Mallinckrodt Submits Investigational New Drug Application for Synacthen® Depot

CHESTERFIELD, United Kingdom, June 13, 2016 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty biopharmaceutical company, today announced it has submitted an Investigational New Drug (IND) application for Synacthen^® Depot to the U.S. Food and Drug Administration (FDA). The company will pursue an indication for the drug in treatment of Duchenne muscular dystrophy (DMD). Synacthen Depot is a depot formulation of Synacthen (tetracosactide), a synthetic 24 amino acid melanocortin receptor agonist. Synacthen Depot is approved and marketed outside of the U.S. for certain autoimmune and inflammatory conditions, but has never been approved for use in patients in the U.S.

Mallinckrodt has invested substantially in the research program, including completing the pre-clinical work necessary to support its IND application filing, and in transferring and updating manufacturing processes for the product. Mallinckrodt remains committed to bringing this treatment option to patients suffering from this disease, and to working closely with the FDA. 

"This IND filing is a critical step toward FDA approval of Synacthen Depot in the U.S. and a significant milestone for our organization," said Steven Romano, M.D., Senior Vice President and Chief Scientific Officer. "Mallinckrodt is committed to investing in reaching underserved patient populations with medicines that provide effective treatment in areas of high unmet medical need. We believe Synacthen Depot may have potential to offer physicians and patients a new alternative for this devastating disease that has very few existing treatment options." 

Mallinckrodt's recent progress with Synacthen Depot exemplifies the company's commitment to innovation, and the company expects continued significant R&D investments in Synacthen Depot as this development program progresses.   

About Duchenne Muscular Distrophy
Duchenne muscular dystrophy (DMD) is a genetic disorder characterized by progressive muscle degeneration and weakness. It is one of nine types of muscular dystrophy.

DMD is caused by an absence of dystrophin, a protein that helps keep muscle cells intact. Symptom onset is in early childhood, usually between ages 3 and 5. The disease primarily affects boys, but in rare cases it can affect girls. Symptoms include muscle weakness, which can begin as early as age 3, first affecting the muscles of the hips, pelvic area, thighs and shoulders, and later the skeletal (voluntary) muscles in the arms, legs and trunk.[1]

About Mallinckrodt
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical and biopharmaceutical products and therapies, as well as nuclear imaging products. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; analgesics and hemostasis products; and central nervous system drugs. 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; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing; and the Nuclear Imaging segment includes nuclear imaging agents. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

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CONTACTS
Investor Relations
Coleman N. Lannum, CFA
Senior Vice President, Investor Strategy and IRO
314-654-6649
[email protected]

Media
Rhonda Sciarra
Senior Communications Manager
314-654-8618
[email protected]

Meredith Fischer
Senior Vice President, Communications and Public Affairs
314-654-3318
meredith.fischer@mallinckrodt

[1] https://www.mda.org/disease/duchenne-muscular-dystrophy (Accessed June 3, 2016)

SOURCE Mallinckrodt Pharmaceuticals

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