Roche Nabs FDA Approval for "Game-changing" Therapy for the Treatment of Multiple Sclerosis

CAMBRIDGE, Mass., March 29, 2017 /PRNewswire/ -- The first quarter of 2017 culminates with one of the most highly anticipated events in the multiple sclerosis (MS) market – the approval of the first disease-modifying therapy (DMT) for primary progressive MS (PPMS), Ocrevus (ocrelizumab).   While Ocrevus was also approved for relapsing forms of MS (RMS), demonstrating superior efficacy to EMD Serono's Rebif on three efficacy parameters, neurologists report that, at least initially, the real appeal is the indication for PPMS where treatment options are virtually non-existent.

Treatment options in the RMS space are far from limited.  In fact, several neurologists participating in the most recent survey expressed feeling "overwhelmed" with the number of DMTs available.  Several other areas of unmet need in MS were rated significantly higher than the need for new DMTs for RMS – such as drugs to improve cognition, gait and fatigue. 

There are major shifts and controversies at play as current players attempt to gain share through differentiation with one of the biggest controversies being the Copaxone-Glatopa saga, where Sandoz's generic version of market leader Copaxone is beginning to see gains.  Over the past year, the prescribing base for Glatopa has increased from about a third to over one-half.  At the same time, reported share for Teva's Copaxone has significantly declined and neurologists predict this will continue as payers apply more pressure to use the generic form.  An ardent group of loyalists does appear to challenge this practice, but overall payers call the shots.  Should Sandoz capture an indication for an extended dosing option, truly placing it on par with Copaxone, a significant barrier for Glatopa will be removed.

Another observation gleaned through the research relates to the continuing expansion of oral DMTs, particularly as first line options.  Sanofi-Genzyme's Aubagio has seen the greatest share gains over the past several quarters.  While Biogen's Tecfidera holds on to the leading oral position and Novartis' Gilenya also remains steady, Aubagio is projected to increase significantly and, for neurologists viewing it as the "safest" oral DMT, share is significantly higher than average.  An interesting theme is emerging as well with the Sanofi-Genyzme portfolio, as neurologists with a preference for Aubagio as the go-to oral are also more likely to be users of Lemtrada.  Overall, nearly a third of the respondents reported increased use of Lemtrada in the last quarter.

But can the positive gains for Lemtrada continue with Ocrevus now in the mix?  Among those intending to use Ocrevus right away, DMTs administered by infusion are expected to see the most erosion according to the surveyed neurologists.  It may all come down to market access where neurologists expect a high degree of payer restriction for Ocrevus outside of the PPMS population.

RealTime Dynamix: Multiple Sclerosis is an independent report series published each quarter.  The series tracks the evolution of the MS market, provides a deep dive on launch effectiveness and highlights opportunities for pipeline agents.  The next wave of research will be fielded in May 2017 and will showcase the initial uptake of Ocrevus in both the PPMS and RMS settings.

About Spherix Global Insights
Spherix Global Insights is a business intelligence and market research company specializing in renal, autoimmune, neurologic and rare disease markets.  We provide clients with strategic insights leveraged from our independent studies conducted with healthcare providers and other stakeholders.

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