Catalent, Biohaven in Fast-Dissolving Oral Solid-Dose Supply PactBy
Catalent has formed an agreement with Biohaven Pharmaceutical Holding Company, the parent company of Biohaven Pharmaceuticals, a clinical-stage biopharmaceutical company, to provide Catalent’s Zydis orally disintegrating tablet (ODT) technology for developing a fast-dissolving formulation for Biohaven’s lead product candidate, rimegepant, a calcitonin gene-related peptide (CGRP) receptor antagonist for treating migraines.
The agreement also provides Biohaven exclusive rights for developing small-molecule CGRP receptor antagonists with the Zydis ODT technology. Catalent’s proprietary Zydis technology is a freeze-dried, oral solid-dosage form that is designed to disperse almost instantly in the mouth without the need for water, according to information from the companies.
Biohaven is progressing multiple formulations across its small-molecule CGRP receptor antagonist platform for preventing migraines. Biohaven has completed enrollment in two Phase III trials testing rimegepant, with more than 2,800 total patients enrolled, and topline data are 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 more than 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 I study in the first half of 2018. Biohaven says it also continues making progress across glutamate modulation technology platforms for neurodegenerative diseases.
Other companies are also advancing CGRP drug candidates for treating migraines, including Teva Pharmaceutical Industries, Amgen, and Novartis. Teva is advancing fremanezumab, a CGRP candidate awarded priority review by the US Food and Drug Administration in December 2017. Amgen is advancing a CGRP drug, Aimovig (erenumab), now in Phase III development and Novartis is progressing with a CGRP migraine drug, erenumab, now in Phase III development.