Pfizer wasn’t part of the initial chase to develop and commercialize the new class of migraine medicines that address a novel protein target associated with the chronic condition. By inking a commercialization pact with Biohaven Pharmaceuticals, the pharmaceutical giant gets a piece of that market now as well as a shot at the next generation of this type of therapy.
The two companies announced an agreement Tuesday covering the global commercialization of Biohaven’s oral migraine drug Nurtec, as well as a migraine treatment still in development in a nasal spray formulation. The deal gives Pfizer rights to sell those drugs globally, except for the U.S. where Biohaven retains the rights. Pfizer is paying Biohaven $500 million up front, which breaks down to $150 million in cash and a $350 million purchase of the biotech’s stock at a 25% premium.
New Haven, Connecticut-based Biohaven could earn up to $740 million in milestone payments from Pfizer, plus royalties from the pharma giant’s sales of the migraine therapies. Those sales could start soon. Nurtec is currently under regulatory review in Europe, as well as by other agencies around the world.
Nurtec is part of a class of drugs that block calcitonin gene-related peptide (CGRP), a protein associated with the onset of migraine attacks. The first CGRP inhibitors were developed as antibody drugs given by injection. CGRP-blocking antibodies from Amgen, Eli Lilly, and Teva Pharmaceutical won FDA approvals in 2018 as migraine prevention treatments. These drugs are injected at intervals ranging from once a month to once every three months.
Oral drugs represent the next generation of CGRP therapies. Ubrelvy, a drug developed by Allergan (now a part of AbbVie), was the first oral CGRP to reach the market following its 2019 FDA approval as a treatment for acute migraine. For the nine months ending Sept. 30, Ubrelvy tallied $369 million in sales compared to $60 million in the same period in 2020. In September, another AbbVie oral drug, Qulipta, won an FDA nod for migraine prevention.
The FDA approved Nurtec last year as a treatment for acute migraine; the regulatory nod in migraine prevention happened in May. Biohaven continues to see strong market uptake for the small molecule drug. In its release of third quarter 2021 financial results Tuesday, the company reported $136 million in revenue from the drug; for the nine months ending Sept. 30, revenue was $272.5 million. Biohaven said in its financial report that it projects the market for oral CGRP inhibitors is between $4 billion and $5 billion in the U.S. alone.
The next Biohaven migraine therapy in the pipeline is another CGRP-blocking small molecule, zavegepent. That drug is being developed as a nasal spray. In September, encouraging data from Phase 2/3 tests of the drug were presented at the International Headache Society – European Headache Federation Joint Congress. Biohaven reported that preventative effects of the drug were observed as early as the first week of treatment. Those effects were sustained after 12 weeks. Furthermore, the company reported that an open-label study showed preventative benefit when the drug was dosed as needed to treat acute migraine attacks.
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