Calliditas Therapeutics is a specialty pharmaceutical company focused on developing high value medical products for patients with significant unmet medical needs in niche indications, where the company can partially or completely participate in the commercialization.
Calliditas is focused on the development and commercialization of its lead product candidate Nefecon, which has successfully completed a Phase 2b clinical trial as a potential new treatment for patients with inflammatory kidney disease (IgA nephropathy) who are at risk of progressing to renal failure.
Backed by a strong investor base with a clear long-term vision and a track record of bringing products to the market, Calliditas aims to take Nefecon through a global Phase 3 study to commercialization. In addition, the company has identified other potential uses of Nefecon in niche indications and will investigate the development of these to provide new medications for patients with unmet medical needs.
The company was founded in 2004 under the name Pharmalink AB and is based in Stockholm, Sweden.
Calliditas’s vision is to leverage its interdisciplinary expertise in pharmaceutical product development to identify, develop and market high value new medicines in niche indications in which there is a significant unmet medical need and where the company can partially or completely participate in the commercialization.
Calliditas focuses on projects which fulfill the criteria of addressing niche indications where there is also a time and cost-effective path to market, including through reformulation and repurposing of existing compounds, and/or to address orphan population needs, as it has done with Nefecon.
Calliditas’s 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.
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.
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