- UK-based drug and medical device company, Mallinckrodt, has agreed to buy Stratatech, which has a therapeutics human skin biologic product, dubbed Stratagraft, in Phase 3 development for treatment of severe burns.
- StrataGraft is a first-in-class biologic that was given orphan drug status by the Food and Drug Administration in 2012. Approval is anticipated for 2020, and (assuming StrataGraft is approved) Mallinckrodt could have regulatory exclusivity extending out through 2032. The severe burn market is worth roughly $300 million.
- Founded in 2001, Stratatech is a privately held company based in Madison, Wisconsin.
"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. We believe Stratatech's technology has the potential to transform the standard of treatment for wound care," said Mallinckrodt CEO Mark Trudeau.
The company's "Acquire to Invest" strategy has led it to make a number of significant acquisitions in the last two years, with the goal of bringing late-stage assets and under-resourced, already-approved therapies into the company's portfolio. Mallinckrodt is widely diversified with specialty and generic products, as well as hospital supplies and rare-disease therapies.
Within the last two years alone, this Chesterfield, UK-based company has acquired Cadence, Questcor Pharma, Ikaria, Therakos, Ofiriview—and now Stratatech. The latest deal will add to Mallinckrodt's hospital portfolio and give the company technology in genetically-enhanced skin tissue. Beyond fitting into the existing portfolio, StrataGraft has the potential to change the standard-of-care for people with third-degree burns, which typically require multiple autologous skin grafts harvested from the patient, resulting in numerous surgeries and hospitalizations, said the company.
Each year, 10,000 people are hospitalized for severe burns. Applications for StrataGraft include both civilian and military uses, which is one reason that the U.S. Department of Health and Human Services and the Biomedical Advanced Research and Development Authority (BARDA) have been involved in product development.
Financial terms of the deal were not disclosed but cover worldwide rights to the product. Stratagraft is also in Phase I development for diabetic foot and venous leg ulcers.