Johnson & Johnson's ($JNJ) Stelara may be under fire in psoriasis. But the New Jersey drugmaker has new data suggesting it'll be able to score elsewhere.
Monday, the pharma giant touted results from a Phase III study of the med in patients with moderate to severe Crohn's disease who had failed first-line therapy. Stelara beat placebo at inducing a clinical response 6 weeks into the study and hit a secondary goal by delivering higher rates of clinical response and clinical remission at the 8-week mark. Newman Yeilding, head of immunology development at J&J's Janssen unit, called the two markers "important goals in the management of Crohn's."
It's a positive finding for J&J--and one that it'll be taking to regulators later this year. The company expects to ask FDA to approve the new use for Stelara before 2015 closes out, Yeilding said in a statement.
It's also good timing for the company, which now faces stepped-up competition for Stelara--and may soon be contending with more. Next-gen psoriasis drugmakers have aimed to beat the therapy in clinical trials, and some have, including Novartis' ($NVS) Cosentyx--which hit the U.S. market earlier this year--and Valeant Pharmaceuticals' ($VRX) brodalumab, which is currently in late-stage development, though it faces some potential safety problems. Merck ($MRK), Eli Lilly ($LLY) and others are working on candidates that could give Stelara a run for its money, too.
And with J&J getting hammered on the hep C front, those are revenues it doesn't want to cede. Stelara chipped in a 12.9% sales increase in Q3, hauling in $613 million for the period.
Stelara is also in Phase III trials for ulcerative colitis, and the way GlobalData analyst Heather Leach sees it, it'll likely become "the preferred treatment option [in] inflammatory bowel disease" if it can win approvals there and in Crohn's, she wrote in a July statement. Those are comorbidities frequently seen with axial spondyloarthritis, and she predicts Stelara will rack up $244.7 million in 2024 from indications in that space, too.
Unfortunately for Janssen, Stelara won't be able to escape the new-age psoriasis treatments in that field, either. Novartis is gunning for its own ankylosing spondylitis nods for Cosentyx, and it's already made filings in both the U.S. and Europe.
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