Celgene’s potential blockbuster gets positive Phase 3 results in multiple sclerosis

pharmafile | February 20, 2017 | News story | Research and Development, Sales and Marketing Celgene, multiple sclerosis 

Celgene’s drug to treat patients suffering with relapsing multiple sclerosis (RMS) was given a boost by positive Phase 3 trial results. The drug, ozanimod, was bought by Celgene for $7.2 billion alongside the company that developed it, Receptos, following promising Phase 2 data. It has, seemingly, repaid that faith – meeting both primary and secondary endpoints in the trial.

Celgene announced positive results in a trial involving 1,346 patients taking 0.5 mg and 1 mg of the oral drug. The drug achieved its primary of ARR and secondary endpoints of the number of new or enlarging hyperintense T2-weighted brain MRI lesions over 12 months and the number of GdE brain MRI lesions at month 12.

Orally administered therapies for MS treatment are currently leading the way in treatment, with Biogen’s Tecfidera bringing in $4 billion, per year, in sales; Novartis’s Gilenya £3.1 billion in sales and Sanofi’s Abuagio $1.4 billion in 2016.

Celgene’s ozanimod has the added bonus of having greater safety over Gilenya that has been associated with a heart rate drop and liver toxicity. By comparison, ozanimod did not display such risks in previous Phase II trials. The data from this current trial is not yet available but it could determine whether ozanimod will enter the market as a first-in-class treatment, as it is expected to do.

“People living with multiple sclerosis need additional therapies and we are pleased that oral ozanimod showed meaningful improvements across primary and measured secondary endpoints in this study,” said Scott Smith, President of Celgene Inflammation and Immunology. “We look forward to data from the confirmatory phase III Radiance trial in the second quarter as we advance toward planned regulatory submissions by year-end.”

Should the data from the Phase 3 trial be as promising as is expected, not only can patients of relapsed multiple sclerosis expect a new beneficial treatment, Celgene will be greatly rewarded for its expensive gamble upon Receptos.

Ben Hargreaves

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