Exelixis’ collaborator Daiichi Sankyo launches MINNEBRO tablets in Japan

— First commercial sale triggers $20 million milestone payment to
Exelixis —

ALAMEDA, Calif.–(BUSINESS WIRE)–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.

Featured image, for illustration: Tablets (provided to the article by pharmaceutical daily)