Teijin Pharma granted Merck exclusive global rights to develop, manufacture, and commercialize a preclinical-stage anti-tau antibody. Merck says the antibody candidate will complement its existing Alzheimer’s disease (AD) portfolio, which includes the late clinical-stage, small-molecule candidate verubecestat (MK-8931). Verubecestat inhibits beta-site amyloid precursor protein cleaving enzyme 1 (BACE1) and is currently undergoing evaluation in the Phase III APECS study in patients with prodromal AD.
Merck has also developed an early-clinical-stage tau ligand [18F]-MK-6240 as a potential positron emission tomography (PET) imaging agent for quantifying neurofibrillary tangles in AD patients. In January, the firm granted Cerveau Technologies global rights to develop and commercialize the imaging agent. The firms were conducting an open-label Phase I study, and Cerveau said it planned to start a Phase III clinical program during early 2018.
No financial details of the deal between Merck and Teijin were disclosed, but the Japanese firm will receive an up-front payment from Merck and will be eligible for development, regulatory, and commercial milestones, plus sales royalties.
Teijin also retains an option to co-promote an approved product in Japan. “Securing alliances with leading industry partners is a key part of The Teijin Group strategy,” said Akihisa Nabeshima, president, Teijin Pharma. “Teijin Pharma believes that Merck’s strong neuroscience expertise makes it well suited to maximize the potential of this candidate.”
“Teijin Pharma scientists have made important progress to advance this investigational anti-tau antibody to this stage of development,” added Darryle Schoepp, Ph.D., vp, neuroscience discovery, Merck Research Laboratories. “Merck remains committed to developing meaningful therapeutic options for the treatment of Alzheimer’s and other neurological diseases.”
WIthin the last couple of months, the firm halted the Phase II/III EPOCH verubecestat study in patients with mild-to-moderate AD because the trial's external data monitoring committee (DMC) concluded after an interim analysis that there was “virtually no chance of finding a positive clinical effect.” The DMC did, however, recommend continuing with the APECS study. Data from APECS are expected in February 2019.