Mallinckrodt Completes Stannsoporfin NDA Filing

STAINES-UPON-THAMES, United Kingdom, Jan. 4, 2018 /PRNewswire/ -- Mallinckrodt (NYSE: MNK), a leading global specialty pharmaceutical company, today announced it has successfully completed the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) to seek approval of its recently acquired developmental product stannsoporfin. If approved, the drug is expected to become the first and only pharmacologic option in the U.S. indicated for treatment of neonates at risk for developing severe hyperbilirubinemia, or severe jaundice.

“We are pleased to complete this important milestone for stannsoporfin,” said Steve Romano, M.D., Chief Scientific Officer and Executive Vice President of Mallinckrodt. “This brings us one step closer to addressing an unmet need for therapies to treat thousands of infants at risk for severe jaundice, and we look forward to working closely with the FDA toward the goal of obtaining approval of stannsoporfin to treat this population.”

ABOUT SEVERE HYPERBILIRUBINEMIA AND STANNSOPORFIN
In the U.S., the total number of term births is estimated at 3.97 million per year^1,2 and, of those, approximately 750,000³ infants are treated for jaundice. Of those treated, some may be unresponsive to phototherapy - the current standard of care - even with extended and repeated courses of the treatment⁴, and patients face the risk of developing severe jaundice prior to discharge. A small percentage of full-term infants may experience elevated bilirubin levels after discharge and be at risk of severe jaundice⁵, requiring hospital readmission. The combined potential patient treatments required annually in the U.S. for severe jaundice is approximately 70,000 to 125,000.

Stannsoporfin, a heme oxygenase inhibitor, is under investigation for its potential to reduce the production of bilirubin. The safety and effectiveness of stannsoporfin have not yet been established by FDA. If approved, stannsoporfin is expected to be used for late-preterm and full-term infants at risk of developing complications associated with severe jaundice.

ABOUT MALLINCKRODT
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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CONTACTS

Media
Rhonda Sciarra
Senior Communications Manager
908-238-6765
rhonda.sciarra@mallinckrodt.com

Meredith Fischer
Chief Public Affairs Officer
314-654-3318
meredith.fischer@mallinckrodt.com

Investor Relations
Coleman N. Lannum, CFA
Senior Vice President, Investor Strategy and IRO
314-654-6649
cole.lannum@mallinckrodt.com

Daniel J. Speciale, CPA
Director, Investor Relations
314-654-3638
daniel.speciale@mallinckrodt.com

¹ https://www.cdc.gov/nchs/data/databriefs/db258.pdf
² https://www.cdc.gov/nchs/nvss/births.htm
³ HCUP (Healthcare Cost and Utilization Project) KID Data
⁴ Mallinckrodt market research/management projections
⁵ http://pediatrics.aappublications.org/content/early/2013/04/03/peds.2012-2634

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SOURCE Mallinckrodt plc