- Biohaven Pharmaceutical Holding Company Ltd. announced the restructure of its licensing deal with Bristol-Myers Squibb Co. for two CGRP receptor antagonists, rimegepant and BHV-3500.
- The company will pay an upfront fee of $50 million to Bristol-Myers and royalty payments will be reduced. Modifying the terms will also allow Biohaven to pull back Bristol-Myers' right of first negotiation on the intellectual property protecting the compounds.
- This move suggests the small biotech company sees value building in the CGRP therapy space. The migraine market is projected to reach $8.7 billion by 2026, driven by the CGRP class, according to a recent report from GlobalData Healthcare.
Biohaven is in close competition with Allergan plc to bring the first oral CGRP inhibitor for acute migraine treatment to market. Earlier this year, Allergan reported positive late-stage, topline results for its candidate ubrogepant. Analysts estimate each of these drugs could be worth more than $1 billion in annual sales.
Originally, Biohaven picked up the rights to rimegepant in July 2016 and to BHV-3500 in October 2016 from Bristol-Myers. The biotech followed these deals with its $168 million initial public offering.
When the agreement was forged, Biohaven would have been required to make tiered royalty payments based on annual global net sales of licensed products upon the products' approval and commercialization.
Rather than pay tiered royalties in the low- to mid-teens for drug candidates that Biohaven sees as potentially major successes, Biohaven cut a new deal that would allow it to pay an upfront lump sum of $50 million to Bristol-Myers. The royalties to the big pharma for rimegepant would be reduced by a "low single-digit" number, whereas the royalties payable for BHV-3500 would be reduced even further and would be in the mid-single digit range.
But that's not all — Biohaven also plans to renege Bristol-Myers' right of first negotiation to regain the intellectual property of the compounds and take back its ability to enter into new licensing deals with other manufacturers, specifically those "with a CGRP antibody program," notes the statement. And, Biohaven will retain its global development and commercialization rights to rimegepant, BHV-3500 and related CGRP molecules.
Several other companies are working in the CGRP space, albeit on prevention of migraine: Amgen Inc. and Novartis AG as well as Eli Lilly & Co. are currently awaiting approval on their respective compounds, while Teva Pharmaceutical Industries Ltd. and Alder Biopharmaceuticals Inc. also have drugs in mid- to late-stage development.
Biohaven remains on track to submit an Investigational New drug Application (IND) in the first half of 2018 for BHV-3500 for the acute treatment and prevention of migraine.
"We believe the revised agreement, along with our recently announced exclusive license for developing small molecule CGRP receptor antagonists with the Zydis ODT technology, significantly enhances our position to create shareholder value through the ongoing development of efficacious, differentiated and patient-friendly therapies for both the acute treatment and prevention of migraine," said Biohaven CEO Vlad Coric in a statement.