The agreement signals the company’s latest efforts to further strengthen its international business footprint
SHANGHAI, March 13, 2022 /PRNewswire/ — Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceuticals to address critical unmet needs in Asia Pacific markets, today announced that it has entered into a licensing agreement with Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) to develop and commercialize NEFECON for the treatment of primary IgA (IgAN) nephropathy in South Koreaextending its license in addition to the rights held in Greater China and Singapore. The agreement signals the company’s latest efforts to further strengthen its international business footprint.
“We are delighted to strengthen our partnership with Calliditas by extending our license agreement to include South Korea and work toward our shared vision for the development and commercialization of NEFECON as a potential new therapy for the treatment of IgAN globally,” said Kerry Blanchard, MD, PhD, President and CEO of Everest Medicines. “While primary IgAN is more common in Asia that elsewhere in the world, there are no established treatments for patients with this 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 a tremendous opportunity,” said Kevin Yong Guo, commercial director of Everest Medicines. “South Korea A sophisticated healthcare model allows innovative medicines such as NEFECON to have a greater 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 we are delighted to have reached an agreement also around South Korea“said CEO Renée Aguiar-Lucander of Calliditas.
In the coming months, Everest Medicines will work with the Ministry of Food and Drug Safety of South Korea prepare regulatory filings and a New Drug Application (NDA) for NEFECON for the treatment of primary IgAN.
Under the terms of the agreement, Calliditas receives an initial upfront payment of 3 million US dollars upon signing the agreement.
NEFECON (approved in United States under accelerated approval under another trade name) is a delayed-release oral formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes extensive first-pass metabolism. NEFECON was designed as a 4mg delayed release capsule and is enteric coated so it remains intact until it reaches the ileum. Each capsule contains budesonide-coated beads that target mucosal B cells found in the ileum, including Peyer’s patches, which are responsible for the production of galactose-deficient IgA1 (Gd-Ag1) antibodies causing IgA nephropathy. It is unknown to what extent the efficacy of NEFECON is mediated by local effects in the ileum versus systemic effects. In June 2019Everest Medicines has entered into an exclusive, royalty-based license agreement with Calliditas, which grants Everest Medicines the exclusive rights to develop and commercialize NEFECON in mainland China, hong kong, Macau, Taiwan and Singapore. The agreement was extended in March 2022 include South Korea as part of the Everest Medicine territories.
About Primary Immunoglobulin A Nephropathy
Primary immunoglobulin A nephropathy (IgA or IgAN nephropathy or Berger’s disease) is a chronic progressive autoimmune disease that attacks the kidneys and occurs when galactose-deficient IgA1s are recognized by autoantibodies, creating IgA1 immune complexes which are deposited in the glomerular mesangium of the kidney. .1.2 This deposition in the kidney can lead to progressive kidney damage and potentially a clinical course leading to end-stage renal disease. IgAN most often develops between the late teens and late thirties.2,3
About drugs Everest
Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address the critical unmet medical needs of patients in Asian markets. Everest Medicines’ management team has deep expertise and extensive experience in high quality clinical development, regulatory affairs, CMC, business development and operations in both China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of eleven potentially first-in-class or best-in-class molecules, many of which are in late-stage clinical development. The Company’s therapeutic areas of interest include oncology, autoimmune diseases, cardio-renal diseases and infectious diseases. For more information, please visit their website at www.everestmedicines.com.
Calliditas Therapeutics is a biopharmaceutical company headquartered in Stockholm, Sweden, focused on the identification, development and commercialization of new treatments in orphan indications, with an initial focus on kidney and liver diseases with significant unmet medical needs. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select Market (ticker: CALT). Visit www.calliditas.com for more information.
1 Barratt, J., & Feehally, J. (2005). IgA nephropathy. J Am Soc Nephrol. 16(7), 2088-2097. https://doi.org/10.1681/ASN.2005020134
2 Barratt, J., Rovin, BH, Cattran, D., et al. (2020). Why target the gut to treat IgA nephropathy? Kidney Int Rep. 5(10), 1620-1624. https://doi.org/10.1016/j.ekir.2020.08.009
3 Jarrick, S., Lundberg, S., Welander, A., et al. (2019). Mortality in IgA nephropathy: a national population-based cohort study. J Am Soc Nephrol. 30(5), 866-876. https://doi.org/10.1681/ASN.2018101017
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SOURCE Everest Medicines