Mallinckrodt Receives FDA Fast-Track Designation for Synacthen® Depot IND Application

CHESTERFIELD, United Kingdom, Aug. 25, 2016 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has granted the company's request for a Fast Track designation for its Investigational New Drug (IND) application for Synacthen^® Depot in the 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.

"We are pleased with the FDA's determination that our IND application for use of Synacthen Depot in treatment of Duchenne muscular dystrophy meets the agency's established criteria for a Fast Track designation, and are happy to report the first patients have been dosed in the initial phase 1 trial," said Steven Romano, M.D., Senior Vice President and Chief Scientific Officer. "DMD is a devastating disease for which there are few effective treatment options, and Mallinckrodt believes Synacthen Depot may have potential to offer physicians and patients a new alternative." 

The agency's Fast Track designation is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions¹.

About 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.²

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, pulmonology and ophthalmology; 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]

Daniel J. Speciale, CPA
Director, Investor Relations
314-654-3638
[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 http://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm
² https://www.mda.org/disease/duchenne-muscular-dystrophy (Accessed August 21, 2016)

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SOURCE Mallinckrodt plc