Late-stage ozanimod data brings Celgene closer to filing
- Celgene Corp. has reported largely positive results from the ozanimod Phase 3 SUNBEAM and RADIANCE multiple sclerosis studies presented at MSParis2017 (7th Joint ECTRIMS - ACTRIMS Meeting), which come after a difficult third quarter.
- In the SUNBEAM study, ozanimod 1 mg and 0.5 mg significantly reduced the annualized relapse rate compared with Avonex (interferon beta-1a) over an average of 13.6 months treatment; ozanimod also significantly reduced new or enlarging T2 lesions, gadolinium-enhanced MRI lesions, and brain volume loss over one year at both doses compared with Avonex.
- In the RADIANCE part B study, which also used Avonex as a comparator, both doses of ozanimod significantly reduced the annualized relapse rate, new or enlarging T2 lesions, and gadolinium-enhanced MRI lesions, this time over two years. The reduction in brain volume loss was nominally significant. The pooled results from the SUNBEAM and RADIANCE part B studies showed a lack of statistical significance in time to 3-month confirmed disability. This miss may, however, be as a result of the low rate of disability progression observed across all treatment groups.
Celgene reported a flat third quarter last week, and lowered its 2020 guidance by $1 billion, at least partly based on much slower growth for its immunotherapeutic Otezla (apremilast). The revision knocked its shares down by 17%. So the company is putting its hope into ozanimod, a sphingosine-1-phosphate receptor-1 (S1P1) agonist in phase 3 for relapsing multiple sclerosis and ulcerative colitis, and Phase 2 for Crohn's disease.
"As physicians, we recognize the increased need for additional effective and safe therapeutic options for use earlier in the treatment of relapsing multiple sclerosis," said Bruce Cree, Associate Professor of Clinical Neurology at the University of California San Francisco Weill Institute for Neurosciences and co-author of the RADIANCE study. "Based on these data, ozanimod has the potential to provide relapsing multiple sclerosis patients and their physicians a novel oral option for treating this debilitating illness."
Celgene's recent termination of its immunology treatment mongersen in Crohn's disease due to lack of efficacy could free up cash for the development of ozanimod, but also puts pressure on the drug to fill in the gap in the pipeline. Mongersen's fate in ulcerative colitis is in the balance, pending Phase 2 data.
"With respect to ozanimod, we're quite confident in what we see in the profile," Celgene's CEO Mark Alles said during the third quarter call. "We think it will be a blockbuster in multiple sclerosis and one of the deltas again we've described is the ulcerative colitis program moving out with the accrual thought to happen a little bit sooner, now it will be mid-2018 and that pushes ozanimod in ulcerative colitis into more of the post-2020 period in terms of an impact."
Michael Yee, equity analyst at Jefferies, is positive about Celgene's long term opportunities. "Bottom line, with ozanimod ulcerative colitis data in 2019, Crohn's disease thereafter and Celgene suggesting additional opportunities in dermatology, neurology and rheumatology, ozanimod could be a significant part of Celgene's I&I platform in 2020-2030," he wrote in a note to clients.
Yee predicts ozanimod as "best-in-class" and projects a filing with the Food and Drug Administration by the end of 2017 in multiple sclerosis, and a European Medicines Agency in early 2018 for both doses, with likely commercialization of the higher dose. If the FDA accepts no first dose monitoring for ozanimod, this could be a key differentiator from a notable competitor. Novartis' Gilenya (fingolimod) requires physicians monitor patients for six hours after their first dose in case of complications.
Follow Suzanne Elvidge on Twitter