Last fall, Pfizer acquired a stake in Biohaven Pharmaceuticals. Partnership with company to commercialize oral migraine drug NurtecNow, the pharma giant is buying the rest of the neuroscience drugmaker for $11.6 billion.
Besides Nurtec, trade Brought Pfizer a nasal spray migraine candidate, zavegepant, which is being submitted to the FDA, and five preclinical assets targeting the same pain target. At the same time, Biohaven’s remaining assets will be spun off into a new public company led by Biohaven’s current management.
Under the terms of the deal, Pfizer will pay $148.50 in cash for each share of Biohaven it does not already own. The price represents a 78.6% premium to Biohaven’s closing price on Monday and a 33% premium to the average selling price for the three months prior to the agreement announced on Tuesday. Pfizer will also take a stake in a company made up of Biohaven’s other assets. Biohaven shareholders, including Pfizer, will receive 0.5 shares of the new company for each Biohaven share they currently own.
At the heart of the deal is Nurtec, a novel migraine drug that targets calcitonin gene-related peptide (CGRP), a protein whose levels rise with the onset of a migraine attack. The first wave of CGRP-blocking drugs hit the market in 2018. Antibody drugs developed and commercialized by Amgen, Eli Lilly and Teva are injectable drugs.
FDA approves Biohaven’s CGRP inhibitor for acute migraine in 2020. Last year, Nurtec added a second FDA approval Migraine PreventionWhile Nurtec lags its CGRP rivals in a market of an estimated 1 billion migraine sufferers worldwide, Biohaven positions its drug as a faster-acting, more patient-friendly product. As a small molecule, Nurtec can be made into an oral drug that is more convenient for patients than injectables. Biohaven formulates Nurtec into tablets that dissolve quickly in the mouth without the need for water, providing a faster treatment effect. Biohaven’s intranasal CGRP inhibitor zavegepant was also developed with speed in mind.
Nurtec isn’t a bestseller yet, but it promises to be. Biohaven reported sales of $462.5 million for the drug in 2021, up more than 600% from 2020 sales. First Quarter 2022 Financial Results report On Tuesday, Biohaven said the drug generated $123.6 million in revenue, up 121% from the same period in 2021. With more than 2 million prescriptions and broader insurance coverage for the drug, the company says it now covers 96 percent of commercially insured lives, representing approximately 263 million people.
In November, Pfizer seized on Nurtec’s rise, signing a deal to sell the drug worldwide, except in the U.S., where Biohaven retained the rights to the drug. The deal also includes zavegepant’s rights outside the United States. The deal paid off when Nurtec received European marketing authorization in late April for acute migraine and migraine prevention (it will be available in Europe as Vydura).
Aamir Malik, Pfizer’s chief business innovation officer, said on a conference call on Tuesday that when the initial deal struck, the pharma giant was excited about the prospect of commercializing Nurtec and zavegepant outside the U.S. Learn more about both drugs and conclude that it will also be able to leverage its U.S. commercialization capabilities.
The new study includes phase 3 data for zavegepant.exist Preliminary results Biohaven said in a December release that the drug began to work in patients 15 minutes after administration. Biohaven CEO Vlad Coric said on the conference call that zavegepant will offer another treatment option that complements Nurtec. Although patients prefer oral rather than intranasal administration, intranasal administration becomes important for quicker treatment of acute migraine headaches when a flare-up occurs.
“We think of it as the EpiPen for migraine,” says Coric, referring to the epinephrine injection devices people carry to quickly respond to asthma and allergy attacks.
Pfizer Exit Neuroscience R&D 2018. Biohaven assets going into the pharma giant will be incorporated into the internal medicine portion of the drug portfolio, which includes cardiometabolic drugs and women’s health products. Angela Hwang, president of Pfizer’s biopharmaceutical group, said that of the estimated 40 million migraine sufferers in the United States, one in five is a woman. She added that Pfizer’s capabilities will expand Nurtec’s reach to more than 70,000 primary care physicians and OB-GYN specialists.
Biohaven plans to submit zavegepant for the treatment of acute migraine to the FDA later this quarter. Nurtec can also lead to more commercialization opportunities. Biohaven has filed with the FDA to begin clinical trials evaluating the tablet for the treatment of chronic sinusitis and temporomandibular disorders, a disease of the jaw muscles and nerves that cause chronic facial pain. Meanwhile, zavegepant is being clinically tested in other indications, including the prevention of migraine and asthma.
The new Biohaven will start with $275 million in cash. Its pipeline includes troluzole, which has reached pivotal testing in obsessive-compulsive disorder and spinocerebellar ataxia, and verdiperstat in phase 3 testing in amyotrophic lateral sclerosis. New Biohaven will also receive tiered royalties from Pfizer on any annual net U.S. sales of Nurtec and zavegepant in excess of $5.25 billion. Pfizer expects Nurtec’s annual sales to peak at $6 billion. The acquisition is a good deal for both Pfizer and Biohaven, analysts at William Blair wrote in a research note.
“We believe that today’s news of Pfizer’s proposed acquisition of Biohaven and spin-off of non-CGRP assets into New Biohaven is a clear demonstration of the value of Nurtec ODT, which has become a leader in migraine, and the broader CGRP portfolio of migraine treatment,” wrote. “We believe the scale of Pfizer’s commercial capabilities will allow the company to realize more value from the assets, and the spin-off will allow the Biohaven team to continue developing innovative therapies in a company that is more focused on research and development.
In addition to the cash Pfizer paid to acquire Biohaven, the pharma giant will make additional payments to pay off the company’s debt and redeem all of its preferred stock. The boards of both companies unanimously approved the deal, but it still needs approval from regulators and Biohaven shareholders. The two companies expect to close the transaction in early 2023.
Photo: Dominica Reuters/AFP, via Getty Images
