Mallinckrodt to buy Stratatech


A regenerative medicine company focused on human skin substitutes

Mallinckrodt, a global speciality pharmaceutical company, is to acquire Stratatech, a privately held regenerative medicine company developing skin substitute products.

No financial details have been revealed.

Stratatech's products include StrataGraft, a regenerative skin tissue and technology for genetically enhanced skin tissues.

This a Phase III investigational product for the treatment of severe burns.

It mimics key attributes of human skin and reduces the need for a skin graft.

The product is to be submitted under FDA Biologic License Application (BLA). If approved, StrataGraft would carry regulatory exclusivity to 2032.

It received FDA orphan designation in 2012.

StrataGraft could be the first biological 'off-the-shelf' skin substitute product for the treatment of severe burns, if validated, said Mallinckrodt.

Stratatech's tissue engineering technology provides potential for new products through genetically enhanced tissues, applied topically, that produce elevated levels of natural wound healing and antimicrobial factors.

Phase 1 development is underway in diabetic foot and venous leg ulcers, with other potential applications under consideration.

Mark Trudeau, Chief Executive Officer and President of Mallinckrodt, said. '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 expertise in cell-based, differentiated regenerative medicine to Mallinckrodt's research team.'

Lynn Allen-Hoffmann, Chief Executive Officer of Stratatech, added: 'In our next phase of development, the unique cell line used to produce living tissue in StrataGraft can also be genetically modified to potentially increase production of a variety of factors to support and promote wound healing, such as antimicrobial and vascular endothelial growth factors.'

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This could be used in a number of skin injury settings beyond burns, she said.