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Shire Settles All Pending Litigation with Actavis and Watson Concerning INTUNIV®

   Shire Settles All Pending Litigation with Actavis and Watson Concerning
                                   INTUNIV®

PR Newswire

PHILADELPHIA, April 25, 2013

PHILADELPHIA, April 25, 2013 /PRNewswire/ --

Shire plc (LSE: SHP, NASDAQ: SHPG), announces that its subsidiary, Shire LLC,
has settled all pending litigation with Actavis, Inc., Actavis LLC, and
Actavis Elizabeth LLC (collectively "Actavis") and Watson Laboratories,
Inc.-Florida, Watson Pharma, Inc. and ANDA, Inc. (collectively "Watson") in
connection with Actavis' and Watson's Abbreviated New Drug Applications
("ANDAs") for generic versions of Shire's INTUNIV^® ( guanfacine
hydrochloride) for the treatment of Attention Deficit Hyperactivity Disorder.

The settlement provides Actavis with a license to make and market Actavis'
generic versions of INTUNIV in the United States on December 1, 2014, or
earlier in certain limited circumstances.  Such sales will require the
payment of a royalty of 25% of gross profits to Shire during the 180 day
period of Actavis' exclusivity. The settlement also provides Watson with a
license to make and market Watson's generic versions of INTUNIV in the United
States 181 days after Actavis' launch of generic INTUNIV, or earlier in
certain limited circumstances. To date, the US Food and Drug Administration
has granted final approval only to Actavis' ANDA for generic versions of
INTUNIV.

These litigations were patent infringement lawsuits relating to U.S. patents
6,287,599 ("the '599 Patent"), 6,811,794 ("the '794 Patent"), 5,854,290 (which
was subsequently dedicated to the public).  As part of the settlement,
Actavis and Watson have agreed to a consent judgment confirming that their
proposed generic products infringe Shire's '599 and '794 Patents and that
those two patents are valid and enforceable with respect to those proposed
generic products and any other generic version of INTUNIV.

The lawsuit against Actavis proceeded to trial in the District Court of
Delaware in September 2012 wherein Teva Pharmaceuticals, USA, Inc. was also a
defendant. The Delaware court has not issued a decision. The lawsuit against
Watson is scheduled for trial to begin on February 10, 2014 wherein Impax
Laboratories, Inc. is also a defendant.

The agreements, which are effective immediately, will be submitted to the US
Federal Trade Commission and Department of Justice for review as required by
law.

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:

  oBehavioral Health and Gastro Intestinal conditions
  oRare Diseases
  oRegenerative 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:

  oShire's products may not be a commercial success;
  orevenues from ADDERALL XR are subject to generic erosion;
  othe 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;
  oShire 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;
  oShire 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;
  othe 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;
  othe 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;
  oinvestigations 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;
  oadverse 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

Gwen Fisher (Specialty Pharma)
gfisher@shire.com
+1-484-595-9836

SOURCE Shire plc
 
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