Ex­elix­is/Dai­ichi Sankyo ask Japan­ese reg­u­la­tors for green light on hy­per­ten­sion drug; Bris­tol-My­ers Squibb li­cens­es GPCR tech from Do­main Ther­a­peu­tics

→ San Fran­cis­co’s Ex­elix­is $EX­EL — and its part­ner Dai­ichi Sankyo — has asked Japan­ese reg­u­la­tors for the OK to sell their in­ves­ti­ga­tion­al hy­per­ten­sion drug called esax­erenone. The two com­pa­nies iden­ti­fied the com­pound dur­ing a re­search col­lab­o­ra­tion that start­ed way back in 2006. Fil­ing for the ap­pli­ca­tion gets Ex­elix­is a $20 mil­lion mile­stone pay­ment from Dai­ichi. As esax­erenone ad­vances, Ex­elix­is is el­i­gi­ble for more fu­ture mile­stones and dou­ble-dig­it roy­al­ties on sales. Esax­erenone is an oral se­lec­tive block­er of the min­er­alo­cor­ti­coid re­cep­tor (MR), a nu­clear hor­mone re­cep­tor im­pli­cat­ed in a va­ri­ety of car­dio­vas­cu­lar and meta­bol­ic dis­eases. MR block­ers can be used to treat hy­per­ten­sion and con­ges­tive heart fail­ure due to their vas­cu­lar pro­tec­tive ef­fects, the com­pa­nies said in a state­ment. This new reg­u­la­to­ry ap­pli­ca­tion for the drug is based on re­sults of Phase III stud­ies, in­clud­ing a ran­dom­ized, dou­ble-blind, three-arm par­al­lel group com­par­i­son study look­ing at esax­erenone ver­sus eplerenone in pa­tients with hy­per­ten­sion. Top-line re­sults for that study were pub­lished in Sep­tem­ber 2017, and Dai­ichi plans to pub­lish the full study re­sults at a fu­ture sci­en­tif­ic meet­ing.

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