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Shire to Acquire SARcode Bioscience, Expands Presence in Ophthalmology



    Shire to Acquire SARcode Bioscience, Expands Presence in Ophthalmology

  PR Newswire

  LEXINGTON, Massachusetts, March 25, 2013

LEXINGTON, Massachusetts, March 25, 2013 /PRNewswire/ --

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

Shire plc (LSE: SHP, NASDAQ: SHPG) 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 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
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