Shire announced that it has reached an agreement in principle with the US government to resolve the previously disclosed civil investigation into its sales and marketing practices in the US relating to the company’s attention deficit hyperactivity disorder (ADHD) drugs, Adderall XR and Vyvanse as well as the ADHD patch Daytrana. The agreement also addresses sales and marketing practices relating to Lialda and Pentasa (both for the treatment of ulcerative colitis), pursuant to a subsequent voluntary disclosure made by Shire.
Shire has provided full cooperation to the US government throughout the process of reaching this agreement. The company will pay out $57.5 million from its fourth quarter earnings in 2012 to cover costs of the agreement and interest. The agreement is subject to change until the matter has been fully resolved. Shire and the US government are in discussions on establishing a final resolution to the investigation.
The investigation, led by the US attorney’s office for the Eastern District of Pennsylvania, was disclosed by Shire in 2009 when the company was asked for documents relating to the sales and marketing of Adderall XR, Vyvanse and Daytrana.