Eli Lilly has just scored the third FDA OK for a CGRP migraine drug, and now the pharma giant is setting out to leapfrog the pioneers who made it to market first.
The agency came through with the formal approval of Emgality (galcanezumab) on Thursday night, setting the stage for an ambitious and aggressive marketing engine to get revved up for a tire-burning late start.
“We certainly don’t think it’s a me-too situation,” says Wei-Li Shao, vice president of the neuroscience business at Eli Lilly.
Objectively, even some of the top players in this group — such as ex-Amgen R&D chief Sean Harper — recognize that the data on these new CGRP drugs bear a lot of similarities. Amgen set the price level with its $575 per month rate, which Teva fell in line with. And now Eli Lilly is following that move down to the penny.
So there’s a lot of competitive me-too thinking that’s going on here. But Eli Lilly is shooting for best-in-class status by staking claims to three key messages:
- Data. One in seven of their patients achieved “migraine freedom,” which is something you can expect to hear a lot about as the promotional work begins. There’s no guarantee, says Shao, but the possibility of freedom from further migraines could be a compelling lure.
True, “most (patients) get about a 50% reduction,” he says, “but this shot at migraine freedom is an important differentiator.”
- Access. Lilly is ready to roll with a promise that consumers will get a chance to start taking their drug with no out-of-pocket contributions to be concerned about.
- Ease of use. Lilly, no stranger to addressing major market diseases where patients have to get actively involved in dosing, is launching with an auto injector that most people who use the drug should be able to swing, no problem.
This is a market they assess as 30 million patients strong, where only 10% of patients are being treated, says Eric Pearlman, senior medical fellow at Eli Lilly. So they know the market is big enough to carve out some big patient populations. Analysts wouldn’t disagree. Some of the top observers in the field believe these companies will divvy up a market with $5 billion to $6 billion in sales potential by the mid-’20s as the full field of drugs are out there. Alder will likely be the 4th player, but can’t arrive before next year.
Lilly has a notable presence in diabetes as well as oncology, but it sees a big future for itself in pain.
Lasmiditan has made some impressive marks in late phase development, promising to add to its presence in the pain field. And then there’s tanezumab for chronic pain, where there’s also some big expectations for future revenue growth.
For Lilly, its migraine drug offers a chance for the marketing team to make up for time lost to an R&D group known for a steady — if not slow — approach to development work.
Just because they’re starting in third place doesn’t mean they can’t be the leader in short order. Now they get to prove it.
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 44,100+ biopharma pros who read Endpoints News by email every day.Free Subscription