Everest Medicines, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced that it has entered into a license agreement with Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) to develop and commercialize NEFECON for the treatment of primary IgA nephropathy (IgAN) in South Korea, expanding its license in addition to rights held in Greater China and Singapore. The deal signals the Company’s latest efforts to further enhance its international commercial footprint.
“We’re thrilled to strengthen our partnership with Calliditas by extending our license agreement to include South Korea and working towards our shared vision of developing and commercializing NEFECON as a potential novel therapy for the treatment of IgAN globally,” said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. “While primary IgAN is more common in Asia than elsewhere in the world, there are no established treatments for patients living with the chronic condition, underscoring the significant and urgent unmet need for innovative medicines.”
“South Korea is the third largest pharmaceutical market in the Asia Pacific region —after China and Japan—and represents tremendous opportunity,” said Kevin Yong Guo, Chief Commercial Officer of Everest Medicines. “South Korea’s sophisticated healthcare model enables innovative medicines such as NEFECON to have a higher potential likelihood of healthcare coverage once approved. We look forward to working closely with all contributing parties to bring NEFECON to patients living with IgAN in South Korea as quickly as possible.”
“We continue to have a fruitful and positive collaboration with Everest and are delighted that we have come to an agreement also around South Korea,” said CEO Renée Aguiar-Lucander of Calliditas.
NEFECON (approved in the United States under accelerated approval under another trade name) is an oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. NEFECON was designed as a 4 mg delayed release capsule and is enteric coated so that it would remain intact until it reaches the ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum, including the Peyer’s patches, which are responsible for the production of galactose-deficient IgA1 antibodies (Gd-Ag1) causing IgA nephropathy. It is unclear to what extent NEFECON’s efficacy is mediated via local effects in the ileum vs systemic effects. In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize NEFECON in Mainland China, Hong Kong, Macau, Taiwan and Singapore. The agreement was extended in March 2022 to include South Korea as part of Everest Medicine’s territories.