Melphalan Flufenamide

DUBAI, United Arab Emirates and STOCKHOLM, Sweden, March 27, 2024 (GLOBE NEWSWIRE) -- Oncopeptides AB (STO: ONCO), a biotech company focused on difficult-to-treat cancers, and Vector Pharma FZCO (“Vector”) today announced a collaboration to commercialize Oncopeptides’ flagship drug Pepaxti (melphalan flufenamide) in the Middle East and North Africa (“MENA”) countries of Saudi Arabia, Qatar, UAE, Bahrain, Kuwait, Oman, Algeria, Tunisia, Morocco, Libya, Lebanon, and Iraq. Under the terms of this exclusive agreement, Vector will distribute Pepaxti to patients in the MENA region for the treatment of patients with multiple myeloma. The two parties have agreed on a revenue split on all Pepaxti sales in the region, with Vector carrying all costs through their existing structure in the region. All sales will be made on a named patient basis, meaning doctors request supply of Pepaxti directly from the manufacturer, a method of sales similar to that being employed by Oncopeptides in Greece. “I am excited to announce this regional agreement with Oncopeptides,” says Vector Pharma FZCO Managing Partner Patrick Jordan. “Mutliple Myeloma continues to be a difficult hematological disease that requires a host of therapies to fight back against the disease. In offering Pepaxti, a drug that is fully approved in the EU, to Health Care Providers in the MENA region, they will now have an important and complementing tool in the arsenal to help treat patients in need.” Vector is a leading distributor of drugs against rare diseases in the MENA region, and also a founding member of the World Orphan Drug Alliance, WODA, providing services required for commercialization of orphan drugs in 152 countries on 6 continents. “Providing Pepaxti to patients also outside of Europe is an important value driver for Oncopeptides, and our partnership with Vector, being a member of the World Orphan Drug Alliance, is an important step forward that we believe has the potential to create additional value for both patients and our shareholders,” says Sofia Heigis, CEO of Oncopeptides. “We are happy for our partnership with Vector and look forward to working together as we enter this promising region together. Through their alliance with WODA, this partnership also has the potential to unlock additional geographies in the future, something which is currently under discussion.” Oncopeptides uses its proprietary Peptide Drug Candidate platform (PDC) to develop compounds that rapidly and selectively deliver cytotoxic agents into cancer cells. Pepaxti is a medicine used to treat adults with multiple myeloma (a cancer of the bone marrow) when the cancer has not responded to previous treatments (refractory). It is used in combination with dexamethasone (an anti-inflammatory medicine) in adults who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti‑CD38 antibody, and whose disease has worsened since the last treatment. About Vector Pharma FZCO Vector Pharma was founded in 2019 with the ambition to be the leading full service distributor for rare diseases, oncology and highly specialized therapeutics in the Middle East, North Africa, and Turkish markets. As the only Trace certified full service distributor in the region, Vector has an equal emphasis on patient demand generation through evidence-based medicine, fast track market access solutions, and highest compliance & ethical standards, all the while striving for the best outcomes for patients, prescribers, and partners. Vector Pharma is also a proud founding member of the World Orphan Drug Alliance (WODA) offering its services together with like-minded sister companies in Switzerland, CEE, Russia & CIS, Israel, Greece/Cyprus/Malta, Africa, Greater China, SE Asia & ANZ, Japan/South Korea and Latin America. More information can be found at www.vectorpharma.me or at custops@vectorpharma.me 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. Oncopeptides is developing several new compounds based on its proprietary technology platforms and is listed on Nasdaq Stockholm with the ticker ONCO. For more information see: www.oncopeptides.com

More than a year after the FDA called on Oncopeptides to withdraw Pepaxto (melphalan flufenamide), the Swedish company has finally lost its appeal, and the FDA is withdrawing the drug. Pepaxto initially won an accelerated approval in 2021 as a fifth-line therapy for the blood cancer known as multiple myeloma. In its final decision letter to Oncopeptides, dated Friday, CBER chief Peter Marks wrote that the grounds for withdrawing Pepaxto’s approval have been met because: “(1) the confirmatory study conducted as a condition of accelerated approval did not confirm Pepaxto’s clinical benefit and (2) the available evidence demonstrates that Pepaxto is not shown to be safe or effective under its conditions of use.”