Biohaven Pharmaceutical has entered into an exclusive worldwide license agreement with Catalent U.K. Swindon Zydis Limited, a subsidiary of Catalent, Inc., to provide Catalent’s Zydis ODT (orally disintegrating tablet) fast-dissolving formulation for the development of Biohaven’s lead calcitonin gene-related peptide (CGRP) receptor antagonist product candidate, rimegepant. The agreement also provides exclusive rights for developing small molecule CGRP receptor antagonists with the Zydis ODT technology. Catalent’s proprietary Zydis technology is a unique, freeze-dried, oral solid dosage form that disperses almost instantly in the mouth, without the need for water.
“This exclusive agreement with Catalent now adds the world’s leading ODT formulation to our CGRP receptor antagonist platform,” said Vlad Coric, chief executive officer, Biohaven. “Fast-dissolve formulations are particularly well suited for people with migraine. Migraine patients need to take acute treatments promptly, whenever and wherever an attack hits. People with migraine often have accompanying nausea and have an aversion to consuming food or liquids during an attack. The Zydis ODT formulation uniquely addresses this issue by allowing such patients to take a fast-dissolving tablet without water.”
Biohaven is progressing multiple formulations across its small molecule CGRP receptor antagonist platform in an effort to meet patient needs across the spectrum of acute treatment and prevention of migraine. Biohaven has completed enrollment in two pivotal Phase 3 trials testing rimegepant, with over 2,800 total patients enrolled, and topline data is expected to be received before the end of the first quarter of 2018. A long-term safety trial that allows up to daily dosing of rimegepant began in August 2017 and currently has over 1,000 patients enrolled and eligible to receive rimegepant for up to one year. Biohaven’s third-generation small molecule CGRP receptor antagonist, BHV3500, is scheduled to begin a Phase 1 study in the first half of 2018. Biohaven also continues making progress across glutamate modulation technology platforms for neurodegenerative diseases with high unmet need.
Elyse Stock, chief of portfolio strategy and development, said, “The Zydis ODT disperses almost instantly in the mouth-no water required, potentially allowing for pre-gastric absorption and rapid onset of action. We are on schedule to initiate an adequate and well-controlled pivotal trial with the rimegepant Zydis ODT in the first quarter of 2018 to allow for the potential to come to market with this preferred formulation without any delay to our timelines.”