News Release

U.S. FDA Designates Mallinckrodt's StrataGraft® as Regenerative Medicine Advanced Therapy

-- Provides Potential for Priority Review and Accelerated Approval under 21st Century Cures Act --

STAINES-UPON-THAMES, United Kingdom, July 18, 2017 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today announced that StrataGraft® regenerative skin tissue is among the first products to be designated as a Regenerative Medicine Advanced Therapy (RMAT) by the U.S. Food and Drug Administration (FDA) under the provisions of the 21st Century Cures Act. The company's investigational, tissue-based therapy is currently under evaluation in a Phase 3 trial to assess its efficacy and safety in the promotion of autologous skin regeneration of complex skin defects due to thermal burns that contain intact dermal elements (also known as deep partial thickness burns).  

Passed in 2016, the 21st Century Cures Act allows the FDA to grant accelerated review approval to products that meet certain criteria.  A product may receive an RMAT designation if the drug is1:

  • defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products;
  • intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and
  • preliminary clinical evidence indicates the drug has the potential to address unmet medical needs for such disease or condition.

"We are very pleased the FDA has determined StrataGraft meets the criteria for RMAT designation, as this offers the possibility of priority review and/or accelerated approval," said Steven Romano, M.D., Chief Scientific Officer and Executive Vice President, Mallinckrodt. "This provides the potential to bring a much-needed therapeutic option to patients even sooner than originally planned."

The RMAT designation allows for earlier and increased interactions with the FDA, including discussions of whether priority review and/or accelerated approval would be appropriate based on surrogate or intermediate endpoints that would be reasonably likely to predict long-term clinical benefit; or reliance upon data obtained from a meaningful number of sites. Once approved, when appropriate, the FDA can require various post-approval commitments.2

"RMAT designation of StrataGraft skin tissue speaks to the strength of the clinical data generated during the prior clinical study," said Lynn Allen-Hoffmann, Senior Vice President, Regenerative Medicine, Mallinckrodt. "Mallinckrodt is committed to developing advanced regenerative medicine therapies such as StrataGraft for patients with serious conditions."

Find more information about the ongoing StrataGraft Phase 3 clinical trial here on the website. Prior clinical study details can be seen here. This project has been funded in part with federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Contracts No. HHSO100201300017C and HHSO100201500027C. BARDA is supporting the development of StrataGraft tissue as a potential medical countermeasure for large-scale burn incidents.

About Serious Thermal Burns Containing Intact Dermal Elements
Deep partial-thickness burns are complex skin injuries where the entire epidermis and more than two thirds of the dermis is destroyed. The treatment for severe complex skin wounds with substantial loss of the dermis such as deep partial-thickness burns is the surgical harvesting of a sheet of healthy skin from an uninjured site on the patient and transplantation of this autologous skin graft to the injury once the wound is ready to receive an autograft. While this process can be effective in providing closure of the original wound, it has significant limitations related to the donor site wounds created during surgical removal of autologous skin tissue for grafting. These donor site wounds are extremely painful, prone to infection and scarring, and can themselves convert to full-thickness wounds that must then be managed to promote healing. In addition, the amount of healthy skin available for harvesting is frequently limited in large burns, necessitating sequential re-harvesting of available donor sites. As a result, there is an urgent need for alternatives to donor site harvesting for treatment of severe burns and other complex skin defects.

About StrataGraft Regenerative Skin Tissue
StrataGraft regenerative skin tissue is a viable, full-thickness product being developed for severe burns and other complex skin defects that is not yet approved by the U.S. Food and Drug Administration. It was designed to mimic natural human skin, with both dermal and fully differentiated epidermal layers. Unlike first generation products, StrataGraft skin tissue can be sutured, stapled or secured with an adhesive and remains intact in the wound bed, providing critical barrier functionality during the wound healing process. StrataGraft skin tissue is produced using NIKS® cells grown in accordance with Good Manufacturing Practice. Because the continuous NIKS skin cell line has been thoroughly characterized, StrataGraft tissue is virus-free, non-tumorigenic, and offers batch-to-batch genetic consistency.

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

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Investor Relations      
Coleman N. Lannum, CFA
Senior Vice President, Investor Strategy and IRO

Daniel J. Speciale, CPA
Director, Investor Relations

Rhonda Sciarra
Senior Communications Manager

Meredith Fischer
Chief Public Affairs Officer


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SOURCE Mallinckrodt Pharmaceuticals