STOCKHOLM, Nov. 9, 2022 /PRNewswire/ — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces the estimated market potential for Pepaxti® in Europe. The potential assumes that the Company’s pending type 2 variation submission to the European Medicines Agency based on OCEAN data, will be approved by the agency, and enable patients with relapsed refractory multiple myeloma access to the drug in an earlier treatment line. Furthermore, the market potential assumes that price negotiations will reflect the degree of innovation of the drug and the clinical benefit to the patients.
“The approval of Pepaxti in EU and EEA-countries in August, set the stage for a new and exciting phase for Oncopeptides,” says Jakob Lindberg, CEO of Oncopeptides. “With the ongoing launch in Germany we are entering a European market with potential revenue of approximately 1.5-2.0 billion SEK, based on a type 2 variation label.”
The European Commission has granted Pepaxti, in combination with dexamethasone, Marketing Authorization in the European Union and countries in the European Economic Area, 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.
For more information, please contact
Global Head of Corporate Communications, Oncopeptides AB (publ)
E-post: [email protected]
Mobil: + 46 70 262 96 28
The information in the press release 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 person above, on November 9, 2022, at 07:57 (CET).
About Oncopeptides
Oncopeptides is a global biotech company focused on research and development 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. On August 18, 2022, the European Commission granted Pepaxti® (melphalan flufenamide, also called melflufen) Marketing Authorization in the European Union and countries in the European Economic Area, 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.
Oncopeptides is developing several new compounds based on its technology platforms. The company is built on a Swedish innovation and is listed in the Mid Cap segment on Nasdaq Stockholm with the ticker ONCO. More information is available on www.oncopeptides.com.
The following files are available for download:
SOURCE Oncopeptides AB
