Amgen ($AMGN) and Novartis ($NVS) have cleared one of the final hurdles in the tight race to bring a CGRP migraine drug to market. The pair became the first riders in the race to post Phase III data in episodic migraines, positioning them to pip Alder Biopharmaceuticals ($ALDR), Eli Lilly ($LLY) and Teva ($TEVA) to the post.
In the Phase III trial, Amgen and Novartis enrolled 577 patients and randomized them to receive either placebo or a once-monthly injection of 70 mg of AMG 334, their experimental blocker of the calcitonin gene-related peptide (CGRP) receptor. Participants in the treatment arm experienced a statistically-significant fall in monthly migraine days as compared to the baseline, causing the study to hit its primary endpoint.
Having experienced an average of eight migraine days a month going into the trial, subjects on AMG 334 had 2.9 fewer migraine days over the final four weeks of the 12-week clinical trial. The number of migraine days in the placebo arm fell by 1.8 over the same period, resulting in a placebo-adjusted reduction of 1.1 days. AMG 334 showed a similar safety profile to placebo, suggesting that won’t pose an obstacle once the drug gets to regulators.
Yet, in a busy field, it is questionable whether the data will be enough to turn AMG 334 into a big drug for Amgen and Novartis. As it stands, it looks like four similar drugs with comparable profiles could win approval in quick succession, a scenario that could trigger a price war and stop any of the contenders from racking up blockbuster sales.
The data generated to date suggest the rivals may struggle to differentiate their programs in terms of efficacy. Teva’s Phase II trial chalked up the biggest drop in placebo-adjusted migraine days--2.5--but participants in that trial had a higher baseline going into the study. Alder and Lilly have both posted placebo-adjusted reductions in migraine days that are almost inseparable from the 1.1 days achieved by AMG 334.
While the Phase III data and real-world use could still uncover meaningful differences between the drugs, the only advantage AMG 334 looks odds on the have is first-to-market status. Amgen and Novartis already have Phase II data they think can support a regulatory filing. And a second Phase III trial is scheduled to be completed by the end of the year. That gives the partners a clear lead over the chasing pack.
Lilly is testing its CGRP drug, LY2951742, in a pair of Phase III episodic migraine studies that are due to end in June, the same month Alder expects to wrap up a late-stage trial of its rival program. Teva has pencilled in an October 2017 end date for its Phase III trial in the indication.