Reaction mixed to Biohaven’s migraine drug results
pharmafile | March 27, 2018 | News story | Manufacturing and Production, Research and Development | Allergan, Biohaven, CGRP, biotech, drugs, migraine, pharma, pharmaceutical
Biohaven is full of confidence in its lead drug, rimegepant, evidenced only a few weeks ago when it decided to restructure its licensing agreement with Bristol-Myers Squibb to reduce royalty payments to the pharma giant.
It seemed the plucky biotech had seen enough on its data readout from two Phase 3 trials into rimegepant, as a treatment for migraines, that it believed sales were going to be strong.
It then released the results and analysts thought very differently, sending its share price spinning down by 40% initially before it recovered to just 7.27% down.
The uncertainty over whether the results are positive enough for the migraine med to find a place in the market is not without reason, despite meeting its endpoints.
The trial of the oral CGRP receptor antagonist hit both of its co-primary endpoints, with pain freedom at two hours being found in 19.2% and 19.6% across two trials against a placebo reaction of 14.2% and 12.0%.
Patients were also found to be free from ‘Most Bothersome Symptoms’ (MBS) at two hours post-dose in 36.6% and 37.6% participants, compared to 27.7% and 25.2% of placebo recipients.
The drug is able to boast a positive impact for patients but, crucially, it doesn’t quite stack up to the injectable types of CGRP receptor antagonists currently being developed, such as Novartis/Amgen’s candidate and Teva’s.
The injectable field, however, won’t be Biohaven’s direct competition, that would be Allergan’s fellow oral med and it was able to boast marginally stronger data in its first Phase 3 trial. For Allergan’s ubrogepant, at a higher dose, 21.2% of patients were pain free at two hours, against 11.8% in the placebo arm, and 37.7% of patients reported an absence of MBS two hours after dose, with placebo being at 27.8%.
The advantage that Biohaven has is that the safety profile of its drug is much stronger than Allergan’s, which has had problems with liver toxicity.
Vlad Coric, Chief Executive Officer of Biohaven, commented, “The topline data from our two pivotal trials show that a single, oral dose of rimegepant has the potential to be an effective and safe acute treatment for migraine, addressing both pain and most bothersome symptoms without the need for repeat dosing or rescue medicines. By combining positive efficacy results and a favourable safety profile with ease of oral dosing, we believe that rimegepant will represent a significant improvement over existing treatment options.”
As mentioned by Coric, BIohaven’s drug also has the advantage of not needing a second dose of the drug, unlike Allergan’s.
Much may depend on how pricing is decided by other companies, with Novartis/Amgen’s likely to be first approved and both Allergan’s and Biohaven’s product scheduled for filing in 2019.
Ben Hargreaves
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