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

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.

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

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

SOURCE Shire plc

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