Celgene’s inflammatory bowel disease (IBD) drug GED-0301 has failed to pass an interim futility review has led to the cancellation of the phase 3 trial. Celgene, who paid $710 million for the drug upfront in 2014 is now confronting the idea of terminating the drug altogether.
Late in 2015 company moved the drug into a 1,000-patient, 52-week phase 3 trial. The trail continued all the way to this month’s interim futility analysis, when it revealed that GED-0301 has hope in the battle against Crohn’s disease. Celgene has also stopped plans to begin a second late-phase trial because of the findings. The New Jersey-based company is waiting to review the full data from a phase 2 trial in ulcerative colitis, the other main component of IBD, before deciding whether to completely discard it or not.
During premarket trading Celgene fell about 6%. That decline basically exposes the removal of GED-0301 from anticipated sales revenues. To purchase GED-0301 from Nogra Pharma, Celgene had initially paid $710 million then pledged to $2 billion more for milestone achievements. The only publicly available clinical data at that time came from a meager 15-subject phase 1 trial. The phase 2 data is what caught Celgene’s eye revealing that GED-0301 effortlessly outperformed the placebo in clinical remission.
There is much skepticism proved warranted by experts about the design of the study. Celgene failing to see the issues adds to uncertainties about its business model.
“[There is] growing negative sentiment around Celgene’s ability to do [business development] and ‘good deals’ since many partner/acquisition deals have not fully played out great and there’s mixed views on their success at this point so could the “model” not be working,” analyst Michael Yee stated.
Celgene’s future IBD optimism now depends on ozanimod, an immunomodulatory drug the company acquired through the $7.2 billion takeover the company Receptos. Phase 3 data on ozanimod in ulcerative colitis will be revealed sometime in mid-2018.