Biohaven Ltd. launched today as a new publicly traded company focused on delivering innovative life-changing treatments for neurological and neuropsychiatric diseases, including rare disorders.
As of today, Biohaven has officially begun operating as a separate independent entity as part of the acquisition agreement with Pfizer in May 2022. The company, led by Vlad Coric as chairman and chief executive officer, launched with approximately $257.8 million in cash at the distribution and no debt.
Coric said: “As Biohaven embarks on a new path today, I am extremely proud of our track record of innovation and success rapidly developing, commercializing and delivering therapeutic breakthrough medicines. We continue our unwavering commitment to patients that aligns with our vision of winning with cutting-edge science.
“I am enthusiastic about continuing to lead our team in new, exciting directions as we strive to bring best-in-class therapies to patients for a broad range of diseases with few or no treatment options. If past is prologue, this proven team will continue to succeed in achieving its mission for patients, shareholders and employees.”
Nurtec ODT and zavegepant
Biohaven has a history of drug development and commercialization. The company received two U.S. Food and Drug Administration (FDA) approvals and a European Medicines Agency (EMA) approval for two indications for Nurtec ODT (rimegepant), the leading novel calcitonin gene-related peptide (CGRP) receptor antagonist for the treatment of migraine in adults and the first and only therapy that both treats and prevents migraine attacks.
Since its launch in 2020, Nurtec ODT has been market leader and the top prescribed novel migraine treatment. Beyond Nurtec ODT, the FDA filed and accepted for review Biohaven’s new drug application (NDA) submission for zavegepant nasal spray with a prescription drug user fee act (PDUFA) goal date of the first quarter of 2023.
If approved, zavegepant would be the only FDA-approved CGRP receptor antagonist in an intranasal formulation, giving patients a new treatment option that provides ultra-rapid pain relief in as little as 15 minutes that lasts through 48 hours after a single dose.
With the acquisition by Pfizer for a total consideration of approximately $13 billion including payoff of existing debt, Pfizer will now exclusively commercialize and develop the Biohaven CGRP franchise globally. Pfizer owns approximately 3% of the new spinoff company Biohaven Ltd.
Biohaven plans to advance a broad portfolio of early- and late-stage innovative product candidates targeting neurological and neuropsychiatric diseases, including rare disorders with unmet medical needs. Therapeutic development will focus on treatments for epilepsy, pain and mood disorders, obsessive compulsive disorder (OCD), spinocerebellar ataxia (SCA) and spinal muscular atrophy (SMA).
Biohaven develops drug candidates based on its proprietary, technology platforms, including its lead program in Kv7 Ion Channel Modulation for epilepsy and other central nervous system disorders associated with pathological hyperactivity.
Key clinical development programs underway that leverage these proprietary technology platforms, include glutamate modulation for SCA and OCD; myostatin inhibition for neuromuscular diseases, and potentially for diabetes and weight loss; and a novel immune modulation platform targeting CD-38 for multiple myeloma.
Building on legacy
Initially, discovery research programs will focus on advancing Kv7 ion channel activation across multiple therapeutic indications, TRPM3 ion channel activation for neuropathic pain and degrader platforms to target immunology and oncology inflammatory disorders and antibody linker technologies.
Matthew Buten, chief financial officer, said: “Our new spinoff company is well poised to build on the legacy of Biohaven – the potential of our proven team, our incredible pipeline and passion of our patient mission will propel us forward. We have spent the last several months preparing for the future, and we will continue to maintain the same fiscal discipline and prudent capital management strategy we employed in years past and will seek creative, tactical financing strategies in the years ahead to support our research, development and commercialization efforts.”