Strategy - Refocusing the company
The voluntary withdrawal of Pepaxto in the US on October 22, 2021 and the major implications this had on business operations, research and development, and the organization, creates a framework for the strategic direction.
Shortly after the withdrawal, Oncopeptides refocused on R&D and scaled down the organization to increase cash runway and build a platform for longer term development and growth. A significant part of the clinical program was discontinued, and the company decided to continue to support the EMA-filing for marketing authorization of melflufen in Europe.
Science is leading the way
In January 2022, Oncopeptides rescinded the voluntary withdrawal of Pepaxto in the US based on further review and analyses of the heterogeneous
overall survival data from the OCEAN study, and other relevant trials. Pepaxto is once again an approved drug in the US. However, it will not be marketed until the company and the FDA have reached an agreement on how to interpret and assess the data.
Oncopeptides has shared comprehensive data with the regulatory agencies in the US and Europe. How these analyses will be interpreted by regulators, scientific communities, and key opinion leaders during the coming months will, regardless of the outcome, influence the future direction of Oncopeptides. The data may have an impact on how OCEAN results are interpreted, and how melflufen may be used in the treatment of Relapsed Refractory Multiple Myeloma (RRMM). Near-term priorities for 2022 are shown in the illustration to the right.
- Potential approval in Europe
The regulatory process with EMA, for a Marketing Authorization of melflufen in Europe, is moving forward according to the timetable. An expert opinion from CHMP is expected in Q2, followed by potential approval by the EU Commission in Q3-2022.
- Regulatory path forward in the US
The dialogue with the FDA is aiming to reach a mutual understanding of the OCEAN data, and an agreement on the regulatory path forward, based on the company’s in-depth analyses of the heterogeneous overall survival data from OCEAN and other relevant trials. The dialogue with FDA is a priority for Oncopeptides, however the FDA has no formal process for the agency interaction, and thus the company cannot specify how long this will take.
- Commercial partnership
Given a successful interaction with the regulatory authorities, Oncopeptides will consider various options to launch the product in the US and on key European markets. The alternatives that will be evaluated include a commercialization together with one or several partners or a subsequent development of an own commercial organization on local markets. The purpose is to make melflufen available for patients, optimize market penetration and maximize shareholder value.
Leveraging technology platform
The 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.