CSL Vifor offers campaign to mollify EC in antitrust probe

CSL Vifor has said it is prepared to carry out a “comprehensive and multi-channel communication campaign” to address allegations by the EU that it disparaged one of its competitor’s products.

The European Commission (EC) is seeking comments on the proposal, which comes two years after it launched an investigation into potentially misleading messaging issued by Vifor Pharma about Pharmacosmos’ Monofer, a rival to its intravenous iron replacement product Ferinject (ferric carboxymaltose).

Both Ferinject and Monofer are high-dose intravenous iron medicines indicated for the treatment of iron deficiency when, for instance, oral preparations are ineffective or cannot be used. If the EU investigation finds Vifor to be at fault, it could face hefty fines.

The EC’s concern was that Vifor Pharma – which was acquired by CSL in an $11.7 billion deal a few months after the probe was announced – had restricted competition by disseminating information that suggested there were safety issues with Monofer, slowing down its uptake in the market.

If proven, that would be an abuse of a dominant position in the EU market, as Ferinject is the top-selling intravenous iron replacement product in several key markets, including Austria, Finland, Germany, Ireland, Portugal, Romania, Spain, Sweden, and the Netherlands, according to an EC statement.

To answer the allegations, CSL Vifor has said it will run an information campaign to “rectify and undo” the effects of the potentially misleading messages on Monofer’s safety, including email, mail, and in-person meetings with healthcare professionals (HCPs) in the nine listed markets.

The company pledges to feature the campaign “prominently” on its website, publish it in medical journals, and allow competitors, including Pharmacosmos, to reference the information in their own dealings with HCPs.

Measures will also be implemented to make sure such a situation cannot recur in its promotional and medical communications, and it would agree to be monitored by a “trustee” appointed by Vifor for a period of 10 years.

In January, the UK Competition and Markets Authority (CMA) also opened its own investigation into the alleged misconduct.

Pharmacosmos told Reuters that it would “carefully study the proposed commitments,” which if accepted could settle the matter without any admission of wrongdoing or a financial penalty. If CSL Vifor was subsequently found to breach the agreement it would face a fine of up to 10% of the company’s worldwide turnover. Interested parties have a month to submit comments.

Ferinject and sister iron replacement product Venofer (iron sucrose) contributed $505 million of CSL Vifor’s $1 billion in revenues in the first half of its current financial year.