Clinical study data on Mallinckrodt's H.P. Acthar Gel to be presented at ACR 2015

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. A 44-week open label extension of this study is ongoing and expected to be completed later this year. 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 (lupus).

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.

"We are pleased that Dr. Furie will share the first results of our pilot study on the effects of Acthar in patients with this challenging disease at the upcoming ACR Annual Meeting," said Steven Romano, M.D., Senior Vice President and Chief Scientific Officer of Mallinckrodt. "Mallinckrodt is focused on completing this important clinical study to determine the benefits of Acthar for lupus patients who often have exhausted other good therapeutic options for this difficult-to-treat condition."


Mallinckrodt plc


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