Shire Reaches Final Agreement with US Government

Shire has reached a final agreement with the US 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, Datrana, 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 5 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 CEO. “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 programme and internal controls to ensure we comply with applicable laws and regulations.”