Protocols

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.

Bristol-Myers Squibb $BMY now has access to a G protein-couple receptors biosensor technology called bioSens-All, through a new licensing agreement with France- and Quebec-based Domain Therapeutics. The deal covers an upfront as well as additional payments upon identification of development candidates, though details were not disclosed. BioSens-All helps drug developers understand what happens when a molecule binds to a target by generating and analyzing signaling data on GPCR drug candidates. The biotech, which has an office in Strasbourg, first licensed the tech from a group of researchers across several Canadian universities.

→  DBV Technologies $DBVT says it came out of a mid-stage study of a new therapy for milk allergies with enough positive data to support a pivotal late-stage program. The data aren’t great, though. Researchers say their 300 µg dose was most effective for children (intent-to-treat (ITT), p=0.042).


With additional reporting from Brittany Meiling.


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