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Oncopeptides receives positive recommendation for Pepaxti by Spanish Pricing Authority

MAR

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.

For more information, please contact:
David Augustsson, Director of Corporate Affairs, Oncopeptides AB (publ)
E-mail: david.augustsson@oncopeptides.com
Cell phone: +46 76 229 38 68

This information is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-02-23 12:49 CET.

About Oncopeptides
Oncopeptides is a biotech company focused on research, development, and commercialization of therapies for difficult-to-treat hematological diseases. The company uses its proprietary Peptide Drug Candidate platform (PDC) to develop compounds that rapidly and selectively deliver cytotoxic agents into cancer cells. 

Pepaxti® (melphalan flufenamide, also called melflufen) has been granted Marketing Authorization, in the European Union, the EEA-countries Iceland, Lichtenstein and Norway, as well as in the UK. Pepaxti is indicated in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation. Melflufen has been granted accelerated approval in the US under the trade name Pepaxto®. The drug is currently not marketed in the US.

Oncopeptides is developing several new compounds based on its proprietary technology platforms and is listed on the Small Cap segment on Nasdaq Stockholm with the ticker ONCO. For more information see: www.oncopeptides.com. 

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Oncopeptides receives positive recommendation for Pepaxti by Spanish Pricing Authority

Datum 2024-02-23, kl 12:49
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Oncopeptides receives positive recommendation for Pepaxti by Spanish Pricing Authority
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