Abbott has agreed to pay Reata Pharmaceuticals $450 million in up-front and near-term cash payments for exclusive rights to develop and commercialize the latter’s pivotal-stage chronic kidney disease candidate bardoxolone methyl worldwide, excluding the U.S. and certain Asian markets. The deal also gives Abbott rights to certain other Reata compounds for chronic kidney disease, cardiovascular, and metabolic indications in the same territories. In addition to the initial cash payments, the firm will also make a minor equity investment in Reata and pay royalties on future product sales.
In December 2009 Reata teamed up with Kyowa Hakko Kirin to develop bardoxolone jointly in Japan and certain other Asian markets. Abbott claims the Reata drug represents a promising new addition to its late-stage pipeline and will build on its existing expertise in renal care. “Early clinical studies suggest that bardoxolone could be a significant improvement to the current standard of care for chronic kidney disease and possibly prevent patients from progressing to the later stages of the disease and dialysis,” remarks John Leonard M.D., senior vp of pharmaceuticals R&D at Abbott.
Bardoxolone is an oral antioxidant inflammation modulator (AIM) that activates the transcription factor Nrf2, which Reata says ultimately leads to a decrease in the level of oxidative stress and suppresses a number of inflammatory mediators. Phase II studies with the drug in patients with stage 3b and 4 chronic kidney disease and type 2 diabetes have shown that treatment results in statistically significant increases in estimated glomerular filtration rate and improvements in other key markers of renal function, the firm points out.
Reata specializes in the discovery and development of oral anti-inflammatory drugs targeting Nrf2, a target that the firm says has been shown to protect against a broad range of diseases associated with inflammation and oxidative stress. Bardoxolone is the firm’s lead compound; it has completed a pivotal Phase IIb study and is poised to start in a pivotal Phase III study. Pivotal studies in nondiabetic chronic kidney disease patients are also being planned.
In July Reata raised $78 million in an equity financing round with existing investors, which it says will fund completion of the clinical development program for bardoxolone. At the time the firm projected the drug could be on the market by 2012. It says estimates suggest the worldwide market for chronic kidney disease therapeutics was approximately $13 billion in 2009 and will grow to $20 billion by 2016.
Reata is separately developing Nrf2-activating candidates against CNS diseases, based on a series of oral AIM molecules that can cross the blood-brain barrier and achieve high concentrations in central nervous system tissues. Potential candidates for the treatment of multiple sclerosis and chronic obstructive pulmonary disease are in preclinical development. Reata‘s preclinical pipeline also includes a superoxide dismutase 1 protein folding stabilizer for the potential treatment of amyotrophic lateral sclerosis, which has shown promising results in animal models.