CSL Vifor has proposed to launch a campaign that would undo the potentially misleading messages it sent about the safety of a rival product, the European Commission (EC) said.
The initiative comes nearly two years after the EC launched an antitrust investigation surrounding Vifor’s alleged efforts to disparage the safety of Pharmacosmos’ intravenous iron deficiency treatment Monofer—which competes one-on-one with Vifor’s blockbuster Ferinject.
After receiving feedback from the companies, the EU will decide whether to accept the proposal, which would end the investigation and allow Vifor to avoid a fine without admitting to wrongdoing.
When the EC began its scrutiny of Vifor, it said the Swiss company had conducted the campaign for years, targeting healthcare professionals in a scheme “which may have unduly hindered Monofer’s uptake.” Friday, the EC said that its “preliminary view” is that Vifor’s conduct was an “abuse” of its “dominant position.”
Ferinject reached the market in Europe in 2007 and six years later in the U.S., where it is known as Injectafer. Monofer was approved in Europe in 2009 and 11 years later in the U.S., where it is known as Monoferric.
Ferinject and Monofer are indicated for those who can’t take or have not had success with oral iron deficiency options. When Pharmacosmos, a small, family-owned company based in Denmark, reported its revenue at 1.788 billion Danish kroner ($256 million) last year, it said that 80% of the sales were from Monofer.
The scrutiny of Vifor began after Australian giant CSL agreed to an $11.7 billion buyout of the kidney disease and iron deficiency specialist. The deal, which was the largest in the biopharma industry in 2021, was finalized in August of 2022, two months after the EU revealed that its investigation was underway. The investigation was triggered after the EU received complaints from Pharmacosmos.
Vifor has proposed to conduct a communication campaign in which it will clarify and correct its past messaging on Monofer. It will publish the information prominently on its website and in medical journals in Europe. For the next 10 years, Vifor has agreed not to engage in external communications—written or orally—on Monofer’s safety profile.