Healthcare Industry News:  Venous Leg Ulcer 

Regenerative Medicine Mergers & Acquisitions

 News Release - August 11, 2016

Mallinckrodt To Acquire Stratatech Corporation, A Regenerative Medicine Company Focused On Proprietary Therapeutic Human Skin Substitute Products

CHESTERFIELD, United Kingdom, Aug. 10, 2016 -- (Healthcare Sales & Marketing Network) -- Mallinckrodt plc (MNK), a leading global specialty pharmaceutical company, today announced that it has entered into a merger agreement with Stratatech Corporation, a privately held regenerative medicine company focused on the development of unique, proprietary skin substitute products. Developmental products include StrataGraft regenerative skin tissue and a technology platform for genetically enhanced skin tissues. Financial terms of the transaction were not disclosed.

Stratatech's Leading-Edge, Innovative Technology Development Platform

If approved, StrataGraft could be the first biological "off-the-shelf" skin substitute product for treatment of severe burns – 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 painful 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 length1.

The 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 1 development is underway in diabetic foot and Venous Leg Ulcers, with other potential applications under consideration.

"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," said Mark Trudeau, Chief Executive Officer and President of Mallinckrodt. "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."

"Stratatech brings dedicated scientific and development know-how to Mallinckrodt, along with a broad, innovative progenitor keratinocyte2 technology platform," said Lynn Allen-Hoffmann, Chief Executive Officer of Stratatech. "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. This could offer utility in a number of skin injury settings beyond burns."

StrataGraft Development and Severe Burn Market

StrataGraft is an investigational product in Phase 3 development for treatment of severe, deep partial thickness burns3, with a U.S. Food and Drug Administration (FDA) approval decision anticipated by 2020. Phase 2 development of StrataGraft is underway for treatment of severe, full thickness burns4. 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.

Source: Mallinckrodt

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