Shire's Dermagraft cleared in Canada; settles Intuniv litigation

6 September 2012

Ireland headquartered Shire (LSE: SHP), NASDAQ: SHPG) says that its lead regenerative medicine product, Dermagraft (human fibroblast-derived dermal substitute) has received approval from medicines regulator 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 USA, where it is currently available, and is an important first step for the company as it continues to develop its international expansion strategy. The product was acquired by Shire last year along with its buy of USA-based regenerative medicine company Advanced BioHealing for $750 million (The Pharma Letter May 18, 2011). Shire’s second-quarter 2012 sales of Dermagraft came in at $52 million.

Regenerative medicines campus in San Diego

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