Biohaven announced that the company has purchased a U.S. Food and Drug Administration (FDA) priority review voucher (PRV) to use with the NDA submission of rimegepant Zydis® ODT in the second quarter of 2019. The PRV entitles the holder to designate an NDA for priority review and provides for an expedited 6-month review.
"This transaction highlights the important benefits to patients of the priority review voucher program – the program motivates more treatments to be developed for rare pediatric diseases and also speeds approval of potential blockbuster therapies,” Vlad Coric, M.D, Chief Executive Officer of Biohaven said. “Millions of patients suffer from debilitating migraines and have long awaited new treatment approaches such as an easy to use oral CGRP receptor antagonist. We are excited about the potential of bringing rimegepant Zydis ODT to patients as quickly as possible."
Biohaven entered into a definitive agreement to purchase the PRV for $105M. The closing of the transaction is subject to customary closing conditions, including antitrust review. In addition to the purchase of the PRV, the company also announced an agreement to raise a total of up to $200M in financing for the purchase of this PRV and general corporate uses. The financing is being provided by the sale of preferred shares to Royalty Pharma and is subject to customary closing conditions. Royalty Pharma will provide $125M at closing and allow the company to draw up to an additional $75M upon FDA acceptance of the rimegepant NDA.
"We are pleased to further support Biohaven in the development of rimegepant. In a matter of days, we worked collaboratively with Biohaven to assist in funding the strategically important acquisition of a PRV,” Pablo Legorreta, CEO of Royalty Pharma said. “We are providing up to $200m of capital with a structured return that is potentially less dilutive than other alternatives. This financing is highly flexible and responsive to the many potential future paths for a dynamic company like Biohaven."
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Biohaven previously announced positive topline results from a randomized, double-blind, placebo-controlled, Phase 3 clinical trial evaluating the efficacy and safety of its Zydis ODT formulation of rimegepant. Rimegepant Zydis ODT was statistically superior to placebo on the two co-primary endpoints as well as the first 21 consecutive primary and secondary outcome measures pre-specified in hierarchical testing. Importantly, the performance of the rimegepant Zydis ODT formulation began to numerically separate from placebo on pain relief as early as 15 minutes after dosing, and this difference was statistically significant at 60 minutes (p < 0.0001). Additionally, a significantly greater percentage of patients treated with rimegepant Zydis ODT returned to normal functioning by 60 minutes as compared to placebo (p = 0.0025). Lasting clinical benefit was observed through 48 hours after a single dose of rimegepant on freedom from pain (p < 0.0001), pain relief (p < 0.0001), freedom from the most bothersome symptom (p = 0.0018), and freedom from functional disability (p < 0.0001). The vast majority of patients treated with rimegepant Zydis ODT (85%) did not use any rescue medications.
Rimegepant is Biohaven's orally-dosed calcitonin gene-related peptide (CGRP) receptor antagonist, which the Company is developing as a treatment for migraine. Rimegepant represents a novel mechanism that targets the underlying pathophysiology of migraine without causing vasoconstriction. The efficacy and safety profile of rimegepant for the acute treatment of migraine has now been established across four randomized controlled trials to date: the three completed pivotal Phase 3 trials, and a Phase 2b trial. The co-primary endpoints achieved in the three Phase 3 trials are consistent with regulatory guidance from the U.S. Food and Drug Administration (FDA) and provide the basis for a planned submission of a new drug application (NDA) to the FDA in the second quarter of 2019.