Press release

Oncopeptides receives positive recommendation for Pepaxti by Spanish Pricing Authority

February 23, 2024 Regulatory

Stockholm, February 23, 2024 – Oncopeptides AB (publ), a biotech company focused on difficult-to-treat cancers, today announces that the Spanish Drug Pricing Authority (CIPM) has published a positive recommendation for the pricing of melflufen, branded in Europe as Pepaxti.

The recommendation from CIPM, formally the Spanish Interministerial Commission on Drug Pricing (Spanish: Comisión Interministerial de Precios de los Medicamentos) is a major step forward in Oncopeptides’ efforts to gain market access in Spain, however well ahead of presumed timelines. The recommendation also reflects the innovation of melflufen and is in line with the financial projections of the company. Following the administrative phase of the process that now commences, a full launch of Pepaxti in Spain could take place already during the second half of 2024.
“We are happy to have taken this decisive step forward in our Spanish market access efforts, quicker than we had expected,” says Sofia Heigis, CEO of Oncopeptides. “This milestone reflects our commitment to bring innovation to patients with an unmet medical need and improving their quality of life.”
The CIPM’s positive proposal will now be turned into a resolution proposal by the Ministry of Health, needing Oncopeptides’ approval. Once approved, a final financing resolution will be issued, and the drug will be listed in the Spanish healthcare registry, allowing healthcare professionals to prescribe it.
Oncopeptides will discuss this event during the presentation of its end-year report on February 27, and communicate further once the agreement with the Spanish Ministry of Health has been finalized.