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| Pfizer and Amgen’s Enbrel |
The good news for Eli Lilly: Its experimental late-stage psoriasis drug has topped Pfizer ($PFE) and Amgen’s ($AMGN) blockbuster Enbrel in a head-to-head study. The not-so-good news: It’s not the only one.
Lilly ($LLY), Novartis ($NVS), Celgene ($CELG), Amgen, AstraZeneca ($AZN) and more are accelerating toward FDA approval, with the first decisions coming as soon as next month. Their next challenge? Standing out from the crowd.
Lilly’s candidate, ixekizumab, surpassed Enbrel in a Phase III study, with 31% to 41% of patients achieving clear skin after 12 weeks of treatment compared with just 5% to 7% of Enbrel patients. The results were strong enough to back a regulatory filing in the first half of next year, the Indianapolis drugmaker said.
Obviously, Enbrel won’t be Lilly’s main competition–or anywhere close to it–if and when ixekizumab makes it to market. Just last month, Novartis’ in-development secukinumab topped Enbrel in another Phase III study, which saw more than half of the patients in the experimental drug arm achieve a skin clearance rate of 90% or more. Just 20.7% of the patients in the Enbrel arm hit that mark.
And that’s not all. Celgene’s oral apremilast, already approved for psoriatic arthritis, is first in line with a September FDA decision date for its psoriasis application. Amgen and AstraZeneca, developers of an IL-17A inhibitor called brodalumab that charted stellar Phase III results in May, comes in behind it.
There are a couple of trailers, too, in Merck’s ($MRK) MK-3222, also in Phase III. Johnson & Johnson’s ($JNJ) guselkumab will move into that phase this year with a prospective approval happening between 2015 and 2017.
The question is which drug–or drugs–can grab the spotlight. Given the variety of trial endpoints, and efficacy and safety data rolling out for each one, every company will have its talking points. The job will be getting some of them to stick.
And then there’s the question of price. Not only will the new generation of treatments be competing with one another, but with Enbrel biosimilars that could join the party in the not-too-distant future. Cipla, Novartis and others have a target on the $8.78-billion-a-year seller, and they’re hoping to bring their cheaper copies to market in time snap up a slice of the pie.
While the competition may be tough down the line, there’s a big prize in store for whichever companies prevail. Novartis has said annual sales for biological psoriasis treatments sit at about $4.8 billion, and the Swiss pharma giant expects that figure to grow 10% a year through 2020.