Shire Acquires Premacure AB

Lexington, Massachusetts (ots/PRNewswire) -

Deal Enhances Shire's Late-Stage Pipeline with the Acquisition of
a Phase II Protein Replacement Therapy Being Investigated for the
Prevention of Retinopathy of Prematurity

Shire plc announces that it has acquired Premacure AB of Uppsala,
Sweden, a privately held biotechnology company developing a protein
replacement therapy, currently in Phase II development, for the
prevention of retinopathy of prematurity (ROP). ROP is a rare and
potentially blinding eye disorder that primarily affects premature
infants and is one of the most common causes of visual loss in
childhood. Currently, only symptomatic treatment is available for
ROP. Shire will purchase Premacure for an upfront payment and certain
contingent payments based on the achievement of pre-specified
development and commercial milestones. This acquisition underscores
and expands Shire's commitment to bringing innovative therapies to
patients with rare disorders worldwide.

During normal gestation, the developing fetus is reliant on
certain growth factors from the maternal serum; full term babies can
produce these growth factors on their own. In preterm infants (born
before 31 weeks of gestation), the early separation from the maternal
circulation results in a loss of specific growth factors, such as
insulin-like growth factor 1 (IGF-1), that are believed to result in
lifelong complications, including ROP.

This acquisition allows Shire HGT to enter a new therapeutic area
- neonatology - while maintaining its focus on developing novel
therapies for the treatment of rare diseases with high unmet medical
need. With the acquisition of Premacure, Shire HGT will continue the
ongoing Phase II study, the primary goal of which is to restore the
IGF-1 levels in the preterm infant to those found during normal in
utero development.

"ROP is a devastating eye disorder that can severely impact
preterm infants for the rest of their lives," said Flemming Ornskov,
MD, CEO Designate, Shire. "This investigational protein has the
potential to provide a first-in-class treatment that may minimize the
development and impact of complications arising from ROP. We will
build on the work that Premacure has done and will apply Shire's
proven ability in developing protein replacement therapies for rare
disorders to bring this much needed therapy to the market."

"The acquisition of Premacure by Shire further underscores the
potential to change the long-term outlook for preterm infants with
ROP and their families," said Jan Borg, founding CEO of Premacure.
"We are excited that this program will become part of the innovative
pipeline at Shire and believe that their experience and resources may
accelerate the development of a product that seeks to prevent some of
the devastating long-term consequences of ROP."

Premacure AB is a private company launched in 2006 by
entrepreneurs and internationally recognized clinicians in the area
of neonatology.

About ROP

Retinopathy of Prematurity (ROP) is a potentially blinding eye
disorder that primarily affects premature infants weighing less than
2 pounds (about 1kg) who are born before 31 weeks of gestation (a
full term pregnancy has a gestation of 38-42 weeks). The smaller a
baby is at birth, the more likely that baby is to develop ROP. This
disorder, which usually develops in both eyes, is one of the most
common causes of visual loss in childhood and can lead to lifelong
vision impairment and blindness.

In the US and EU, there are approximately 87,000 and 54,000
premature infants (born) born annually. Each year approximately
14,000-16,000 preterm infants in the US are affected by some degree
of ROP. In 1,100-1,500 of these infants the ROP is severe enough to
require medical treatment, and consequently 400-600 infants become
legally blind.

About Insulin-Like Growth Factor 1

IGF-1 is primarily produced by the liver and supports normal
childhood growth and development. Administration of IGF-1 to
premature infants, as a substitute for the maternal and endogenous
source, allows for the establishment of a physiological level of the
hormone comparable to that present in utero. Such a treatment is
believed to promote normal development and thereby prevent the
development of complications of ROP.

Premacure initiated the clinical development of the preventative
treatment with a formulation of recombinant human IGF-1 combined with
a recombinant version of its naturally occurring binding protein,
insulin-like growth factor-1 binding protein-3 (IFGBP3).

A Phase I clinical trial was conducted and results showed that the
levels of IGF-1 were increased to within physiological levels and
that administration of the investigational protein to preterm infants
is generally well tolerated. A Phase II, safety and efficacy
multi-centre clinical trial has started in Sweden and is on-going.

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.

http://www.shire.com

FORWARD-LOOKING STATEMENTS - "SAFE HARBOR" STATEMENT UNDER THE
PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included in this announcement that are not historical
facts are forward-looking statements. 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,
Shire's results could be materially adversely affected. The risks and
uncertainties include, but are not limited to, that:

- Shire's products may not be a commercial success;
- revenues from ADDERALL XR are subject to generic erosion;
- the failure to obtain and maintain reimbursement, or an adequate level of
reimbursement, by third-party payors in a timely manner for Shire's products may
impact future revenues and earnings;
- Shire relies on a single source for manufacture of certain of its products and
a disruption to the supply chain for those products may result in Shire being unable
to continue marketing or developing a product or may result in Shire being unable to
do so on a commercially viable basis;
- Shire uses third party manufacturers to manufacture many of its products and
is reliant upon third party contractors for certain goods and services, and any
inability of these third party manufacturers to manufacture products, or any failure
of these third party contractors to provide these goods and services, in each case in
accordance with its respective contractual obligations, could adversely affect Shire's
ability to manage its manufacturing processes or to operate its business;
- the development, approval and manufacturing of Shire's products is subject to
extensive oversight by various regulatory agencies and regulatory approvals or
interventions associated with changes to manufacturing sites, ingredients or
manufacturing processes could lead to significant delays, increase in operating costs,
lost product sales, an interruption of research activities or the delay of new product
launches;
- the actions of certain customers could affect Shire 's ability to sell or
market products profitably and fluctuations in buying or distribution patterns by such
customers could adversely impact Shire's revenues, financial conditions or results of
operations;
- investigations or enforcement action by regulatory authorities or law
enforcement agencies relating to Shire's activities in the highly regulated markets in
which it operates may result in the distraction of senior management, significant
legal costs and the payment of substantial compensation or fines;
- adverse outcomes in legal matters and other disputes, including Shire's
ability to obtain, maintain, enforce and defend patents and other intellectual
property rights required for its business, could have a material adverse effect on
Shire's revenues, financial condition or results of operations;

and other risks and uncertainties detailed from time to time in
Shire's filings with the U.S. Securities and Exchange Commission,
including its most recent Annual Report on Form 10-K.

For further information please contact:

Investor Relations
Eric Rojas, erojas@shire.com, +1-781-482-0999
Sarah Elton-Farr, seltonfarr@shire.com, +44-1256-894157

Media
Jessica Mann (Corporate), jmann@shire.com, +44-1256-894-280
Jessica Cotrone (Human Genetic Therapies), jcotrone@shire.com, +1-781-482-9538

ots Originaltext: Shire Pharmaceuticals Group Plc
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