Cephalon finalises agreement on sales and promotion investigation

Cephalon has announced the finalisation of a previously-announced agreement regarding an investigation into its sales and promotional practices.

This means all federal and state investigations into such procedures in the US are now complete.

Under the agreement with the department of justice, attorney’s office for the eastern district of Pennsylvania and other agencies, all inquiries have now been settled.

These probes began in 2004 and concerned three of the company’s products; Actiq (oral transmucosal fentanyl citrate) [C-II], Provigil (modafinil) tablets [C-IV] and GabitRil (tiagabine hydrochloride).

Cephalon has agreed to pay $425 million (238.8 million pounds) it reserved last year, in addition to a further $12 million in interest, as well as pleading guilty to a misdemeanour violation of the US Food, Drug Cosmetic Act.

It will also enter into a five-year corporate integrity agreement (CIA).

Valli Baldassano, executive vice-president and chief compliance officer, said: “We believe our existing compliance policies and procedures already address the majority of the requirements outlined in the CIA.”

He added the robust compliance infrastructure now in place at the firm has enhanced the transparency of its actions and accountability of its employees.

In July 2008, Cephalon said it exceeded its sales and earnings guidance for the second quarter of 2008, with revenues of $485 million.