BELGIUM – EU antitrust regulators have launched an investigation into whether Vifor Pharma, which is being acquired by CSL Ltd, disparaged its rival Pharmacosmos in order to hinder competition with its blockbuster iron deficiency medicine Ferinject.

Pharmacosmos is Vifor Phama’s closest – and potentially only – competitor in Europe.

According to the Commission, the alleged conduct stems from an effort by Vifor to thwart competition against its high-dose intravenous iron treatment Ferinject (ferric carboxymaltose).

Pharmacosmos sells a similar iron replacement treatment called Monofer (iron isomaltoside). Both products are given when oral preparations are ineffective or cannot be used.

The Commission will now carry out its in-depth investigation as a matter of priority. The opening of formal proceedings does not prejudge the outcome of the investigation.

Misleading communication campaign

According to the European Union’s executive arm, the company could have hindered competition in intravenous iron treatments by spreading misleading information around the safety of Monofer treatment by competitor Pharmacosmos.

The EU competition regulator stated it has “indications” that the alleged conduct may have been going on for many years.

The Commission is concerned that Vifor Pharma pursued a misleading communication campaign, primarily targeting healthcare professionals, which may have unduly hindered Monofer’s uptake in the European Economic Area (EEA), in breach of rules against companies abusing their dominant position.

“Vifor Pharma’s conduct appears to be aimed at hindering competition against its blockbuster high-dose intravenous iron treatment medicine, Ferinject,” the Commission said.

Approximately 1.8 million patients suffering from iron deficiency are currently being treated with high-dose intravenous iron products annually in the EEA.

Margrethe Vestager, the commissioner in charge of competition policy, said the dissemination of misleading information around the safety of Pharmacosmos’s product could harm patients by stifling competition from an innovative medicine.

The investigation was prompted by a complaint filed by Pharmacosmos. If the Commission’s concerns are proven, Vifor Pharma’s behavior may amount to an abuse of dominant position and infringe Article 102 of the Treaty on the Functioning of the European Union (TFEU) and Article 54 of the EEA Agreement.

The Commission will now carry out its in-depth investigation as a matter of priority. The opening of formal proceedings does not prejudge the outcome of the investigation.

Commenting on the probe, Vifor stated “we are fully cooperating with the European Commission during this process and are convinced that we have not engaged in any anti-competitive behavior.”

This is the Commission’s second formal investigation into potential abuses relating to exclusionary disparagement of competing products in the pharmaceutical industry.

In March 2021, the Commission opened a formal investigation into possible anticompetitive conduct of Teva in relation to a blockbuster multiple sclerosis medicine.

Vifor is in the process of being acquired by CSL for about US$11.7 billion, which would give the Australian pharmaceutical firm access to Vifor’s treatments for iron deficiency, kidney and cardio-renal diseases, as well as its production sites in Switzerland and Portugal.

The deal was originally supposed to complete this month, but CSL said in May that the acquisition process would take “a few more months” as it awaits the go-ahead from regulatory authorities.

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