Biohaven Pharmaceutical Holding Co. Ltd. BHVN, -0.83% 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 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 AGN.
Allergan shares rose 1.6% in premarket trade. Allergan announced positive late-stage results for its migraine drug, ubrogepant, in February, and also expects to file with the FDA in 2019.
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 EvercoreISI 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. Biohaven, Allergan and Eli Lilly & Co. LLY, +0.45% 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. In mid-March, Biohaven paid Bristol-Myers Squibb Co. BMY, -0.08% $50 million for a low single-digit reduction in royalties payable on rimegepant sales, among other things. Biohaven shares have dropped 26.9% over the last month, compared with a 4.6% drop in the S&P 500 SPX,
Published: Mar 26, 2018