Uptake of Biogen's Tecfidera and Increased Availability of Merck KGaA's Mavenclad Fueling Significant Increase in Oral Disease-Modifying Therapy Share of Multiple Sclerosis Patients in Europe to the Detriment of Teva's Copaxone

EXTON, Pa., Oct. 9, 2018 /PRNewswire/ -- Driven by the availability of Merck KGaA's Mavenclad and substantial uptake of Biogen's Tecfidera, the oral disease-modifying therapy (DMT) class share of DMT-treated multiple sclerosis (MS) patients increased significantly in the EU over the past six months, putting significant pressure on Teva's Copaxone. Following the May funding decision by the UK's National Institute for Health and Care Excellence (NICE) on the use of injectable DMTs by the National Health Service (NHS), the current RealTime Dynamix™: Multiple Sclerosis (EU) report finds that overall shares in the UK of the interferon and glatiramer acetate classes have decreased, with share shifting instead to Tecfidera. Similarly, in France, where oral DMTs are predominantly used for the treatment of MS and bolstered by Tecfidera's first-line marketing authorization, Tecfidera share increased by five percentage points ─ mirrored by the same magnitude drop for Copaxone ─ compared to a year ago. With two-thirds of EU neurologists (n=250) agreeing with being comfortable prescribing oral DMTs as first-line agents, Tecfidera's competitive profile for first-line use is solidified by efficacy expectations, oral dosing convenience, and clinical experience, as well as broad access across countries.

With Sanofi's Aubagio and Novartis' Gilenya shares remaining flat, significant increases in Mavenclad trial and adoption in Germany and the UK are also contributing factors fueling oral DMT class growth. At one year post-approval, Mavenclad trial rate reached 44% among German neurologists and, following the positive NICE guidance in November 2017, 50% among UK neurologists. Almost all Mavenclad-treated patients in these two countries are diagnosed with relapsing remitting MS (RRMS), with some additional use among active secondary progressive MS (SPMS), consistent with the EMA label for highly active relapsing MS (RMS). Mavenclad appears to be positioned early in the treatment algorithm with more than one out of five patients in Germany and the UK initiated Mavenclad as their first-line DMT and switches typically occurring from early-line DMTs, such as interferons and Tecfidera. While still low, EU neurologists agree significantly more that they are comfortable using Mavenclad as a first-line agent for their RMS patients compared to even just six months ago. Consistent with this early aggressive approach, Mavenclad is seen to be competing most strongly for potential candidates with Sanofi's Lemtrada in the UK and Gilenya and Roche's Ocrevus in Germany.

The launch of Ocrevus, approved for active RMS and early primary progressive MS (PPMS) in January 2018, has been hampered by the initial NICE draft guidance in June (later finalized in September) not recommending Ocrevus for the treatment of early PPMS due to lack of cost-effectiveness. As a result, Ocrevus trial remained relatively flat in the UK over the past six months where Ocrevus is only approved for the treatment of active RRMS in patients otherwise contraindicated for Lemtrada setting up strong competitive headwinds for the brand in a crowded market. Conversely, trial increased significantly in Germany where neurologists have access to Ocrevus for both active RMS and early PPMS indications. A reversal of the PPMS NICE draft guidance will be necessary to see substantial uptake in the UK, as much of Ocrevus' early adoption came from first-line use among PPMS patients due to the high unmet need and the agent's first-to-market PPMS indication. Only one-third of neurologists report being comfortable using Ocrevus first-line in RMS (versus 57% in PPMS) resulting in Ocrevus needing to compete with the same DMTs already under pressure from Mavenclad (i.e., Biogen's Tysabri, Lemtrada, and Gilenya) for RRMS candidates. Conversely, the PPMS segment allows for easier trial as Ocrevus prescribers perceive either no direct competition or competition with off-label rituximab for PPMS candidates. In addition, EU neurologists estimate that almost half of their PPMS patients currently treated with a DMT are not receiving satisfactory results creating, assuming access is granted, a sizeable bolus of potential candidates for Ocrevus switches.

Compared to the RealTime Dynamix™: Multiple Sclerosis (US) survey fielded in parallel, more EU neurologists are most interested in the future availability of Novartis' siponimod, a once-daily oral S1P receptor modulator. With the FDA and EMA siponimod submissions both accepted yesterday for the treatment of SPMS, interest in siponimod is driven by the possibility of a new therapy for yet another indication with great unmet need (similar to Ocrevus for PPMS) and encouraging efficacy data fueling high expectations. Indeed, EU neurologists rank a significant reduction in disability progression risk in SPMS versus placebo ─ the primary endpoint of the recently published EXPAND Phase III trial ─ as the most advantageous attribute for a new S1P receptor modulator. The majority of neurologists plan to use siponimod in SPMS patients with evidence of inflammatory disease and/or in RRMS patients that they believe are transitioning SPMS. EU neurologists estimate that 13% of their RRMS patients have transitioned to SPMS within the past year, typically identified by evidence of disability progression independent of relapse activity and/or six-month confirmed EDSS progression. This translates into one in five MS patients being potential siponimod candidates.

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 April 2019.

RealTime Dynamix™: Multiple Sclerosis (US), an independent report series published on a quarterly basis, will next be published in December 2018.

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.

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