After FDA rebuff, Celgene on track to refile ozanimod—in 2019

Celgene
The delay is a blow to a potential blockbuster that would, with a better safety profile, rival Novartis’ Gilenya. (Celgene)

Celgene suffered an embarrassing setback in February when it got a refuse-to-file letter for its multiple sclerosis drug ozanimod. Now, the company says, it expects to resubmit the NDA in the first quarter of 2019, delaying its timeline by a year.

The delay is a blow to a potential blockbuster that would, with a better safety profile, rival Novartis’ Gilenya. Celgene will have to wait a little longer to start reaping sales that could reach $5 billion a year. But it could be worse—while the 2019 timeframe isn’t great, it is still “better than worst fears of 2020 refiling and long delay,” wrote Jefferies analysts in a note to investors.

“Key questions will be around what FDA wanted for refiling (likely two-year animal cancer carcinogenicity studies due to new metabolite found at high levels in humans),” the analysts said.

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The FDA sent the refuse-to-file notice because the Celgene failed to provide the necessary preclinical and clinical pharmacology information on ozanimod. At the time, management explained that the letter was not related to concerns about S1P receptor modulators and said it thought it could use existing activities to address some of the agency’s feedback.

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While Celgene was optimistic, the impact of the FDA’s refusal and the ensuing delay could extend beyond ozanimod’s immediate future. It may also color perceptions of Celgene and confidence in its ability to deliver in the coming years.

“This just adds even more uncertainty and credibility questions, which is not helpful right now given Celgene is in a period where they need to instill confidence after the recent disappointments,” wrote Jefferies analyst Michael Yee in February.