IRVING, Texas, March 29, 2018 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (Nasdaq:RETA) (Reata or Company), a clinical-stage biopharmaceutical company, today announced that its licensee, Kyowa Hakko Kirin Co. Ltd. (Kyowa Hakko Kirin), received designation under the Priority Review and Designation System, or SAKIGAKE Designation, by the Japanese Ministry of Health, Labour and Welfare, for bardoxolone methyl (bardoxolone) for the treatment of diabetic kidney disease (DKD).
The Priority Review and Designation System in Japan is designed to accelerate the development of new treatments with the potential to demonstrate significant improvements in efficacy over existing therapies. Designated products are eligible to receive prioritized consultation services and premarket pharmaceutical affairs review by the Japanese regulatory authority.
In December 2009, Reata granted Kyowa Hakko Kirin the exclusive license to develop and commercialize bardoxolone in renal disease and certain other indications in Japan, China, Taiwan, South Korea, and Southeast Asia. Kyowa Hakko Kirin is planning to initiate a Phase 3 clinical study in DKD during 2018 in Japan to validate the efficacy and safety of bardoxolone. Kyowa Hakko Kirin is also currently collaborating with Reata in Japan on the ongoing Phase 3 CARDINAL study for bardoxolone in Alport syndrome, a severe, hereditary form of kidney disease.
About Bardoxolone
Bardoxolone is an experimental, oral, once-daily activator of Nrf2, a transcription factor that activates molecular pathways that promote the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling. The FDA has granted orphan designation to bardoxolone for the treatment of Alport syndrome and pulmonary arterial hypertension. Bardoxolone is currently being studied in CARDINAL, a Phase 3 study for the treatment of Alport syndrome, and CATALYST, a Phase 3 study for the treatment of connective tissue disease associated pulmonary arterial hypertension.
About Reata Pharmaceuticals, Inc.
Reata is a clinical-stage biopharmaceutical company that develops novel therapeutics for patients with serious or life-threatening diseases by targeting molecular pathways involved in the regulation of cellular metabolism and inflammation. Reata’s two most advanced clinical candidates, bardoxolone methyl and omaveloxolone, target the important transcription factor Nrf2 that promotes the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling.
About Kyowa Hakko Kirin
Kyowa Hakko Kirin Co., Ltd. is a research-based life sciences company with special strengths in biotechnologies. In the core therapeutic areas of oncology, nephrology, and immunology/allergy, Kyowa Hakko Kirin leverages leading-edge biotechnologies centered on antibody technologies to continually discover innovative new drugs and to develop and market those drugs world-wide. In this way, the company is working to realize its vision of becoming a Japan-based global specialty pharmaceutical company that contributes to the health and wellbeing of people around the world.
