SAN DIEGO, September 5, 2012-Shire plc (LSE: SHP, NASDAQ: SHPG), today announced that its lead regenerative medicine product, DERMAGRAFT (human fibroblast-derived dermal substitute) has received regulatory approval from Health Canada as a class IV medical device for the treatment of diabetic foot ulcers (DFUs), a complication of diabetes.
This approval gives Shire Regenerative Medicine the potential to extend availability of DERMAGRAFT to people with DFUs beyond the U.S., where it is currently available, and is an important first step for the company as it continues to develop its international expansion strategy.
"We're thrilled to have the opportunity to bring DERMAGRAFT to Canada, as we believe it plays an important role in the treatment of DFUs," said Matt Pauls, Vice President of Global Commercial Operations for Shire Regenerative Medicine. "This approval represents an important milestone in our strategic growth plan to build a global business that provides regenerative medicine solutions for people around the world with life-altering conditions."
This announcement follows Shire's recent commitment to build a new regenerative medicine campus in San Diego to gain increased capacity to meet future demand for DERMAGRAFT, as well as additional space and infrastructure to develop and manufacture new regenerative medicine products.
Shire Regenerative Medicine intends to make DERMAGRAFT available in Canada in Q1 2013, and will leverage Shire's current infrastructure and commercial knowledge of the Canadian healthcare system, where the total population with diabetes was estimated to be 2.7 million people (7.6% of the total Canadian population) in 2010, and is projected to rise to 4.2 million people (10.8% of the total Canadian population) by 2020. In 2008, the Canadian Association of Wound Care estimated that 345,000 people with diabetes will develop a DFU in their lifetime and that DFUs were costing Canada's healthcare system more than $150 million annually.
Health Canada's approval of DERMAGRAFT on August 21, 2012 is based on a Canadian Device License Application submitted by Shire Regenerative Medicine in 2011.
PR Newswire