Shire and Impax Settle Litigation Concerning Supply of Adderall XR Authorized Generic

Shire and Impax Settle Litigation Concerning Supply of Adderall XR Authorized

  PR Newswire

  PHILADELPHIA, February 8, 2013

PHILADELPHIA, February 8, 2013 /PRNewswire/ --

Shire plc (LSE: SHP, NASDAQ: SHPG), announces that its subsidiary, Shire LLC,
has settled all pending litigation with Impax Laboratories, Inc. ("Impax")
over Shire's supply of an authorized generic version of Adderall XR. Shire
has been supplying Impax with authorized generic Adderall XR since October
2009 pursuant to a supply agreement between the parties. 

In November 2010, Impax filed suit claiming that Shire was in breach of its
supply obligations, and Shire brought a counterclaim against Impax relating to
its ordering practices under the agreement. Under the terms of the
settlement, both Impax's claim and Shire's counterclaim will be dismissed, and
the parties have entered into an amended supply agreement which will govern
the supply of authorized generic Adderall XR from Shire to Impax until the end
of the supply term on September 30, 2014. Also as part of the settlement,
Shire will make a one-time cash payment to Impax of $48.0 million, which has
been recorded as a liability at December 31, 2012. In accordance with US
GAAP, as this represents a payment to a customer, the amount has been recorded
in the Income Statement as a reduction in reported ADDERALL XR product sales
and royalties in 2012. The reduction to revenues for the fourth quarter of
2012 was $8.0 million, with the balance having been recorded in earlier
periods. The above mentioned charges will not change Shire's updated
financial guidance for 2012 and 2013, as provided on January 8, 2013.


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.


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 +1-781-482-0999

Sarah Elton-Farr +44-1256-894157


Jessica Mann (Corporate) +44-1256-894-280

Gwen Fisher (Specialty Pharma) +1-484-595-9836
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