Exelixis collaborator, Daiichi Sankyo, Receives Regulatory Approval for MINNEBRO™ (Esaxerenone) Tablets for Hypertension in Japan
Exelixis (EXEL) and Daiichi Sankyo announced that the the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Minnebro™ (esaxerenone) tablets of ,1.25 mg, 2.5 mg, and 5 mg, for hypertension.
Minnebro was identified during a prior research collaboration between Exelixis and Daiichi Sankyo, which was entered into in March 2006. The product has been subsequently developed by Daiichi Sankyo.
The Terms of the Collaboration Agreement:
Exelixis is to 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.
Daiichi Sankyo has been responsible for all subsequent preclinical and clinical development, as well as overseeing regulatory, manufacturing and commercialization activities for the new anti-hypertension drug.
The approval of Minnebro is important for hypertensive patients in Japan for the following reasons:
According to the 2012 Japan National Health and Nutrition Survey there are an estimated 43 million patients with hypertension in the country, that accounts for 60 percent of men and 45 percent of women over the age of 30, in the general Japanese population. Only approximately 30 percent of men and 40 percent of women with hypertension, who are treated with anti-hypertensive medication, typically achieve the goal of systolic and diastolic blood pressure lower than 140/90mm Hg.
This risk of uncontrolled high blood pressure is huge.
Uncontrolled high blood pressure results in life-threatening cardiovascular conditions, including stroke and coronary heart disease. Also, uncontrolled hypertension increases the vulnerability to chronic kidney disease and end-stage renal disease. In Japan, the substantial percentage of middle age Japanese who are not benefiting from their blood pressure treatments constitute a very serious problem.
Excessive mineralocorticoid receptor activation was found to be involved in hypertension. Minnebro’s action is blocking the mineralocorticoid receptor activation resulting in its anti-hypertensive effect.
The approval for essential hypertension was based on the positive results from phase 3 studies including ESAX-HTN. The study is a randomized, double-blind, three-arm parallel group comparison study evaluating the efficacy and safety of Minnebro’s versus eplerenone in patients with essential hypertension in Japan. The primary endpoint is the sitting systolic blood pressure (SBP)/diastolic blood pressure (DBP) change from baseline after 12 weeks of treatment.
Minnebro’s approval is, indeed, a significant scientific milestone for Exelixis. It is the third molecule from Exelixis’ discovery engine to be approved, following the approval and marketing of cabozantinib and cobimetinib. We believe that Minnebro will have the chance to be approved in Japan for other diseases. Daiichi Sankyo is currently evaluating the compound’s effectiveness in Japanese patients with diabetic nephropathy in the ongoing phase 3 pivotal ESAX-DN study.
We congratulate both Exelixis and Daiichi Sankyo on the approval. We also congratulate our subscribers for their bright decision those made to continue holding EXEL during the market volatility and the yo-yoing of the stock’s price, especially when, for no understandable reason and following good news, EXEL was sold instead of being bought.