Oncopeptides has been granted an accelerated approval of PEPAXTO (melphalan flufenamide) in the US, and submitted an application for conditional marketing authorization. The strategy going forward is to ensure a successful commercialization in the US and to develop the product for a potential broadening of the indication, marketing authorization and commercialization in other regions on our own or in collaboration with partners.
The patients have a disease that is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one anti-CD-38 monoclonal antibody, i.e., triple-class refractory multiple myeloma patients.
Following the approval by the FDA, our strategy is to commercialize melphalan flufenamide (also known as melflufen) in the US with our own organization. Based on the outcomes of the phase 3 OCEAN study we may submit a supplementary New Drug Application, to broaden the indication of melflufen. Our intention is to develop melflufen as a backbone in the treatment of relapsed, refractory multiple myeloma.
Increasing geographical footprint
In april 2021, Oncopeptides submitted melflufen to the European Medicines Agency for a potential conditional marketing authorization. During 2021 we will further strengthen our presence in Europe and develop a dedicated medical affairs and commercial organization that can pave the way for a commercial launch. Also, in Europe, our intention is to launch melflufen with our own commercial organization.
While our primary focus is to further expand the organization in the U.S. and Europe to fully support the commercial launch of melflufen, and optimize patient access, we will also explore options to broaden our geographical footprint, through commercial partnerships.
Leveraging technology platform
The new drug development facility in Solna, Sweden will enable us to further expand the development of our PDC platform and generate new drug candidates for other hematological indications where there is a significant unmet medical need. Our goal is to establish a stream of new clinical candidates going forward. In 2021, we expect to select a new candidate drug, and start toxicology studies before year end.