Key label advantages related to cortical grey matter/thalamic volume loss reduction and superior safety compared to Novartis’ Gilenya will be fundamental for preferential uptake of Bristol Myers Squibb’s Zeposia (ozanimod), according to Spherix Global Insights
EXTON, Pa., March 10, 2020 ― In the last year, the US multiple sclerosis (MS) market saw the introduction of three new disease-modifying therapies (DMTs) for the treatment of relapsing forms of MS (RMS). Fielded between January 21 and February 12, data from 100 neurologists surveyed for the Q1 wave of the ongoing quarterly report series, included in Spherix’s RealTime Dynamix™: Multiple Sclerosis (US) service, provide insight into the current patterns underlying each of these individual launches.
In March 2019, alongside the approvals of Mayzent and Mavenclad, the FDA revised the RMS label for previously approved DMTs to explicitly include clinically isolated syndrome (CIS)1 and active secondary progressive MS (SPMS). The expanded label has had an immediate impact, with neurologists significantly more likely to agree that DMTs approved for RMS would be effective in active SPMS compared to a year ago. While historically among the most commonly switched-to DMTs for active SPMS, this change may also have provided Genentech’s Ocrevus with fuel for further uptake, as chronic/advanced disease is now seen a less of a barrier to treat active SPMS patients.
Competitiveness of Novartis’ Mayzent with Genentech’s Ocrevus for active SPMS appears to be slipping, with fewer active SPMS patients identified as appropriate Mayzent candidates and neurologists more likely to believe that Ocrevus outperforms Mayzent on efficacy in active SPMS compared to nine months ago. Perhaps as a result, Novartis appears to be focusing more on the broad RMS indication and encouraging use in place of Novartis’ own Gilenya, the first S1P receptor modulator launched back in 2010.
The reported prescriber base for EMD Serono’s Mavenclad has remained flat over the past three months. Neurologists who have yet to prescribe are less likely to believe in Mavenclad’s efficacy in reducing the risk of disability progression, favorable risk/benefit profile, and status as a preferred active SPMS option compared to prescribers. In addition, even these early adopters appear less enthusiastic about the breadth of their future Mavenclad uptake, with substantial declines in the estimated percentage of RRMS and active SPMS patients who would be appropriate candidates for the brand over the past three months. EMD Serono will need to prioritize discussions related to appropriate post-Mavenclad maintenance therapy and long-term safety data, while continuing to promote the therapy’s unique dosing profile, to compete successfully with Ocrevus.
Trial of Biogen’s Vumerity, a next-generation fumarate agent with an improved gastrointestinal tolerability profile compared to Biogen’s own Tecfidera, has been swift within the first month of availability — with most uptake occurring among RRMS patients switching from Tecfidera. However, remaining nonprescribers may be a tougher sell as they are less likely to believe in the superior tolerability profile or to agree that Vumerity will replace Tecfidera in treatment-naïve patients who are candidates for a fumarate agent. As such, almost half plan to wait at least six months before initiating a patient on Vumerity. Reflecting a change from Spherix’s Q4 2019 pre-launch assessment, neurologists now estimate a flat fumarate class share over the next six months, highlighting the strong competition within the fumarate class. Patient outreach and education may be a vastly underutilized opportunity for Vumerity, as the majority of patient requests resulted in a prescription and yet only 12% of neurologists have received a Vumerity request within the past three months.
Even with these recent launches of new oral options, the neurologist-reported oral DMT class share has remained flat over the past year, due to stagnant shares of established oral DMTs — Gilenya, Tecfidera, and Genzyme’s Aubagio. With Gilenya and Tecfidera under pressure from their respective next-generation molecules, neurologists anticipate significant share declines for these brands over the next six months. While Aubagio appears to be immune for now, the Genzyme brand may feel increasing heat with the much-anticipated June 2020 regulatory decision for Novartis’ ofatumumab, as the subcutaneous anti-CD20 monoclonal antibody was shown to be superior to Aubagio for the treatment of RMS in the Phase III ASCLEPIOS clinical trials.
Along with ofatumumab, two more S1P receptor modulators may be entering the US market within the next nine months — Bristol Myers Squibb’s Zeposia (ozanimod) with a March 25th PDUFA date and Janssen’s ponesimod with a potential decision by the end of 2020. Pre-launch assessment data captured in the current survey suggest that Zeposia uptake patterns will differ from those seen for Mayzent, with a greater opportunity within RRMS compared to active SPMS. However, as the third-to-market S1P receptor modulator, anticipated Zeposia trial rate within the first six months of availability is substantially lower than what Spherix measured at the same time pre-Mayzent launch.
Yet, pre-launch perception does not need to become post-launch reality. A Zeposia label with data on cortical grey matter and thalamic volume loss reduction and delayed cognitive worsening, combined with no first-dose observation requirement and no liver function abnormalities, could help Zeposia become the S1P receptor modulator of choice for the treatment of RRMS. Indeed, one-third of neurologists selected one of these four attributes as the greatest competitive advantage for a new S1P receptor modulator. Assuming an approval later this month and commercial availability soon after, Spherix will track the first 18 months of the Zeposia launch beginning in May, allowing for benchmarking to earlier launches of Vumerity, Mayzent, Mavenclad, and Ocrevus in the MS market.
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 18th wave of research will publish in June 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.
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- Genzyme’s Lemtrada and EMD Serono’s Mavenclad, generally recommended for use after one or more previous failure, did not have the CIS indication added in their RMS label.
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