Celgene MS pill can’t beat older rival on disability progression

Celgene’s ozanimod multiple sclerosis pill has produced a mixed bag of phase 3 results, meeting a key goal of reducing relapse rate, but failing to keep disability progression in check more effectively than Biogen’s older Avonex.

Although Celgene is best known for its work in blood cancer, the company is branching out into new areas and in 2015 bought biotech Receptos for $7.2 billion, mainly to get its hands on ozanimod.

Results released earlier this week seem to vindicate that decision, although in the view of some analysts the disappointing disability figures compared with Avonex may limit the drug’s commercial potential.

Peak sales of ozanimod are expected to be between $1 billion and $2 billion, but the MS drug market is becoming increasingly competitive with a range of options, including injections and oral therapies, already approved.

In March, Roche’s Ocrevus (ocrelizumab) became the first disease- modifying drug approved for the debilitating primary progressive MS, as well as relapsing disease and a potential $4 billion-a-year blockbuster.

Ozanimod looks likely to gain FDA approval, but the new data suggests it won’t be a leader in the field.

Findings from the RADIANCE trial, involving 1,313 relapsing MS patients across 147 sites in 21 countries showed both ozanimod 0.5 mg and 1 mg doses demonstrated statistically significant and clinically meaningful reductions in the primary endpoint of annualised response rate.

It also met secondary endpoints of the number of new or enlarging T2 MRI lesions over 24 months of treatment compared to Avonex and the number of gadolinium-enhancing MRI lesions at 24 months of treatment compared to Avonex.

Pooled data from RADIANCE and another phase 3 trial, SUNBEAM, showed a “very low rate” of disability progression, but this did not meat statistical significance compared with Avonex.

But both ozanimod doses showed statistically signficant reductions in brain atrophy compared with Avonex.

Safety and side effects will also be important for ozanimod’s success. Biogen’s big-selling MS drug, Tecfidera (dimethyl fumarate) has unpleasant gastrointestinal side effects that cause some patients to stop treatment.

Celgene said side effects seen in RADIANCE were in line with those in the phase 2 part of the trial announced last year – minor infections, headache and occasionally high levels of the liver enzyme alanine aminotransferase.

There was no mention of gastro side effects, and no cardiac, pulmonary, serious opportunistic infections, ophthalmologic, or malignancy-related events.

The drug’s side effect profile could therefore come under scrutiny when Celgene announces further details from RADIANCE at a forthcoming medical congress.

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