Disease Analysis: Multiple Sclerosis

Disease Analysis: Multiple Sclerosis

  • May 2020 •
  • 80 pages •
  • Report ID: 5868661 •
  • Format: PDF
Latest key takeaways

The analyst estimates that in 2018, there were 2.1 million prevalent cases of multiple sclerosis (MS) worldwide, and forecasts that number to increase to 2.2 million prevalent cases by 2027.
A large selection of disease-modifying therapies (DMTs) are currently available in the MS market, with a sizable range of attributes, potencies, and safety profiles. Consequently, this set of DMTs typically can yield some relief for this chronic condition.
Utilization of first-generation DMTs, such as Avonex, Betaseron, Copaxone, and Rebif, is declining due to their comparatively poor safety, efficacy, and administration profiles versus newer DMTs. Most are genericized, but still see some use in the first-line treatment setting, particularly for less severe cases of MS and especially where payer pressure is involved.
Since Ocrevus’s launch in 2017, the drug has quickly risen to realize its gold-standard potential in the wider MS field. Its efficacy is unparalleled, and coupled with its six-month dosing regimen, the drug is popular with patients and physicians alike. As the only approved therapy for primary progressive MS (PPMS), it has little competition in this patient segment. Furthermore, Ocrevus is increasingly being prescribed at the first and second lines of treatment in other MS subtypes, and particularly in more rapidly progressing and severe cases.
Key patent litigation trials of Novartis’s Gilenya could reach a verdict either this year or in coming years, and a wave of generic versions of fingolimod could enter the market, with several generic manufacturers already achieving regulatory approvals. On the other hand, if Novartis upholds its patents as Biogen recently did for Tecfidera in February 2020, the company could potentially see associated revenues maintained until the end of the decade.
Recent key events in MS include Novartis’s anti-CD20 targeting drug, Arzerra, advancing in development. Positive pivotal trial results in 2019 put Novartis on track to file Arzerra for approval in relapsing-remitting MS (RRMS) in late 2020, potentially providing competition for Roche’s dominant Ocrevus as Arzerra has the advantage of a more appealing subcutaneous administration route.
In addition, Bristol Myers Squibb’s Zeposia, a sphingosine-1-phosphate (S1P) modulator, was recently approved for relapsing MS, providing competition for rival S1P drugs Gilenya and Mayzent. Johnson and Johnson’s pipeline asset ponesimod demonstrated somewhat positive results, although more robust efficacy and/or safety may need to be demonstrated to compete with the numerous S1P-modulating drugs already on the market. Finally, Gocovri, a symptomatic MS walking impairment hopeful, produced overall lackluster pivotal trial results, and Adamas is consequently re-evaluating pursual of the drug in MS.
Among the most anticipated future events expected this year in the MS drug market is the expected PDUFA decision for Novartis’s subcutaneous anti-CD20 monoclonal antibody, Arzerra, in June 2020. Additionally, ublituximab’s pivotal trial results are expected later in the year, potentially pointing towards another “me-too” drug reaching the market (in that it targets CD20).