Everest Medicines Announces The China Center for Drug Evaluation, National Medical Products Administration Recommends Breakthrough Therapy Designation for Nefecon for the Treatment of IgA Nephropathy

SHANGHAI, China, Dec. 02, 2020 (GLOBE NEWSWIRE) -- Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, today announced that the China Center for Drug Evaluation, National Medical Products Administration (CDE, NMPA) has recommended Breakthrough Therapy Designation (BTD) for Nefecon for the treatment of IgA nephropathy (IgAN).

Nefecon is a potential first-in-disease, oral, targeted-release formulation of budesonide and is currently being investigated in a Phase 3 global registrational study, NefIgArd, to evaluate its efficacy and safety in patients with primary IgAN. Everest is currently enrolling patients as part of the NefIgArd clinical trial to support approval for IgAN patients in China.  

Everest Medicines’ licensing partner, Calliditas Therapeutics AB (NASDAQ: CALT) ("Calliditas") reported positive topline results on November 8, 2020 from Part A of the global NefIgArd trial demonstrating Nefecon met its primary endpoint of a statistically significant reduction in urine protein creatinine ratio, or proteinuria, after 9 months of treatment, with significant continued improvement at 12 months. In addition, Nefecon has been granted Orphan Drug Designation for the treatment of IgAN by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).

“We are thrilled that the CDE has recommended Breakthrough Therapy Designation for Nefecon, reinforcing its potential to serve as the first-ever therapeutic option for an estimated 2 million people living with IgAN in China,” said Zhengying Zhu, PhD, Chief Medical Officer for Internal Medicine at Everest Medicines. “We look forward to working closely with the CDE to bring this innovative treatment to patients in China as quickly as possible.”

“Nefecon continues to experience rapid global clinical and regulatory advancements, and in just a few short months has achieved positive top-line data from the NefIgArd Phase 3 global registrational study, first patient dosed and continued enrollment and treatment in NefIgArd in China, and now recommendation for Breakthrough Therapy Designation in China,” said Kerry Blanchard, MD, PhD, CEO of Everest Medicines. “We are encouraged by the pace and progress of this important global registrational clinical trial and are committed to accelerating Nefecon’s late-stage development in order to bring this novel therapeutic to IgAN patients in China.”

BTD, which is part of the recently revised Drug Registration Regulation, is designed to expedite the development and review of therapies in China that are being developed for treatment of serious diseases for which there is no existing treatment and where preliminary evidence indicates advantages of the therapy over current available treatment options.

About Nefecon

Nefecon, an oral, targeted-release formulation of budesonide, is a potential first-in-disease product for the treatment of IgA nephropathy. This novel formulation delivers budesonide to the Peyer’s patch in the ileum, which is responsible for the production of secretory immunoglobulin A (IgA). Treatment with Nefecon was previously demonstrated to cause a statistically significant reduction in proteinuria levels and stabilization of eGFR, compared to placebo, in a randomized, double-blind Phase 3 clinical trial conducted by our partner Calliditas Therapeutics AB (Nasdaq: CALT). Nefecon has been granted Orphan Drug Designation for the treatment of IgAN by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). 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.

About IgA Nephropathy

IgA nephropathy (IgAN), a leading cause of chronic kidney disease (CKD) and renal failure, is a chronic, progressive, autoimmune disease associated with progressive renal impairment. A central finding in patients with lgAN is the presence of circulating and glomerular immune complexes comprised of galactose-deficient IgA1, an IgG autoantibody directed against the hinge region O-glycans, and C3. Glomerular sclerosis, renal interstitial fibrosis, renal dysfunction, proteinuria and hypertension are associated with disease progression. 50% of IgAN patients will develop end stage renal disease within 30 years. The standard of care for ESRD is dialysis or kidney transplant, which represents a significant health economic burden as well as a material impact on patients' quality of life. Currently, there are no approved treatments for IgAN in China and globally.

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 Greater China and other 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 eight 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 .

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