Everest Medicines Announces Acceptance of Nefecon® New Drug Applications for the Treatment of Primary IgA Nephropathy in Adult Patients in South Korea

Everest Medicines, a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced today that its New Drug Application (NDA) for Nefecon® has been accepted for review by South Korean's Ministry of Food and Drug Safety (MFDS) for the treatment of primary immunoglobulin A nephropathy (IgAN) in adult patients. Nefecon® was the first ever targeted treatment for IgAN approved in the United States, European Union and China. Everest expects to receive NDA approval in South Korea in 2024.

"Everest is committed to expanding Nefecon® regulatory approvals across our licensing territories as IgAN is most prevalent in East Asian population and people of Pacific Asian origin has a significantly increased risk of progressing to end-stage renal disease," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "While we look forward to the imminent launch of this first-in-disease therapy in China, where disease prevalence is approximately five million IgAN patients, we also aim to quickly bring Nefecon® to patients throughout Asia including Singapore, Hong Kong, Taiwan and South Korea over the next year to meet urgent needs for innovative therapies like Nefecon® that target disease origin and can delay disease progression."

South Korea's MFDS granted Global Innovative product on Fast Track (GIFT) designation to Nefecon® earlier this year. Nefecon® was the second product and the first non-oncology product included in MFDS' GIFT program. Inclusion in the GIFT program is expected to accelerate regulatory review time by 25% and allow for rolling review.

The Phase 3 NefIgArd clinical trial, a randomized, double-blind, multicenter study, evaluated the efficacy and safety of Nefecon® at a once-daily dose of 16 mg, compared to placebo, in adult patients with primary IgAN on optimized RASi therapy. The NefIgArd study is a 2-year trial, which consisted of nine months of treatment with Nefecon® or placebo, followed by a 15-month follow-up period off study drug. The primary endpoint, time-weighted average of eGFR over 2 years, showed a statistically significant and clinically meaningful benefit of Nefecon® over placebo (p-value < 0.0001). It also showed a difference in 2-year total eGFR slope of 2.95 mL/min per 1.73 m2 per year in favor of Nefecon®. The data reflected treatment benefits across the entire study population, regardless of UPCR baseline level.

The full two-year results of the NefIgArd trial (n=364 patients) were further analyzed to assess potential differences in response to Nefecon® treatment based on self-reported Asian (n=83) or White (n=275) ancestry in patients with IgAN. Treatment with Nefecon® 16 mg/day over a 9-month period resulted in clinically meaningful preservation of kidney function in both subgroups, as evidenced by reduction in proteinuria and stabilization of eGFR in these two subgroups when compared to placebo.

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.

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