Spherix Global Insights

December 11, 2018

Spherix Global Insights’ Quarterly Update on the Multiple Sclerosis Market Reveals a Unique Role for Genzyme’s Aubagio As the Only Oral Standard-Efficacy Therapy for First-Line Treatment of Relapsing-Remitting Multiple Sclerosis

Currently positioned by US neurologists to compete with Novartis’ siponimod in the later-line secondary progressive multiple sclerosis patient segment, EMD Serono’s Mavenclad could compete most successfully by strategically positioning the brand for first-line use in highly active relapsing multiple sclerosis patients, according to a new report from Spherix Global Insights

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EXTON, Pa., December 11, 2018 ―Oral disease-modifying therapies (DMTs) are neurologists’ most preferred therapeutic choice for first-line treatment of relapsing-remitting multiple sclerosis (RRMS) patients. In the current quarter of the ongoing quarterly  RealTime Dynamix™: Multiple Sclerosis (US) report series, approximately half of US neurologists (n=100) would select an oral DMT first line irrespective of disease activity level at therapy initiation. That being said, for a newly diagnosed RRMS patient presenting with high disease activity, neurologists shifted away from the injectable DMTs, in particular Teva’s Copaxone, and moved towards Novartis’ Gilenya, Biogen’s Tysabri, and Genentech’s Ocrevus. Following recent quarter-over-quarter increases, reported first-line Ocrevus use among RRMS patients remained flat even as a “first-line indication” message was increasingly recalled among detailed neurologists. Competition from Gilenya, Biogen’s Tecfidera, and Tysabri for newly diagnosed RRMS patients with highly active disease, payer restrictions on first-line use, and lingering safety concerns among neurologists and patients will most likely limit the full realization of the brand’s potential among new start RRMS patients.

Neurologists’ perceptions of efficacy categorization for first-line use fell mostly along DMT class lines. As an example, most neurologists categorized the monoclonal antibody DMTs as high-efficacy agents for first-line use. While a small subset of neurologists categorized Gilenya and Tecfidera as high efficacy, the majority considered them to be moderate-efficacy options for new start patients. These two moderate-efficacy oral DMTs captured almost 40% of self-reported recent new start share ─ similar to the collective share of the nine standard-efficacy injectable DMTs.

Challenging the association between class and efficacy perceptions, Genzyme’s Aubagio was most likely to be categorized with the injectable DMTs as a standard-efficacy DMT for first-line use. Among the standard-efficacy DMTs, Aubagio captured the second highest self-reported recent share of new start patients ─ trailing only Copaxone which was neurologists’ most preferred standard-efficacy DMT ─ revealing a unique opportunity for brand differentiation from the oral DMTs and from the other standard-efficacy options. To position Aubagio as the standard-efficacy therapy of choice, especially when desiring an oral dosing profile, Genzyme should focus on the attributes that drive Copaxone preference and message on safety record, tolerability, and limited monitoring requirements to drive greater preference for the brand.

Spherix’s prelaunch data suggest that EMD Serono’s Mavenclad (cladribine tablets), under FDA review for the treatment of RMS with an anticipated Q2 2019 decision, would be most competitive if positioned as an induction therapy for highly active RRMS patients or Clinically Isolated Syndrome (CIS) patients with concerning prognostic profiles. In the face of a potential March 2019 launch of Novartis’ siponimod for secondary progressive MS (SPMS), enthusiasm for Mavenclad is relatively more muted both in terms of anticipated time to trial and willingness to prescribe across multiple possible patient types compared to prelaunch siponimod data collected in the previous quarter. While neurologists’ willingness to prescribe Mavenclad was highest for RRMS patients transitioning to SPMS, siponimod’s head start in the market and SPMS label could provide substantial competitive headwinds to Mavenclad uptake in this patient segment. Instead, EMD Serono should position Mavenclad to capitalize on its induction potential as supported by the Phase III ORACLE data in CIS patients and current first-line data in the EU (highlighted in the recent RealTime Dynamix™: Multiple Sclerosis (EU)) to separate the brand from siponimod. Indeed, treatment-naive RRMS patient with highly active disease was the only patient type asked in both prelaunch assessments for which US neurologists were slightly more willing to prescribe Mavenclad compared to siponimod. For such Mavenclad induction positioning to be successful, prelaunch strategy should focus on addressing neurologists’ safety concerns and post-Mavenclad therapeutic sequencing questions, emphasizing the CIS data in the NDA resubmission during payer negotiations, and preparing competitive messaging against Gilenya, Tecfidera, Ocrevus, and Tysabri.

Spherix Global Insights will further analyze brand share and reasons for brand selection among MS patients recently started on their first DMT in the upcoming RealWorld Dynamix™: DMT New Starts patient audit. The audit will also capture the potential for first-line prescribing of DMTs in development, including Mavenclad, Celgene’s ozanimod, and Biogen’s diroximel fumarate (BIIB098), based upon real world patient situations.

About RealTime Dynamix™
RealTime Dynamix™: Multiple Sclerosis (US) is an independent report series published on a quarterly basis. 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., siponimod, Mavenclad, and diroximel fumarate 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 next wave of research will be published in March 2019.

About RealWorld Dynamix™
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 edition of the audit will publish in February 2019.

About Spherix Global Insights
Spherix Global Insights is an independent business intelligence and market research company, specializing in renal, autoimmune, neurologic and rare disease markets. Our aim is to apply our commercial experience and unique relationships within core specialty markets to translate data into insight, enabling our clients to make smarter business decisions.

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

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