Another embarrassing and costly blunder has befallen Celgene. The Food and Drug Administration is refusing to review ozanimod, an experimental treatment for multiple sclerosis and Celgene’s most important pipeline product, the company said Tuesday.
Celgene said the FDA issued the so-called refuse to file letter because “nonclinical and clinical pharmacology” sections of the ozanimod application were insufficient. The company said it intends to meet with the FDA to determine what additional information is required to resubmit the drug.
“Obviously, we are very disappointed, but at this time, we think we understand the FDA’s position and what we need to do,” said Celgene CEO Mark Alles, speaking on a conference call.
The ozanimod application was filed with the FDA last December, which suggested a third-quarter approval and commercial launch. Celgene won’t offer a revised timeline until after the FDA meeting, Alles said.
The ozanimod regulatory delay is a big blow to Celgene, which is counting heavily on the drug for growth beyond its multiple myeloma drug Revlimid. Ozanimod became even more important to Celgene’s future outlook last October when development of a Crohn’s disease drug was halted prematurely.
“We view ozanimod as one of the most, if not the most, important pipeline programs for Celgene, though without additional info, it is difficult to know how material of a setback this is,” said RBC analyst Brian Abrahams, in a research note emailed to clients.
Despite Wednesday’s misstep, Celgene reiterated its long-term financial guidance, which forecasts total revenue in the range of $19-20 billion and adjusted earnings greater than $12 per share. The company believes any shortfall in ozanimod sales can be made up with other products.
Celgene shares closed Wednesday at $95.78 but then fell 6 percent to $89.50, a four-year low, in after-hours trading.
FEBRUARY 27, 2018