Celgene ($CELG) bet big on the little-known Irish biotech Nogra Pharma when it partnered on a mid-stage drug for Crohn's disease. And today Celgene spelled out the reasons why it gambled $710 million upfront on a Phase II drug, highlighting data that support a clear case that the therapy can help spur clinical remission in a broad group of patients.
"Clinical remission was achieved by significantly greater proportions of patients receiving Mongersen (GED-0301) 40 (55.0%) and 160 mg/day (65.1%) compared with placebo (9.5%; p<0.0001 for both)," Celgene noted in an abstract. "No significant difference in clinical remission was seen for 10 mg/day (12.2%) vs. placebo. The rate of clinical response was significantly greater among patients receiving 10 (36.6%), 40 (57.5%) or 160 mg/day (72.1%) of Mongersen vs. placebo (16.7%; p=0.039, p=0.0001 and p<0.0001, respectively). The rates of adverse events (AEs) and serious AEs (SAEs) were similar across groups."
Mongersen is an oral antisense oligonucleotide that is designed to zero in on Smad7 near the end of the colon, where it can incite an inflammatory response. Celgene had already seen these results when it bought in for the upfront plus $1.9 billion in development and sales milestones. For analysts, who had to adjust their expectations for Celgene after the deal, the numbers helped underscore the potential for this drug.
"Overall, data from the ~160 patient trial (40 per arm) is at the high end of our expectations and perhaps roughly in-line with consensus Street expectations," notes ISI's Mark Schoenebaum. "Thus, my best guess at this point is that the stock will rise modestly today."
"GED-0301, a first-in-class oral antisense therapy, has the potential to change the treatment landscape for Crohn's disease," said Scott Smith, who runs Celgene's inflammation and immunology group. "Celgene is excited to pursue the clinical development program for this novel therapy in phase III trials in the near future."
Celgene is no stranger to the world of biotech deals. The company has one of the most active partnering groups in the industry, and there's a big interest in diversifying the company's product portfolio outside of cancer.
For now, Celgene appears ready to deliver on that promise. Mongersen is slated to start Phase III before the end of this year.
- here's the release