Biogen, Novartis, Sanofi catch a break with holdup to Celgene MS prospect

The FDA has handed Celgene a "refuse to file" letter over MS prospect ozanimod. (FDA)

Companies expecting competition from Celgene multiple sclerosis candidate ozanimod just got a reprieve.

Late Tuesday, the big biotech revealed that the FDA refused to accept its approval application, thanks to “incomplete” pharmacology information. And that means more time for its future MS rivals to rack up sales unchallenged.

Other oral MS meds will particularly benefit from the slowdown to Celgene's pill, which the company picked up in its $7.2 billion buyout of Receptos in 2015. Novartis, Biogen and Sanofi all market their own pills—dubbed Gilenya, Tecfidera and Aubagio, respectively—and Celgene had been hoping to position its prospect as a safer alternative.


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Now, though, it’ll be at least a year before it can do that, Bernstein’s Ronny Gal wrote on Wednesday in a note to clients. Leerink Partners’ Geoffrey Porges was a little less optimistic, writing to his own clients that “under a standard 9-month NDA review, it appears the best-case scenario is that ozanimod will launch in Q3 2019, instead of Q4 2018.”

RELATED: Celgene heaps pressure on MS pills as blockbuster hopeful ozanimod hits its marks

Plus, by the time ozanimod can launch, things won’t be the same in the oral MS lineup. Generics of Gilenya are expected to descend early in 2019, and “as payers get used to the lower cost of the generic, it may be tougher for ozanimod to gain formulary traction in at least some programs,” Gal pointed out.

RELATED: Novartis' Gilenya patent loss sets MS market up for battle with early generics

Meanwhile, Celgene is also developing ozanimod in the ultracompetitive disease areas of ulcerative colitis and Crohn’s, though its would-be rivals in those fields won’t benefit from the MS holdup.

“Celgene believes the issues will not delay the development timeline for ozanimod in inflammatory bowel disease,” Porges wrote, adding that “this suggestion is consistent with the lack of direct or alarming clinical effects being behind the delay.”

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