Shire ($SHPG) said it has nailed down Canadian regulatory approval for its diabetic foot ulcer treatment, a little over a year after buying the company that had been developing it for $750 million in cash.
The Canadian approval adds to a long-held FDA premarket approval for Dermagraft, which Advanced BioHealing had acquired from Smith & Nephew ($SNN) before Shire snatched up Advanced BioHealing in May 2011. Dermagraft, with approval as a Class III medical device in the U.S., is made from human fibroblast cells derived from newborn foreskin tissue, which are seeded onto a bioresorbable scaffold.
Dermagraft is used to treat diabetic foot ulcers that haven't healed in 6 weeks or more.
Health Canada signed off on Dermagraft as a Class IV medical device (higher risk). Shire said the Canadian approval is its first regulatory sign-off outside of the U.S. in what is a broader focus on expanding Dermagraft's availability internationally. Clinical trials continue, for example, elsewhere in Europe and South Africa. While Canada isn't the U.S. market in size or scope, Shire says it expects to reach a potential market of at least 2.7 million people with diabetes, a number that should rise to 4.2 million, or nearly 11% of the Canadian population, by 2020. Plans call for rolling out the product by the 2013 first quarter.
Shire established its regenerative medicine business unit after acquiring Advanced BioHealing.
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