Physician Views: Is Celgene's ozanimod a threat to Gilenya?

Long-awaited data from two Phase III studies have been presented, but the jury remains out on whether Celgene's ozanimod – an oral, selective sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator for the treatment of relapsing multiple sclerosis – can effectively replace Novartis' Gilenya as a best-in-class product on the grounds of safety. Particularly as Novartis' agent is poised to lose patent exclusivity in 2019.

Initial assessment of new pivotal-stage data presented at the joint ECTRIMS – ACTRIMS meeting this weekend suggests that while ozanimod appears to have a superior cardiovascular safety profile to Gilenya, a clean label for Celgene's drug will be critical in driving future market share gains. Under such a scenario, the indirect competition posed by generic Gilenya still looms large.

To better assess the outlook for ozanimod, we are snap-polling US and EU5 neurologists…   

In new Phase III data, ozanimod demonstrated comparable efficacy in reducing annualised relapse rates (ARR) in relapsing multiple sclerosis to other available oral agents. As a potential same-class competitor to fingolimod (Gilenya), the key value proposition for ozanimod is potentially better cardiac safety. Phase III data show a c.6 bpm reduction in heart rate versus placebo, but no QT prolongations or second degree or higher atrioventricular blocks were seen with ozanimod.   

How compelling is the proposition of an agent that is similar to fingolimod, but that offers better cardiac safety?

Not compelling

Slightly compelling

Moderately compelling

Very compelling

Extremely compelling

Do cardiac safety concerns limit your current utilisation of fingolimod?

Never

Rarely

Sometimes

Often

Always

In terms of driving future utilisation of ozanimod, how much of an advantage would exclusion of first-dose monitoring requirements (on its label) provide?

None

Marginal advantage

Moderate advantage

Significant advantage

Very significant advantage

If this feature (improved cardiac safety) was the main differentiator between marketed ozanimod and fingolimod, would it prevent erosion to use of ozanimod once cheaper generic versions of fingolimod reach the market?

No

Marginal protection

Moderate protection

Significant protection

Very significant protection   

In the SUNBEAM trial, brain volume loss, a measure associated with MS disease progression, was reduced by 33% with 1mg ozanimod and 12% with 0.5mg ozanimod versus Avonex (interferon beta-1a) at one year. In the RADIANCE trial, brain volume loss was reduced by 27% with 1mg ozanimod and 25% with 0.5mg ozanimod versus Avonex at two years.

In comparison to available oral agents, do these data strike you as therapeutically compelling?

No

Marginally

Moderately

Significantly

Very significantly

Results and related analysis will shortly be published for FirstWord Pharma PLUS subscribers to read, with the opportunity for non-FirstWord Pharma PLUS subscribers to purchase these findings. To be notified when poll results and analysis become available, please click here.

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