- Celgene is one step closing to bringing its first multiple sclerosis drug, ozanimod, to market, announcing Friday positive topline results of a Phase 3 trial.
- The SUNBEAM trail tested two doses of the oral drug, .5mg and a 1mg, against Biogen's Avonex (interferon beta-1a) in 1,346 people with relapsing multiple sclerosis (RMS). The early data showed both doses reduced annualized relapse rates (ARR) better than Avonex.
- More complete results will become available at an upcoming scientific meeting, the company said in a Feb. 17 statement. In the meantime, data from another, confirmatory late-stage study of ozanimod should begin rolling out in the second quarter.
The company didn't give any specifics about a timeline for regulatory filing of ozanimad, though has said previously it expects to file a New Drug Application with the Food and Drug Administration this year.
Ozanimod's approval would be big, not only for Celgene, but for the multiple sclerosis market.
There are currently 13 drugs for RMS on the market, but only three of them are administered orally, according to the National Multiple Sclerosis Society. What's more, Celgene's candidate regulates what's known as sphingosine 1-phosphate receptors, which, among other things, control the movement of lymphocytes and play a roll in the development of multiple sclerosis. Many consider ozanimod the best-in-class for this type of therapy, based on clinical results.
"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," Scott Smith, president of Celgene's inflammation and immunology business, said in the statement.
From Celgene's perspective, the company has been adamant about expanding its pipeline, particularly because about 60% of its revenue comes from a single cancer drug: Revlimid (lenalidomide). The company said during a fourth quarter earnings call in late January it intends to bring on more oncology and autoimmune candidates, and has laid the groundwork for potential acquisitions leading to that end.