The company touted that the drug had met both registrational co-primary endpoints in the two trials, and said it plans to file for approval with the Food and Drug Administration in 2019, but it will also have a formidable rival in this drug category, biopharmaceutical company Allergan . Allergan announced positive late-stage results for its migraine drug, ubrogepant, in February, and also expects to file with the FDA in 2019. shares dropped nearly 23% in premarket trade Monday after the company released data from two phase 3 clinical trials for its migraine drug rimegepant.The latest clinical trial data for Biohaven's rimegepant appeared to have no signal of liver toxicity issues, which has been a concern with these oral drugs intended to treat acute symptoms of migraine, said Evercore ISI analyst Umer Raffat, though he noted that one of the studies had a p-value of 0.03 on a measure of freedom from pain at two hours, though the p-value threshold was 0.05.In addition, Biohaven and Allergan's trials were not designed exactly the same, Raffat said.Still, how Allergan's 25-mg dose looks in the second phase 3 trial will be "especially important if they can hit on efficacy and not have liver [toxicity]," he said, and results for a new phase 3 trial run by Biohaven with a different formulation will also matter.Many companies are rushing to develop new migraine therapies, many of them intended to prevent painful migraines before they occur. are among those developing drugs for acute migraine, intended to relieve the attacks once they occur.Biohaven expects to release additional results from the trials at scientific meetings this year.
Biohaven shares have dropped 26.9% over the last month, compared with a 4.6% drop in the S&P 500 . Allergan previously made a deal with the New York state American Indian tribe the St.Regis Mohawk Tribe to protect Restasis from competition using the tribe's sovereign immunity as a shield against patent challenges, a deal that was widely criticized, including by lawmakers.Generic drugmaker Mylan made the patent challenge against Allergan's Restasis, which targets six patents.Mylan Chief Executive Health Bresch called Allergan's deal with the tribe "a sham." The tribe had not established that its sovereign immunity applied to the specific patent challenge proceedings, the PTAB said, and that even if it did apply, the challenge could continue because Allergan was still involved as an owner of the patents.
An oral hearing on the case is tentatively scheduled for April 3, and a final written decision is expected by June 6.
A Texas district court judge also previously ruled against Allergan on similar issues last fall. shares rose 1.7% and 1.1% respectively in premarket trade Wednesday after the companies announced that their drug met its primary endpoint in a phase 3 trial testing it in women with uterine fibroids.