Calliditas’ vision is to leverage its interdisciplinary expertise in pharmaceutical product development to identify, develop and commercialize novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. To achieve this objective, Calliditas intends to pursue the following strategies:
- Rapidly and efficiently advance Nefecon through Phase 3 clinical development and regulatory approval in order to establish a new standard of care for IgAN.
- Maximize the potential of Nefecon, if approved, through commercialization independently and through opportunistic collaborations with third parties.
- Leverage our proprietary formulation and significant experience with drug release technology to explore treatments in select orphan hepatic diseases.
- Enhance our product portfolio by identifying and in-licensing attractive product candidates for renal and orphan diseases.
Calliditas’ strategy is to progress Nefecon through Phase 3 clinical development and towards regulatory approval and subsequent commercialization. Upon potential accelerated approval, Calliditas intends to commercialize Nefecon for IgA nephropathy on a standalone basis in the United States market and most likely through partnerships in other regions.
Calliditas will also selectively explore line extensions for Nefecon in other diseases where there is a strong scientific and clinical rationale and attractive commercial opportunities, such as in certain liver diseases. Calliditas may also selectively consider leveraging the company’s capabilities through accessing additional product candidates with a strong strategic and commercial fit with Nefecon for development and commercialization.