Biohaven scores CGRP OK for acute migraine — can the commercial team catch up with Allergan on its debut?
Seven years after spinning out of Yale, Biohaven has entered the ranks of commercial-stage biotechs.
The FDA handed down an OK for its CGRP drug, rimegepant, as an acute treatment. Dubbed Nurtec, the orally dissolving pill will join Allergan’s (soon to be AbbVie’s) Ubrelvy and Lilly’s Reyvow on the market amid a new wave of migraine therapies reshaping the disease space.
In a pivotal Phase III trial, Nurtec hit the co-primary endpoints on pain freedom and freedom from most bothersome symptoms at two hours post dose, proving superior to placebo.
On top of the new entrants, Nurtec will also be competing with entrenched generic medicines such as triptans — available at low cost but with a transient effect. CEO Vlad Coric said the company would be able to compete, citing concerns around triptans’ efficacy and the large number of Americans – 40 million – with migraines.
”A large portion of that number are not satisfied with triptans, are not responding to triptans or can’t take triptans,” Coric told Endpoints News. “So very important drug for patients first and a very important drug for the company given the large market size.”
He also said patients will prefer Nurtec pills to injections, the delivery route for most of the new migraine drugs, although that still leaves Lilly’s Reyvow as an oral competitor.
Biohaven has yet to announce the list price. Ubrelvy, a CGRP drug that’s taken once or twice a day, has a sticker price of $4,896 per year — a price that drug-pricing watchdog ICER has now concluded is cost-effective. Meanwhile Reyvow, which binds to 5-HT1F receptors, is $640 for an eight-pill pack.
“The marketing strategy for the product focuses on three levels of differentiation: (a) fast onset at ~60 min, (b) durable effect of up to 48 hours post dose, and (c) easily administered ODT formulation,” SVB Leerink analyst Marc Goodman noted, based on discussion with execs.
He added that the company has a full sales force ready, at a number “significantly above 200 reps but not 1,000 reps.”
The rollout execution would be crucial for Nurtec to reach the $1.03 billion in sales that analysts at Cortellis have envisioned.
The drug is also being tested for the prevention of migraines with topline data expected later this quarter, although Biohaven will face even tougher competition there with four offerings already in place. Then there’s vazegepant, its intranasal take on CGRP, which also scored promising Phase II/III results.
With additional reporting by Jason Mast