A Paradigm Shift in Disease-Modifying Therapy Treatment Rates for Progressive Forms of Multiple Sclerosis Largely Dependent Upon Genentech's Ocrevus Prescribing Patterns

EXTON, Pa., June 26, 2018 /PRNewswire/ -- Largely fueled by Genentech's Ocrevus availability, a paradigm shift has occurred in the US multiple sclerosis (MS) market resulting in increased rates of disease-modifying therapy (DMT) treatment for certain types of progressive forms of MS (PfMS). As noted earlier in the ongoing quarterly RealTime Dynamix: Multiple Sclerosis report series, Ocrevus, with its first-to-market primary progressive MS (PPMS) label, has had a material impact on the self-reported PPMS treatment rate. In the most current report, the PPMS treatment rate now appears to be stable following an increasing trend since Q4 2016. Ocrevus prescribers and non-prescribers did not differ in their reported PPMS treatment rate, suggesting that even non-prescribers have increased treatment, perhaps in reaction to more PPMS patient requests for treatment whereby non-prescribers turn instead to the DMTs they have the most comfort with. Indeed, the non-prescribers' shrinking Ocrevus candidate pool quarter-over-quarter among PPMS patients and the dwindling number of non-prescribers comfortable with using Ocrevus first-line for PPMS suggest limited motivation among these neurologists to initiate Ocrevus trial. Thus, the PPMS prescriber base and treatment rate is expected to remain constant for the foreseeable future.

The next inflection in PPMS treatment rate will most likely be powered by the potential second-to-market and third-to-market launches of MedDay Pharmaceuticals' MD-1003 and AB Science's masitinib, respectively. However, initiated or soon-to-initiate PPMS clinical trials of Ocrevus (in PPMS patients with higher disability scores than allowed in the pivotal trial), Genzyme's Lemtrada, and EMD Serono's Mavenclad could encourage broader use of Ocrevus or earlier trial of Lemtrada and Mavenclad among PPMS patients before MD-1003 or masitinib enter the market.

The active secondary progressive MS (SPMS) treatment rate also appears to have stabilized at a level close to that for relapsing remitting MS following consistent increases in the treatment rate since early in the Ocrevus launch. The treatment rate plateau is consistent with the active SPMS share of Ocrevus-treated patients having dropped back slightly compared to the prior quarter, with a greater share instead going to PPMS. The DMT-treated active SPMS patient pool will most likely remain stable until the anticipated launch of Novartis' siponimod, a next-generation S1P receptor modulator filed with the FDA in Q2 2018 for a first-to-market SPMS indication. With neurologists anticipating the most frequent siponimod use in SPMS patients with clinical or radiological evidence of inflammatory activity, siponimod could grow the size of the DMT-treated active SPMS patient pool although much of its business will most likely come from switches.

Finally, for the not active SPMS patient segment, the DMT treatment rate has remained low with no observable impact from the Ocrevus launch due to minimal (and decreasing) use in the subtype. Unlike with active SPMS, most neurologists state that they do not switch their patients from their current DMT when they transition to not active SPMS ─ instead being more likely to keep them on the DMT initiated during the relapsing form of MS (RMS). However, the greatest percent of neurologists also believe that DMTs approved for RMS are not effective in not active SPMS, setting these patients up for efficacy-related discontinuations that suppresses the overall treatment rate. While two out of five neurologists anticipate siponimod use in SPMS patients with no clinical or radiological evidence of inflammatory activity, the minimal use of Ocrevus, even with its disability progression risk reduction data in PPMS, suggests that a concerted strategy highlighting efficacy data specifically in this subtype will be necessary to produce a significant increase in treatment rate. Conversely, masitinib, in development for PPMS and relapse-free SPMS, could potentially launch with not active SPMS-specific disability and quality of life data potentially providing for more favorable payer coverage and an incentive for neurologist trial in this subtype. To capitalize on this potential, AB Science will need to overcome the product's current low awareness and interest level among neurologists.

Spherix Global Insights will be further analyzing PfMS 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 PfMS 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 September 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 will field in August/September and 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.

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

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