UCB agrees $34.4 million settlement for off-label promotion of Keppra in USA; Novo to pay $25 million over NovoSeven

The US subsidiary of Belgian pharmaceutical manufacturer UCB SA (Euronext Brussels: UCB) last week pleaded guilty to the off-label promotion of its epilepsy drug Keppra (levetiracetam) and will pay more than $34 million to resolve criminal and civil liability arising out of its illegal conduct, the Department of Justice announced.

UCB said that, as previously reported, the issues that were the subject of this investigation occurred more than six years ago, and as recognized by the DOJ, UCB has cooperated fully with the USA since learning of the investigation in 2008.

UCB allegedly promoted Keppra for use in the treatment for migraines when the drug was approved as an anti-epileptic drug, the Justice Department said. Keppra, which has lost patent exclusivity in the USA, generated net sales of 942 million euros ($1.37 billion) last year, of which 83 million euros came from Keppra XR in the USA, which is 3% higher than the previous year.