In the wake of the Mayzent EMA approval, neurologists expect to diagnose more patients with active secondary progressive multiple sclerosis to broaden the pool of patients eligible for the second-to-market S1P receptor modulator, according to Spherix Global Insights

EXTON, Pa., April 9, 2020 /PRNewswire/ --Driven by expanded access to and uptake of disease-modifying therapies (DMTs) to treat advanced stages of relapsing multiple sclerosis (MS), the MS market in Europe shows signs of continued expansion of the number of patients treated with DMTs. Spherix collected data from 247 EU5 neurologists surveyed between February 5th and March 3rd for the most recent semiannual report included in Spherix's RealTime Dynamix: Multiple Sclerosis (EU) service. Findings confirm that the introductions of Roche's Ocrevus, Merck KGaA's Mavenclad, and (most recently) Novartis' Mayzent have contributed to the growth in treatment rates for relapsing remitting MS (RRMS), active secondary progressive MS (SPMS), and primary progressive MS (PPMS). Ocrevus has shown tremendous ability to usurp historical mainstays just two years after its initial launches in Europe, the anti-CD20 monoclonal antibody (mAb) has replaced glatiramer acetate (GA) as one of the most preferred DMTs on the market. Generic alternatives to Copaxone could have cut back on the erosion of the GA class, but Teva's success in patent litigation and continued Copaxone brand loyalty have minimized generic disruption. Indeed, steady declines in overall GA share reveal that the first generics in the MS market have struggled to establish a foothold capable of buoying the class back to its historical level of popularity.

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Increasing use of Ocrevus in patients starting on a DMT for the first time, as well as patients switching to a different brand, are both driving Ocrevus' quickly rising reported share in MS. Within the segment of new start patients, Biogen's Tecfidera and Sanofi's Aubagio are currently the share leaders, as neurologists have become accustomed to relying on the convenience of oral DMTs for their MS patients initiating DMT treatmentespecially in France. However, with many neurologists favoring induction treatment, in which new patients are initiated on an aggressive approach with a high efficacy agent, Ocrevus is an increasingly popular option for patients starting on DMT treatment. In the UK, where induction treatment is especially common, the rise of Ocrevus use in new start patients accompanies a corresponding drop in Tecfidera use among the same group, threatening the latter DMT's dominance in early lines of therapy.

Among switch patients, Ocrevus is now the most prescribed therapy, besting Novartis' Gilenya and Biogen's Tysabri. With European Medicines Agency (EMA) restrictions placed on use of Sanofi's Lemtrada beginning in November 2019, prescribing of Lemtrada as a switch-to agent has dropped significantly, and overall preference for and reported share of the DMT have fallen. Neurologists now appear to be replacing prior use of Lemtrada with more prescribing of Ocrevus, especially in Germany, Italy, and Spain. Tecfidera, the second most frequently prescribed switch-to agent just one year ago, has also experienced a substantial contraction of reported share in France and Germany.

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Ocrevus' growth trajectory has been impressive and sustained over the past two years, but new and emerging agents are poised to abate its increasing dominance. Approved by the EMA on January 13th, just weeks before survey fielding, Novartis' Mayzent is now the only therapy, besides Bayer's Betaferon, indicated specifically for the treatment of active SPMS. Given the decline of interferon shares and the desire to use high-efficacy treatments for patients with advanced disease, neurologists expect that Mayzent's true competition will be with Ocrevus. Indeed, audit data from 1,266 charts of EU patients recently switched to a new DMT, analyzed as part of Spherix's RealWorld Dynamix: DMT Switching in Multiple Sclerosis (EU) service, showed that Ocrevus was the active SPMS switch segment leader. Early perceptions among neurologists suggest that Mayzent could become a key option for active SPMS. More than half of EU neurologists are extremely willing to prescribe Mayzent to a patient with active SPMS, and diagnosis of active SPMS is expected to increase considerably over the next two years indicating that neurologists plan to reclassify a proportion of their RRMS patients as having active SPMS in order to make them eligible for Mayzent treatment.

Along with Mayzent's ability to establish a niche in active SPMS, the other threat to Ocrevus further along the horizon may again come from Novartis, with the company's subcutaneous anti-CD20 mAb, ofatumumab. Although the agent is approximately a year away from an EMA decision, EU neurologists have high hopes for its efficacy (expected to be comparable to that of Ocrevus given its mechanistic similarities) and convenient route of administration allowing it to be administered at home. One German neurologist considers ofatumumab a "highly effective therapy concept with better controllability than [Ocrevus]."

Although optimism is high for ofatumumab's at-home administration capabilities, neurologists are accustomed to the built-in opportunities for patient monitoring that come with infusion mAbs; in reality, candidacy for ofatumumab may depend heavily on likelihood of good patient compliance and adherence. In the upcoming EU RealWorld Dynamix audit, Spherix will evaluate the impact of DMT dosing profile on brand selection during a switch. The audit will also gauge Mayzent's early performance in the active SPMS market and the brand's success in competing with current preferred DMTs for that patient segment.

About RealTime Dynamix RealTime Dynamix: Multiple Sclerosis (EU)is an independent service providing strategic guidance through rapid and comprehensive twice-yearly reports, which include market trending, launch tracking, and a fresh infusion of unique content with each wave. The 7th wave of research will publish in April 2020.

About RealWorld Dynamix RealWorld Dynamix: DMT Switching in Multiple Sclerosis (EU) is an independent, data-driven service unmasking real patient management patterns through annual reports based on chart audits of ~1,250 patients switched to a new DMT within the previous three months. The report uncovers the "why" behind treatment decisions, includes year over year trending to quantify key aspects of market evolution, and integrates specialists' attitudinal & demographic data to highlight differences between stated and actual treatment patterns. The second annual report will publish in July 2020.

About Spherix Global InsightsSpherix 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.

Spherix was recently recognized by Philadelphia Business Journal as a 2019 Soaring 76 recipient for the fastest growing companies in the Greater Philadelphia area and by The Philadelphia Inquirer as an Entrepreneurs' Forum 2019 Philadelphia 100 Winner for the fastest growing privately-held companies in the Greater Philadelphia area.

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

For more information contact:Meg Stabb, Neurology Insights DirectorEmail:info@spherixglobalinsights.comwww.spherixglobalinsights.com

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Roche's Ocrevus Continues to Impress in the EU with Strong Uptake in New Start and Switch Multiple Sclerosis Patient Segments, but Novartis' Mayzent...