Dive Brief:
- Biohaven Pharmaceutical Holding Company Ltd. has signed an exclusive worldwide drug delivery deal to use Catalent, Inc.'s Zydis ODT (orally disintegrating tablet) fast-dissolving formulation for use with Biohaven's lead migraine drug, rimegepant.
- The deal, signed with Catalent subsidiary Catalent U.K. Swindon Zydis Limited, also grants Biohaven exclusive rights to use Zydis ODT technology to deliver small molecule CGRP receptor antagonists.
- A pivotal study of rimegepant Zydis ODT is expected to begin in the first quarter of 2018.
Dive Insight:
Biohaven is developing the second-generation calcitonin gene-related peptide receptor antagonist rimegepant for the acute treatment of migraine. This, its lead drug, is in two Phase 3 trials, which are expected to read out in the first quarter of 2018, and a long term safety trial, with results expected at the end of the year. The Food and Drug Administration has given its agreement on Biohaven's initial pediatric study plan for rimegepant, required before submission of a New Drug Application.
Biohaven is in close competition with Allergan to bring the first oral CGRP inhibitor for migraine treatment to market. Earlier this year, Allergan reported positive late-stage, topline results for its candidate, ubrogepant. Analysts estimate that each of these drugs could be worth more than $1 billion in annual sales.
The company also has a third-generation CGRP antagonist, BHV3500, gearing up towards clinical development, this time for the prevention of episodic and chronic migraine. The Phase 1 trial is planned for the first half of 2018. This is also part of the agreement with Catalent.
Drugs formulated with Catalent, Inc.'s Zydis ODT dissolve almost instantly in the mouth without the need for water.
"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," said Biohaven CEO Vlad Coric.
In January, Biohaven announced positive results from a bioequivalence study of a sublingual formulation of riluzole, which uses the Zydis ODT technology. The topline data confirmed equivalence with the reference drug, Rilutek, the standard-of-care in amyotrophic lateral sclerosis. Submission is planned, through the Section 505(b)(2) pathway, in the first half of 2018.