Eisai revises US Akynzeo deal with Helsinn

The US subsidiary of Japanese pharma major Eisai (TYO: 4523) has agreed to revise the joint promotion agreement with Switzerland’s Helsinn Healthcare for their chemotherapy-induced nausea and vomiting (CINV) franchise.

Under the new arrangement, from April 1, 2016, Helsinn Therapeutics Inc will obtain exclusive rights to promote and sell Akynzeo (netupitant/palonosetron), its oral fixed dose combination product for the prevention of CINV. Akynzeo had previously been co-promoted in the USA by both Helsinn US and Eisai Inc. As part of the revised agreement, Eisai and Helsinn US will continue to co-promote Aloxi (palonosetron HCl) injection in the USA for CINV.

…Withdraws NDA for ultra-high dose mecobalamin

Separately, Eisai announced today that it has withdrawn its new drug application for ultra-high dose mecobalamin (development code: E0302) as a treatment for amyotrophic lateral sclerosis (ALS) in Japan.

On May 27, 2015, Eisai submitted an NDA for mecobalamin seeking approval as a treatment for ALS. As a result of meetings with the Pharmaceuticals and Medical Devices Agency (PMDA), the application package submitted was not sufficient for approval, and therefore Eisai has withdrawn the application. Eisai will carefully reconsider the future development strategy for mecobalamin after consultation with the regulatory authority.