The European Commission announced yesterday that it has opened a formal antitrust investigation into Danish drugmaker H Lundbeck.

The Commission says it will investigate, “as a matter of priority,” potential breaches by the company of European Union (EU) rules on restrictive business practices and abuse of a dominant market position. In particular, it intends to probe “unilateral behaviour and agreements” by Lundbeck related to delays in entry of generic versions of its antidepressant Celexa/Cipramil (citalopram) into European Economic Area (EEA) markets. Lundbeck’s patent on the drug, a selective serotonin reuptake inhibitor (SSRI), expired in 2003.

The proceedings have been opened based on knowledge acquired by the Commission during its inquiry into the pharmaceutical sector - which specifically examined the ways originator firms obstruct the entry of generic drugs on to the market - and allowed it to “draw conclusions” as to whether action by the Commission based on competition law could be appropriate and effective, it says. There is no deadline for completion of the proceedings against Lundbeck, and they are separate from the sector inquiry, it adds.

EU investigators first raided Lundbeck’s premises - in Denmark, Italy and Hungary - in 2005 and, at that time, the firm said the visit was probably related to citalopram. Last month, its office in Milan received another visit from the Commission - the fourth in a round of surprise inspections carried out since the EU sector inquiry began in January 2008 – and the firm said again that the purpose had been to identify whether it had misused a dominant position or been involved in anticompetitive activities in the Italian market for antidepressants.

Yesterday, Lundbeck confirmed that formal EU proceedings had begun, and that these seem to be related to the 2005 investigation. It added that it is “cooperating fully” with the Commission, is “confident” that it has complied with all relevant national and EU competition legislation, and believes it has nothing to hide and has done nothing wrong.

Last September, European Competition Commissioner Neelie Kroes warned drugmakers that the Commission was “now capitalising” on its pharmaceutical sector inquiry with new cases, and that they should “look out for” new antitrust investigations over the coming months. In the final report of its sector inquiry, published last July, the Commission had said it intended to “intensify its scrutiny of the pharmaceutical sector…including monitoring of settlements between originator and generic drug companies.”

“When it comes to generic entry, every week and month of delay costs money to patients and taxpayers. We will not hesitate to apply the antitrust rules where such delays result from anticompetitive practices,” said Commissioner Kroes. On the same day, the Commission announced a formal investigation into whether French drugmaker Servier had agreed deals with certain generics firms aimed at delaying competition to its heart disease drug perindopril.