Celgene has posted some new late-stage data from a second pivotal test in multiple sclerosis for its $7.2 billion oral candidate ozanimod, showing it could beat out Biogen’s marketed MS drug Avonex in reducing annualized relapse rates in a head-to-head, hitting its primary endpoint.
That was the good news; the bad news is that when the big biotech used that data from this test, known as Radiance, and pooled it with data from another phase 3 trial, Sunbeam, and while “a very low rate of disability progression was observed across the three treatment groups,” the candidate “did not reach statistical significance compared to Avonex” when it came to meeting its disability endpoint.
The company added that both doses of ozanimod (0.5mg and 1mg) did show “statistically significant reductions in brain atrophy compared to Avonex” in each phase 3 trial. Its miss on disability, however, may hamper its future commercial prospects.
It hasn’t, though, dampened its resolve to get the drug to market, which is also in testing for certain forms of inflammatory bowel disease, as its plans an NDA with the FDA by the end of the year in relapsing forms of MS.
Analysts have previously seen the med raking in major blockbuster figures at peak, with around $2 billion slated to come from the MS portion of sales.
Barclays said in a note to clients this morning on the data: “In our view, the only wrinkle [from its Radiance data] is that ozanimod did not show a difference in the pooled time to confirmed disability progression analysis, which is a key component of the Special Protocol Assessment (SPA) agreement reached with the FDA.
“Still, pending additional detailed data, we view the totality of the ozanimod data as supporting approval as a new option in the RMS population.”