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.
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)
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:
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
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.
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Director, Investor Relations
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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.