Mallinckrodt plc MNK announced that Stratatech (acquired in 2016) 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 funding is expected to support pediatric studies of StrataGraft skin tissue in thermal burns. The additional funding was effective Sept 29, 2018.
StrataGraft is a viable, engineered, bilayer human skin substitute being developed for severe burns and other complex skin defects.
We note that BARDA is supporting the development of StrataGraft as a potential medical countermeasure for large-scale burn incidents. The agency had earlier granted funding to support phase III 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).
The additional funding will bring the total to approximately $86 million with potential future funding of $160 million.
StrataGraft was among the first products designated as Regenerative Medicine Advanced Therapy (RMAT) by the U.S. Food and Drug Administration (FDA) under the provisions of the 21st Century Cures Act.
Ongoing pricing pressure and competition has affected most players in the industry like Mylan MYL, among others. Mallinckrodt is striving hard to revive its product portfolio/pipeline. The company sold a portion of its hemostasis business, inclusive of its PreveLeakSurgical Sealant and Recothrom Thrombin topical products to Baxter International, Inc. BAX for approximately $185.0 million. The company had acquired these products from The Medicines Co. MDCO.
The company is currently streamlining its business to focus better on its innovative medicines and therapies like terlipressin and StrataGraft. A tentative approval will boost growth prospects.
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