Novartis AG, the world’s fourth-largest drug maker by market value, said the US attorney’s office in Philadelphia is investigating the possible improper promotion of its Trileptal epilepsy treatment.
The civil and criminal probes are looking at whether the Basel, Switzerland, company, whose research headquarters is in Cambridge, promoted the drug’s use in conditions for which it hasn’t been approved, Novartis said yesterday in a US Securities and Exchange Commission filing.
”At this time, we are unable to express an opinion as to the likely outcome of these investigations,” the company said in the SEC filing.
Trileptal, which brought in $518 million in 2004, is used for the treatment of partial seizures in adults and in children between 4 and 16 years old with epilepsy.
Although doctors can prescribe medicines for uses that haven’t been approved by the US Food and Drug Administration, companies aren’t allowed to promote the drugs for such uses. Novartis got a subpoena on May 26, the company said in the filing. Novartis didn’t provide additional details.
Pfizer Inc., the world’s biggest drug maker, was sued in 2003 by a consumer group that said its Parke-Davis unit promoted the epilepsy drug Neurontin for so-called off-label uses, such as controlling bipolar mental disorders, in order to boost sales.
Pfizer last year agreed to pay at least $400 million to settle all US and state investigations related to the promotion and marketing of Neurontin.