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Shire Enters Into Agreement to Supply Adderall XR® Authorized Generic



    Shire Enters Into Agreement to Supply Adderall XR® Authorized Generic

  PR Newswire

  PHILADELPHIA, December 2, 2013

PHILADELPHIA, December 2, 2013 /PRNewswire/ --

Shire plc (LSE: SHP, NASDAQ: SHPG), announces that its subsidiary Shire US
Inc. has entered into an agreement to supply an authorized generic version of
its product Adderall XR.  Under the agreement, Sandoz Inc. will market an
authorized generic version of Adderall XR ^® beginning July 1, 2016.  From the
December 1, 2013 effective date of the agreement through the end of the
agreement's five-year term, Sandoz has agreed to exclusively sell the
authorized generic version of Adderall XR supplied by Shire.

Shire will manufacture and supply Sandoz with all dosage strengths of the
authorized generic product.  Sandoz will distribute the product in the United
States.  Shire will receive a royalty from Sandoz's sales of the product.

NOTES TO EDITORS

Shire enables people with life-altering conditions to lead better lives.

Our strategy is to focus on developing and marketing innovative specialty
medicines to meet significant unmet patient needs.

We provide treatments in Neuroscience, Rare Diseases, Gastrointestinal,
Internal Medicine and Regenerative Medicine and we are developing treatments
for symptomatic conditions treated by specialist physicians in other targeted
therapeutic areas.

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 jmann@shire.com +44-1256-894-280

Gwen Fisher gfisher@shire.com +1-484-595-9836

 
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