Disease Analysis: Multiple Sclerosis
Author: Daniel Digaudio
Publisher: Datamonitor Healthcare
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LATEST KEY TAKEAWAYS
- Datamonitor Healthcare 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 & 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).
CONTENTS
7 OVERVIEW
7 Latest key takeaways
8 DISEASE BACKGROUND
8 Definition
8 Patient segmentation
9 Symptoms
10 Risk factors
10 Diagnosis
11 TREATMENT
16 Summary of key treatment guideline recommendations
19 EPIDEMIOLOGY
19 Prevalence methodology
22 MARKETED DRUGS
27 PIPELINE DRUGS
35 KEY REGULATORY EVENTS
35 AstraZeneca/MSD’s Koselugo Among 14 New Hopefuls At EMA
35 BMS Gets US Approval Of Ozanimod For Relapsing MS, But Launch Delayed
35 Teva Sues FDA For Excluding Copaxone From BLA Transition; Wants To Use Biosimilar Litigation Process
35 Keeping Track: J&J Submits Ponesimod NDA For MS
36 EU Approval Decision Delay For BMS’s Ozanimod
36 Novartis MS Drug Mayzent Gets Europe OK
36 UK’s NICE Not Convinced By Cannabis-Based Medicines
36 Resubmission After Withdrawal: US FDA’s Mavenclad Approval Acknowledges Long Regulatory History
37 EMA Restricts Sanofi’s Lemtrada Use, Initiates Risk-Benefit Review
38 PROBABILITY OF SUCCESS
39 LICENSING AND ASSET ACQUISITION DEALS
39 Bayer Returns UK Rights For Sativex Spray To GW
39 Sanofi To Co-Develop Digital Therapeutic For MS Patients
39 Sandoz And Polpharma Strike Global Deal For Natalizumab
40 CLINICAL TRIAL LANDSCAPE
41 Sponsors by status
42 Sponsors by phase
43 Recent events
45 DRUG ASSESSMENT MODEL
47 MARKET DYNAMICS
48 FUTURE TRENDS
48 Widespread genericization will deplete key brands’ market share
48 Drugs utilizing novel mechanisms for MS are in development
49 Key brands will face competition from pipeline “me-too” drugs, though uptake may be slow if distinguishing factors cannot be established
49 More DMTs will become available for other MS patient populations
50 CONSENSUS FORECASTS
54 RECENT EVENTS AND ANALYST OPINION
54 Qizenday for Multiple Sclerosis (March 10, 2020)
55 Masitinib for Multiple Sclerosis (February 20, 2020)
57 SAR442168 for Multiple Sclerosis (February 6, 2020)
58 Gocovri for Multiple Sclerosis (December 17, 2019)
59 Ponesimod for Multiple Sclerosis (September 11, 2019)
60 Biosimilar Natalizumab (Sandoz) for Multiple Sclerosis (September 3, 2019)
61 Arzerra (Autoimmune) for Multiple Sclerosis (August 30, 2019)
63 Vumerity for Multiple Sclerosis (July 30, 2019)
65 Ponesimod for Multiple Sclerosis (July 25, 2019)
66 Botox – Therapeutic for Multiple Sclerosis (June 25, 2019)
67 Pear-006 for Multiple Sclerosis (May 3, 2019)
68 GNbAC1 for Multiple Sclerosis (March 12, 2019)
70 Lemtrada for Multiple Sclerosis (November 20, 2018)
73 KEY UPCOMING EVENTS
74 KEY OPINION LEADER INSIGHTS
74 Quotes regarding specific drug use
74 Quote regarding unmet needs
74 Quote regarding pricing
76 UNMET NEEDS
76 More effective therapies for PPMS/SPMS
76 Development of neuroprotective/remyelinating therapies
77 BIBLIOGRAPHY
77 Prescription information
79 APPENDIX
LIST OF FIGURES
21 Figure 1: Trends in prevalent cases of multiple sclerosis, 2018–27
