Dive Brief:
- Merck & Co. has shown that it is staying in the challenging Alzheimer's disease field by signing a deal with Japanese company Teijin Pharma for exclusive worldwide rights to a pre-clinical antibody with potential in this form of dementia.
- Rather than targeting the amyloid plaques, an approach that doesn't seem to have had much impact, the antibody targets the misfolded tau protein, which forms tangles in the brains of people with Alzheimer's disease.
- Although the financial details have not been released, the two companies have announced that Merck & Co. will pay out an upfront payment along with development, regulatory and sales milestone payments and Teijin Pharma retains an option to co-promote an approved product in Japan.
Dive Insight:
Alzheimer's disease research has hit a low of late, with the beta amyloid theory being questioned after some high profile drug failures. This deal demonstrates big pharma's continuing interest in what has potential to be a vast market, and an increasing level of hope being placed on tau as a target. Other companies looking at tau-based drugs include Biogen, AbbVie, Eli Lilly and Aberdeen University spinout TauRx Therapeutics, although the latter has already seen failure at Phase 3 in all but a subset of patients.
"Teijin Pharma scientists have made important progress to advance this investigational anti-tau antibody to this stage of development,” said Darryle Schoepp, VP of neuroscience discovery at Merck Research Laboratories.
The deal is part of Teijin's strategy of creating licensing and collaboration deals for its in house-developed products, under the company's 2017-2019 management plan. Late last year Teijin granted Amgen exclusive rights ex-Japan to potential agents for kidney disease.
This isn't Merck's only toe in the water where Alzheimer's disease is concerned. Merck has developed [18F]-MK-6240, a tau ligand that could have potential as a positron emission tomography (PET) imaging agent to quantify the brain burden of neurofibrillary tangle pathology. This was licensed to Cerveau Technology in January 2017 for development and commercialization, with a Phase 3 trial planned for early 2018.
The company still retains an interest in the beta amyloid theory, however. Despite pulling the plug on the Phase 3 EPOCH study of verubecestat (MK-8931), an inhibitor of the beta-site amyloid precursor protein cleaving enzyme 1 (BACE1), in mild-to moderate Alzheimer's disease, the drug's development is continuing in people with early stage (prodromal) Alzheimer's disease. This study, known as APECS, is expected to read out in February 2019.