June 13, 2017
By Mark Terry, BioSpace.com Breaking News Staff
For a company that is widely admired and has what David Liang, writing for The Motley Fool, calls “the best growth rate in large-cap biotech,” Celgene ’s stock seems to underperform. It’s been generally below the S&P this year, even though it has three blockbuster drugs. Liang takes a look.
Possibly investors are waiting on Celgene’s new drug, ozanimod. Celgene picked it up in July 2015 when it acquired Receptos for $7.2 billion. Belonging to a new class of drug, ozanimod is a S1P agonist, which basically controls white blood cells in the lymph nodes. This has implications for treating autoimmune diseases. The drug is being evaluated in a number of autoimmune diseases, including relapsing multiple sclerosis (RMS), ulcerative colitis (UC), and Crohn’s disease.
On February 17, Celgenereleased the results of its Phase III SUNBEAM trial, which evaluated ozanimod in relapsing multiple sclerosis. The drug met the primary endpoint, reducing annualized relapse rate (ARR) compared to weekly interferon (Avonex).
And on May 22, it announced that its Phase III RADIANCE trial, which also evaluated ozanimod in relapsing multiple sclerosis met its primary endpoint in reducing annualized relapse rate (ARR) compared to weekly interferon (Avonex).
“The results of the Phase III RADIANCE trial confirm the data observed in SUNBEAM and are consistent with the long-term Phase II RADIANCE trial,” said Bruce Cree, associate professor of Neurology, Multiple Sclerosis Center, University of California, San Francisco, in a statement. “The significant effects seen with ozanimod on relapse and MRI outcomes, including brain volume loss, coupled with the safety and tolerability profile observed in the two Phase III trials, represent an exciting advancement for a disease which needs additional oral therapies with favorable benefit-risk profiles.”
And the safety profile is very close to that of the placebo. Liang notes that other S1P drugs, including Novartis ’s Gilenya for MS, has package warnings about possible infections, heart problems, and liver damage.
Liang writes, “The autoimmune market—particularly the multiple sclerosis market—is huge. Second only to rheumatoid arthritis, multiple sclerosis is the most valuable specialty indication to treat, worth $17.2 billion in 2014. While Biogen has historically held the lion’s share of this market (MS drugs accounted for $8.8 billion of revenue for Biogen in 2016), newer players such as Sanofi’s Aubagio and Novartis’ Gilenya have been steadily chipping away at Biogen’s MS empire.”
Analysts project ozanimod peak sales from $1 to $2 billion, which, if approved, would make Celgene’s fourth blockbuster. And if the drug is effective for Crohn’s disease, it would double that figure. Liang points out that Gilenya brought in $3.1 billion for Novartis, and it isn’t even approved for Crohn’s disease.
Celgene expects to submit a new drug application (NDA) to the FDA by the end of this year. If approved, it could launch in early 2018.
Meanwhile, Celgene plans to push ozanimod into the clinic for ulcerative colitis and Crohn’s disease. Celgene already completed a Phase II trial of ozanimod in Crohn’s, although it hasn’t released the full data yet. It has indicated results were positive with plans to move into Phase III by the end of this year.
In addition to ozanimod, Celgene has 18 Phase III programs that will read out in the next two years.
Celgene is currently trading at $119.45.
