It was good news today in Japan as Exelixis, Inc. (NASDAQ:EXEL) has announced that its collaborator Daiichi Sankyo Company has received approval from Japan’s MHLW (Ministry of Health, Labour and Welfare for the esaxerenone tablets, MINNEBRO 1.25 mg, 2.5 mg, and 5 mg.
Good News for Hypertension Patients
Patients with hypertension in the country can now breath with a sigh of relieve with the approval of MINNEBRO. With the approval, it means that MINNEBRO is free for marketing within Japan. There was a submission for approval early February last year basing on the results that included phase 3 clinical trials that were conducted in Japan with essential hypertension patients.
Besides, Sankyo is also ongoing with an evaluation of the effectiveness of the compound in patients in Japan with diabetic nephropathy with the continuing phase 3 pivotal ESAX-DN study. It’s well to say that MINNEBRO approval brings a significant therapeutic option to the Japanese clinicians.
Another Milestone for Exelixis
It’s in March 2006 that Exelixis and Daiichi Sankyo made collaboration and MINNEBRO is the compound that was identified during the companies’ prior research and subsequently developed by Sankyo. For Exelixis, the approval is another significant scientific milestone which joins cobimetinib and cabozantinib from their discovery efforts receiving regulatory approval.
Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis had to congratulate their partners Daiichi Sankyo and indicated that the collaboration revenues would be used in reinvesting businesses, the building of the pipeline as well as pursuing long-term sustainable growth.
The collaboration means Exelixis will receive a total of a $20m milestone payment of the first commercial sale of the partnered compound, MINNEBRO in Japan. Previously in the first quarter, it had received a $20m payment as a result of Sankyo’s associated regulatory application.
Generally, Japanese patients are in for a treat which has a
high number of patients with hypertension according to Japan National Health
and Nutrition. It has been found that excess of mineralocorticoid receptor
activation is involved in hypertension with now MINNEBRO considered exerting
some antihypertensive effect to block the receptor activation. For now,
everything looks positive for Japanese hypertension patients.