January 8th, 2010
Kyowa Hakko Kirin and Reata Pharmaceuticals entered into a licensing agreement on bardoxolone methyl in Japan and other selected Asian markets.- Bardoxolone methyl is a small molecule compound currently being developed in Phase II clinical trials in the US by Reata Pharmaceuticals for the treatment of chronic kidney disease in diabetic patients. -
Kyowa Hakko Kirin Co., Ltd. (Kyowa Hakko Kirin) based in Tokyo, Japan and Reata Pharmaceuticals, Inc. (Reata) based in Irving, Texas, USA announced that they have entered into a licensing agreement that provides Kyowa Hakko Kirin with the exclusive right to develop and commercialize Reata’s lead compound, bardoxolone methyl, in Japan, China, Taiwan, Korea and Southeast Asian markets.
Under the terms of the agreement, Reata will receive an up-front payment of $35 million and $97 million in development milestones and also be entitled to receive up to $140 million in sales milestones as well as double-digit royalties from Kyowa Hakko Kirin sales in the licensed territories. Reata retains the rights to develop and commercialize bardoxolone methyl in all other territories not licensed to Kyowa Hakko Kirin.
Bardoxolone methyl activates the Nrf2 gene*1, 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 known that chronic inflammation promotes type 2 diabetes and its complications, including cardiovascular disease and CKD.
In two Phase II trials conducted by Reata in the US, bardoxolone methyl significantly improved renal function in diabetic nephropathy patients (type 2 diabetic patients with CKD). More than 90% of patients in these studies experienced an increase in estimated glomerular filtration rate (eGFR)*2, a marker of renal function, from baseline. Significant improvements were also seen in other markers of renal function, glycemic control, and cardiovascular disease.
Kyowa Hakko Kirin is focusing its efforts to create new medical values, with its core R&D target of oncology, nephrology and immunology fields. The partnership with Reata will enrich the product pipeline in the nephrology field, which provides new therapeutic options to patients and medical professionals and contributes to the treatment of renal disease.
Nrf2 gene activates the production of antioxidant and detoxification proteins. Activation of Nrf2 protects tissues by increasing cellular antioxidant content and suppressing inflammatory signaling pathways (production of inflammatory cytokines).
The eGFR, estimated glomerular filtration rate, is the flow rate of filtered fluid through the kidney and calculated from serum creatinine level, age and sex. The eGFR is a marker of renal function and decreases in patients with kidney disease.
Reata is the leader in discovering and developing novel anti-inflammatory drugs targeting Nrf2, which controls the body's production of antioxidant and detoxification enzymes and has been shown to protect against a broad range of diseases associated with inflammation and oxidative stress. Reata is developing a portfolio of AIMs for a variety of inflammation-related diseases, including renal/cardiovascular diseases, respiratory diseases (COPD), CNS diseases, cancer, and autoimmune diseases. The company's most advanced program is in pivotal trials for the treatment of CKD. For more information, visit www.reatapharma.com.
About Kyowa Hakko Kirin
Kyowa Hakko Kirin Co., Ltd. is a leading biopharmaceutical company in Japan. It had a new start in October 2008 following the merger of Kyowa Hakko Kogyo Co., Ltd. and Kirin Pharma Company, Limited, with the aim of becoming a global specialty pharmaceutical company that creates innovative new drugs. Kyowa Hakko Kirin is focusing its core business areas of oncology, nephrology and immunology to create new value in the life sciences and to contribute to the health and well-being of people around the world. For more information, visit www.kyowa-kirin.co.jp/english/