Bristol Myers Squibb's Zeposia and Janssen's Ponesimod Could Be Early-Line Winners, While Biogen's Vumerity Appears Relegated to Tolerability Switches Within the Fumarate Class

EXTON, Pa., June 16, 2020 /PRNewswire/ -- Neurologist-reported treatment patterns in multiple sclerosis (MS) reveal a continued trend of using more high-efficacy disease-modifying therapies (DMTs), according to the most recent report included in Spherix's RealTime Dynamix™: Multiple Sclerosis (US) service. The report, which collected the responses of 103 neurologists in the United States surveyed between May 1^st and May 18^th, finds that the share of MS patients receiving monoclonal antibody (mAb) DMTs has increased by more than 36% over the past year.  

This growing preference for aggressive treatment in MS may come under close examination in light of COVID-19, with nearly two-thirds of neurologists claiming that the pandemic has had a high impact on their practice. Indeed, among the subset of neurologists who report decreased use of Genentech's Ocrevus over the past three months, nearly all cite COVID-19 as a strong influencer of the change. However, neurologists are more likely to report recent increases than decreases in Ocrevus use, and overall use of the anti-CD20 monoclonal antibody (mAb) DMT continues to rise quarter over quarter. The ongoing Special Report: Multi-Specialty Impact of COVID-19 series further delves into the complex and quickly changing implications of the pandemic on neurology practices, with the 7^th wave publishing later this month.

Ocrevus' impressive resilience, thus far, in the face of COVID-19 has created a challenging environment for uptake of the two newest high-efficacy DMTs, EMD Serono's Mavenclad and Novartis' Mayzent. Through natural positioning and manufacturer promotional efforts, both agents derive most business from the active secondary progressive MS (SPMS) segment—a space in which Ocrevus has already established itself as the most frequently preferred DMT. Nearly twice as many physicians believe that Ocrevus has an advantage regarding efficacy in active SPMS than those who believe Mayzent has the upper hand. While the dominance of Ocrevus over Mavenclad is less stark, the separation between the brands has notably widened over the past six months due to a sizeable gain in the percentage of neurologists who believe Ocrevus is the superior agent for efficacy in active SPMS.

In addition to stiff competition from Ocrevus, Mayzent will soon have to contend with more players in the S1P receptor modulator class. With the US in the midst of the COVID-19 pandemic, following approval in late March, Bristol Myers Squibb elected to delay launch of Zeposia (ozanimod) for more than two months to June 1^st, allowing Mayzent some extra time to establish itself in the market. However, neurologists indicate that had Zeposia launched immediately upon approval, the DMT would have already amassed a large prescriber base and patient volume—including a sizeable proportion of first-line prescriptions—potentially spelling trouble for Mayzent and Novartis' Gilenya, which are often considered second- or later-line options.

Conversely, Janssen's ponesimod, currently undergoing FDA review with a decision anticipated later this year, is poised to become the fourth S1P receptor modulator to enter the market. With three other mechanistically similar options available by the time of ponesimod's potential US launch (and with relatively high reported awareness), there is lukewarm interest in the DMT. Many neurologists struggle to see ponesimod's incremental value to the already-crowded market.

The fumarate class has similarly expanded with Biogen's launch of Vumerity, believed to have comparable efficacy to, but improved gastrointestinal tolerability over, Biogen's first fumarate, Tecfidera. Despite Vumerity's accepted advantage over Tecfidera, a common first-line favorite for the treatment of relapsing forms of MS (RMS), the newest DMT has yet to find a foothold in the MS market. Fewer than half of surveyed neurologists have prescribed Vumerity, and most current use is among patients switching from Tecfidera (rather than first-line use in place of Tecfidera). With potential dimethyl fumarate generics looming on the horizon, modest Vumerity uptake may provide an incomplete shield against erosion of the branded fumarate agents.

The US MS market was expecting its next addition in June, but with the FDA pushing back the PDUFA date for Novartis' ofatumumab to September, neurologists will have to wait three more months for access to the next-generation anti-CD20 mAb DMT. Ofatumumab's once-monthly subcutaneous (SC) dosing allows for at-home administration, and is thus well-suited to challenge Ocrevus' dominance in RMS. Indeed, neurologists anticipate strong initial uptake of ofatumumab at the expense of Ocrevus, with a sizeable minority believing that their use of ofatumumab will surpass that of Ocrevus within two years. However, ofatumumab's dosing profile alone may be insufficient to unseat the mAb DMT share leader; some neurologists believe that what SC dosing offers in terms of patient convenience may be overshadowed by potential shortcomings on patient adherence. Spherix will continue to track neurologists' pre-market perceptions of ofatumumab as the anticipated FDA decision nears.

About RealTime Dynamix™
RealTime Dynamix™: Multiple Sclerosis (US) is an independent service providing strategic guidance through rapid and comprehensive quarterly reports, which include market trending, launch tracking, and a fresh infusion of unique content with each wave. The next quarterly report publishes in September.

Parallel services, RealTime Dynamix™: Multiple Sclerosis (EU) and RealTime Dynamix™: Multiple Sclerosis (Canada) track the evolution of multiple sclerosis market in Europe and Canada on a semiannual basis.

About the Special Report
Special Report: Multi-Specialty Impact of COVID-19 is an ongoing series of weekly (until mid-May) and monthly (from June to September) monitoring that evaluates the impact of COVID-19 on physicians and their practices – including, but not limited to, the utilization of telemedicine, at-risk patient groups, key concerns, support from industry, and future changes in prescribing patterns. Specialty reports are available for dermatology, gastroenterology, nephrology, neurology, and rheumatology.

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 immunology, nephrology, and neurology markets.

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

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Kristen Henn, Business Development Manager
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www.spherixglobalinsights.com

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