Shire to Acquire SARcode Bioscience, Expands Presence in Ophthalmology

Lexington, Massachusetts (ots/PRNewswire) -

Acquisition brings Shire a new phase 3 compound being investigated
for the signs and symptoms of Dry Eye Disease

Shire plc today announced that it will acquire SARcode Bioscience
Inc., a privately held biopharmaceutical company based in Brisbane,
California. This acquisition continues to build Shire's presence in
the ophthalmology therapeutic category and brings a new phase 3
compound - LIFITEGRAST - currently under development for the signs
and symptoms of dry eye disease, into Shire's portfolio. Shire
anticipates launching LIFITEGRAST in the United States as early as
2016 pending a positive outcome of the phase 3 clinical development
program and regulatory approvals. Shire is acquiring the global
rights to LIFITEGRAST and will evaluate an appropriate regulatory
filing strategy for markets outside of the United States.

Some 25 million people in the United States suffer from dry eye
disease, and, of the approximate 9 million patients who are
candidates for prescription drug treatment, approximately 10% are
treated with the only currently approved prescription product for dry
eye disease, indicated to help increase the eyes' natural ability to
produce tears, which may be suppressed by inflammation due to chronic
dry eye. However, there is no approved treatment indication which
includes symptoms of dry eye (one of the most common complaints to
eye care specialists).

"The acquisition of SARcode is a demonstration of Shire's focus on
continuing to build our research and development pipeline with
innovative, well-differentiated assets that address significant unmet
patient need," said Flemming Ornskov, M.D., Shire's CEO Designate.
"This acquisition and our recent acquisition of Premacure have the
potential to provide the basis for an attractive ophthalmology
business for our company, given the significant growth opportunities
in this therapeutic area as well as Shire's proven expertise in
specialist markets."

The global ophthalmic pharmaceutical market, valued at
approximately $13 billion in 2012 with a compound annual growth rate
of 4.5 percent, is consistent with Shire's focus on the specialty
market. There are approximately 42,000 office-based ophthalmologists,
optometrists and retinal specialists in the United States.

Under the terms of agreement, Shire will make an upfront payment
of $160 million and SARcode shareholders will be eligible to receive
additional undisclosed payments upon achievement of certain clinical,
regulatory, and/or commercial milestones. The transaction is expected
to close in the second quarter, subject to regulatory approval in the
United States, and other customary closing conditions.

The acquisition of SARcode will introduce a new late-stage phase 3
clinical program to Shire's research and development portfolio. Shire
is currently conducting a prioritization review of its portfolio to
accommodate this new expenditure in 2013.

Barclays acted as financial advisor to Shire and Davis Polk LLP
acted as legal counsel to Shire. J.P. Morgan Securities LLC acted as
financial advisor to SARCode and Wilson Sonsini Goodrich & Roasati
acted as legal counsel to Sarcode.

LIFITEGRAST and its Clinical Development Program

LIFITEGRAST, a small-molecule integrin antagonist, is believed to
work by reducing inflammation through binding inhibition of the
proteins lymphocyte function - associated antigen 1 (LFA-1) and
intercellular adhesion molecule-1 (ICAM-1), influencing T-cell
activation and cytokine (protein) release. The interaction between
these two proteins plays a key role in the chronic inflammation
associated with dry eye. T-cells are important components of the
immune system that help control the body's response to a foreign or
harmful substance or stimuli. LIFITEGRAST is administered via a
preservative-free topical eye solution.

Three clinical trials - OPUS-1, OPUS-2 and SONATA - currently make
up the phase 3 clinical development program for LIFITEGRAST. OPUS-1,
a safety and efficacy study, concluded in 2012. In this study the
co-primary endpoint of reducing signs of dry eye was met. Although
the co-primary endpoint of reducing symptoms was not achieved, this
study was the basis of a positive meeting with the FDA and for the
continuation of the phase 3 clinical program, including OPUS-2, a
safety and efficacy study of both signs and symptoms of dry eye
disease, which is currently ongoing. In addition to the OPUS-2
clinical efficacy study, SONATA, a randomized, placebo-controlled
safety study is also ongoing. Shire is excited about the potential
contribution of this product to the treatment options for patients
with dry eye disease.

About Dry Eye Disease

Dry eye disease varies in severity and etiology, and symptoms most
commonly manifest as ocular discomfort, eye dryness, and tear film
instability due to decreased quality or quantity of tears. A major
contributing factor towards the development of dry eye is
inflammation caused by T-cell infiltration, proliferation and
inflammatory cytokine production that can lead to reduction in tear
film quality and ocular surface damage.

Some 25 million people are affected in the United States. This
number is expected to grow substantially in the next decade due to an
aging population, a contributor to higher rates of dry eye disease.

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
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- Shire's products may not be a commercial success;
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- 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;
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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
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is reliant upon third party contractors for certain goods and services, and any
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accordance with its respective contractual obligations, could adversely affect Shire's
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extensive oversight by various regulatory agencies and regulatory approvals or
interventions associated with changes to manufacturing sites, ingredients or
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lost product sales, an interruption of research activities or the delay of new product
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- adverse outcomes in legal matters and other disputes, including Shire's
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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.

ots Originaltext: Shire Pharmaceuticals Group Plc
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