Mallinckrodt Announces Acceptance of U.S. FDA Filing Biologics License Application for StrataGraft® Regenerative Skin Tissue for the Treatment of Adults with Deep Partial Thickness Thermal Burns

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STAINES-UPON-THAMES, UK, Aug 10, 2020 / PRNewswire / – Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced that the United States Food and Drug Administration (FDA) has accepted the review of the Stratatech (BLA) Biologics License Application for StrataGraft®, an experimental skin tissue regenerative therapy in development for the treatment of adult patients with deep partial thickness thermal burns. The FDA prioritized review of the application and set the Prescription Drug User Fee Act (PDUFA) target date of February 2, 2021.

Autologous transplantation, the current standard of care for deep partial thickness thermal burns, involves the surgical removal of healthy skin from an uninjured site on the patient and transplantation of the skin graft to the injury. , leaving the patient with more injured areas requiring care. Each year, approximately 40,000 patients in the United States require hospitalization for the treatment of severe burns.1 The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services (HHS), has expressed interest in StrataGraft skin tissue as a medical countermeasure in response to large scale burns and provided funding and technical support for the continued development of StrataGraft skin tissue.

“Advances in treatment are needed to help minimize or eliminate the need for autologous transplants. FDA Acceptance of BLA Submission for StrataGraft Skin Tissue Examination Brings Us One Step Closer to Providing Adult Burn Patients in United States with a potential new treatment option for deep thermal partial thickness burns, ”said Steven romano, MD, Executive Vice President and Scientific Director of Mallinckrodt. “We are focused on providing solutions to patients with severe and critical medical conditions, and we look forward to working with the FDA during the StrataGraft skin tissue regulatory review process. “

StrataGraft Skin Tissue BLA is based on Phase 3 pivotal data STRATES2016 clinical trial, previously published as summarized in the Journal of Burn Care & Research and presented via pre-recorded video at the American Burn Association Virtual 52sd Annual meeting, with the support of the STRATA2011 clinical trial, previously published in Burns. The first results of the Phase 3 StrataGraft skin tissue trial, which met the two primary endpoints in adults with deep partial thickness thermal burns, including autograft preservation and closure lasting wound, have been announcement in September 2019.

The completion of BLA’s continuous submission was announcement to June 9, 2020. The FDA granted StrataGraft Orphan Drug Designation for Skin Tissue, and it was among the first products designated by the Agency as Advanced Therapy in Regenerative Medicine (RMAT) under the provisions of the 21st Century Cures Act. .

About StrataGraft
StrataGraft Regenerative Skin Tissue is an investigational treatment in development to reduce autografting in patients with severe thermal burns. An engineered bilayer tissue, StrataGraft Skin Tissue is designed to mimic natural human skin with inner dermis-like and outer epidermis-like layers. StrataGraft skin tissue can be sutured, stapled, or secured with an adhesive. StrataGraft skin tissue is cryopreserved to provide viable cells upon application.

Mallinckrodt is currently conducting a continuous access clinical trial for StrataGraft skin tissue (StrataCAT, NCT04123548) as part of an Expanded Access Program (EAP). Trial sites involved in the pivotal phase 3 trial (STRATA2016, NCT03005106) have the opportunity to participate in this open-label, multi-center study. The company plans to evaluate StrataGraft skin tissue for the treatment of adults with full-thickness burns (also known as third-degree burns). Besides, Mallinckrodt plans to conduct a study evaluating StrataGraft skin tissue in the treatment of pediatric populations.

StrataGraft Skin Tissue is an investigational product, and its safety and efficacy have not yet been established by the FDA.

Further development of StrataGraft skin tissue, including the pivotal Phase 3 clinical study (STRATA2016) and BLA process for StrataGraft skin tissue in United States, is supported by a partnership with BARDA, under the direction of the Assistant Secretary of Preparedness and Response, in the US Department of Health and Human Services, under Project BioShield contract # HHSO100201500027C. These efforts are part of BARDA’s strategy to strengthen emergency preparedness in response to mass casualty events involving trauma and thermal burns by developing new medical countermeasures for adult and at-risk populations. In the event of a severe thermal burn event, the Government Accountability Office estimates that more than 10,000 patients may require thermal burn care.2 The limited number of specialized centers for serious burns and related medical infrastructures in United States creates a public health need for therapies that could be rapidly deployed for use in these and other healthcare sites.

About Deep Partial Thickness Thermal Burns
Partial-thickness deep thermal burns are complex skin lesions in which the damage extends to the entire epidermis (outermost layer of the skin) and to the lower part of the dermis (innermost layer of the skin) .

The autograft is considered the standard of care by many for deep thermal partial thickness burns. It involves the surgical removal of healthy skin tissue from an uninjured site on the patient and the transplantation of the skin graft to the injury. While this process may be effective in ensuring closure of the original wound, it has significant limitations related to donor site wounds created during the surgical removal of skin tissue for grafting. Donor site wounds are painful and can create additional scarring and infection risks. In addition, the amount of healthy skin available for harvesting is frequently limited in patients with severe burns, requiring sequential re-sampling from available donor sites. Accordingly, there is a need for alternatives to donor site harvesting for the treatment of severe burns.

On Mallinckrodt
Mallinckrodt is a global company made up of several wholly owned subsidiaries that develop, manufacture, market and distribute pharmaceuticals and specialty therapies. The areas of focus of the Company’s specialty brands reportable segment include autoimmune and rare diseases in specialty areas such as neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal intensive respiratory care therapies; analgesics and gastrointestinal products. Its specialty generics reportable segment includes generic specialty drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

Mallinckrodt uses its website as a channel for distributing important company information, such as press releases, investor presentations, and other financial information. It also uses its website to expedite public access to urgent information about the company before or instead of distributing a press release or filing with the United States Securities and Exchange Commission (SEC) disclosing the same information. . Therefore, investors should visit the Investor Relations page of the website for important and urgent information. Visitors to the website can also sign up to receive an automatic email and other notifications alerting them when new information becomes available on the website’s Investor Relations page.

Cautions Regarding Forward-Looking Statements
This release includes forward-looking statements regarding StrataGraft Regenerative Skin Tissue, including the intended regulatory review process, its potential impact on patients, and the expected benefits associated with its use. Statements are based on assumptions about many important factors, including the following, that could cause actual results to differ materially from those of forward-looking statements: meeting regulatory and other requirements; actions of regulators and other government authorities; changes in laws and regulations; problems with the quality, manufacture or supply of the product, or patient safety issues; and other risks identified and described in more detail in the “Risk Factors” section of by Mallinckrodt the most recent annual report on Form 10-K and other documents filed with the SEC, all available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt assumes no 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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© 2020 Mallinckrodt. US-2001226 07/20/20.

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1 American Burn Association. Fact sheet on the incidence of burns. http://ameriburn.org/who-we-are/media/burn-incidence-fact-sheet/. Accessed May 15, 2020.
2 United States Government Accountability Office. National preparation: countermeasures for thermal burns. https://www.gao.gov/assets/590/588738.pdf. Accessed February 12, 2020.

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