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Mallinckrodt Statement on October 7, 2017, CHEST® Journal Article

Mallinckrodt Statement on October 7, 2017, CHEST® Journal Article

October 9, 2017

An article entitled, “Higher Priced Older Pharmaceuticals: How Should We Respond?” appeared on the website of the CHEST® Journal on October 7, 2017, comprised of editorials by a variety of healthcare stakeholders. The article purports to ‘recap’ discussions from a symposium held at CHEST 2016, the annual meeting of the American College of Chest Physicians, in which viewpoints were offered on how to address the issue of medication pricing. H.P. Acthar® Gel (repository corticotropin injection, or RCI) was the index case for the session.

Mallinckrodt did not participate in the fall 2016 symposium, but was invited to contribute to the  October 2017 recap in CHEST following a series of conversations with key editorial staff members including: Dr. Richard S. Irwin, CHEST Editor in Chief; Dr. Scott Manaker, an Associate Editor of CHEST; and Dr. Mark Metersky, an Editorial Board Member of CHEST. Mallinckrodt appreciates this dialogue and the opportunity to contribute to the discussion and is pleased to offer its view on the value of H.P. Acthar Gel as a treatment option for symptomatic sarcoidosis in a contribution authored by Dr. Tunde Otulana, Senior Vice President and Chief Medical Officer.

Mallinckrodt disagrees with many of the conclusions in these editorials. H.P. Acthar Gel makes a significant difference in the lives of very sick patients with unmet medical needs. The U.S. Food and Drug Administration (FDA) reviewed H.P. Acthar Gel’s label in 2010, and determined there was sufficient evidence to support the 19 indications in the current label. H.P. Acthar Gel is, in fact, one of only two FDA-approved treatment options for patients with symptomatic sarcoidosis and is typically used as a treatment alternative. H.P. Acthar Gel is not a corticosteroid.

Since acquiring H.P. Acthar Gel, Mallinckrodt has initiated six well-designed, company-sponsored, randomized, controlled clinical studies across a number of indications, targeting combined enrollment of more than 1,100 patients. Additionally, over 100 publications about H.P. Acthar Gel have been developed and presented including manuscripts, abstracts, and posters -- stemming from a mix of preclinical and clinical work as well as health economics and outcomes research data introduced by Mallinckrodt and investigator-initiated research.

H.P. Acthar Gel is new to many pulmonologists and the company has recently announced it will conduct a new Phase 4, multi-center, randomized, double blind, placebo-controlled study (that will soon be posted on clinicaltrials.gov) to further assess the efficacy of Acthar as a therapy option in patients with symptomatic sarcoidosis, one of 19 indications approved by the FDA. The new phase 4 study – a ‘pilot’ study in 100 patients - is being designed as an exploratory evaluation of a subset of the more challenging patients, many of whom have not responded to multiple previous therapies. The study will help us better understand and outline for physicians which patients may benefit from a treatment alternative like Acthar – perhaps those who aren’t responding to traditional treatments.

Mallinckrodt understands and empathizes with concerns over the cost of medicines particularly as patient out-of-pocket costs grow with increasingly higher deductibles in health insurance plans. The company takes its responsibility as a pharmaceutical manufacturer very seriously, and remains committed to providing data to providers and working with managed care to assure that H.P. Acthar Gel is accessible and affordable for appropriate patients, including those with symptomatic sarcoidosis. For more information on the company’s Patient Assistance Program, please visit http://www.acthar.com/patient. To view Mallinckrodt’s philosophy on drug pricing, visit www.mallinckrodt.com/responsibility. 

About 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. In people with sarcoidosis, the immune system overreacts, forming clumps of cells called granulomas that result in inflammation to the body's tissues.1 The disease can impact any organ, but it most often impacts the lungs, lymph nodes, eyes, and skin.1 Over 90 percent of people with sarcoidosis will suffer lung problems.1 Concomitant involvement of organs outside of the lungs is common, occurring in as many as half of all sarcoidosis cases.

About H.P. Acthar Gel (repository corticotropin injection)

Indications
H.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:

 
• Treatment during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus
 
• Monotherapy for the treatment of infantile spasms in infants and children under 2 years of age
 
• The treatment of acute exacerbations of multiple sclerosis in adults. Controlled clinical trials have shown H.P. Acthar Gel 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
 
• Inducing a diuresis or a remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus
 
• Treatment during an exacerbation or as maintenance therapy in selected cases of systemic dermatomyositis (polymyositis)
 
• The treatment of symptomatic sarcoidosis
 
• Adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)
 
• Treatment of 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

IMPORTANT SAFETY INFORMATION

Contraindications

 
• 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

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-axis (HPA) 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 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. Blood pressure, sodium and potassium levels may need to be monitored
 
• 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 GI bleeding and gastric ulcer. There is also an increased risk for perforation in patients with certain gastrointestinal disorders. Monitor for signs of bleeding
 
• Acthar may be associated with central nervous system effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, and severe depression, and 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. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH activity
 
• There is 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 for patients on 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

Adverse Reactions

• Common adverse reactions for Acthar are similar to those of corticosteroids and 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

Other adverse events reported are included in the full Prescribing Information.
Please see full Prescribing Information.
For parents and caregivers of IS patients, please also see Medication Guide.

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.

CONTACTS

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

Daniel J. Speciale, CPA
Director, Investor Relations
314-654-3638
daniel.speciale@mallinckrodt.com

Media
Rhonda Sciarra
Senior Communications Manager
908-238-6765
rhonda.sciarra@mallinckrodt.com

Meredith Fischer
Chief Public Affairs Officer
314-654-3318
meredith.fischer@mallinckrodt.com

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¹What Is Sarcoidosis?  Acthar Sarcoidosis website. Available at:  http://www.actharsarcoidosis.com/understand-symptomatic-sarcoidosis/overview.html.  Accessed August 11, 2017.

²About Symptomatic Sarcoidosis. Pulmonary Center for Healthcare Professionals website. Available at: https://www.actharpulmonology.com/about-symptomatic-sarcoidosis.Accessed August  11, 2017.