Regarding recent media attention

On Friday, January 31, the Danish Medicines Council, an independent council that produces recommendations and guidelines on medicines for the country’s five regions, published a decision (link in Danish) to recommend a restriction on the use of the drug lenalidomide. While no immediate effect on Oncopeptides or its products, it has led to media attention where Oncopeptides has been mentioned.

See, for example, Expressen, Fokus, Nyhetsbyrån Direkt, Dagens PS (all links in Swedish).

Oncopeptides would like to emphasize that, since we made the findings of our OCEAN trial, we have on several occasions in contact with a number of various stakeholders in the medical community, pointed out the different treatment effects in patients with multiple myeloma, in line with what is now being reported. The analyses from the Medicines Council are in line with our own scientific analyses and thus complement our findings.

For example, in mid-July, 2021, Oncopeptides reported to the U.S. Food and Drug Administration, FDA, that pomalidomide has a survival benefit that differs by patient age (and age-related factors) without any reflection in surrogate endpoints such as PFS. The same information was provided to U.S. and European authorities in late December 2021, as well as repeatedly during 2022. In August 2023, a detailed memorandum was provided by Oncopeptides to the FDA in that in detail outlines the issue. The same findings were later presented in a joint meeting with the Center for Drug Evaluation and Research, part of the FDA.

The document is publicly available here.

For any questions, please reach out to David Augustsson, Director of Communication and IR: david.augustsson@oncopeptides.com