Everest Medicines Enters into Agreement with Calliditas Therapeutics, Expanding Territory License to Develop and Commercialize NEFECON in South Korea

Deal signals Company's latest efforts to further enhance its international commercial footprint

SHANGHAI, March 13, 2022 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced today 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.

In the coming months, Everest Medicines will collaborate with the Ministry of Food and Drug Safety of South Korea to 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 USD$3 million at signing of the agreement.

About NEFECON 

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.

About Primary Immunoglobulin A Nephropathy

Primary immunoglobulin A nephropathy (IgA nephropathy or IgAN or Berger's Disease) is a progressive, chronic autoimmune disease that attacks the kidneys and occurs when galactose-deficient IgA1 are recognized by autoantibodies, creating IgA1 immune complexes that become 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 resulting in end- stage renal disease. IgAN most often develops between late teens and late 30s.^2,3

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of eleven potentially global 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 disorders, cardio-renal diseases and infectious diseases. For more information, please visit its website at www.everestmedicines.com.

About Calliditas

Calliditas Therapeutics is a biopharma company headquartered in Stockholm, Sweden, focused on identifying, developing, and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic 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 further 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, B. H., 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 Nationwide Population-Based Cohort Study. J Am Soc Nephrol. 30(5), 866-876. https://doi.org/10.1681/ASN.2018101017

Forward-Looking Statements:

This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.

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SOURCE Everest Medicines