Opportunity for EMD Serono's Mavenclad is Growing in the Relapsing-Remitting Multiple Sclerosis Segment of the Canada Market, Although Increasingly Deferred Treatment Algorithm Positioning Is a Threat That Could Benefit Roche's Ocrevus and Novartis' Gilenya

EXTON, Pa., Nov. 19, 2019 /PRNewswire/ -- Once approved by Health Canada and accessible on provincial drug formularies, the Canadian multiple sclerosis (MS) market is primed for swift adoption and solid uptake of Novartis' Mayzent, especially if granted a first-in-market unrestricted secondary progressive MS (SPMS) indication. Data from 50 neurologists surveyed in October for an ongoing twice-yearly report series included in Spherix's RealTime Dynamix™: Multiple Sclerosis (Canada) service confirm that lack of approved therapies is the greatest obstacle to more expansive treatment of SPMS (whether active or not active) with disease-modifying therapies (DMTs). Indeed, neurologists estimate that only 21% of not active SPMS patients are treated with off label therapies and that more than one-third of DMT-treated active SPMS patients, for which only interferons are approved, are not receiving satisfactory results with their current DMT. With the high level of unmet need, most neurologists expect to prescribe Mayzent within the first six months of access, primarily focused on trial among active SPMS candidates. With the final Mayzent label an unknown, neurologists are noticeably less optimistic about future impact on not active SPMS treatment patterns. Competition from Novartis' own Gilenya and recently launched generic fingolimod will be potential barriers to Mayzent success, depending upon restrictions placed by provincial drug formularies.

Compared to six months ago, neurologists consider substantially more relapsing-remitting MS (RRMS) and active SPMS patients to be appropriate candidates for EMD Serono's Mavenclad. Current Mavenclad prescribers, which represent the majority of neurologists in Canada, are especially optimistic about the RRMS opportunity. If prescribers have positive clinical experience, Mavenclad could become more competitive with segment leaders (i.e., Roche's Ocrevus, Biogen's Tecfidera, and Novartis' Gilenya) in this sizeable, but crowded, portion of the MS market. Neurologists are most likely to perceive Mavenclad to be competing directly with high-efficacy DMTs, Ocrevus and Gilenya, for appropriate patients.

However, RRMS treatment algorithm positioning constitutes a potential threat to Mavenclad's success, as the brand, which is approved for use as early as second-line DMT treatment, is increasingly being used as a third or later-line option. If continued trending supports the brand being pushed back in the treatment algorithm, Ocrevus and/or Gilenya will be provided the opportunity to be selected ahead of Mavenclad, considerably decreasing new business opportunities for EMD Serono's oral DMT. Ocrevus competition for an early first switch is especially strong as neurologists are most likely to believe that the monoclonal antibody (mAb) DMT outperforms Mavenclad on RRMS efficacy. Conversely, Mavenclad is perceived to be superior on RRMS efficacy compared to Gilenya. While convenience administration and low PML risk are clear benefits for Mavenclad over either competitor, Spherix data highlight the need for greater education on treatment sequencing strategies and pregnancy/teratogenicity risks to continue to broaden the Mavenclad prescriber base.

The majority of neurologists in Canada agree that they prefer to use an aggressive approach, using high-efficacy DMTs as first-line options ― up substantially compared to just six months ago. Three out of five neurologists agree that they always propose at least one mAb DMT when initiating a highly active RRMS patient on their first DMT. Indeed, almost half of RRMS patients with concerning prognostic profiles who were started on their first DMT within the past six months were prescribed a mAb DMT (typically Ocrevus). In comparison, more than half of RRMS patients without concerning prognostic profiles were initiated on a first-line oral DMT (typically Tecfidera). Consistent with Tecfidera being the most preferred DMT for RRMS and the market leader in overall share, Tecfidera was equally likely to be prescribed to treatment-naïve RRMS patients, regardless of prognostic profile. Conversely, Sanofi Genzyme's Aubagio appears to be reserved for patients with more benign presentations.

Looking forward, Novartis is well positioned to become the MS market leader in Canada, based upon the high interest in Mayzent and growing awareness of ofatumumab, a subcutaneous anti-CD20 mAb DMT that will be positioned as a more convenient alternative to Ocrevus. Almost half of neurologists are aware that ofatumumab was superior to Aubagio in two pivotal RRMS clinical trials. As a result, interest in having access to ofatumumab has grown over the past six months, being driven by strong clinical data with an active comparator, high efficacy expectations, and convenient dosing. With the potential for a growing and diverse MS franchise in Canada, more neurologists rate Novartis as highly credible in the MS space compared to any other current or emerging company.

About RealTime Dynamix™
RealTime Dynamix™: Multiple Sclerosis (Canada) is an independent service providing strategic guidance through rapid and comprehensive twice-yearly reports, which include market trending, launch tracking, and a fresh infusion of unique content with each wave. The 3^rd wave of research in Canada will publish in May 2020.

Parallel services include the quarterly series in the US, with the 16^th wave of RealTime Dynamix™: Multiple Sclerosis (US) publishing in December 2019, and twice-yearly series in the EU, with the 6^th wave of RealTime Dynamix™: Multiple Sclerosis (EU) publishing in April 2020.

About Spherix Global Insights
Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select immunology, nephrology, and neurology markets.

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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