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Mallinckrodt and Washington University St. Louis Select First Collaborative Research Endeavor

Press Release from Mallinckrodt Inc

STAINES-UPON-THAMES, United Kingdom, April 11, 2019 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today announced it has selected the first collaborative research endeavor with Washington University School of Medicine in St. Louis, a leader in medical research, teaching and patient care, under the multi-year partnership formed in 2018. This initiative marks the first grant provided by Mallinckrodt as part of the collaboration.

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Scientists from the company and the university are working jointly on this discovery program, aimed at identifying potential new drugs that will target chronic itch. The lack of understanding of chronic itch-specific mediators makes the translational research particularly difficult. Scientists in the Washington University laboratory found a receptor expressed in the spinal cord dorsal horn – a section of the spinal cord containing sensory neurons – and have shown that it functions as an itch-specific receptor. Consequently, novel antagonists identified by the research team that block this receptor could be a potential treatment for patients that suffer from chronic itch.

This research aligns closely with Mallinckrodt's focus on meeting the needs of underserved patients, including those with certain underlying causes of chronic itch such as liver disease and kidney failure. It also supports an important therapeutic area being advanced by scientists at Washington University School of Medicine. The program is expected to run approximately three years, and is designed to deliver lead drug candidates the company could consider for development to address this unmet need.

"We are excited about this initial collaboration with Washington University School of Medicine under our research partnership, and look forward to seeing the results of applying the scientific and research expertise of both organizations to address this condition, often driven by underlying systemic causes," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer. "We have a strong strategic focus on improving outcomes for underserved patients with severe and critical conditions, and hope to find novel therapeutic solutions for patients with these complex clinical needs."

More broadly, the partnership will fund additional promising research projects based on competitive review by a governance committee composed of leaders from both institutions. Mallinckrodt plans to fund two types of grants – program and challenge – while also supporting direct collaboration with Washington University School of Medicine, guided by a joint steering committee with representatives from both parties.

"We are pleased that our collaboration with Mallinckrodt Pharmaceuticals has moved to this next important milestone – the identification of innovative research that shows great potential for bringing novel therapies to patients," said Karen Seibert, PhD, a professor of anesthesiology at Washington University and chair of the joint steering committee. "We look forward to working with Mallinckrodt to identify additional areas of discovery that are aligned with the research interests of both Washington University and the company."

ABOUT MALLINCKRODT
Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's 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. Its Specialty Generics and Amitiza® reportable segment includes specialty generic drugs, active pharmaceutical ingredients and AMITIZA (lubiprostone). To learn more about Mallinckrodt, visit www.mallinckrodt.com.

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CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements concerning the collaboration, including expectations regarding future research plans. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: uncertainties inherent in research and development; satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.

CONTACTS

Media
Daniel Yunger
Kekst CNC
212-521-4879
mallinckrodt@kekstcnc.com

Investor Relations
Daniel J. Speciale, CPA
Vice President, Investor Relations and IRO
314-654-3638
daniel.speciale@mnk.com

Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company.
© 2019 Mallinckrodt. 4/19

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