Shire plc (LSE: SHP, NASDAQ: SHPG), today announced that it has reached a final agreement with the U.S. Attorney’s Offices for the Eastern the District of Pennsylvania and Northern District of Illinois, all 50 states and District of Columbia to resolve a previously disclosed civil investigation of its sales and marketing practices for a period ending in 2010 relating to ADDERALL XR®, VYVANSE® DAYTRANA®, LIALDA® and PENTASA®.
Under the agreement, Shire will pay $56.5 million, and interest, fees, and costs, to resolve all issues investigated by the government. This final settlement includes the resolution of two related qui tam complaints filed against the Company and a voluntary disclosure relating to LIALDA and PENTASA. In addition, Shire will pay $2.9 million to resolve a previously disclosed civil complaint filed by the State of Louisiana alleging that the Company’s sales, marketing, and promotion of ADDERALL, ADDERALL XR, DAYTRANA, VYVANSE and INTUNIV violated state law. Shire has also entered into a Corporate Integrity Agreement with the Office of Inspector General for the Department of Health and Human Services for a term of five years. Shire has not admitted any wrongdoing in connection with the agreement.
“We are pleased to have reached a resolution and to put this matter behind us,” said Flemming Ornskov, Shire’s Chief Executive Officer. “We remain focused on our mission of enabling people with life-altering conditions to lead better lives, and we are committed to conducting our activities to meet the highest ethical standards. The Company has had, and will continue to have, a comprehensive compliance program and internal controls to ensure we comply with applicable laws and regulations.”
Shire cooperated fully with the government throughout the process that led to the agreement. The Company will continue to work collaboratively with regulators on its business activities.
For further information please contact:
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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 focus on providing treatments in Neuroscience, Rare Diseases, and Gastrointestinal and Internal Medicine and are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas, such as Ophthalmology.
THE “SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts are forward-looking statements. Such 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:
and other risks and uncertainties detailed from time to time in Shire’s filings with the Securities and Exchange Commission, including those risks outlined in “Item 1A: Risk Factors” in Shire’s Annual Report on Form 10-K for the year ended December 31, 2013.
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