DERMAGRAFT® now available in Canada for the treatment of Diabetic Foot Ulcers

DERMAGRAFT® now available in Canada for the treatment of Diabetic Foot Ulcers 
The launch marks the beginning of Shire's Regenerative Medicine business in 
the country 
MONTREAL, March 25, 2013 /CNW Telbec/ - Shire Canada Inc. announced today that 
DERMAGRAFT (human fibroblast-derived dermal substitute) is now available in 
Canada for the treatment of diabetic foot ulcers (DFUs) greater than 6 weeks 
duration, which extend through the dermis, but without tendon, muscle, joint 
capsule, or bone exposure. 
Health Canada issued a licence for DERMAGRAFT as a class IV medical device 
designed to be externally applied onto DFUs. 
"DERMAGRAFT constitutes a true, additional treatment option to help patients 
with diabetic foot ulcers," said Dr. Gary Sibbald, MD, FRCPC, MACP, FAAD, 
M.Ed., MAPWCA, Professor of Medicine and Public Health at the University of 
Toronto. "DERMAGRAFT can lead to significant improvement in wound closure for 
stalled healable wounds compared to conventional therapy alone.'' 
One of the most devastating complications of diabetes, DFUs constitute a 
serious health issue estimated to cost the Canadian healthcare system more 
than $150 million annually(1). In its first and only report to date, the 
Health Care Innovation Working Group, created by the Council of Federation, 
identified DFUs as a leading health challenge(2). 
"We are excited to be bringing DERMAGRAFT to Canada, as we believe it plays an 
important role in the treatment of DFUs," said Jeff Jonas, MD, President of 
Shire Regenerative Medicine, Inc, the division of Shire that markets 
DERMAGRAFT. "This is an important first step for Shire as we continue to build 
a global business that provides regenerative medicine solutions for people 
around the world with life-altering conditions." 
"The Shire Canada team is pleased to be expanding into a new therapeutic 
area," added Claude Perron, Vice President and General Manager, Shire Canada 
Inc. "We hope that Canadian patients and healthcare professionals will benefit 
from having DERMAGRAFT available as a new therapeutic option to treat DFUs." 
About DFUs
DFUs are chronic sores that can develop on the feet of people with diabetes. 
Among Canadians living with diabetes, up to 15% will experience a DFU in their 
lifetime(3). 
About DERMAGRAFT
DERMAGRAFT is approved as a class IV medical device in Canada for the 
treatment of DFUs. DERMAGRAFT is manufactured from human fibroblast cells 
derived from donated newborn foreskin tissue. During the manufacturing 
process, the human fibroblasts are seeded onto a bioabsorbable 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 
DERMAGRAFTgroup of the pivotal registration trial (terms ≥ 5%) included 
infection, accidental injury, skin dysfunction/blister, flu syndrome, 
osteomyelitis, surgeries involving study ulcer, wound enlargement/skin ulcer, 
cellulitis and peripheral edema/localized swelling. Refer to DERMAGRAFT 
Directions for Use for more information. 
Notes to editors 
SHIRE PLC 
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.

--------------------------------

(1) Canadian Association Wound Care website
    (http://cawc.net/index.php/public/facts-stats-and-tools/statistics/)

(2) The Council of the Federation website
    (http://www.councilofthefederation.ca/pdfs/Health%20Innovation%20Report-E-WEB.pdf)

(3) Canadian Association Wound Care website
    (http://cawc.net/index.php/public/facts-stats-and-tools/statistics/)



Media  Brigitte Viel (Shire Canada) bviel@shire.com (514) 787-5114  Lindsey 
Hart (Shire Regenerative Medicine) lhart@shire.com +1 (206) 335-0114  

SOURCE: Shire Canada Inc.

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CO: Shire Canada Inc.
ST: Quebec
NI: MTC BTC HEA NP 

-0- Mar/25/2013 15:18 GMT


 
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