Mallinckrodt's Stratatech Company Awarded $26 Million in Additional BARDA Funding for Pediatric Studies of StrataGraft® Skin Tissue in Thermal Burns

-- Award Continues Collaboration to Bring Therapy to Burn Patients with High Unmet Need --

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Oct 15, 2018, 06:45 ET

STAINES-UPON-THAMES, United Kingdom, Oct. 15, 2018 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today announced that Stratatech, a Mallinckrodt company, was awarded approximately $26 million in additional Project BioShield funding by the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response. The latest award will provide support for pediatric studies related to the company's StrataGraft^® viable, engineered skin tissue. The additional funding was effective Sept. 29, 2018.

Mallinckrodt is committed to developing new therapies for the pediatric population worldwide. BARDA is supporting the development of StrataGraft as a potential medical countermeasure for large-scale burn incidents. BARDA has previously allocated funding to Stratatech to support its Phase 3 trial in adults to assess StrataGraft's 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). With this additional award, funding under this program is approximately $86 million with potential future funding of $160 million.

The company's investigational therapy was among the first products designated as a Regenerative Medicine Advanced Therapy (RMAT) by the U.S. Food and Drug Administration (FDA) under the provisions of the 21^st Century Cures Act[1].

"We are very pleased that BARDA has continued to see the potential benefit StrataGraft can bring as a much-needed therapeutic option for patients – both adults and children – with high unmet medical need," said Steven Romano, M.D., Chief Scientific Officer and Executive Vice President, Mallinckrodt. "This is particularly important in the event of tragic mass burn incidents. The expanded partnership with BARDA to assess StrataGraft's efficacy and safety in the vulnerable pediatric population is aligned with Mallinckrodt's focus on improving outcomes for patients with severe and critical conditions in particularly vulnerable 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. Successful approval by the FDA would position StrataGraft for deployment as a medical countermeasure.

Find more information about the ongoing StrataGraft Phase 3 clinical trial here on the ClinicalTrials.gov website.

The program's funding is being provided under BARDA Project BioShield Contract HHSO100201500027C.

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 is a viable, engineered, bilayer human skin substitute being developed for severe burns and other complex skin defects that is not yet approved by the FDA. It was designed to mimic natural human skin, with both an inner dermis-like and outer epidermis-like layers. StrataGraft skin tissue is designed to be sutured, stapled or secured with an adhesive and to initially provide a barrier function 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.

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; analgesics and gastrointestinal products. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements concerning StrataGraft including expectations with regard to future research plans, regulatory actions and potential impact on patients. 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: 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; future commercialization efforts; 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
Investor Relations
Daniel J. Speciale, CPA
Investor Relations and Strategy Officer
314-654-3638
[email protected]

Media
Rhonda Sciarra
Senior Communications Manager
908-238-6765
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Meredith Fischer
Chief Public Affairs Officer
908-997-9294
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Mallinckrodt, the "M" brandmark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. © 2018 Document #US-1800444

¹ 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 is 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. https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm537670.htm, accessed Sept. 23, 2018.
² https://www.gao.gov/assets/590/588738.pdf

SOURCE Mallinckrodt plc