When pharma companies launch marketing campaigns, they typically seek to spotlight positive factors about their medicines. But in a special case, CSL Vifor will need to use its commercialization prowess to resolve an antitrust case in Europe.
The European Commission (EC) has accepted Vifor’s commitments, including the launch of a “comprehensive and multi-channel communication campaign,” to address alleged anti-competitive actions against a rival, the agency said Monday.
The EU antitrust concerns centered on Vifor’s “potential disparagement” of Pharmacosmos’ high-dose intravenous iron replacement therapy Monofer. The drug is one—and potentially only—competitor to Vifor’s flagship iron medicine, Ferinject, in Europe.
As Ferinject is the better-selling product, EU regulators argued that Vifor may have abused its dominant market position—and restricted competition—by disseminating potentially misleading information about the safety of Monofer.
In a statement to Fierce Pharma, CSL Vifor said it is “grateful for the constructive discussions with the EC” but stressed that the commitments were offered without any admission of liability or wrongdoing. CSL Limited acquired Vifor Pharma for $11.7 billion in late 2021.
European authorities opened a formal antitrust investigation into Vifor’s behavior in June 2022, following a complaint filed by Pharmacosmos. At that time, the EC estimated that about 1.8 million patients with iron deficiency were being treated with high-dose IV iron products per year in the European Economic Area.
In February 2024, the two companies reached a confidential settlement on the issue. And then in April, CSL Vifor proposed its preliminary commitments to address the EC’s concerns. EC tested the offers for about a month and consulted third parties to verify their impact.
As part of the “comprehensive” communication campaign, Vifor will “disseminate via email, mail and in-person meetings a succinct and factual clarificatory communication to a significant number of healthcare professionals” in the nine member states where it holds a dominant position, according to EC. The CSL unit will also publish such communication “prominently” on its website and in leading medical journals.
In addition, Vifor promised to take measures to ensure that its internal training materials are in line with external communications and that it has a mechanism in place to confirm compliance.
A third-party trustee, appointed by Vifor, will monitor the implementation of the agreement, which lasts for 10 years. If Vifor fails to honor the commitments, the EC may impose a fine of up to 10% of the company’s annual turnover or 5% per day of its daily turnover for the period of non-compliance.
The investigation is the second the EC has opened against a pharma company’s alleged disparagement of a competitor. The agency in 2022 dinged Teva for allegedly “systematically spreading misleading information” about a competitor to the company’s multiple sclerosis drug Copaxone and for “artificially extending patent protection” of its drug.
In another previous case brought by several individual European countries, local authorities argued that Novartis and Roche, to protect their Lucentis sales position in age-related macular degeneration, propelled misinformation to discredit the off-label use of the cheaper anti-VEGF drug Avastin.
Vifor’s European marketing commitments come as the company deals with the loss of U.S. market exclusivity for its low-dose iron product, Venofer, and a shift in the iron market brought on by increasing pressure from payers. These headwinds, plus some late-stage trial setbacks, have “dampened” CSL’s near-term sales expectations for Vifor, the company said in February.
For the six months that ended in December, CSL Vifor recorded $505 million in total iron sales, an 18% increase year over year.