Everest Medicines Collaborates with Kezar Life Sciences to Develop Zetomipzomib in Greater China and other Asian Markets

21 September 2023 | Thursday | News

Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced today it has entered into a collaboration and license agreement with Kezar Life Sciences ("Kezar"), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune mediated and oncologic disorders, to develop and commercialize Kezar's lead drug candidate zetomipzomib, a novel, first-in-class, selective inhibitor of the immunoproteasome for a range of autoimmune diseases including lupus nephritis (LN), in Greater China, South Korea and some Southeast Asian countries.
Image Source : Public Domain

Image Source : Public Domain

"We are glad to form a partnership with Kezar through our cooperation on zetomipzomib, which will add to our existing renal pipeline, and help solidify Everest's leading position in renal and autoimmune diseases in Asia," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "Renal and autoimmune diseases are key therapeutic areas for Everest and we look forward to working closely with our partner on the clinical trials, utilizing Everest's strong expertise in clinical development and regulatory filings, to bring this innovative therapy to the region as quickly as possible."

"Lupus Nephritis is the most common secondary immune-mediated glomerular disease, which may gradually lead to kidney function failure.  In China alone, it is estimated that there are 1 million SLE patients in total, 40-60% SLE patients have renal disease, and the risk of mortality is significantly increased due to renal disease," said Zhengying Zhu, Ph.D., Chief Medical Officer for Internal Medicine at Everest Medicines. "Zetomipzomib can modulate innate and acquired immune responses to down regulate inflammation, which is differentiated from direct immunosuppression. This enables its treatment potential in a wide range of autoimmune diseases including LN and SLE."

"This partnership with Everest Medicines is an important milestone in the development of zetomipzomib," said John Fowler, co-founder and CEO of Kezar. "Everest stood out as an ideal regional partner due to its strong nephrology focus and outstanding team with deep global pharma experience.  It is clear that they understand zetomipzomib's broad potential and that their team will integrate seamlessly with ours to help drive enrollment in PALIZADE, our global lupus nephritis trial.  It's well-known that prevalence rates for many autoimmune diseases, including LN and SLE, are higher in Asia, and we are happy that even more patients in need will now get access to zetomipzomib as a result of this partnership."   

Under the terms of the agreement, Kezar is entitled to receive an upfront payment of $7 million, and clinical and commercial milestone payments of up to $125.5 million, as well as tiered single-digit to low-teens royalties on net sales of products. Everest will also have the option to localize manufacturing.

Everest will join Kezar on PALIZADE, a global, placebo-controlled Phase 2b clinical trial evaluating the efficacy and safety of two dose-levels of zetomipzomib in patients with active LN. PALIZADE was initiated in mid-2023 and targets to enroll 279 patients. Data generated from prior clinical trials provide evidence that zetomipzomib exhibits a favorable safety and tolerability profile and LN patients showed a clinically meaningful overall renal response after 6 months of treatment with zetomipzomib. In addition to LN, Everest and Kezar have the opportunity to collaborate on future clinical trials and indications for the continued development of zetomipzomib.

Among Everest's renal pipeline, Nefecon®, the first-in-disease therapy for the treatment of primary immunoglobulin A nephropathy (IgAN), has been granted priority review for its NDA by the China National Medical Products Administration and is expected to get approval in the second half of this year. In addition, EVER001, a next-generation covalent reversible Bruton's tyrosine kinase (BTK) inhibitor, is in clinical development for the treatment of glomerular diseases. The company also has several programs at discovery stage with the most advanced candidate expected to file an IND next year. In the autoimmune space, Everest completed patient enrollment in a multi-center Phase 3 clinical trial of etrasimod in Asia for the treatment of moderate-severe active ulcerative colitis and aims to file NDA as soon as possible.

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