Celgene refiles potential MS blockbuster ozanimod with FDA

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Celgene

Celgene has filed its highly anticipated oral MS drug ozanimod with the US regulator, more than a year after the FDA rejected it because of a bureaucratic foul-up.

Last February Celgene received a “Refuse to File” notice from the FDA after finding issues with the dossier submitted by the company’s Receptos unit, which first developed the drug.

After the rejection a top executive from Celgene pinned the blame on Receptos for a substandard filing.

Nadim Ahmed said he regretted that the big US pharma had taken an arm’s-length relationship with Receptos after its acquisition in 2015 for $7.2 billion.

Without Celgene overseeing the dossier Ahmed said Receptos had failed to provide the necessary preclinical and clinical pharmacology information on the MS drug.

Celgene will be hoping the issues are in the past with its new filing for ozanimod in relapsing forms of the disease, which is tipped for annual sales in the region of $5 billion, although a newly-approved rival in the shape of Novartis’ rival pill Mayzent (siponimod) could make this much harder to achieve.

Ozanimod will be particularly important in the coming years should the $74 billion merger with Bristol-Myers Squibb go ahead next month.

With Celgene’s revenues from multi-billion dollar blood cancer drug Revlimid under threat from generic rivals in coming years, it’s hoped that ozanimod will help make up for lost sales of a drug that could generate more than $10 billion in revenues this year.

Celgene has also filed ozanimod with the European Medicines Agency, paving the way for a potential launch some time next year if all goes well.

Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator, which binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5).

It is backed by efficacy and safety data from the SUNBEAM and RADIANCE part B phase 3 trials.

Jay Backstrom, chief medical officer for Celgene, said: “New oral treatment options with differentiated profiles like ozanimod are needed to help address an unmet need for people with relapsing forms of MS.

“With concurrent applications in the U.S. and EU, we look forward to advancing this promising medicine through the regulatory review process to provide a new option for the treatment of RMS in 2020.”