STAINES-UPON-THAMES, United Kingdom — Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today celebrated the completion of its expanded operations and manufacturing facility for the investigational StrataGraft® regenerative skin tissue, in Madison, Wis. Stratatech, a Mallinckrodt company, recently completed patient enrollment in its ongoing pivotal Phase 3 clinical trial, which is evaluating the efficacy and safety of StrataGraft in the promotion of autologous skin regeneration of complex skin defects due to severe thermal burns that contain intact dermal elements (also known as deep partial-thickness burns). The safety and effectiveness of StrataGraft have not yet been established by the U.S. Food and Drug Administration (FDA).

The 35,000-square-foot facility provides the necessary capacity to develop and manufacture StrataGraft regenerative skin tissue for both clinical trials and commercial availability, if approved by the FDA. The state-of-the-art facility offers a fully sterile environment for manufacturing, with controlled temperature, humidity and constant carbon dioxide levels. It also features biosafety cabinets, incubators, freezers, a quality control lab and a warehouse for shipping.

“The expansion of our StrataGraft regenerative skin tissue manufacturing facility and enrollment of the final patient in our pivotal Phase 3 trial represent important milestones in the development of this investigational therapy, which we hope to bring to patients with severe burns as a paradigm-changing treatment,” said Mark Trudeau, President and Chief Executive Officer of Mallinckrodt. “Initially developed in Madison, StrataGraft has benefited from public/private efforts to advance its development both in Wisconsin and through a partnership with BARDA1, including this new facility. This underscores the power of these partnerships in translating important scientific discoveries into innovative therapies that can positively impact patients in need. We are proud to be part of the Madison community, an excellent place to develop and manufacture highly innovative therapies.”

The celebration featured a ribbon-cutting ceremony with remarks by Wisconsin Gov. Tony Evers; U.S. Rep. Mark Pocan (D-Wis.); Mr. Trudeau; Steven Romano, M.D., Executive Vice President and Chief Scientific Officer of Mallinckrodt; B. Lynn Allen-Hoffmann, Ph.D., Senior Vice President, Regenerative Medicine, of Mallinckrodt; and Aaron Olver, Managing Director, University Research Park. Distinguished guests in attendance included Deputy Secretary Tricia Braun from the Wisconsin Economic Development Corporation; state Rep. Shelia Stubbs (D-Madison); University of Wisconsin Chancellor Rebecca Blank; representatives from University Research Park; a burn patient; and other Mallinckrodt leaders. Attendees were invited to participate in tours of the facility, and learn more about the current standard of care and the need for new options for burn treatment.

“Our motto in Wisconsin is Forward, which speaks to our continuous efforts to drive forward and succeed,” explained Gov. Evers. “The opening of this facility is a solid example of this, and we are proud Wisconsin can play a role in driving forward scientific innovation that can positively impact patients in need.”

“It’s exciting that Madison has become a life science hub, and the investment of significant resources to expand the manufacturing facility here is a testament to that,” said U.S. Rep.  Pocan. “With Mallinckrodt as a life sciences partner, we can continue advancing our scientific understanding and strengthening Wisconsin’s position as a leader in technology and innovation.”

Mallinckrodt anticipates submitting a Biologics License Application in 2020 with the FDA if data from the Phase 3 trial of StrataGraft regenerative skin tissue is supportive. The FDA has granted StrataGraft orphan drug status, and it was among the first products designated by the Agency as a Regenerative Medicine Advanced Therapy under the provisions of the 21st Century Cures Act.

Mallinckrodt’s long-standing presence in Madison also includes its critical care device manufacturing facility.

About StrataGraft Regenerative Skin Tissue
StrataGraft is an engineered, bilayer human skin substitute in development for patients with severe burns or other complex skin defects. Designed to mimic natural human skin with both inner dermis-like and outer epidermis-like layers, StrataGraft is being developed to be sutured, stapled or secured with an adhesive and initially provide coverage during the wound healing process. StrataGraft tissues are cryopreserved in order to deliver viable cells upon application.

StrataGraft regenerative skin tissue is an investigational product. The safety and effectiveness of StrataGraft have not yet been established by the FDA.

StrataGraft regenerative skin tissue is produced using Near-Diploid Immortal Keratinocytes (NIKS®) cells and human dermal fibroblasts grown in accordance with current Good Manufacturing Practice. StrataGraft tissue, as well as the NIKS cells and dermal fibroblasts, have been thoroughly characterized, helping to ensure consistent delivery of tissue that is virus-free, non-tumorigenic, and consistent genetically batch-to-batch.

In addition to the Phase 3 trial, the company is evaluating StrataGraft in an ongoing Phase 2 trial for the treatment of adults with full-thickness complex skin defects resulting from burns and select other etiologies. There are also plans to study the safety and efficacy of StrataGraft in pediatric populations.

Funding and technical support for the development of StrataGraft regenerative skin tissue is being provided by the Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response, within the U.S. Department of Health and Human Services, under Project BioShield Contract No. HHSO100201500027C. These efforts are part of BARDA’s strategy to build emergency preparedness in response to mass casualty events involving trauma and thermal burns by developing novel medical countermeasures for adult and pediatric populations. In the case of a mass casualty thermal burn event, the Government Accountability Office estimates that more than 10,000 patients might require thermal burn care.2 The limited number of specialized burn centers and related medical infrastructure in the U.S. creates a public health need for therapies that could be deployed quickly for use in these and other care sites.

About Serious Thermal Burns Containing Intact Dermal Elements
Serious thermal burns containing intact dermal elements, also known as deep partial-thickness burns, are complex skin injuries in which the entire epidermis and more than two-thirds of the dermis are destroyed.

Current standard of care for severe acute complex skin wounds often involves the surgical harvesting of healthy skin tissue from an uninjured site on the patient and transplanting the autologous skin graft to the injury. 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. Donor site wounds are extremely painful and can create risks of additional scarring and infection. 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 acute complex skin defects.

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 StrataGraft regenerative skin tissue, including expectations with regard to manufacturing capabilities, related clinical data and regulatory filings, its potential impact on patients, and anticipated benefits associated with its use. 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: clinical trial results; 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.

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As posted by CISION PR Newswire on April 24, 2019