Clinical Data on Mallinckrodt Pharmaceuticals' H.P. Acthar® Gel to be Unveiled at American College of Rheumatology

-- Data Describe Pilot Study in Patients with Persistently Active Systemic Lupus Erythematosus Requiring Corticosteroids --

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Mallinckrodt plc

Oct 13, 2015, 04:30 ET

CHESTERFIELD, United Kingdom, Oct. 13, 2015 /PRNewswire/ -- UPDATED RELEASE -- Mallinckrodt plc (NYSE: MNK), a leading specialty biopharmaceutical company, today announced that data from a pilot study for its H.P. Acthar Gel (repository corticotropin injection) will be presented at the American College of Rheumatology (ACR) 2015 Annual Meeting to be held November 7-11 in San Francisco.

The company-sponsored pilot study, titled "Repository Corticotropin Injection (H.P. Acthar Gel) Attenuates Disease Activity in Patients with Persistently Active Systemic Lupus Erythematosus (SLE) Requiring Corticosteroids," was an eight-week, double-blind, randomized, placebo-controlled study that assessed clinical efficacy of repository corticotropin injection in patients with persistently active SLE despite moderate dose corticosteroids. An open label extension of this study is ongoing. Acthar is approved by the U.S. Food and Drug Administration for use during an exacerbation or as a maintenance therapy in select patients with SLE.

The poster will be presented at the ACR Annual Meeting at 9:00 a.m. Pacific Time on Sunday, November 8, by the lead investigator, Richard A. Furie, M.D. Dr. Furie is Chief of the Division of Rheumatology, Hofstra North Shore LIJ School of Medicine, Great Neck, New York. The abstract is currently available on the ACR website.

About H.P. Acthar Gel (repository corticotropin injection)
H.P. Acthar Gel (repository corticotropin injection), is an injectable drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of 19 indications. Of these 19 indications, the product currently generates substantially all of its net sales from the following on-label indications: the treatment of proteinuria in the nephrotic syndrome of the idiopathic type (NS), the treatment of acute exacerbations of multiple sclerosis (MS) in adults, the treatment of infantile spasms (IS) in infants and children under two years of age, and the treatment of certain rheumatology related conditions, including the treatment of the rare and closely related neuromuscular disorders dermatomyositis and polymyositis. The company is also exploring the possibility of developing other on-label indications and the possibility of pursuing FDA approval of additional indications not currently on the Acthar label where there is high unmet medical need. 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 following may be associated with Acthar: increased susceptibility to infections, hypothalamic-pituitary-axis suppression and adrenal insufficiency, Cushing's Syndrome, elevated blood pressure, salt and water retention and hypokalemia, masking of symptoms of other disorders, gastrointestinal perforation and bleeding, behavioral and mood disturbances, worsening of comorbid diseases, ophthalmic effects, immunogenicity potential, negative effects on growth and physical development, decrease in bone density and embryocidal effect. Patients may need to be monitored for signs and symptoms.
Common adverse reactions for Acthar are similar to those of corticosteroids and include fluid retention, alternation 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.

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

About Mallinckrodt
Mallinckrodt is a global specialty biopharmaceutical and imaging business that develops, manufactures, markets and distributes specialty pharmaceutical products and imaging agents. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

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