Shire reaches agreement in principle with US Government

SHIRE PLC - Shire reaches agreement in principle with US Government

PR Newswire

London, February 1

Shire reaches agreement in principle with U.S. Government

Philadelphia, PA, United States - February 1, 2013 - Shire plc (LSE: SHP,NASDAQ: SHPG), today announced that it has reached an agreement in principle toresolve the previously disclosed civil investigation into Shire's U.S. salesand marketing practices relating to ADDERALL XR®, VYVANSE® and DAYTRANA®.

The investigation was led by the U.S. Attorney's Office for the EasternDistrict of Pennsylvania, and Shire disclosed the investigation in 2009. Theagreement also addresses sales and marketing practices relating to LIALDA® andPENTASA® pursuant to a subsequent voluntary disclosure made by Shire.

Shire cooperated with the U.S. Government throughout the process that led tothis agreement in principle. Shire has recorded a $57.5M charge in the fourthquarter of 2012, comprised of the agreement in principle amount, interest andcosts.

The agreement in principle is subject to change until this matter is finallyresolved. Discussions between Shire and the U.S. Government are ongoing toestablish a final resolution to the investigation.

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

Through our deep understanding of patients' needs, we develop and providehealthcare in the areas of:

as well as other symptomatic conditions treated by specialist physicians.

We aspire to imagine and lead the future of healthcare, creating value forpatients, physicians, policymakers, payors and our shareholders.

"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF1995

Statements included herein that are not historical facts are forward-lookingstatements. Such forward-looking statements involve a number of risks anduncertainties and are subject to change at any time. In the event such risks oruncertainties materialize, the Company's results could be materially adverselyaffected. The risks and uncertainties include, but are not limited to, risksassociated with: the inherent uncertainty of research, development, approval,reimbursement, manufacturing and commercialization of the Company's SpecialtyPharmaceuticals, Human Genetic Therapies and Regenerative Medicine products, aswell as the ability to secure new products for commercialization and/ordevelopment; government regulation of the Company's products; the Company'sability to manufacture its products in sufficient quantities to meet demand;the impact of competitive therapies on the Company's products; the Company'sability to register, maintain and enforce patents and other intellectualproperty rights relating to its products; the Company's ability to obtain andmaintain government and other third-party reimbursement for its products; andother risks and uncertainties detailed from time to time in the Company'sfilings with the Securities and Exchange Commission.

DAYTRANA® is a trademark of Noven Pharmaceutical Inc.

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