Exelixis’ Collaborator Daiichi Sankyo Launches MINNEBRO (Esaxerenone) Tablets in Japan

Exelixis, Inc. (Nasdaq: EXEL) today announced its partner Daiichi Sankyo Company, Limited (“Daiichi Sankyo”) has launched MINNEBRO (esaxerenone) tablets as a treatment for patients with hypertension in Japan. With Daiichi Sankyo’s first commercial sale of MINNEBRO, Exelixis will receive an associated $20 million milestone payment from Daiichi Sankyo under the terms of the companies’ collaboration agreement. Exelixis anticipates receiving the payment during the second quarter of 2019.

“Daiichi Sankyo’s launch of MINNEBRO in Japan is an important advance for patients with hypertension in Japan, as well as for our two companies,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. “We congratulate Daiichi Sankyo on this milestone and look forward to the company’s further progress in MINNEBRO’s clinical development and commercialization.”

MINNEBRO is a novel mineralocorticoid receptor blocker identified during the prior research collaboration between Exelixis and Daiichi Sankyo and subsequently developed and commercialized by Daiichi Sankyo. The companies entered into their research collaboration in March 2006. MINNEBRO’s regulatory application acceptance in Japan in the first quarter of 2018 triggered a previous $20 million milestone payment, and Exelixis remains eligible for substantial commercialization 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).

About MINNEBRO (Esaxerenone) Tablets

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 (MR) activation has been found to be involved in hypertension, and MINNEBRO is considered to exert an antihypertensive effect by blocking this receptor activation.