Mallinckrodt, a specialty pharma company, announced a merger agreement with Stratatech, a regenerative medicine company. Financial terms were not disclosed, though the acquisition does include worldwide product rights.
Stratatech focuses on proprietary skin substitute products. It’s StrataGraft tech, when approved, will be the first “off-the-shelf” skin substitute that could be used to treat severe burns. Stratatech uses proprietary tissue engineering tech which creates living tissue. That tissue mimics human skin and promotes tissue regeneration.
Autograft--the current standard care for those suffering second- and third-degree burns--is painful and requires harvesting uninjured tissue from an uninjured area. That tissue is grafted to the burned area.
“The [StrataGraft] technology platform provides potential for new products through genetically enhanced tissues, applied topically, that produce elevated levels of natural wound healing and antimicrobial factors,” Mallinckrodt explained in the announcement.
Mark Trudeau, the CEO and president of Mallinckrodt, noted that this acquisition will boost Mallinckrodt’s hosptial growth business.
"The addition of this highly durable, cutting-edge development portfolio and technology platform to our hospital growth business is an excellent example of Mallinckrodt's Acquire to Invest strategy," Trudeau said in the announcement. "We believe Stratatech's technology has the potential to transform the standard of treatment for wound care. Additionally, the acquisition will bring world-class Stratatech researchers with deep expertise in cell-based, differentiated regenerative medicine to Mallinckrodt's research team."
StrataGraft is currently an investigational product in Phase III development for the treatment of severe, deep partial thickness burns. It is expected that the FDA will have an approval decision by 2020.
The FDA gave StrataGraft orphan product status in 2012. The product is being developed as a biologic and would be filed under a BLA. This would offer regulatory protection until 2032.
Stratatech is also working under two contracts, one with the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, and the Biomedical Advanced Research and Development Authority (BARDA). Mallinckrodt will be required to continue seamless execution of all contractual obligations per the agreement with BARDA. These contracts will help advance development in manufacturing, clinical studies and product procurement with the two agencies.
Stratatech has independent agreements with the U.S. Department of Defense.
- here's the press release
Stratatech nabs $247M BARDA contract for skin tissue device