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Biohaven secures FDA PRV to use with NDA submission of rimegepant Zydis ODT.

Biohaven Pharmaceutical announced that the company has purchased a U.S. FDA priority review voucher to use with the NDA submission of rimegepant Zydis ODT in the second quarter. The PRV entitles the holder to designate an NDA for priority review and provides for an expedited 6-month review. 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.

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Publication:The Fly
Date:Mar 18, 2019
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