Kyowa Hakko Kirin is paying $35 million for rights to Reata Pharmaceuticals’ Phase III chronic kidney disease (CKD) drug bardoxolone methyl in Japan and other select Asian markets. Reata is eligible to receive up to $97 million in development milestones and $140 million in sales milestones in addition to escalating double-digit royalties.
Kyowa Hakko Kirin will have the exclusive rights to develop, market, and sell bardoxolone for CKD and related indications in Japan, China, Taiwan, Korea, and Southeast Asian countries. Reata retains the rights to develop and commercialize bardoxolone in all other territories including the U.S., Europe, Latin America, and Asian markets not licensed to Kyowa Hakko Kirin.
Bardoxolone activates the Nrf2 gene, which controls the production of over 250 antioxidant and detoxification proteins. Activation of Nrf2 protects tissues by increasing cellular antioxidant content and suppressing inflammatory signaling pathways, the companies explain. It is now known that chronic metabolic inflammation promotes type 2 diabetes and its complications including cardiovascular disease and CKD.
The firm has initiated a first Phase III study in diabetic patients with advanced CKD. In two Phase II trials, bardoxolone reportedly improved renal function in type 2 diabetic patients with advanced CKD. Ninety percent of patients in these studies experienced an increase in estimated glomerular filtration rate (GFR) from baseline. This suggests that bardoxolone may be able to delay or prevent the initiation of dialysis in diabetic patients. Significant improvements were also seen in other markers of renal function, glycemic control, and cardiovascular disease, according to Reata.
“CKD is a large and rapidly growing problem in Japan and the rest of Asia,” points out Ken Yamazumi, Ph.D., COO of Kyowa Hakko Kirin. “The Phase II data with bardoxolone suggests for the first time that a drug may be able to arrest or reverse progression of the disease.”