Spherix Global Insights

May 25, 2021

Bristol Myers Squibb’s Zeposia and Novartis’ Mayzent Have Both Experienced Strong Launches in Canada, But Spherix Data Uncover Numerous Internal and External Threats for Sustained Success

Neurologists in Canada are receptive to having a fourth S1P receptor modulator option in Janssen’s Ponvory, although increasing the clinical relevance of the agent’s comparative efficacy to Sanofi Genzyme’s Aubagio and fatigue secondary endpoint data is a must for any notable uptake

EXTON, Pa., May 25, 2021/PRNewswire – Over the past two years, two new S1P receptor modulator agents have been approved by Health Canada for the treatment of multiple sclerosis (MS) and a third one is waiting in the wings. Building upon the established success of Novartis’ Gilenya in Canada, these next-generation disease-modifying therapies (DMTs) offer proven efficacy for MS subtypes with high unmet need, easier onboarding with no or limited first-dose observation, and data against unique secondary endpoints.

The approval of Novartis’ Mayzent, the second-to-market S1P after the company’s own Gilenya, offered patients with active secondary progressive MS (SPMS) a DMT option that had been specifically studied in a typical SPMS population. In October 2020, Bristol Myers Squibb’s Zeposia was approved for the treatment of relapsing-remitting MS (RRMS) with a label that, unlike Gilenya, allowed for prescribing to treatment-naïve patients. Looking forward, Janssen’s Ponvory is teed up to be the potential fourth S1P receptor modulator to enter the market in Canada.

Launch analyses of the two most recent S1Ps included in Spherix’s RealTime Dynamix™: Multiple Sclerosis (Canada) service suggest that, while Mayzent and Zeposia have both found a place within the treatment armamentarium, sustained relevance may be harder to achieve. Spherix data trends over the past year show declining brand satisfaction and diminished active SPMS patient candidacy rate among the expanding Mayzent prescriber base.

Mayzent may be losing some of its footing due to eroding differentiation from Roche’s Ocrevus. While neurologists are still more likely to believe that oral Mayzent outperforms intravenous Ocrevus on efficacy and convenient administration, the degree to which Mayzent is favored has slipped with each fielding.

With Gilenya already under pressure from generic fingolimod in the RRMS segment, Novartis may benefit from broadening the Mayzent positioning to include this common MS subtype. Almost half of surveyed neurologists already claim to have prescribed Mayzent to at least some RRMS patients, and reported first-line use of the brand (while still minimal) has steadily increased. However, such a pivot would necessitate negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) to include reimbursement for the brand in patients that have not yet transitioned to SPMS.

Zeposia’s unique first-line RRMS label, relative ease of onboarding, and secondary endpoint data appear to have helped the brand overcome some of the drawbacks of its third-to-market status. While new DMTs are often initially trialed among more refractory patients, prescribers estimate that more than one-third of patients were treatment-naïve when initiated on Zeposia. Neurologists are three times as likely to state that Zeposia outperforms Gilenya in terms of onboarding ease compared to vice versa. Zeposia trial also appears to be tied to early adopters’ belief that the therapy will have a clinically significant effect on delaying cognitive worsening in their RRMS patients.

While initial uptake has been strong within the limited prescriber pool, these early Zeposia adopters do not anticipate any further share growth for the brand within RRMS. BMS will need to rely on obtaining Canadian Agency for Drugs and Technologies in Health (CADTH) recommendation and completing pCPA negotiations, as well as expanding the prescriber base through broader physician engagements, to help trends move in the right direction.

With both Mayzent and Zeposia facing their own challenges, Spherix uncovered some opportunities and threats for Janssen’s Ponvory based upon assessment of prelaunch perceptions and anticipated use patterns. On the positive side, neurologists believe that there will be a clear role for this fourth-to-market S1P in their practice and that patients would benefit from having access to another in-class option. Interestingly, few neurologists believe that Ponvory would compete directly with Mayzent or Zeposia, with impact primarily restricted to continued erosion of fingolimod and the interferons.

However, Ponvory may struggle to achieve substantial uptake in Canada as neurologists are currently more willing to use Zeposia than Ponvory for key patient types. The impact of Ponvory’s late entry into the market is further underscored by the lack of perceived differentiation from Zeposia across all assessed clinical metrics. Prelaunch data suggest that Janssen’s emphasis on Ponvory’s superiority over Genzyme’s Aubagio in pivotal trials and positive outcomes on fatigue secondary endpoint could be most effective in differentiating the brand – but even then, perhaps with only a receptive subset of Canadian neurologists.

About RealTime Dynamix™
RealTime Dynamix™ is an independent service providing strategic guidance through quarterly or semiannual reports, which include market trending and a fresh infusion of event-driven and variable content with each wave. The reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of experts.

The Q2 2021 report is the fifth semiannual edition included in the RealTime Dynamix™: Multiple Sclerosis (Canada) service. Parallel services are available for the US (quarterly) and EU (semiannual) MS markets. Learn more about our services here.

About Spherix Global Insights
Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select dermatology, gastroenterology, nephrology, neurology, and rheumatology markets.

All company, brand or product names in this document are trademarks of their respective holders.