27 Figure 2: Overview of pipeline drugs for multiple sclerosis in the US
27 Figure 3: Pipeline drugs for multiple sclerosis, by company
28 Figure 4: Pipeline drugs for multiple sclerosis, by drug type
28 Figure 5: Pipeline drugs for multiple sclerosis, by classification
38 Figure 6: Probability of success in the multiple sclerosis pipeline
40 Figure 7: Clinical trials in multiple sclerosis
40 Figure 8: Top 10 drugs for clinical trials in multiple sclerosis
41 Figure 9: Top 10 companies for clinical trials in multiple sclerosis
41 Figure 10: Trial locations in multiple sclerosis
42 Figure 11: Multiple sclerosis trials status
43 Figure 12: Multiple sclerosis trials sponsors, by phase
45 Figure 13: Datamonitor Healthcare’s drug assessment summary for multiple sclerosis
47 Figure 14: Market dynamics in multiple sclerosis
48 Figure 15: Future trends in multiple sclerosis
55 Figure 16: Qizenday for Multiple Sclerosis (March 10, 2020): Phase III – MS-SPI2
57 Figure 17: Masitinib for Multiple Sclerosis (February 20, 2020): Phase IIb/III – PPMS/SPMS
59 Figure 18: Gocovri for Multiple Sclerosis (December 17, 2019): Phase III – INROADS (Walking Impairment)
60 Figure 19: Ponesimod for Multiple Sclerosis (September 11, 2019): Phase III – OPTIMUM
63 Figure 20: Arzerra (Autoimmune) for Multiple Sclerosis (August 30, 2019): Phase III – ASCLEPIOS I and II
65 Figure 21: Vumerity for Multiple Sclerosis (July 30, 2019): Phase III – EVOLVE-MS-2 (vs. Tecfidera)
66 Figure 22: Ponesimod for Multiple Sclerosis (July 25, 2019): Phase III – OPTIMUM
70 Figure 23: GNbAC1 for Multiple Sclerosis (March 12, 2019): Phase III – ANGEL-MS (RRMS)
73 Figure 24: Key upcoming events in multiple sclerosis
LIST OF TABLES
9 Table 1: Clinical subtypes of multiple sclerosis
12 Table 2: Leading disease-modifying therapies for multiple sclerosis
17 Table 3: Available DMTs and the strength of the evidence base supporting their efficacy in preventing MS relapses
20 Table 4: Prevalent cases of multiple sclerosis, 2018–27
23 Table 5: Marketed drugs for multiple sclerosis
29 Table 6: Pipeline drugs for multiple sclerosis
51 Table 7: Historical global sales, by drug ($m), 2015–19
52 Table 8: Forecasted global sales, by drug ($m), 2020–24
54 Table 9: Qizenday for Multiple Sclerosis (March 10, 2020)
56 Table 10: Masitinib for Multiple Sclerosis (February 20, 2020)
57 Table 11: SAR442168 for Multiple Sclerosis (February 6, 2020)
58 Table 12: Gocovri for Multiple Sclerosis (December 17, 2019)
59 Table 13: Ponesimod for Multiple Sclerosis (September 11, 2019)
61 Table 14: Biosimilar Natalizumab (Sandoz) for Multiple Sclerosis (September 3, 2019)
62 Table 15: Arzerra (Autoimmune) for Multiple Sclerosis (August 30, 2019)
64 Table 16: Vumerity for Multiple Sclerosis (July 30, 2019)
65 Table 17: Ponesimod for Multiple Sclerosis (July 25, 2019)
67 Table 18: Botox – Therapeutic for Multiple Sclerosis (June 25, 2019)
68 Table 19: Pear-006 for Multiple Sclerosis (May 3, 2019)
69 Table 20: GNbAC1 for Multiple Sclerosis (March 12, 2019)
70 Table 21: Lemtrada for Multiple Sclerosis (November 20, 2018)
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