Everest Medicines' Partner Calliditas Therapeutics Announces U.S. FDA Grants an Additional Seven-Year Orphan Drug Exclusivity Period for Nefecon®

SHANGHAI, March 12, 2024 /PRNewswire/ — Everest Medicines (HKEX 1952.HK, “Everest”, or the “Company”)’s licensing partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) announced that the U.S. FDA has granted an orphan drug exclusivity period of seven years for Nefecon^®, expiring in December 2030 based on Calliditas obtaining full approval with a new indication for this drug product in December 2023.

Following full approval in December 2023, Nefecon^® is indicated “to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression”. The exclusivity period reflects the new indication covering all adult patients with primary IgAN at risk of disease progression based on a confirmed reduction of kidney loss reflecting a clinical benefit on kidney function for adult patients with primary IgAN.

“We congratulate our partner for receiving seven more years of market exclusivity for Nefecon^® in the US, which is a further testament of FDA’s recognition of the drug’s capability to preserve kidney function and significantly delay disease progression for all adult patients,” said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. “Nefecon^® represents a revolutionary first-in-disease therapeutic option for Chinese patients who have more rapid disease progression in IgAN with no effective treatment options. Following its NDA approval in mainland China in November and successful commercialization in Macau in December, we now look forward to Nefecon^®‘s imminent commercial launch in mainland China to make the drug available to 5 million IgAN patients as soon as possible.”

South Korea’s Ministry of Food and Drug Safety granted Orphan Drug Designation status for Nefecon^® in November 2022.

About Nefecon^®

Nefecon^® is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. The formulation is designed as a delayed release capsule that is enteric coated so that it remains intact until it releases budesonide to the distal ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum where the disease originates, as per the predominant pathogenesis models.

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 Everest Medicines

Everest Medicines is a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines 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 from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company’s core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com.

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Source : Everest Medicines' Partner Calliditas Therapeutics Announces U.S. FDA Grants an Additional Seven-Year Orphan Drug Exclusivity Period for Nefecon®

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