With Novartis' Mayzent Firmly Positioned for Transitioning Relapsing-Remitting Multiple Sclerosis and Secondary Progressive Multiple Sclerosis Use, EMD Serono's Mavenclad Could Be Most Competitive as an Ideal First Switch Following Efficacy Failure

EXTON, Pa., June 26, 2019 /PRNewswire/ -- During the last week of March 2019, both Novartis' Mayzent and EMD Serono's Mavenclad were approved by the FDA as disease-modifying therapies (DMTs) for the treatment of relapsing forms of multiple sclerosis (MS), with active secondary progressive MS (SPMS) explicitly included in the labels of both new market entrants. Data from the 100 neurologists surveyed for the Q2 wave of the ongoing quarterly RealTime Dynamix™: Multiple Sclerosis (US) report series confirm that use among active SPMS and transitioning relapsing-remitting MS (RRMS) patients will be a given for both brands. Indeed, during recent sales representative interactions, EMD Serono and Novartis were heavily advocating use in these overlapping patient populations with few neurologists recalling a primary RRMS focus. However, interest in and opportunity for Mayzent outpaces Mavenclad among the active SPMS and transitioning RRMS segments and more than one in five patients recently prescribed Mayzent represented lost opportunities for Mavenclad (second only to Genentech's Ocrevus). As such, EMD Serono may be better served by shifting focus to differentiate Mavenclad outside of Mayzent's current later line niche.

Early launch perceptions and uptake patterns support an ideal first switch position for Mavenclad following efficacy failure among RRMS patients. Early Mavenclad adopters see significantly greater opportunity in the crowded RRMS segment and are more willing to prescribe Mavenclad to an RRMS patient requiring an efficacy-related switch compared to non-prescribers. More than half of the Mavenclad-treated patients managed by these initial prescribers were switched from typical first-line DMTs, including Genzyme's Aubagio, Biogen's Tecfidera, and the injectable DMTs. In addition, focusing on early switches could ease market access barriers as neurologists rate efficacy-related switch as the easiest scenario for which to obtain payer approval. Positioning Mavenclad as an early switch therapy would offer the brand an opportunity to win prescriber loyalty and payer favor within the US MS market, while remaining within the FDA's general recommendation for second or later line use.

With neurologists optimistic about the continued uptake of Ocrevus and strong growth of the new oral DMTs, Biogen's MS franchise is projected to be hit especially hard over the next six months. While Tysabri share will most likely continue the slow decline observed since Ocrevus launch, Spherix data collected quarterly over the past three years suggest that future Tecfidera share may remain resilient even in the face of increased pressure from competitors. As neurologists' most preferred RRMS therapy, especially among treatment-naïve patients, Tecfidera success will be more dependent upon effective competition with Teva's Copaxone and Sandoz's and Mylan's generic glatiramer acetate agents for the first-line position, rather than with the newest oral DMTs. However, patient-level data from Spherix's third annual RealWorld Dynamix™: DMT New Starts in Multiple Sclerosis (US) audit suggest that the glatiramer acetate class continues to outpace Tecfidera nearly 2:1 within the new start patient segment. Glatiramer acetate is frequently selected as a first-line therapy due to favorable safety and tolerability perceptions, as well as comfort with family planning considerations. With first-line Tecfidera patients already significantly younger and more likely to be female compared to the other oral DMTs, robust clinical data support of a Tecfidera position as the ideal oral DMT for treatment-naïve patients considering family planning could be a highly effective strategy for first-line competitiveness.

About RealTime Dynamix™
RealTime Dynamix™: Multiple Sclerosis (US) is an independent report series published on a quarterly basis providing trending back to Q1 2016. The series provides a close-quarters analysis of key performance metrics, focusing on brand gains and losses, industry contact rates, familiarity and adoption patterns of recently launched products (e.g., Mayzent, Mavenclad, and Vumerity in 2019) and awareness of products in development. Product perceptions, disease awareness and attitudes, practice management and other topics are rotated throughout the year to provide an ongoing probe of the crucial drivers of change. The 15^th wave of research will publish in September 2019.

RealWorld Dynamix™: DMT New Starts in Multiple Sclerosis (US) blends attitudinal and demographic physician survey data with previously treatment-naive patient record data to uncover how practice type and setting and certain beliefs influence the treatment pathway and to understand how marketed DMTs are being used by physicians and for what patient types. The report also captures physician's perspectives about products in development and the impact they will have on the current treatment paradigm among new start patients.  The third annual RealWorld Dynamix™: DMT New Starts in Multiple Sclerosis (US) published in February 2019. Parallel audits include the fourth annual RealWorld Dynamix™: DMT Switching in Multiple Sclerosis (US), which published in April 2019, the first annual RealWorld Dynamix™: DMT Switching in Multiple Sclerosis (EU), publishing in July 2019, and the second annual RealWorld Dynamix™: Progressive Forms of Multiple Sclerosis (US), publishing in November 2019.

About Spherix Global Insights
Spherix Global Insights is a hyper-focused market intelligence firm that leverages its own independent data and expertise to provide strategic guidance so biopharma stakeholders can make decisions with confidence.

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: [email protected]
www.spherixglobalinsights.com

SOURCE Spherix Global Insights

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