Policy & Regulation
Exelixis' Collaborator Daiichi Sankyo Launches Minnebro Tablets in Japan
17 May 2019 - - US-based biotechnology company Exelixis, Inc.'s (NASDAQ: EXEL) partner, Japan-based Daiichi Sankyo Company, Ltd. has launched Minnebro (esaxerenone) tablets as a treatment for patients with hypertension in Japan, the company said.

With Daiichi Sankyo's first commercial sale of Minnebro, Exelixis will receive an associated USD 20m milestone payment from Daiichi Sankyo under the terms of the companies' collaboration agreement. Exelixis anticipates receiving the payment during 2Q19.

Minnebro is a novel mineralocorticoid receptor blocker identified during the prior research collaboration between Exelixis and Daiichi Sankyo and subsequently developed and commercialised by Daiichi Sankyo.

The companies entered into their research collaboration in March 2006.

Minnebro's regulatory application acceptance in Japan in 1Q18 triggered a previous USD 20m milestone payment, and Exelixis remains eligible for substantial commercialisation milestones, as well as low double-digit royalties on Minnebro sales.

Daiichi Sankyo is also conducting an ongoing phase 3 trial of esaxerenone in patients with diabetic nephropathy in Japan (ESAX-DN).

Minnebro (Esaxerenone) tablets (1.25 mg, 2.5 mg and 5 mg) are approved by the Japanese Ministry of Health, Labour, and Welfare as a treatment for patients with hypertension in Japan.

The application for approval was submitted in Japan in February 2018 on the basis of results that included data from a phase 3 clinical trial conducted in Japan (ESAX-HTN study) in patients with essential hypertension.

Excessive mineralocorticoid receptor activation has been found to be involved in hypertension, and Minnebro is considered to exert an antihypertensive effect by blocking this receptor activation.

According to the 2012 Japan National Health and Nutrition Survey, there are an estimated 43m patients with hypertension in the country, which accounts for 60% of men and 45% of women over the age of 30 in the general Japanese population.

Only approximately 30% of men and 40% of women with hypertension who are treated with antihypertensive medication typically achieve the goal of systolic and diastolic blood pressure lower than 140/90mm Hg.

Hypertension is one of the major risk factors for cardiovascular disease, such as stroke and coronary heart disease, and the condition also raises the risk of chronic kidney disease and end-stage renal disease.

Essential hypertension is the most common form of hypertension, affecting 90% of hypertensive patients, and is associated with heterogeneous contributory factors such as genetics and lifestyle habits, while secondary hypertension is associated with identified underlying disease factors.

Founded in 1994, Exelixis, Inc. (NASDAQ: EXEL) is an oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers.
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