Celgene has officially embarked on ozanimod’s comeback regulatory journey, submitting an application to the EMA days before it plans to knock on the FDA’s door — just in time for the deadline it has set for itself.
Saying Celgene — and Bristol-Myers, which is set to acquire the biotech as long as the growing investor opposition doesn’t derail the deal — has a lot riding on the decision would be an understatement. Following an embarrassing refuse-to-file episode with the FDA last February, positive progress here is crucial not just to materialize ozanimod’s blockbuster promises as a cash cow as Revlimid approaches a patent cliff, but to prove Celgene’s team still possesses the development shrewdness that marked the company for years.
For the European application, Celgene has provided data from the SUNBEAM and RADIANCE Part B Phase III, which offered encouraging comparisons with Avonex in treating patients with relapsing multiple sclerosis.
Back when the trial read out in 2017, upbeat analysts also ran their own cross-trial comparisons with Novartis’ Gilenya and concluded that Celgene might leap out onto the market with a similar efficacy profile but better safety features.
One of them, Brian Skorney of Baird, remains optimistic — if slightly more cautious. From a recent note:
Management cited that they expect to resubmit the NDA for ozanimod in March, file for approval of liso-cel in the second half of this year, and secure approval of bb2121 by EOY 2020. We continue to believe that the eventual approval of these three assets within the given timelines is more likely than not. Based on the available clinical information and the anticipated timelines of the ongoing clinical trial programs, our estimates for the likelihood of success of each asset are ~75% for ozanimod, ~90% for liso-cel, and ~85% for bb2121.
Fresh from a major late-stage implosion surrounding mongersen, Celgene shook investors when it disclosed the RTF more than a year ago. The FDA, it said back then, had determined “that the nonclinical and clinical pharmacology sections in the NDA were insufficient to permit a complete review.”
Then the company managed to attract side eyes again when a top exec pinned the blame for the fiasco on Receptos, the original developer of the drug — which was bought out by Celgene 2.5 years before the filing, its ex-CEO pointed out in response. In its glory days, Celgene has said ozanimod is worth $4 billion to $6 billion a year in peak sales, but that’s becoming an increasingly tough pitch with analysts, especially with new safety trials now under way raising questions about potential drug-drug interactions.
Celgene, meanwhile, still “believes ozanimod could be a best-in-class, oral option for use early in the treatment of relapsing forms of multiple sclerosis,” CMO Jay Backstrom said in a statement.
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