Reata
Pharmaceuticals, Inc. (Reata) and Kyowa
Hakko Kirin Co., Ltd. (Kyowa Hakko Kirin) announced today that they
have entered into a licensing agreement that provides Kyowa Hakko Kirin
with the exclusive rights to develop and commercialize Reata’s lead
compound, bardoxolone
methyl (bardoxolone), in Japan and other selected Asian markets.
Under the terms of the agreement, Reata is eligible to receive up to
$272 million in up-front fees and milestone payments, in addition to
double-digit royalties.
“We are looking forward to collaborating with Kyowa Hakko Kirin to bring
bardoxolone to market for the millions of Asian patients who have CKD
and face dialysis without effective treatment options”
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. It is now known that
chronic “metabolic inflammation” promotes Type 2 diabetes and its
complications, including cardiovascular disease and chronic kidney
disease (CKD).
In two
Phase 2 trials, bardoxolone significantly 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. Significant improvements were also
seen in other markers of renal function, glycemic control, and
cardiovascular disease. The observed increases in GFR suggest that
bardoxolone may be able to delay or prevent the initiation of dialysis
in diabetic patients. On the basis of the Phase 2 studies, Reata has
initiated a first pivotal study of bardoxolone in diabetic patients with
advanced CKD.
“We are looking forward to collaborating with Kyowa Hakko Kirin to bring
bardoxolone to market for the millions of Asian patients who have CKD
and face dialysis without effective treatment options,” commented Warren
Huff, CEO of Reata. “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. They bring to this collaboration a
proven track record of developing, marketing, and selling innovative
renal therapies as well as a sophisticated understanding of the novel
pharmacology of bardoxolone.”