Mar 10, 2020   SOURCE: PR NewsWire

2020 Disease Analysis: Multiple Sclerosis - Sanofi to Co-Develop Digital Therapeutic for MS Patients

DUBLIN, March 10, 2020 /PRNewswire/ -- The "Disease Analysis: Multiple Sclerosis" report has been added to ResearchAndMarkets.com's offering.

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The research 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, Johnson & Johnson's ponesimod demonstrated somewhat positive results, although more robust efficacy and/or safety may need to be demonstrated to compete with other sphingosine-1-phosphate (S1P) modulating drugs already on the market, such as Gilenya. Finally, Gocovri, a symptomatic MS walking impairment hopeful, produced overall lackluster pivotal trial results, and Adamas is consequently revaluating pursual of the drug in MS.

Some of the most anticipated future events in the MS drug market include data for MedDay Pharmaceuticals' Qizenday (a highly concentrated formulation of D biotin), with additional pivotal trial results from the MS-SPI2 trial in progressive MS patients expected in Q1 2020. Ozanimod, another S1P-targeting drug, has a PDUFA date set for 25 March, and this may shed light on the FDA's views of another same-class DMT entering the market. Finally, results from ublituximab's pivotal trials are expected later in 2020, pointing towards another me-too drug reaching the market (in that it targets CD20).

Key Topics Covered:

1. OVERVIEW

    --  Latest key takeaways

2. DISEASE BACKGROUND

    --  Definition
    --  Patient segmentation
    --  Symptoms
    --  Risk factors
    --  Diagnosis

3. TREATMENT

    --  Summary of key treatment guideline recommendations

4. EPIDEMIOLOGY

    --  Prevalence methodology

5. MARKETED DRUGS

6. PIPELINE DRUGS

7. KEY REGULATORY EVENTS

    --  UK's NICE Not Convinced By Cannabis-Based Medicines
    --  Resubmission After Withdrawal: US FDA's Mavenclad Approval Acknowledges
        Long Regulatory History
    --  EMA Restricts Sanofi's Lemtrada Use, Initiates Risk-Benefit Review
    --  US FDA Enriches Trial Guidance With Recent Examples

8. PROBABILITY OF SUCCESS

9. LICENSING AND ASSET ACQUISITION DEALS

    --  Sanofi To Co-Develop Digital Therapeutic For MS Patients
    --  Sandoz And Polpharma Strike Global Deal For Natalizumab

10. CLINICAL TRIAL LANDSCAPE

    --  Sponsors by status
    --  Sponsors by phase
    --  Recent events

11. DRUG ASSESSMENT MODEL

12. MARKET DYNAMICS

13. FUTURE TRENDS

    --  Widespread genericization will deplete key brands' market share
    --  Key brands will face competition from pipeline me-too drugs, though
        uptake may be slow if distinguishing factors cannot be established
    --  Numerous drugs utilizing novel mechanisms for MS are in development
    --  More DMTs will become available for other MS patient populations

14. CONSENSUS FORECASTS

15. RECENT EVENTS AND ANALYST OPINION

    --  Gocovri for Multiple Sclerosis (December 17, 2019)
    --  Ponesimod for Multiple Sclerosis (September 11, 2019)
    --  Biosimilar Natalizumab (Sandoz) for Multiple Sclerosis (September 3,
        2019)
    --  Arzerra (Autoimmune) for Multiple Sclerosis (August 30, 2019)
    --  Vumerity for Multiple Sclerosis (July 30, 2019)
    --  Ponesimod for Multiple Sclerosis (July 25, 2019)
    --  Botox - Therapeutic for Multiple Sclerosis (June 25, 2019)
    --  Pear-006 for Multiple Sclerosis (May 3, 2019)
    --  GNbAC1 for Multiple Sclerosis (March 12, 2019)
    --  Lemtrada for Multiple Sclerosis (November 20, 2018)

16. KEY UPCOMING EVENTS

17. KEY OPINION LEADER INSIGHTS

    --  Quotes regarding specific drug use
    --  Quote regarding unmet needs
    --  Quote regarding pricing

18. UNMET NEEDS

    --  More effective therapies for PPMS/SPMS
    --  Development of neuroprotective/remyelinating therapies

For more information about this report visit https://www.researchandmarkets.com/r/kd2avj

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