Biohaven tacks on brain disorder med to its pipeline, lining up $970M for ex-China rights to Highlightll drug

Biohaven continues to flesh out its non-migraine pipeline, offering almost $1 billion in payments and biobucks for the ex-China rights to a potential treatment for immune-mediated diseases. 

In return for the license to the TYK2 and JAK1 inhibitor, dubbed BHV-800, Biohaven is paying $10 million in upfront cash, $10 million in equity and potentially up to $950 million in biobucks to Highlightll Pharmaceuticals. Biohaven CEO Vlad Coric, M.D., said the deal is the result of the company scouring the industry for the best potential treatment of neuroinflammation. 

“Finding a compound like this, and now being able to test it in really bad neurodegenerative disorders, will be our first validation of these types of immune modulators and CNS disorders,” Coric told Fierce Biotech in an interview. 

Coric said Biohaven plans to launch a study in patients with early Parkinson’s disease in 2023 and no later than the first quarter of 2024. The rationale for buying into the modality is that as mediators of the immune pathway, inhibiting TYK2 and JAK1 could stunt inflammation that leads to serious neurological events.

Much of the current treatment landscape using TYK2 inhibitors focuses on immunological conditions outside of the brain, like lupus or psoriasis. Bristol Myers Squibb’s Sotyktu became the first-approved TYK2 inhibitor when it nabbed an FDA greenlight in September to treat plaque psoriasis. JAK inhibitors are much more popular and include approved meds like AbbVie’s Rinvoq and Incyte’s Opzelura. 

It’s the most significant deal for Biohaven since relaunching after the sale of its migraine program to Pfizer for more than $11 billion in 2022. Coric said the deal structure for BHV-8000, which is laden with backend milestone payments, partly reflects how expensive it is to run neurodegenerative trials.

“Part of the partnership and risk sharing is that we both believe in the asset and in Parkinson's and we're going to fund the development of it,” he said, adding that he’s wary of companies that push for large upfront payments for assets that lack convincing data. 

The licensing deal comes as Biohaven is continuing to press ahead with clinical work of its Kv7 platform, acquired from Channel Biosciences in early 2022. Data presented earlier this month from a phase 1 trial of the platform’s lead asset, BHV-7000, found that the med was well-tolerated as a treatment for epilepsy among 17 patients. Coric said he hopes to start pivotal trials in epilepsy and bipolar disorder before the end of the year. 

“We did not have the CNS effects in the phase one human study of dizziness and somnolence and fatigue that have plagued this whole class of anti-seizure meds,” he said. “That is the paradigm shift that we are chasing here.”