Results

Celgene scores another win for megablockbuster contender ozanimod, but it’s haunted by key disability miss

Bob Hugin, Celgene

Celgene posted another key Phase III success for its megablockbuster contender ozanimod, once again underscoring its potential to disrupt the multiple sclerosis field.

Investigators held back the data, but ozanimod beat Avonex in reducing the annualized rate of relapsing and remitting MS. And that will be added to the earlier promising Phase III results being packaged for an FDA application later in the year.

There was, however, a potentially big hitch this time around. Celgene’s drug did not demonstrate a disability benefit over Avonex on a pooled basis, which will likely blunt its commercial prospects. Said Baird’s Brian Skorney:

Though the market doesn’t seem to be reacting to this, we’re disappointed by the lack of effect on disability progression, as a stat-sig effect would have been a key differentiator from Gilenya, which is set to go generic in 2019.

Evercore ISI’s Umer Raffat flagged it early.

As we discussed in our deep dive couple of weeks ago, we had found investor expectations around the disability endpoint to be a bit misplaced because Gilenya’s data never demonstrated an extraordinary stat sig disability benefit over an active comparator like Avonex … and as per CELG press release, rate of disability progression was very low in the trials.

Celgene picked up this drug in its $7.2 billion Receptos buyout. Not only did it hit the primary endpoint in the latest Phase III showdown, it also scored on the key secondary endpoints of the “number of new or enlarging T2 MRI lesions over 24 months of treatment compared to Avonex and the number of gadolinium-enhancing MRI lesions at 24 months of treatment compared to Avonex.”

Bruce Cree

“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. “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.”

The story, though, has a long way to go before Celgene can claim total victory. MS is a fast-changing field with new therapies like Roche’s Ocrevus coming in to shake things up. Big franchise drugs like Tecfidera have been faltering and Celgene’s Phase III data will be closely and carefully examined to see how it stacks up against growing competition.

The jury is still out on whether or not this is a game changer. For one thing, Celgene is also developing the drug for inflammatory bowel disease. Adds Raffat:

From my perspective, one of the most impt drivers of commercial uptake for ozanimod will depend on whether Gilenya is generic in 2019 or not.  I think there is realistic chance that Gilenya is branded beyond 2019 … there are impt Gilenya patents that have not been vetted by the Street.

Celgene’s executive chairman Bob Hugin staked the company’s reputation on this drug’s ability to hit $4 billion to $6 billion in annual revenue.

Before Celgene got a chance to buy this drug, then Teva CEO Jeremy Levin got a shot at it. That deal, though, fell through, leaving Teva to push ahead with laquinimod, which just failed a Phase III in MS, blighting its hopes for a successor to Copaxone.

Today, as Teva works on restructuring its operations, more than one exec is likely to be wondering about what may have happened if that deal had gone through.


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