Shire Adds new Technology Platform and Phase 2 Product Candidate to its Regenerative Medicine Business

Dublin (ots/PRNewswire) -

Shire plc , the global specialty biopharmaceutical company, today
announced that it has signed an agreement to acquire substantially
all the assets of Pervasis Therapeutics. Shire will provide Pervasis
with an upfront payment, plus potential post-closing milestone
payments that are dependent on Shire's achievement of certain
clinical development, regulatory and sales targets.

- Clinical stage development assets bring to Shire a new cell-based
technology platform (endothelial cell technology) with potential global opportunity,
and leverage many existing capabilities-specialized marketing approach, cell-based
manufacturing, unique reimbursement, outpatient call point
- Establishes technology relationship with world-leading scientist Elazer
Edelman, MD, PhD, professor of Health Sciences and Technology at MIT, professor of
medicine at Harvard Medical School, and coronary care unit cardiologist at the Brigham
and Women's Hospital in Boston
- Acquisition complements the 2011 purchase of Advanced BioHealing, further
demonstrating Shire's commitment to investing in and building out its portfolio of
regenerative medicine therapies as the partner of choice for development-stage
companies
- Lead program (Vascugel(R)) addresses significant unmet medical need for acute
vascular repair technologies focused on improving hemodialysis access for patients
with end-stage renal disease (ESRD)
- Strong strategic fit with existing product, Dermagraft, which is indicated for
diabetic foot ulcers. Diabetes is the global leading cause of ESRD, and accounts for
approximately 40% of ESRD patients treated in the U.S.[i] Diabetic patients on
dialysis have a greater risk of developing a diabetic foot ulcer than diabetics not
receiving dialysis treatment[ii]
- Shire will initially focus on completing a Phase II program to address
maturation and maintenance of arteriovenous (AV) access for hemodialysis patients,
which will instruct future development pathway

Shire's Regenerative Medicine President, Kevin Rakin says:

"There are currently no approved therapies that directly target
the underlying physiological processes associated with the creation
of AV access sites in hemodialysis patients, including inflammation,
thrombosis, and restenosis. As a result, there remains a significant
unmet need for technologies that improve hemodialysis access for
patients with ESRD. We believe Vascugel has the potential to enhance
the rate of blood vessel repair while also providing for increased
maintenance of the access site for a prolonged period of time as
compared to current treatments. This acquisition marks a very
important step for Shire in building a Regenerative Medicine business
focused on tissue repair and regeneration."

"Shire's vision of bringing new regenerative medicine therapies
to patients with chronic diseases was a critical factor in our
decision to proceed with this transaction," said Frederic Chereau,
President and Chief Executive Officer at Pervasis. "I am excited to
be partnering with Shire, which has demonstrated both the capability
and commitment to bringing this promising cell-based technology to
the patients with end stage renal disease who need it."

The closing of the acquisition is subject to ancillary
conditions.

About VASCUGEL

Vascugel is an endothelial cell-based therapy in development for
enhancing blood vessel repair and improving hemodialysis access for
patients with end-stage renal disease. Vascugel utilizes adult
allogeneic endothelial cells embedded into a polymer matrix, and is
placed on the outside of the blood vessel at the arteriovenous (AV)
access site during the surgical intervention to create the access.
Vascugel has received Orphan Product designation from the U.S. Food
and Drug Administration and the European Medical Agency.

About Arteriovenous (AV) Access for Hemodialysis

End-stage renal disease (ESRD) is an advanced and irreversible
kidney disease, treated mainly by hemodialysis or kidney
transplantation. It is estimated that each year, there are more than
570,000 patients with ESRD treated in the U.S. and more than 250,000
patients in the EU[i,iii]. Approximately 70% of these patients
receive hemodialysis[i]. Before patients can undergo hemodialysis, an
arteriovenous (AV) access site must be created where blood can be
removed, filtered and returned to the body. The majority of AV access
is achieved through either an AV fistula, where the vein is connected
directly to the artery, or an AV graft, where the vein and artery are
connected via a tube. There are an estimated 100,000 AV fistulas and
60,000 AV grafts occurring annually in the U.S.[iv,v] Unfortunately,
complications following AV access procedures are common and can
include infection, blood clots, and narrowing of the vessel, which
frequently lead to AV access failure. An estimated 60% of AV grafts
fail after one year, requiring a procedure to restore flow or to
create another AV access site[vi,vii].

Notes to editors

SHIRE PLC

Shire's strategic goal is to become the leading specialty
biopharmaceutical company that focuses on meeting the needs of the
specialist physician. Shire focuses its business on attention deficit
hyperactivity disorder, human genetic therapies, gastrointestinal
diseases and regenerative medicine as well as opportunities in other
therapeutic areas to the extent they arise through acquisitions.
Shire's in-licensing, merger and acquisition efforts are focused on
products in specialist markets with strong intellectual property
protection and global rights. Shire believes that a carefully
selected and balanced portfolio of products with strategically
aligned and relatively small-scale sales forces will deliver strong
results.

For further information on Shire, please visit the Company's
website: http://www.shire.com.

"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] 2011 United States Renal Data System Annual Data Report (
http://www.usrds.org/2011/view/default.asp). [ii] Ndip et al.
Dialysis treatment is an independent risk factor for foot ulceration
in patients with diabetes and stage 4 or 5 chronic kidney disease.
Diabetes Care. 2012; 33:1811-1816. [iii] Policy Options for Kidney
Health in Europe. European Kidney Health Alliance (
http://www.era-edta.org/images/2012_EKHA-policy_paper.pdf) [iv]
Fistula First Breakthrough Initiative 2011 dashboard (
http://www.fistulafirst.org/AboutFistulaFirst/FFBIData.aspx) [v]
National Kidney Foundation Kidney Disease Outcome Quality Initiative
Guidelines ( http://www.kidney.org/professionals/KDOQI/guideline_upHD
_PD_VA/index.htm) [vi] Dixon et al. DAC Study Group.Effect of
dipyridamole plus aspirin on hemodialysis graft patency. N Engl J
Med. 2009; 360: 2191-2201. [vii] Hayashi et al. Vascular access for
hemodialysis. Nat ClinPractNephrol. 2006; 2: 504-513.

For further information please contact:
Investor Relations
Eric Rojas
erojas@shire.com
+1-7814820999
Sarah Elton-Farr
seltonfarr@shire.com
+44-1256-894157
Media
Jessica Mann (Corporate)
jmann@shire.com
+44-1256-894-280
Lindsey Hart (Regenerative Medicine)
lhart@abh.com
+1-615-250-3311

ots Originaltext: Shire Pharmaceuticals Group Plc
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