Biohaven, sporting new data, moves closer to CGRP finish line—and maybe M&A

Aiming to break into a three-way battle among large drugmakers in the brand-new CGRP migraine class, tiny Biohaven Pharmaceutical has released detailed data for its own candidate, which one group of analysts figures could reach blockbuster status.

Biohaven already has its new drug application for the drug, rimegepant, at the FDA’s desk, and in March it bought a priority review voucher in hopes of bringing the drug to market faster. Unlike other existing CGRP injections, namely Amgen and Novartis’ Aimovig, Teva’s Ajovy and Eli Lilly’s Emgality, rimegepant is an oral drug.

In a phase 3 trial involving 1,186 patients that tested the drug’s ability to treat acute migraine, about 19.6% of rimegepant patients were completely free from pain two hours after taking the tablet, versus 12.0% in the placebo group, according to data just published in the New England Journal of Medicine. The difference was statistically significant, researchers found.

Currently, Aimovig, Ajovy and Emgality are locked in a three-way battle. Aimovig leads the class thanks to a first-to-market advantage. But in what will likely be the next two years, oral CGRPs are poised to grab over half of the total market share, Piper Jaffray analyst Christopher Raymond’s team said in a Thursday note, citing a survey conducted in over 100 high-volume headache specialists.

Of course, Biohaven is also looking at the potentially larger—due to higher treatment frequency—migraine prevention market. Top-line results from a phase 3 study testing rimegepant as a preventive migraine treatment are expected in the fourth quarter.

Based on the survey results, Raymond figures oral CGRPs could nab $4 billion in the prevention setting alone. Of that, surveyed physicians believe Biohaven can capture nearly half, which Raymond noted is much higher than the $1 billion-plus his team was projecting.

Considering a higher conversion rate to orals, Raymond’s team is dialing down Aimovig revenue estimates to $1.21 billion in 2025 from $1.40 billion.

But RBC Capital analyst Randall Stanicky, while agreeing there’s "an important niche in the market for oral CGRPs," warned of potential hurdles in an April note to clients. A key opinion leader Stanicky interviewed pointed out that oral drugs’ efficacy is not a "game-changer," and he worried that compliance on oral drugs would likely be worse compared with injectables. "Moreover, pricing is something to watch given the availability of so many other low-cost oral options for acute migraine," the RBC analyst said.

Rimegepant’s list of enemies includes more than just those injectable CGRPs. Allergan, which could soon become AbbVie after a mammoth merger agreement, also has oral CGRP ubrogepant in development. The company's New Drug Application has been accepted by the FDA, with a decision expected toward the end of the year. And the race is on to be the first oral now that Biohaven has slashed rimegepant’s review time by four months with the voucher.

Allergan is obviously the more experienced marketer: Its Botox appears to be holding its own in migraine as the anti-CGRP class gains traction. But Biohaven is ready to roll. In April, it hired William "BJ" Jones as chief commercial officer of migraine and common disease. Jones joined from Takeda and boasts commercial experience that includes launches for Excedrin Migraine, diabetes drug Farxiga, blood thinner Pradaxa and antipsychotic Abilify. Separately, on Thursday, Biohaven launched a campaign called "Demand More" featuring what patients are looking for from an acute treatment for migraine.

And Biohaven may not have to launch rimegepant on its own. Jefferies analyst Michael Yee previously said that Biogen could be looking at acquisitions after its big aducanumab Alzheimer’s flop, and Biohaven is on the list of possible targets. Then in April, Bloomberg reported that the New Haven, Connecticut-based company is indeed exploring options, including a possible sale, after attracting interest from potential bidders. Piper Jaffray’s Raymond, in his note, suggested that Amgen resolve an Aimovig dispute with Novartis as soon as possible "and seriously consider acquiring Biohaven to gain access to rimegepant and remove what appears to be a growing competitive threat."