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Oncopeptides receives first order of Pepaxti in Italy

Stockholm – March 11, 2025 – Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on difficult-to-treat cancers, today announces that it has received the first order of its flagship drug Pepaxti (melflufen) from an Italian hospital.

Following the positive reimbursement decision and publication in the Gazzetta Ufficiale, Pepaxti has now entered the Italian healthcare system. This allows hospitals to, in certain cases, order the product even before full regional access has been finalized.

“The speed at which Pepaxti has moved from regulatory approval to first patient treatment in Italy is a testament to the high unmet need for new options in relapsed and refractory multiple myeloma,” says Sofia Heigis, CEO of Oncopeptides. “Italy has played a key role in the clinical development of Pepaxti, and we are pleased to see physicians and patients now gaining access to this important treatment so quickly.”

Italy has a strong foundation of clinical experience with Pepaxti, with 79 patients across 10 hospitals participating in its clinical trials and over 80 patients treated in the Early Access Program (EAP) before formal reimbursement. The country has an estimated 6,000 new cases of multiple myeloma annually, with approximately 1,800 patients within Pepaxti’s target population.

Oncopeptides is currently expanding its team in Italy and investing in regional access along with awareness and education initiatives to support the launch of Pepaxti.
For more information, please visit www.oncopeptides.com.

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

About Oncopeptides
Oncopeptides is a Swedish biotech company focusing on research, development and commercialization of targeted therapies for difficult-to-treat cancers. 

The company uses its proprietary Peptide Drug Candidate platform (PDC) to develop compounds that rapidly and selectively deliver cytotoxic agents into cancer cells. Its flagship drug is currently being commercialized in Europe with partnership agreements for South Korea, the Middle East and Africa and elsewhere.

Oncopeptides is also developing several new compounds based on its two proprietary technology platforms PDC and SPiKE.

The company was founded in 2000, has about 80 employees with operations in Sweden, Germany, Austria, Spain and Italy. Oncopeptides is listed on Nasdaq Stockholm with the ticker ONCO.

For more information see: www.oncopeptides.com

About Pepaxti
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.

Source: Oncopeptides