UPDATED: Shire plant feeds expansion in regenerative medicine

Rendering of San Diego expansion--courtesy of Shire

With the approval in Canada last week of its foot ulcer treatment Dermagraft, Shire may be needing its new manufacturing capacity in La Jolla, CA, sooner rather than later.

The fast-growing Shire ($SHPG) announced in June that it would expand in the San Diego area, with a 150,000 square foot manufacturing and support operation that can meet growth in demand in the U.S. and abroad for its new regenerative medicine division. It will break ground on the facility in Sorrento Mesa by early next year, says Shire spokesperson Lindsey Hart. It expects to move into the new facility in 2014 and, assuming it gets all the needed FDA and other approvals, be fully operational in 2015. The company has said it will hire several hundred people as part of the expansion, which is slated to cost in excess of $100 million.

Hart says that the company's existing 115,000 square foot manufacturing facility in La Jolla will be able to meet the added demand for Dermagraft from Canada when it launches the product there in the first quarter of 2013, as well as growing demand from the U.S. It intends to keep that plant operating when the new plant goes online and the two facilities will give it the capacity to handle growing demand from inside and outside North America as well, Hart says. It has trials in South Africa and several European countries. The San Diego facility is being designed to manufacture new regenerative medicine products.

Shire, which also makes such drugs as Adderall XR, its very popular attention-deficit hyperactivity disorder drug, picked up Dermagraft and the La Jolla facility when it acquired Advanced BioHealing last year 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 the company in May 2011. Dermagraft is made from human fibroblast cells derived from newborn foreskin tissue, which are seeded onto a bioresorbable scaffold. It is used to treat diabetic foot ulcers that haven't healed in 6 weeks or more. It has approval as a class III medical device in the U.S.

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