This Drug Could Rattle Biogen and Be the Next Billion-Dollar Blockbuster for Celgene
February 20, 2017
By Mark Terry, BioSpace.com Breaking News Staff
On Friday, February 17, Summit, NJ-based Celgene Corporation announced positive results for its Phase III SUNBEAM trial of ozanimod for relapsing multiple sclerosis (RMS). Not only is this very good news for Celgene, it is potentially devastating news for Cambridge, Mass.-based Biogen .
Ozanimod is an oral, selective S1P 1 and 5 receptor modulator. In the SUNBEAM trial, the drug met its primary endpoint, which was reducing annualized relapse rate (ARR) compared to weekly interferon (IFN) beta-1a (Biogen’s Avonex). There were also clinically meaningful improvements compared to Avonex for the secondary endpoints of the number of gadolinium-enhancing MRI lesions and the number of new or enlarging T2 MRI lesions at 12 months.
“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,” said Scott Smith, president of Celgene Inflammation and Immunology, in a statement. “We look forward to data from the confirmatory Phase III RADIANCE trial in the second quarter as we advance toward planned regulatory submissions by year-end.”
MS is a $19 billion market and Biogen’s portfolio has dominated it. Other companies, including Teva Pharmaceutical , Novartis and Sanofi are also big players, bringing in billions in annual sales.
Todd Campbell, writing for The Motley Fool, says, “Over the past few years, the biggest advance in MS treatment has been the launch of oral drugs that pose less of a burden on patients. Oral drugs have quickly won away market share from long-standing go-to therapies, including Teva Pharmaceutical’s Copaxone and Biogen’s Avonex.”
Biogen’s top sell is Tefidera, which brings in about $4 billion annually. Novartis’ Gilenya had sales of $3.1 billion last year and Sanofi’s Aubagio raked in $1.4 billion.
Celgene acquired Receptos and ozanimod in 2015 for $7.2 billion on the basis of Phase II trial results. After Friday’s announcement, the company plans to file with the U.S. Food and Drug Administration (FDA) this year. And based on results so far, if approved, could be the “best-in-class oral MS option,” per Campbell.
Both ozanimod and Gilenya target S1P1, but Gilenya has some side effects that include cardiac risks and liver toxicity. It appears that ozanimod avoids those.
As a result, Campbell writes, “Celgene has slapped multibillion-dollar blockbuster-drug expectations on ozanimod, and these Phase III results appear to back up that heady forecast, given the size of the addressable market.”
Celgene didn’t release much specific data from the Phase III trial in Friday’s announcement, although it plans to at a conference soon. If the trial data is better than its smaller Phase II trials, optimism over FDA approval will be justified.
Expect a high-priced drug, which in the current political climate could be toxic, although possibly not for a disease like MS. Gilenya’s dosage is $90,000 per year.
If approved, Campbell writes, “ozanimod could become the latest in a long string of Celgene successes. Celgene’s $7 billion-per-year Revlimid is the top-selling first- and second-line multiple myeloma drug. Its Pomalyst is the top-selling third-line multiple myeloma drug, with roughly $1.3 billion in sales. Its Abraxane is a go-to pancreatic cancer treatment, with about $1 billion in annual sales. Celgene’s most recently launched drug, Otezla, which treats psoriasis, is racking up sales at an annualized $1.2 billion pace, too.”