Shire plc , today announced that it has reached an agreement in principle to resolve the previously disclosed civil investigation into Shire’s U.S. sales and marketing practices relating to ADDERALL XR®, VYVANSE® and DAYTRANA®.
The investigation was led by the U.S. Attorney’s Office for the Eastern District of Pennsylvania, and Shire disclosed the investigation in 2009. The agreement also addresses sales and marketing practices relating to LIALDA® and PENTASA® pursuant to a subsequent voluntary disclosure made by Shire.
Shire cooperated with the U.S. Government throughout the process that led to this agreement in principle. Shire has recorded a $57.5M charge in the fourth quarter of 2012, comprised of the agreement in principle amount, interest and costs.
The agreement in principle is subject to change until this matter is finally resolved. Discussions between Shire and the U.S. Government are ongoing to establish a final resolution to the investigation.
