The British biotech giant said Health Canada approved DermaGraft as a Class IV medical device for diabetic foot ulcers, noting in a press release that the approval is "an important first step for the company as it continues to develop its international expansion strategy."
A launch in Canada is slated for the 1st quarter of 2013, according to the release.
Shire is betting big on regenerative medicine, eyeing a $1 billion return on its investment in the sector. Shire spent $750 million on Advanced BioHealing and DermaGraft, only to be dealt a blow after a clinical trial for leg ulcers failed to meet its primary endpoint.
The San Diego, Calif.-based company is putting more than $100 million into a new 150,000-square-foot campus to house the headquarters, manufacturing and laboratory space of recent $750 million acquisition Advanced BioHealing.
In April, the Shire revealed a U.S. Justice Dept. probe into its marketing practices for Dermagraft, saying in a regulatory filing that the DOJ, in conjunction with U.S. Attorney’s Offices for the Middle District of Florida and Washington, D.C., launched civil and criminal investigations into the company’s sales and marketing practices.
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