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Oncopeptides ensures five years extended market exclusivity for Pepaxti in Europe

MAR

Stockholm, February 15, 2024 – Oncopeptides AB (publ), a biotech company focused on difficult-to-treat cancers, today announces that it will receive an extension of a key patent ensuring market exclusivity for melflufen, marketed in Europe as Pepaxti, in Europe until 2037, an extension of five years.

The so-called supplementary protection certificate (SPC) extension ensures that Oncopeptides will have the exclusive rights to produce and market melflufen in Europe for another five years. The company has previously communicated that it estimates market potential for Pepaxti in Europe at 1.5 billion SEK per year.

“The extended exclusivity on the European market for Pepaxti creates added opportunity for Oncopeptides, and we look forward to being able to continue serving the high unmet need for patients suffering from relapsing, refractory multiple myeloma for even longer, which we believe could create significant benefits for both patients and our shareholders,” says Sofia Heigis, CEO of Oncopeptides.

For more information, please visit www.oncopeptides.com/en where a Q&A for investors will be posted. Oncopeptides intends to also comment further on this event during the presentation of its Q4 2023 report on February 27 at 9.00 CET (invitation to come separately).

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 2024-02-15 10:45 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 ensures five years extended market exclusivity for Pepaxti in Europe

Datum 2024-02-15, kl 10:45
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Oncopeptides ensures five years extended market exclusivity for Pepaxti in Europe
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