, 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[i]. 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.[ii]
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.
DFUs are chronic sores that can develop on the feet of people with diabetes. Among people with diabetes, up to 25% experience a DFU in their lifetime,[iii,iv] and approximately 2% develop a DFU each year.[v] If not properly treated, DFUs may result in serious complications.
DERMAGRAFT is approved as a class III medical device in the U.S. and a class IV medical device in Canada for the treatment of diabetic foot ulcers. DERMAGRAFT is manufactured from human fibroblast cells derived from newborn foreskin tissue. During the manufacturing process, the human fibroblasts are seeded onto a bioresorbable scaffold. The fibroblasts proliferate to fill the interstices of this scaffold and secrete human dermal collagen, matrix proteins, growth factors, and cytokines to create a three-dimensional human dermal substitute containing metabolically active, living cells.
Important Safety Information About DERMAGRAFT
DERMAGRAFT is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than 6 weeks duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure. DERMAGRAFT should be used in conjunction with standard wound care regimens and in patients that have adequate blood supply to the involved foot. DERMAGRAFT is contraindicated for use in ulcers that have signs of clinical infection or in ulcers with sinus tracts. DERMAGRAFT is contraindicated in patients with known hypersensitivity to bovine products, as it may contain trace amounts of bovine proteins from the manufacturing medium and storage solution. The most frequently reported adverse events experienced by patients in the DERMAGRAFT group of the pivotal registration trial (terms 5%) included infection, accidental injury, skin dysfunction/blister, flu syndrome, osteomyelitis (study ulcer), surgeries involving study ulcer, wound enlargement/skin ulcer (non-study ulcer), cellulitis and peripheral edema/localized swelling. The overall incidence of adverse events was comparable between DERMAGRAFT and control groups. Refer to DERMAGRAFT Directions for Use for more information.
Notes to editors
Shire enables people with life-altering conditions to lead better lives.
Through our deep understanding of patients' needs, we develop and provide healthcare in the areas of:
- Behavioral Health and Gastro Intestinal conditions
- Rare Diseases
- Regenerative Medicine
as well as other symptomatic conditions treated by specialist physicians.
We aspire to imagine and lead the future of healthcare, creating value for patients, physicians, policymakers, payors and our shareholders.
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company's Specialty Pharmaceuticals, Human Genetic Therapies and Regenerative Medicine products, as well as the ability to secure new products for commercialization and/or development; government regulation of the Company's products; the Company's ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company's products; the Company's ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company's ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission.
[i] Canadian Diabetes Association. Diabetes: Canada at the Tipping Point - Charting a New Path. http://www.diabetes.ca/documents/get-involved/WEB_Eng.CDA_Report_.pdf.
[ii] Canadian Association of Wound Care website (8/24/12)
[iii] Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA. 2005;293:217-28.
[iv] Sanders LJ. Diabetes mellitus: prevention of amputation. J Am Podiatric Assoc. 1994;84:322-328.
[v] Ramsey et al. Incidence, outcomes, and cost of foot ulcers in patients with diabetes. Diabetes Care. 1999;22:382-387.
For further information please contact:
Jessica Mann (Corporate)
Lindsey Hart (Regenerative Medicine)
SOURCE Shire plc