Everest will obtain exclusive rights to develop and commercialise zetomipzomib in Greater China, South Korea, and other South Asian markets in exchange for an initial upfront payment of $7m and milestone payments of up to $125.5m and tiered royalties
Everest to develop and market Kezar’s zetomipzomib. (Credit: Steve Buissinne from Pixabay)
US-based biotechnology company Kezar Life Sciences has signed a collaboration and licence agreement with Everest Medicines, a China-based biopharmaceutical company, to develop and commercialise its zetomipzomib in certain Asian markets.
Kezar’s lead drug candidate, zetomipzomib is a novel, selective immunoproteasome inhibitor with a wide-ranging therapeutic potential across multiple autoimmune diseases.
Under the terms of the agreement, the US-based firm will receive an initial upfront payment of $7m, along with clinical and commercial milestone payments of up to $125.5m.
Everest will obtain exclusive rights to develop and commercialise zetomipzomib in Greater China, South Korea, Singapore, Malaysia, Thailand, Indonesia, Vietnam, and the Philippines.
The Chinese company will also pay tiered royalties on net sales of the product and can also localise the manufacturing.
Kezar co-founder and CEO John Fowler said: “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 enrolment 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 potentially get access to zetomipzomib as a result of this partnership.”
As part of the collaboration, Everest Medicines and Kezar will jointly conduct PALIZADE, a Phase 2b placebo-controlled, randomised, double-blind clinical trial of zetomipzomib.
The Phase 2b study aims to evaluate the efficacy and safety of two dose levels of zetomipzomib in patients with active lupus nephritis (LN), in Greater China, South Korea and Southeast Asia.
In the study, 279 patients will be randomly assigned to receive 30mg zetomipzomib, 60mg zetomipzomib or placebo, once weekly for 52 weeks.
Everest will contribute its local regulatory and clinical trial expertise for the PALIZADE trial and will fund the study expenses in the licensed territories.
In addition to LN, Kezar and Everest may also collaborate on future clinical trials and indications for the continued development of zetomipzomib.
Everest Medicines internal medicine chief medical officer Zhengying Zhu said: “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% of SLE patients have renal disease, and the risk of mortality is significantly increased due to renal disease.
“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.”