Inflammation and immunology pipeline
Celgene (CELG) is focused on advancing its diversified inflammation and immunology (or I&I) research pipeline in 2018.
Otezla label expansion
According to the company’s investor presentation, Celgene is currently studying Otezla in phase 3b trial DISCREET in the genital psoriasis indication, and in the phase 3 trial SPROUT in the pediatric moderate-to-severe plaque psoriasis indication. Additionally, Otezla is also being studied in a Phase 4 trial in moderate psoriatic arthritis indication.
Ozanimod research program
According to Celgene’s third-quarter earnings conference call, Celgene aims to submit applications seeking approval for ozanimod in the multiple sclerosis (or MS) indication, both in the US and Europe, in the first quarter of 2019. The company is working on various pre-launch activities for ozanimod in the MS indication.
On October 16, 2017, Celgene issued a press release highlighting the positive findings from phase 2 trials STEPSTONE and TOUCHSTONE, which evaluated ozanimod in Crohn’s disease and ulcerative colitis indications, respectively. The company then started phase 3 trial YELLOWSTONE to study ozanimod in the Crohn’s disease indication. The company is currently enrolling patients in another phase 3 trial, TRUE NORTH, which aims to study ozanimod in ulcerative colitis indication. This trial is expected to be fully enrolled by the middle of 2019.
According to Celgene’s third-quarter earnings conference call, the company has presented positive data for its investigational I&I therapy, RPC4046, in the eosinophilic esophagitis (or EoE) indication, from an open-label extension of the Phase 2 trial, HEROES. Since there are no FDA-approved therapies in the EoE indication, this investigational therapy can become a prominent asset for Celgene.
According to Celgene’s third-quarter earnings conference call, the company has withdrawn its regulatory submission seeking approval for Otezla as a once-daily formulation. The company plans to evaluate its manufacturing capabilities as well as the Otezla once-a-day formulation.
In the next article, we’ll discuss Revlimid growth trends in greater detail.