, 2016.
14 Lupus Foundation of America Press Kit. Statistics on Lupus. Available at: http://www.lupus.org/about/statistics-on-lupus. Accessed July 19, 2017.
15 What Is Sarcoidosis? Acthar Sarcoidosis website. Available at: http://www.actharsarcoidosis.com/understand-symptomatic-sarcoidosis/overview.html. Accessed July 19, 2017.
16 About Symptomatic Sarcoidosis. Pulmonary Center for Healthcare Professionals website. Available at: https://www.actharpulmonology.com/about-symptomatic-sarcoidosis. Accessed July 19, 2017.
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