Summary
- Today, we take an in-depth look at Biohaven Pharmaceutical, a CNS concern with multiple 'shots on goal'.
- A recent secondary offering seemed to drain the acquisition premium out of its stock.
- Despite the 35% plunge in the company’s shares, little has changed except it now has enough cash to fund its many clinical trials well into 2021.
- We provide an updated investment analysis on Biohaven in the paragraphs below.
- Looking for a portfolio of ideas like this one? Members of The Biotech Forum get exclusive access to our model portfolio. Get started today »
Bullying builds character like nuclear waste creates superheroes. It's a rare occurrence and often does much more damage than endowment." ? Zack W. Van
Today, we look at a mid-cap play with multiple 'shots on goal' focused on therapies to treat afflictions of the central nervous system.
Company Overview
Biohaven Pharmaceutical Holding Company Ltd. (BHVN) is a clinical-stage biopharmaceutical concern with a portfolio of candidates targeting the central nervous system. Based in the British Virgin Islands and operating out of New Haven, Connecticut, the company was founded in 2013 and went public in May 2017, raising net proceeds of $152.7 million at $17 per share. Biohaven employs ~63 and commands a market cap of ~$2 billion.
Pipeline
The company has three separate platforms from which it develops therapies directed at neurological and neuropsychiatric diseases. Its calcitonin gene-related peptide (CGRP) receptor antagonist, glutamate modulator, and myeloperoxidase (MPO) inhibitor platforms have spawned four late stage candidates, which are being evaluated in seven indications.
Rimegepant for Migraines. From Biohaven's CGRP platform comes oral rimegepant for the treatment of migraines. The CGRP receptor is believed to play a significant role in migraine pathophysiology, responsible for neurogenic inflammation, artery dilation, and pain transmission. Studies have found that serum levels of CGRP are elevated during migraine attacks.
This approach to migraine relief is divergent from triptans, the current standard of care since the early 1990s, which are serotonin 5-HT1B and 5-HT1D receptor antagonists. They are only partially effective and are contraindicated for cardiovascular disease and other vascular conditions. Approximately 4 million Americans experience chronic migraines, defined as suffering from at least 15 headache days per month, of which at least eight are migraine, for more than three months. For these and others afflicted, nearly 14 million triptan scripts and nearly 10 million beta-block scripts are written annually. Beta-blockers are employed both as a treatment and preventative measure. In 2018, three subcutaneously administered CGRP monoclonal antibodies (mAbs) were approved, for which there has been rapid early uptake.
Owing to rimegepant's high receptor affinity and long half-life, it may not only provide acute relief but also possess preventive effects. In three Phase 3 trials - two as a tablet and one as an oral dissolving tablet (ODT) - rimegepant was shown to be safe and well tolerated while meeting its co-primary efficacy endpoints each time, demonstrating superiority to placebo at two hours post-dose on measures of pain freedom and liberation from the patients' most bothersome symptom (MBS) - either nausea, photophobia, or phonophobia.
Given its excellent safety profile, oral availability, and expected lower cost versus CGRP mAbs, rimegepant offers excellent potential. The only fly in the ointment is Allergan's (AGN) oral CGRP receptor antagonist ubrogepant, for which an NDA was filed in April 2019. If approved, ubrogepant is expected to launch in 2020. Although Biohaven has yet to file NDAs for both oral formulations of its candidate -filings are imminent - rimegepant has demonstrated more rapid onset and longer duration of effect versus placebo than ubrogepant in its clinical trials, which will likely make it best in class when/if both forms of the treatment are approved. To speed the approval process, Biohaven purchased a Priority Review Voucher from GW Pharmaceuticals (GWPH) for $105 million that will be employed in its rimegepant ODT filing.
