Mallinckrodt To Acquire Regenerative Medicine CompanyBy
Mallinckrodt, a specialty pharmaceutical company, has agreed to acquire Stratatech Corporation, a privately held regenerative medicine company focused on skin-substitute products. Financial terms were not disclosed.
Stratech’s developmental products include StrataGraft regenerative skin tissue and a technology platform for genetically enhanced skin tissues. If approved, StrataGraft could be the first biological “off-the-shelf” skin substitute product for treatment of severe burns, according to the companies. It is in Phase III development for treating severe, deep partial thickness burns with a U.S. Food and Drug Administration (FDA) approval decision anticipated by 2020. Phase II development of StrataGraft is underway for treatment of severe, full thickness burns. In 2012, the FDA granted StrataGraft orphan product status, and the product is being developed as a biologic to be filed under a BLA that would confer regulatory protection until 2032.
Stratatech’s proprietary tissue-engineering technology produces living tissues designed to mimic human skin and promote tissue regeneration. The current standard of care for second- and third-degree burns requires autograft, the harvesting of a patient’s tissue from an uninjured area to graft into another burned area. Severe burns can frequently cause extensive scarring, create multiple channels for infection risk and may result in multiple surgeries, all of which lead to hospitalizations of highly variable, unspecified length, according to the companies. If approved, Mallinckrodt expects the products to be commercialized by the company’s existing hospital-focused organization.
The company’s technology platform provides potential for new products through genetically enhanced tissues, applied topically, that produce elevated levels of natural wound healing and antimicrobial factors. Phase I development is underway in diabetic foot and venous leg ulcers, with other potential applications under consideration.
Stratatech is currently executing two contracts that support advanced development including manufacturing, clinical studies, and eventual product procurement by the US Department of Health and Human Services, Office of Assistant Secretary for Preparedness and Response, and the Biomedical Advanced Research and Development Authority (BARDA). Under the terms and conditions of the contract with BARDA, Mallinckrodt is required to continu execution of all contractual obligations. Stratatech also has independent contracts with the US Department of Defense covering other aspects of product development.
The acquisition is subject to customary terms and conditions, Mallinckrodt anticipates the transaction will close in the second half of calendar 2016.