With Pfizer sale in the rearview, Biohaven veers toward Kv7 platform following late-stage trial fails, delays

Hours after Pfizer officially closed its buyout of Biohaven and its migraine program on Monday, CEO of the biotech Vlad Coric swapped his dealmaking hat for that of a salesman. To hear him tell it, the company that had elevated from a $176.1 million IPO in 2017 to raking in $11.6 billion from the Pfizer sale was Biohaven 1.0.

The company that spun out of the deal and will be tasked with tackling the future clinical terrain is just as reliable but also a reinvigorated, next-gen version: Biohaven 2.0.

Coric’s pitch? Biohaven 2.0 is turning its R&D engine toward epilepsy, with the goal of building a Nurtec-like success story once more. But drumming up investor excitement for another trip around the drug development sun comes as the “new” Biohaven has faced the harsh reality of life outside of a goldmine.

“Being in the neuroscience area, we know there are going to be challenging indications we go after,” said Coric. “We have to advance the science, we're not going to win in them all.” 

Up until the sale, Coric explained, the general strategy was diverting 70% of Biohaven’s resources towards developing its CGRP portfolio and 30% towards “these higher risk programs.” The former investments, as is evidenced by a marketed CGRP drug, have paid dividends, while the latter investments have yet to pan out. 

In late May, a late-stage trial of troriluzole in spinocerebellar ataxia failed due in part to slower than expected disease progression, the company said at the time. And while Biohaven saw enough promising signs in a genetic subgroup to warrant further FDA discussion, Coric wouldn’t say whether or not a follow-up meeting with regulators had been scheduled.

Also, a phase 3 testing the same med but in obsessive-compulsive disorder (OCD) was supposed to read out by the end of the year, but Coric said COVID-related trial delays have pushed that timeline back by about a year. Recruitment for the trial, which aims to enroll 700 patients, has not yet been completed. 

The company’s other higher-risk bet, verdiperstat, also recently failed. That phase 3 ALS trial flop was the second loss for the med since Biohaven acquired it from AstraZeneca. While the company is not axing it from the pipeline yet, Coric said it’s being placed on the backburner. 

“We’re not going to make it a priority at this point,” he explained. “We’re going to take our time, we’re going to meet with [key opinion leaders], we’ll make our decisions from some external input, as well as internal input where we should go next.”

Now, Biohaven has $258 million in cash to shake off the sequential losses and make the most out of the Kv7 platform it acquired from Channel Biosciences in February. It also has a new chief scientific officer, naming Bruce Car, Ph.D., to the role just this morning (Oct. 4). Car was previously CSO at Agios Pharmaceuticals after more than 19 years at Bristol Myers Squibb.

The clinical mindset, however, remains unchanged. Just like Biohaven played catchup with Allergan (which has since been bought by AbbVie) and its migraine med Ubrelvy, it’s two steps behind Xenon Pharmaceuticals in the epilepsy race. That’s no problem for Coric. 

“This is going to be our Kv7 versus Xenon’s Kv7,” he said. “We think we can move quickly. We think we can make up a lot of lost time and compete with them to get to market as soon as possible.” 

Coric says Nurtec was about 18 months behind Ubrelvy in the development process, but the gap with Xenon may be even larger. Biohaven had anticipated bringing its first med from the platform, BHV-7000, into the clinic sometime this year, according to the company's first-quarter financial report. No trials are shown via the U.S. federal clinical trial registry but the company had its clinical trial application approved in Canada in the second quarter, although the trial designs have yet to be finalized. Xenon plans to launch XEN1101 into a phase 3 trial in the second half of the year. 

Motivation aside, drug development centers on available money in the bank, and Biohaven’s $258 million provides a runway that’s expected to last “over a year,” according to Coric. That all but guarantees the company will need to raise additional funds should it hope to independently develop BHV-7000, given its early clinical stage. Coric declined to specify whether or not that’s expected to be enough cash to last through a readout of the phase 3 troriluzole trial in OCD.

Editor's note: This story was updated at 1:33 p.m. ET on October 10 to note that a clinical trial application for BHV-7000 has been approved in Canada.