Press Release (ePRNews.com) - EXTON, PA - Sep 19, 2018 - A recent survey of U.S. neurologists (n=99) finds that the multiple sclerosis (MS) market remains focused on Genentech’s Ocrevus 18 months postlaunch with strong uptake displacing Biogen’s Tysabri as the monoclonal antibody (mAb) class leader for the first time. In the current quarter of the ongoing quarterly RealTime Dynamix: Multiple Sclerosis US report series, self-reported Ocrevus share actually surpassed neurologists’ projections for Q3 share (7.4%) from six months ago, implying no near-term slowing of uptake. The dominance of Ocrevus within the class may be related to Genentech’s efforts to promote earlier use in relapsing remitting MS (RRMS) patients as, while still relatively infrequent, Ocrevus prescribers report that significantly more of their Ocrevus-treated RRMS patients initiated the disease-modifying therapy (DMT) as their first therapy compared to a year ago. Adding to the growing potential within the large RRMS segment, compared to a year ago, neurologists are significantly more comfortable with using Ocrevus first line in relapsing forms of MS (RMS) and view significantly more RRMS patients as appropriate candidates for the drug.
Similar to other high-efficacy DMTs, like Tysabri and Novartis’ Gilenya, the greatest opportunity for first-line Ocrevus use is among newly diagnosed patients presenting with concerning prognostic profiles. While less than half of RRMS patients initiated on their first DMT within the past six months presented with such a profile, those RRMS patients were significantly more likely to be started on Ocrevus, Tysabri, or Gilenya compared to those with a more benign prognostic profile. This Ocrevus positioning is consistent with an aggressive initial DMT approach to control disease activity in appropriate candidates and Genentech sales representatives’ focus on patients with aggressive or active disease when discussing ideal Ocrevus patient types. Interestingly, the prescriber bases of neurologists who initiated Ocrevus as RRMS patients’ first-line DMT were similar regardless of prognostic profile, suggesting a willingness among a subset of neurologists to consider the agent as one of their standard first-line choices. Ocrevus first-line use in patients without concerning prognostic profiles would compete directly with the oral DMTs (i.e., Biogen’s Tecfidera) and the GA agents (i.e., Teva’s Copaxone) for patients.
Looking towards the late-stage DMT pipeline, awareness of EMD Serono’s Mavenclad, a once-yearly short course oral selective immune reconstitution therapy, jumped up with the FDA’s acceptance of the resubmitted NDA in July that sets up for a potential Q2 2019 launch. However, the increase in awareness did not correlate with an increase in familiarity rating over the past year, suggesting that awareness may be limited to just a knowledge of the regulatory filing as opposed to specifics related to the DMT profile. According to Dr. Patricia Coyle, a recognized MS expert and advisor to Spherix Global Insights, “As a drug that may launch in 2019, this survey demonstrates that at this point there does not appear to be a significant growing awareness of or interest in oral cladribine.” Indeed, neurologists remain split on the relevancy of Mavenclad with high interest being driven by the concept of an innovative, high-potency DMT with a convenient oral dosing schedule and lack of interest focused solely on safety concerns.
“As a drug that may launch in 2019, this survey demonstrates that at this point there does not appear to be a significant growing awareness of or interest in oral cladribine.”
Boding well for Novartis’ siponimod, a once-daily oral S1P receptor modulator in development for secondary progressive MS (SPMS), almost all neurologists rate the unmet need for SPMS therapies extremely high and siponimod was most frequently selected as the pipeline DMT they are most interested in having available for prescribing. That being said, the percent most interested in siponimod decreased steadily over the last two quarters, and only 24% agree that they are eagerly awaiting siponimod approval (versus 52% for Ocrevus four months prior to approval) ─ perhaps a reaction to the lack of FDA response to the confirmed NDA filing with a Priority Voucher Review during the second quarter. Assuming FDA approval, neurologists rate their willingness to use siponimod in RRMS patients transitioning to SPMS (whether due to progression related to or independent of relapses) and SPMS patients with evidence of inflammatory activity significantly higher compared to other patient types, including SPMS patients with no evidence of inflammatory activity. Even with data recently released demonstrating siponimod’s effect on reducing the risk of disability progression in nonrelapsing patients, less than one-third of neurologists believe that siponimod would be appropriate for use in SPMS patients with no inflammatory activity, potentially limiting uptake if approved with a broad SPMS label. However, compared to active SPMS, not active SPMS represents a greater opportunity due to its larger untreated patient pool ─ a group that would be receptive to a disability risk reduction message coupled with improved tolerability related to the agent’s greater receptor selectivity. If Novartis does get an SPMS label, educating neurologists and patients on siponimod’s significance in SPMS with no evidence of inflammatory activity will be key for fully realizing the DMT’s market potential.
Spherix Global Insights will be further analyzing SPMS patient demographics and treatment sequencing in the upcoming RealWorld Dynamix: Progressive Forms of Multiple Sclerosis patient audit. The audit will also capture the potential uptake of the DMTs in development for progressive forms of MS based upon real world patient situations.
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 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 research will be published in December 2018.
RealWorld Dynamix™: Progressive Forms of MS (US) blends attitudinal and demographic physician survey data (n=150) with patient record data (n=±750) 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 PfMS 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 PfMS patients. The audit fielded in August/September and will publish in early November 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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Virginia Schobel, Neurology Franchise Head
Spherix Global Insights