Safety profile will help bring ozanimod to multiple sclerosis market, says Celgene

Celgene says there remains opportunity in MS for agents with better safety and efficacy.

When Celgene reported its second pivotal trial for multiple sclerosis hope ozanimod a few days ago, a miss on a secondary endpoint led to speculation about the prospects for the drug—but the company is confident it won't hinder it commercially.

Celgene Chief Financial Officer Peter Kellogg told analysts at Barclays that the safety profile of the S1P inhibitor compared to rival Gilenya (fingolimod) from Novartis—coupled with the reduction in annualized relapse rates seen with ozanimod in the RADIANCE trial—gives him confidence about its prospects for FDA approval. The company has previously said it plans to file for approval of the drug in MS before year-end.

The safety profile of Gilenya—which added more than $3.1 billion to Novartis' coffers last year—"makes it less than ideal for some patients," say the analysts, who note that Celgene thinks its candidate looks better especially with regard to "liver toxicities, QT prolongation, and bradycardia."

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Oral ozanimod reduced annualized relapse rates in the head-to-head comparison with Biogen's injectable Avonex (interferon beta-1a) therapy in RADIANCE, but was no better at reducing the rate of disability progression. However, it did show significant reductions in brain atrophy compared to Avonex.

"The company noted that no improvement in disability was the base case when compared to Avonex," said Barclays in its research note. "Overall, the company sees what is characterized as a real unmet need for what could be a longer-term therapy with good tolerability and efficacy."

Celgene is confident of an "optimized and efficient" launch of ozanimod in MS, and is working on its rollout plans. It plans to market it on its own in the U.S. and Europe, but may partner in some ex-U.S. countries.

Ahead of the RADIANCE readout, analysts were predicting sales of $2 billion or more for the drug at peak from MS alone, with possible upside if it can claim follow-up approvals in inflammatory bowel disease. That level of sales would justify the $7.2 billion Celgene forked out for ozanimod's developer Receptos in 2015.

With regard to future development plans for the drug, Kellogg told Barclays it is "still figuring out" how to position the drug in IBD, i.e., ulcerative colitis and Crohn's disease, but with positive phase 2 data in hand the company reckons it has significant opportunity, as current drugs for IBD don't provide long-lasting relief or halt disease progression.

Next week Celgene's attention will turn from CNS to its cancer portfolio, as it showcases a host of new studies at the American Society of Clinical Oncology annual meeting in Chicago.

Among the candidates highlighted will be Agios-partnered enasidenib, a selective inhibitor of mutant isocitrate dehydrogenase 2 in trials for acute myeloid leukemia that was filed with the FDA in March, with a verdict due in August.