Novartis' Gilenya, Sanofi's Aubagio, Biogen's Tysabri and Tecfidera Capture the Majority of Recent Switches in the European Multiple Sclerosis Market Boosted by Frequent Neurologist Endorsement

EXTON, Pa., Aug. 13, 2019 /PRNewswire/ -- According to Spherix's new audit included in the RealWorld Dynamix: DMT Switching in Multiple Sclerosis (EU) service, the relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (SPMS) subtypes offer the greatest opportunity for new disease-modifying therapy (DMT) business within the switch segment due to relatively high treatment and switch rates reported by the 276 contributing neurologists in France, Germany, Italy, Spain, and the UK. Data collected from 1,266 multiple sclerosis (MS) patients recently switched to a new DMT within the three months prior to fielding reveal Novartis' Gilenya, Sanofi's Aubagio, and Biogen's Tysabri and Tecfidera as the switch segment leaders in Europe. In France, where access to Sanofi's Lemtrada and Merck KGaA's Mavenclad remains restricted, Tysabri and Aubagio switch shares exceed that obtained in the other countries. Among the injectable DMTs, Teva's Copaxone dominates recent switches in all countries but the UK, although the brand's share is highly dependent upon selections within the first switch (i.e., second line of therapy) position. Likewise, Aubagio is significantly more likely to be recommended by the neurologists as the patient's optimal treatment option for first compared to second switches stressing the critical importance of being part of therapy selection discussions early in the treatment journey for this brand.

Designed to understand the drivers of switches from and to DMT brands, the Spherix audit confirms efficacy as the most common reason for switches away from the prior DMT, with relapse activity being the most prevalent cause for such switches across all EU5 countries. Among the other efficacy-related issues, significantly more switches in Spain were due to the development of clinical disability compared to in France, where MRI worsening was more influential. Among drivers of current DMT selection, patient request was influential in one out of five recent switch DMT selections. With oral DMTs being the most commonly recommended switch options by neurologists for optimal treatment, it is interesting to note that patient request was more frequent in switches to injectable DMTs (compared to the other DMT classes) and that Copaxone was requested by name by most Copaxone-switched patients. The advocacy by patients to switch to Copaxone may be related to the high rate of active pregnancy planning/pregnancy among Copaxone-switched females under the age of 50 years old. Compared to the brand, patient request and pregnancy planning rates are substantially lower among those patients who switched to generic glatiramer acetate suggesting comfort with family planning does not transfer to the therapeutically equivalent generic agent.

Even with the 2018 approval of Roche's Ocrevus, few patients with primary progressive MS (PPMS) are treated with a DMT and, as such, European neurologists estimate a comparatively low switch rate. Among those patients that have recently switched to a new DMT, Ocrevus clearly dominates within the PPMS subtype, capturing the majority of therapy selections. Indeed, Ocrevus' unique PPMS indication was a factor in almost half of all PPMS switches. Interestingly, comparing self-reported estimates and audit share, neurologists underestimate their reliance on Ocrevus and the role that its indication plays in the decision to switch from the prior DMT. If the current DMT is not successful for PPMS audit patients, more than one-third will discontinue DMT therapy stressing the continued unmet need for additional therapeutic options for these patients.

Currently, MedDay Pharmaceuticals' Qizenday, AB Science's masitinib, and MediciNova's ibudilast are the only therapies in late-stage clinical development for PPMS. If these agents had been available at the time of the recent switch selections, two-thirds or more of audit PPMS patients were identified by contributing neurologists as potential candidates for an alternative switch to one or more of these pipeline products. However, for Qizenday and masitinib, the switch opportunity is even greater among the not active SPMS subtype where Novartis' Mayzent, if approved later this year with a broad SPMS indication, would stand alone as competition.

About RealWorld Dynamix(TM)
RealWorld Dynamix(TM): 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 ~1,000 patients. 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. Parallel services include RealWorld Dynamix(TM): DMT New Starts in Multiple Sclerosis (US), third annual report published in February 2019; RealWorld Dynamix(TM): DMT Switching in Multiple Sclerosis (US), fourth annual report published in April 2019; and RealWorld Dynamix(TM): Progressive Forms of Multiple Sclerosis (US), second annual report publishing in November 2019.

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.

For more information contact:
Virginia Schobel, Neurology Franchise Head
Email: info@spherixglobalinsights.com
www.spherixglobalinsights.com

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