Reata signs kidney drug deal with Kyowa Hakko Kirin

The USA’s Reata Pharmaceuticals,has secured a major deal with Japan’s Kyowa Hakko Kirin to develop and market its promising chronic kidney disease drug bardoxolone.

Under the terms of the licensing agreement, which covers Japan and other selected Asian markets (including China), Reata is eligible to receive up to $272 million in upfront fees and milestone payments, in addition to double-digit royalties. Bardoxolone activates the Nrf2 gene, which controls the production of over 250 antioxidant and detoxification proteins, the companies note, and in two Phase II trials, the drug significantly improved renal function in type 2 diabetics with advanced CKD.

Reata says that 90% of patients in these studies experienced an increase in estimated glomerular filtration rate (GFR) from baseline, which suggest that bardoxolone may be able to delay or prevent the initiation of dialysis. Significant improvements were also seen in other markers of renal function, glycaemic control and cardiovascular disease.

Warren Huff, Reata’s chief executive, said Kyowa Hakko Kirin “is the clear leader in the renal field in the licensed markets, with an extensive product pipeline and strong sales forces in the field.” He added that the Tokyo-based firm has “a sophisticated understanding of the novel pharmacology of bardoxolone.”

Ken Yamazumi, chief operating officer for Kyowa Hakko Kirin, said “the renal field is one of three strategic focuses of the company” and CKD is “a large and rapidly growing problem in Japan and the rest of Asia”. He added that 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”.

Reata is keeping hold of the rights elsewhere to the compound for the timebeing and signing up Kyowa Hakko Kirin could lead to possible deals in other territories. The Irving, Texas-based firm is thought to be looking at a possible co-promotion deal in the USA.