Genentech’s best strategy for escaping the competitive pressure from these new oral market entrants, as well as future monoclonal antibodies like Novartis’ ofatumumab and TG Therapeutics’ ublituximab, will be the continued execution on establishing Ocrevus as a preferred first-line option in the relapsing-remitting multiple sclerosis treatment algorithm

 EXTON, Pa., September 9, 2019 ― Four months postlaunch, Novartis’ Mayzent and EMD Serono’s Mavenclad have both broadened their prescriber bases among US neurologists managing patients diagnosed with multiple sclerosis (MS). Data from 100 neurologists surveyed in August for the Q3 wave of the ongoing quarterly report series included in Spherix’s RealTime Dynamix™: Multiple Sclerosis (US) service confirm, for both new market entrants, that approximately one-third of neurologists have initiated one or more MS patient on the respective brands. While Genentech’s Ocrevus, a high-efficacy monoclonal antibody (mAb), clearly emerges as the competitor most at risk within the space, Mayzent and Mavenclad uptake patterns also suggest that the oral disease-modifying therapies (DMTs) will place considerable pressure on each other to capture use among appropriate candidates.

Patients are most likely to be considered appropriate candidates when diagnosed with active secondary progressive MS (SPMS), although the potential pool among the larger relapsing-remitting MS (RRMS) segment has grown for both brands since the Q2 wave which fielded one month postlaunch. For Mavenclad in particular, current prescribers estimate significantly more of their RRMS patients would be appropriate for the brand compared to those neurologists without clinical experience, although such use would be limited by its FDA label to RRMS patients who have failed one or more prior DMTs. Neurologists perceive both Mayzent and Mavenclad to be strong growth brands over the next six months, with new business in the relapsing forms of MS (RMS) segment primarily due to switches from Biogen’s Tecfidera and Tysabri (to Mavenclad) and from Tecfidera and Novartis’ own Gilenya (to Mayzent).

Competitive pressure on Ocrevus is only primed to increase with the potential approval of Novartis’ ofatumumab, a monthly subcutaneous anti-CD20 DMT, by the end of 2020 for the treatment of RMS. Released after the Q3 survey fielding, Novartis announced that ofatumumab bested Genzyme’s Aubagio on the primary endpoint of annualized relapse rate reduction and key secondary endpoints in ASCLEPIOS I and II clinical trials. With an Ocrevus-like mechanism of action coupled with a dosing profile allowing for at-home administration, neurologists rate their familiarity similar to that of Celgene’s ozanimod, currently under regulatory review with a potential PDUFA in March 2020, but are twice as likely to select it as the DMT in development they are most interested in.

Novartis, quickly building a solid MS franchise including Mayzent, Gilenya, Extavia, Glatopa, and potentially a biosimilar natalizumab, scores a high company credibility rating among neurologists, which should only help to foster further interest ahead of an ofatumumab launch. TG Therapeutics’ ublituximab, the sole other anti-CD20 mAb in late-stage development for RMS, lags behind ofatumumab across metrics of company awareness and credibility, and agent awareness, familiarity, and interest. By 2022, assuming a successful ublituximab approval and launch, the mAb DMT class’ competitive landscape could look very different with two well-established anti-CD20 agents and biosimilar version(s) of Biogen’s Tysabri.

Genentech’s efforts to move Ocrevus use up earlier in the RRMS treatment algorithm may also be instrumental in shifting MS treatment patterns, while also providing protection from new market entrant-related share erosion ― frequently bestowed upon preferred first-line agents. Indeed, compared to one year ago, neurologists estimate that twice as many treatment-naive RRMS patients without a concerning prognostic profile have recently been initiated on Ocrevus. Among patients with a concerning prognostic profile, Ocrevus use has also increased and is now double that of the brand’s share among the less severe patients. Regardless of prognosis, neurologists’ greater reliance on first-line Ocrevus has had the strongest erosive effect on Gilenya, the lone high-efficacy oral DMT on the US market prior to the launch of Mayzent and Mavenclad. However, for Ocrevus to truly compete in the new start segment, Genentech will need to be persuasive in justifying the selection of the mAb DMT over Tecfidera and the injectable DMTs, specifically Teva’s Copaxone, which together continues to capture over half of neurologists’ self-reported recent first-line initiations. In the upcoming fourth annual RealWorld Dynamix: DMT New Starts in Multiple Sclerosis (US), Spherix will evaluate whether Ocrevus’ historically flat year-over-year share among previously treatment-naïve RRMS patients has finally begun to catch up with neurologists’ perceived treatment patterns.

About RealTime Dynamix™
RealTime Dynamix™: Multiple Sclerosis (US) is an independent service providing strategic guidance through rapid and comprehensive quarterly reports, which include market trending, launch tracking, and a fresh infusion of unique content with each wave. The 16th wave of research will publish in December 2019.

About RealWorld Dynamix™
RealWorld Dynamix™: DMT New Starts in Multiple Sclerosis (US) is an independent, data-driven service unmasking real patient management patterns through annual reports based on chart audits of ~1,000 patients started on their first DMT within the previous three months. The report uncovers the “why” behind treatment decisions, includes year over year trending to quantify key aspects of market evolution, and integrates specialists’ attitudinal & demographic data to highlight differences between stated and actual treatment patterns. This will be the fourth annual report publishing in February 2020. Parallel US services include RealWorld Dynamix™: Progressive Forms of Multiple Sclerosis (US), second annual report publishing in November 2019; RealWorld Dynamix™: DMT Switching in Multiple Sclerosis (US), fifth annual report published 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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