Preferential First-Line Use of Biogen’s Tecfidera and Continued Uptake of Merck KGaA’s Mavenclad Drives the Significant Increase in Oral Disease-Modifying Therapy Class Share in the European Multiple Sclerosis Market Over the Past Year

EXTON, Pa., April 10, 2019 /PRNewswire/ — Self-reported oral disease-modifying therapy (DMT) class share has increased significantly over the past year in the EU multiple sclerosis (MS) market, pulling share from the injectable DMT classes. In the current wave of the ongoing biannual RealTime Dynamix™: Multiple Sclerosis (EU) report series, EU neurologists (n=253) indicate that the favorable shifts in oral DMT prescribing have been propelled predominantly by increased share of Biogen’s Tecfidera, although uptake of Merck KGaA’s Mavenclad has also contributed, while shares of Novartis’ Gilenya and Sanofi’s Aubagio remain flat. Conversely, Teva’s Copaxone has experienced the greatest decline among the injectable DMTs, especially among Italian neurologists where the focus is shifting towards greater prescribing of the high-efficacy DMTs. Among neurologists who report a decline in recent injectable DMT use, the majority attribute the shift in prescribing patterns to patients being more likely to start on or switch to oral DMTs, with Tecfidera and Aubagio benefiting most from recent first-line prescribing and Gilenya from recent switches. With advantageous positioning for points of new business in the treatment algorithm, the established oral brands are anticipated to experience strong growth over the next six months.

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Spherix Global Insights, which tracks the initial 18 months of each MS launch in the United States, Europe, and Canada, finds that Mavenclad share continues to lag that of Roche’s Ocrevus. Approved in August 2017 and January 2018, respectively, neurologists report broad access to Mavenclad in Germany, Spain, and the UK, while Ocrevus still has limited access only in the UK where NICE continues to deliberate with Roche regarding funding for the brand’s first-to-market early primary progressive MS (PPMS) indication. Both Mavenclad and Ocrevus have experienced significant increases in share and prescriber base over the past year. However, Ocrevus share is now about twice that of Mavenclad, driven in part by a broader prescriber base and high reported Ocrevus shares in Germany and Italy. In the UK, where access to Ocrevus is still limited to relapsing-remitting MS (RRMS) and, even then, only among RRMS patients contraindicated for treatment with Sanofi’s Lemtrada, self-reported share for Mavenclad is higher than that of Ocrevus.

In the EU market, Biogen is well positioned to own the new start RRMS segment when a moderate- or high-efficacy therapy, as defined by the neurologist, is required. Half of EU neurologists report having prescribed Tecfidera first line in the prior week, demonstrating the dominance of the brand in the segment. Indeed, neurologists in Spain and the UK are most likely to choose Tecfidera as their most preferred moderate-efficacy DMT for first-line RRMS treatment, with safety record, market access, and unrestricted label more influential drivers of Tecfidera preference compared to other moderate-efficacy DMTs. While both Mavenclad and Ocrevus are winning some first-line business among new RRMS patients, Biogen’s Tysabri remains the most preferred high-efficacy DMT across all countries with the exception of the UK where Lemtrada continues to be most preferred. Not surprisingly, efficacy is the most common driver of preference for a high-efficacy DMT; however, personal experience and post-marketing experience play more of a role in the selection of Tysabri. As competition increases in the high-efficacy segment, Biogen should keep an eye on the preference drivers for the other high-efficacy DMTs, as tolerability and risk-benefit profile influence the selection of Ocrevus and risk-benefit profile, convenient dosing profile, and personal experience the selection of Gilenya.

Considering the very active MS pipeline, EU neurologists are highly aware of and most interested in Novartis’ Mayzent, the potential second-to-market S1P receptor modulator currently under review by the European Medicines Agency for the treatment of secondary progressive MS (SPMS). Neurologists are most willing to prescribe Mayzent to active SPMS patients and transitioning RRMS patients. However, transitioning RRMS, a concept heavily messaged by Novartis following the FDA approval of Mayzent for the treatment of relapsing forms of MS (RMS), was rarely mentioned unaided by neurologists, revealing that such a patient type is not currently top-of-mind. Assuming approval and depending upon the final label in the EU, transitioning RRMS may offer a unique position for Novartis in the MS market but will require educational strategies targeted to both neurologists and people impacted by MS.

The introduction of any DMT onto the MS market introduces new competitive pressure on currently marketed DMTs. Prelaunch, EU neurologists foresee Mayzent representing the greatest threat to Novartis’ own Gilenya (the first S1P receptor modulator), Bayer’s Betaferon (approved for RMS including active SPMS), and Copaxone (well tolerated, though off label, option for not active SPMS). In the upcoming large-scale RealWorld Dynamix™: DMT Switching in Multiple Sclerosis (EU) patient audit, Spherix Global Insights will look to validate the DMTs most under competitive pressure by pipeline products, including Mayzent, Celgene’s ozanimod, MedDay Pharmaceuticals’ Qizenday (MD1003), Janssen/Actelion’s ponesimod, AB Science’s masitinib, Novartis’ ofatumumab, and TG Therapeutics’ ublituximab.

About RealTime Dynamix™
RealTime Dynamix™: Multiple Sclerosis (EU) is an independent report series published on a biannual basis that provides rapid response trending on the key issues affecting the MS market based upon surveys fielded in France, Germany, Italy, Spain, and the United Kingdom. The series provides a close-quarters analysis of key performance metrics, focusing on brand gains and losses, industry contact rates, familiarity and adoption rates of recently launched products 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 EU research will be published in October 2019.

About RealWorld Dynamix™
RealWorld Dynamix™: DMT Switching in Multiple Sclerosis (EU) blends physician self-reported data with actual patient chart records from the same physicians to uncover differences in how physicians report managing their patients and how specific populations are managed differently. It augments secondary data by providing the “why” behind the switching behavior and by providing essential details often not available in secondary data that may be driving the switch, such as MS subtype, payer pressure, co-morbid conditions, or patient requests. The inaugural audit will publish in July 2019.

About Spherix Global Insights
Spherix Global Insights is an independent business intelligence and market research company, specializing in renal, autoimmune, and neurologic 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.

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Virginia Schobel, Neurology Franchise Head

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