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 annually1. 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 challenge2.
"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
"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."
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 lifetime3.
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 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
as well as other symptomatic conditions treated by specialist
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.
SOURCE: Shire Canada Inc.
For further information:
Brigitte Viel (Shire Canada)
Lindsey Hart (Shire Regenerative Medicine)
+1 (206) 335-0114