Oncopeptides’ strategy is to develop melflufen to the point of marketing approval and then move to commercialise the product either by the Company itself or in collaboration with a partner or partners.
Key elements of the Oncopeptides strategy include:
- Submitt a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for accelerated market approval in the United States based on available data from the pivotal HORIZON study.
- Development of melflufen for the treatment of relapsed and refractory multiple myeloma patients through multiple phase 3 clinical studies including OCEAN and LIGHTHOUSE
- Further build a commercial presence in the US and prepare for the European market. This is done in parallel to evaluating one or more collaboration partners
- Based on pre-clinical data, continue research into and development of melflufen for use in the treatment of other types of cancer
IP and Orphan Drug Designation
Melflufen has been granted orphan drug status in both the US and Europe, which provides benefits including market exclusivity for seven and ten years respectively. Orphan drug status is granted to treatments that target rare diseases where it is unlikely that the costs of developing such treatments would be recovered through sales.
Oncopeptides AB has an active patent strategy encompassing all major geographic markets including the US, Europe, Canada and Japan. The company has secured five patent families consisting of more than 24 granted patents and 26 pending patent applications in major markets across the world, including the US, Europe, Canada and Japan and there is the potential for some of these to be extended following the granting of marketing approval. Oncopeptides AB has patents granted and patent applications pending covering melflufen, its formulations, manufacturing processes and its medical applications.
Oncopeptides AB also has significant know-how invested in its proprietary freeze-dried formulation.