Company: Biohaven Pharmaceutical
Used for: migraine
Est. 2024 sales: $897 million
Three marketed CGRP drugs—Amgen and Novartis’ Aimovig, Teva’s Ajovy and Eli Lilly’s Emgality—are injections approved to prevent migraine. Biohaven Pharmaceutical is aiming to bring an oral option to the table.
But first, instead of the prevention market, Biohaven is gunning for an approval of oral rimegepant in the acute treatment setting. It’s used a priority review voucher for an expedited six-month review, with an FDA decision now expected by the end of June.
According to topline results from a phase 3 trial, about 19.6% of rimegepant patients were completely free from pain two hours after taking the tablet, versus 12.0% in the placebo arm.
In a separate phase 3, an orally dissolving formulation demonstrated earlier onset of action, as the pain relief benefit of rimegepant started to numerically separate from placebo as early as 15 minutes after dosing, and the difference turned statistically significant at one hour. After two hours, 21.2% of rimegepant and 10.9% of placebo patients were pain-free.
Although Biohaven has already lost the first-to-market oral CGRP race to Allergan, which nabbed an FDA nod for Ubrelvy (ubrogepant) at the end of 2019, industry watchers figured rimegepant represents a more successful sales opportunity. EvaluatePharma analysts previously predicted the Allergan version would generate $302 million by 2024, well below rimegepant’s projected $897 million.
There’s also Lilly’s newly launched oral drug Reyvow, the first in the serotonin (5-HT)1F receptor agonist class. But SVB Leerink analyst Marc Goodman suggested that the therapy’s side effects, including dizziness and drowsiness, could limit its sales performance to under $500 million at peak.
The question is, can small Biohaven, with rimegepant as its first commercial product, challenge all those Big Pharma players? Biohaven CEO Vlad Coric, M.D., has expressed confidence that it can. The company “will strive to outpace them with a more efficient and innovative commercial launch, using modern-day strategies,” he told FiercePharma in a recent email interview.
While acute treatment could be rimegepant’s first indication, Biohaven is also looking to expand into the larger prevention market. It finished enrollment of more than 1,600 patients in a phase 3 trial, though it hasn’t yet released topline data as originally planned for the fourth quarter of 2019.
To further complicate the market landscape, neurology specialist Lundbeck recently paid $2 billion to acquire Alder BioPharmaceuticals and its late-stage CGRP quarterly infusion drug eptinezumab, which expects an FDA ruling in migraine prevention by Feb. 21, 2020. RBC Capital analyst Brian Abrahams previously pegged that drug’s peak sales at $750 million.