CHESTERFIELD, United Kingdom, August 31, 2016 / PRNewswire / – Mallinckrodt plc (NYSE: MNK), a leading specialty pharmaceutical company, today announced that it has completed the acquisition of Stratatech Corporation, a privately-held regenerative medicine company focused on the development of proprietary and proprietary skin replacement products. Development products include StrataGraft® regenerative skin tissue and a technology platform for genetically enhanced skin tissue.
Under by Mallinckrodt Acquire to invest As an operating model, the company will invest to bring this advanced phase 3 development product to patients. If approved, StrataGraft could be the first ‘ready-to-use’ biologic skin replacement product for the treatment of severe burns – Stratatech’s proprietary tissue-engineered technology produces living tissue designed to mimic skin human and promote tissue regeneration. The technology platform offers potential for new products through genetically improved, topically applied tissues that produce high levels of natural wound healing and antimicrobial factors. Phase 1 development is underway in the treatment of diabetic foot ulcers and venous leg ulcers, with other potential applications being investigated.
“We believe this differentiated cell-based medicine technology has the potential to transform the standard of treatment for wound healing,” said Marc Trudeau, CEO and President of Mallinckrodt. “We are excited about these highly sustainable development pipeline additions to our hospital growth business, further diversifying our specialty brand portfolio and delivering value to patients with significant unmet medical needs. ”
StrataGraft is an investigational product in Phase 3 development for the treatment of severe and deep partial thickness burns1, with a US Food and Drug Administration (FDA) approval decision expected by 2020. Phase 2 development of StrataGraft is underway for the treatment of severe full thickness burns2. In 2012, the FDA granted orphan product status to StrataGraft, and the product is under development as a filing biologic under a biologic license application that would provide regulatory protection until 2032. In the United States, approximately 10,000 patients are hospitalized each year for the treatment of severe burns, and the United States market for skin graft products used in this application is estimated to be approximately $ 300 million. Additional opportunities exist internationally, and the acquisition includes rights to the products worldwide.
IN REGARDS TO MALLINCKRODT
Mallinckrodt is a global company that develops, manufactures, markets and distributes specialty pharmaceutical and biopharmaceutical products and therapies, as well as nuclear imaging products. Areas of interest include autoimmune and rare diseases in specialist areas such as neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal intensive respiratory care therapies; analgesics and hemostasis products; and central nervous system drugs. The main strengths of the company include the acquisition and management of highly regulated raw materials and specialized capabilities in chemistry, formulation and manufacturing. The Company’s specialty brands segment includes brand name drugs; its specialty generics segment includes generic specialty drugs, active pharmaceutical ingredients and outsourcing; and the Nuclear Imaging segment comprises nuclear imaging agents. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
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Coleman N. Lannum, CFA
Senior Vice President, Investor Strategy and IRO
Daniel J. Special, CPA
Director, Investor Relations
Senior Communications Officer
Senior Vice-President, Communications and Public Affairs
1 Second degree burns: Burns that impact the dermis
2 Third degree burns: burns that spread to subcutaneous tissue, muscles or bones and often causes extensive scarring
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