Exelixis announced its partner Daiichi Sankyo received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for esaxerenone tablets, MINNEBRO 1.25 mg, 2.5 mg, and 5 mg, as a treatment for patients with hypertension. This approval allows for the marketing of MINNEBRO for this indication within Japan. MINNEBRO is a compound identified during the prior research collaboration between Exelixis and Daiichi Sankyo, which the companies entered into in March 2006, and has been subsequently developed by Daiichi Sankyo.
“The approval of MINNEBRO brings an important new therapeutic option to clinicians in Japan. It also marks a significant scientific milestone for Exelixis, joining cabozantinib and cobimetinib as the third molecule from our discovery efforts to receive regulatory approval,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. “We congratulate our partner Daiichi Sankyo on their superb clinical development program and recent approval. As partnered compounds like MINNEBRO are commercialized, we are committed to using resulting collaboration revenues to reinvest in our business, build our pipeline, and pursue long-term, sustainable growth.”
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Per the collaboration agreement between Exelixis and Daiichi Sankyo, Exelixis will receive a $20 million milestone payment upon the first commercial sale of MINNEBRO in Japan. Exelixis previously received a $20 million milestone payment in the first quarter of 2018 triggered by the filing of Daiichi Sankyo’s associated regulatory application. Exelixis is eligible for substantial commercialization milestones, as well as low double-digit royalties on sales of MINNEBRO. Since the conclusion of Exelixis and Daiichi Sankyo’s joint research period in November 2007, Daiichi Sankyo has been responsible for all subsequent preclinical and clinical development, and also oversees regulatory, manufacturing and commercialization activities for MINNEBRO.
The MINNEBRO approval was based on the results of phase 3 studies including ESAX-HTN, a randomized, double-blind, three-arm parallel group comparison study evaluating the efficacy and safety of esaxerenone versus eplerenone in patients with essential hypertension in Japan, with a primary endpoint of sitting systolic blood pressure (SBP) / diastolic blood pressure (DBP) change from baseline after 12 weeks of treatment. Daiichi Sankyo is also evaluating the compound’s effectiveness in Japanese patients with diabetic nephropathy in the ongoing phase 3 pivotal ESAX-DN study.