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.
By Alyssa Huntley
Source: Fierce Biotech
Thermo Fisher Scientific has acquired Novasep’s viral vector manufacturing business in Belgium, Henogen, for about €725m ($874.5m) in cash. Henogen offers biotechnology firms, as well as biopharma customers contract manufacturing services for vaccines and therapies.
Research and development group of Eli Lilly and Company, Loxo Oncology at Lilly, and clinical-stage oncology company Merus have announced a research collaboration and exclusive license agreement to develop T-Cell re-directing bispecific antibodies.
Chinese cancer biotech Adagene has filed to raise up to $125 million in a Nasdaq IPO. The listing will give Adagene the means to run early-phase clinical trials of antibodies against CD137 and CTLA-4.