- Several years ago, Biogen Inc. teamed up with Japan's Eisai Co. Ltd. to hedge its bets in regards to the potential Alzheimer's disease treatments both companies were developing, opting to share both development costs and profits.
- Now that those treatments have moved forward a bit, Eisai has opted into the 2014 licensing agreement, establishing commercialization agreements for Biogen's yet-to-be approved aducanumab, as well as its already-marketed portfolio of multiple sclerosis treatments.
- Under the deal, Biogen will receive 55% of the profits from aducanumab in the U.S. and 68.5% of the profits for the drug in Europe. Eisai, on the other hand, will receive 80% of the profits from the Alzheimer’s disease drug in Japan and other Asian nations, with a 50:50 split in the rest of the world.
Under the original deal, Biogen and Eisai had agreed to begin developing two Alzheimer's disease candidates that Eisai had brought to the table. The Japanese company had developed the beta amyloid precursor protein cleaving enzyme (BACE) inhibitor E2609 in-house and had developed BAN2401 through a collaboration with BioArctic Neuroscience AB. That agreement also left Eisai the option to help develop and commercialize two Alzheimer's compounds that Biogen had developed.
Fast forward three-plus years and Eisai is ready to opt in, showing its confidence that aducanumab could actually make it to market.
Alzheimer's disease development has been notoriously difficult, but could be a huge market should any therapy prove to be disease-modifying. So far, the field has been scarred by dozens of late-stage failures largely due to lack of efficacy.
While most big pharmas have now pulled away from the risky development space, a few have persevered, pushing development into earlier and earlier patient populations in hopes of seeing a result. (Check out BioPharma Dive's recent Spotlight on Alzheimer's disease for a deeper look.)
Biogen's aducanumab is considered one of the hottest prospects in the space. The drug showed that it could have the potential to reduce the accumulation of amyloid plaque — thought to be a potential cause of the devastating neurological disease —and had the potential to slow cognitive decline. But those results were from a Phase 1b trial and are too early to tell if the drug really works.
The study was enough for Biogen though, pushing the big biotech to begin two Phase 3 studies of aducanumab. Those studies aren't expected to read out until 2019 and 2020.
Biogen will continue funding the development of aducanumab by itself until April 2018. Eisai will pay 15% of costs from April until December. After that time, the Japanese pharma will fund 45% of development costs.
The new agreement also changes the milestone structure of the original deal. No upfront will be paid by either company for the opt-in to aducanumab and there will no longer be milestone payments related to aducanumab or BAN2401.
In addition to the terms around aducanumab, Eisai will co-promote Biogen’s multiple sclerosis treatments, Avonex (interferon beta-1a), Tysabri (natalizumab) and Tecfidera (dimethyl fumarate) in Japan to those accounts that Biogen currently does not call upon.
"The fact that Eisai has decided to opt-in helps further validate aducanumab's potential in our view, and perhaps diminishes confidence in BAN2401, which most investors do not believe will work anyway," wrote a Mizuho analyst in a Oct. 23 note to clients.