Celgene pumped out its Phase III data on its blockbuster contender ozanimod over the weekend, offering some encouraging comparisons with Avonex in treating patients with relapsing multiple sclerosis. But some of these numbers will likely trigger some second guessing about the drug’s peak sales ability after Celgene paid $7.2 billion to get its hands on the drug.
Investigators recruited 1,346 patients for the SUNBEAM trial, posting statistically significant scores for the annualized relapse rate. But in a pooled analysis of SUNBEAM and RADIANCE Part B studies, their drug did not hit the goal for the time to 3-month confirmed disability progression.
Analysts have been doing some cross-trial comparisons with Novartis’ Gilenya, which is coming off patent protection at the end of 2019, and concluded that Celgene looks like it could leap out onto the market with a similar efficacy profile but better safety features. If so, Celgene could gain a significant edge in the rivalry to come for this drug, which Celgene has said is worth $4 billion to $6 billion a year in peak sales.
Several analysts were willing to give Celgene — long a darling of the biotech investor crowd — a thumb’s up for the data, which the big biotech badly needs after its missteps over the last two weeks, cutting longterm forecasts and triggering an 18% drop in the share price $CELG. Just before that, Celgene was forced to concede that its program for mongersen had imploded in Phase III.
“The posters and presentations suggest that ozanimod indeed has a differentiated safety and efficacy profile to other widely used medicines in the MS category,” noted Leerink’s Geoffrey Porges, who says an OK in MS along with inflammatory bowel disease and more could create $2.9 billion in sales by 2022. “This product, along with luspatercept, has become the standard bearer for Celgene’s late stage pipeline, and in our view the data at the meeting justify some recovery in sentiment about the company’s portfolio and outlook.”
SunTrust’s Yatin Suneja did some basic math and came out upbeat about Celgene’s market prospects.
Efficacy highlights (primarily focused on ozanimod 1mg) included (1) 48% ARR reduction vs. Avonex (primary endpoint; broadly in-line with Gilenya’s 52% reduction in TRANSFORMS, in our view), (2) T1 GdE lesion reduction at month 12 of 63% vs. Avonex (which we believe is better than Gilenya’s 55% reduction in TRANSFORMS) and (3) 33% reduction in whole brain volume loss vs. Avonex (at least in-line with Gilenya’s 32% reduction in TRANSFORMS). While the trial was not powered for 3-month confirmed disability progression (an exploratory endpoint), there was a 31% reduction vs. Avonex.
Baird’s Brian Skorney has been following the program, and I asked for his take on the results. His response:
I think the ozanimod data had no surprises, which given the last two weeks of Celgene surprises is a relatively good thing. I think everyone expected an efficacy profile that looks on par with Gilenya and a safety profile that looks better than Gilenya and that is what we saw. It definitely appears to have a better cardiac profile. We will see how the FDA labels around that but without initial dose monitoring, it seems like a more compelling oral to start patients on than Gilenya. Everything is a cross trial comparison but the perspective is that Avonex is really safe and ozanimod seemed to match it pretty nicely, so compared to Gilenya, it will be perceived as looking safe. Things that people are concerned about with Gilenya, like liver tox and infection risk, all look better here. I don’t think this is a paradigm shifting drug though, the way Ocrevus appears to be.
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