Disease Analysis: Multiple Sclerosis
Author: Daniel Digaudio
Publisher: Datamonitor Healthcare
- Description
- Contents
- Enquire
Definition
Multiple sclerosis (MS) is widely recognized as the most common neurological and inflammatory disorder of the central nervous system (CNS) in the adult population. It is a chronic, recurrent, progressive autoimmune disorder characterized by repeated episodes of inflammation of the white matter nervous tissue of the CNS. The location of the inflammation varies from person to person and from episode to episode, and as such, results in a variety of clinical symptoms. The periventricular regions, optic nerves, brainstem, cerebellum, and spinal cord are common locations for inflammation in MS. The average age for disease onset is 30 years, with women being twice as likely to develop MS compared to men.
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 from 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-monthly 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.
- Long-awaited decisions have come from the key patent litigation trials of former blockbuster DMTs. In 2020 it was ruled that Biogen’s ‘514 patent, protecting Tecfidera until 2028, was invalid. This paved the way for Mylan to gain FDA approval for its dimethyl fumarate generic and launch the drug in rapid succession.
- Novartis fared better in litigation trials, as a US district court upheld the validity of the Gilenya dosing regimen patent, which is set to expire in December 2027 (inclusive of the pediatric exclusivity extension). However, Novartis has previously settled agreements with some generic drug companies, and generic fingolimod will likely enter the market before the expiration of the Gilenya patent. Nevertheless, at least for the next few years, Novartis will enjoy exclusivity for its blockbuster oral MS therapy.
- Bristol Myers Squibb’s Zeposia, a sphingosine-1-phosphate (S1P) receptor modulator, was approved in 2020 for relapsing forms of multiple sclerosis (RMS), and will provide stiff competition for rival S1P drugs Gilenya and Mayzent. Meanwhile, market penetration may be difficult for Johnson & Johnson’s Ponvory, which was approved in March 2021. As another S1P receptor modulator, the drug lacks a clearly distinguished profile from its rivals.
- Another recent event in the MS space was Novartis’s anti-CD20 targeting drug Kesimpta receiving FDA approval for the treatment of RMS in adults. This positions the drug as a direct market competitor of Roche’s dominant Ocrevus, though Roche has the underserved PPMS segment contained in the Ocrevus label. Kesimpta, however, has the advantage of a more appealing subcutaneous administration route.
- High-impact upcoming events for drugs in the MS space that are expected by the end of 2021 include an EU approval decision for Vumerity and Phase II topline results for elezanumab.
CONTENTS
8 OVERVIEW
8 Latest key takeaways
9 DISEASE BACKGROUND
9 Definition
9 Patient segmentation
10 Symptoms
11 Risk factors
11 Diagnosis
12 TREATMENT
16 Summary of key treatment guideline recommendations
19 EPIDEMIOLOGY
19 Prevalence methodology
22 MARKETED DRUGS
27 PIPELINE DRUGS
35 KEY REGULATORY EVENTS
35 Tysabri Stays IV, For Now
35 NICE Funding Wins For Enhertu & Kesimpta Are Firsts For England
35 Breakthrough Device That Improves Gait In People With MS Authorized By FDA
35 CHMP Recommends EU-Wide Approval Of Ponvory
36 Janssen’s Newly Approved Ponvory Joins Crowded MS Space
36 Teva Under Investigation For Creating ‘False Perceptions’ Of Generics
36 FDA Approves Intramuscular Formulation For Plegridy
37 Novartis Wins EU Thumbs Up For MS Treatment
37 Diroximel Fumarate Among New EU Filings
37 NICE OKs Sarclisa & Mayzent For Funding In England, But Rejects Vindaqel
38 Novartis’s Kesimpta Goes Up Against Roche’s Ocrevus In MS
38 EMA To Revisit Rejection Of Elzonris & Gamifant
38 Updated: Mylan Presses On With US Tecfidera Launch ‘At Risk’
38 Resubmission Of NDA For Osmotica’s Arbaclofen Extended Release
39 English Funding Setback For Novartis’s Mayzent
39 Novartis’s MS Franchise Setback For Ofatumumab In US
39 Mylan Pulls Generic Gilenya Application Over Study Concerns
40 New Approvals In Spotlight As China Gears For National Congress
40 MAA Withdrawals
41 PROBABILITY OF SUCCESS
42 LICENSING AND ASSET ACQUISITION DEALS
42 Sorrento Acquires Abivertinib Partner ACEA
42 Lilly Broadens Its CNS Reach With Rigel RIPK1 Deal
42 Jazz Wades Into Cannabinoid Weeds With $7.2bn GW Buy
43 Clene Nanomedicine Goes Public In SPAC Buyout
43 MyMD Goes Public Through Reverse Merger With Akers
43 Cytocom Goes Public Via Merger With Cleveland BioLabs
43 Progentec Licenses University IP For MS-Related DX Products
44 Bristol Opts To Expand Celgene Partnership With Dragonfly
45 CLINICAL TRIAL LANDSCAPE
46 Sponsors by status
47 Sponsors by phase
48 Recent events
50 DRUG ASSESSMENT MODEL
50 Genericized DMTs
50 Anti-CD20 drugs
51 S1P receptor modulator drugs
51 Pipeline drugs
53 MARKET DYNAMICS
54 FUTURE TRENDS
54 Widespread genericization will deplete key brands’ market share
54 Drugs utilizing novel mechanisms for MS are in development
54 Key brands will face competition from pipeline “me-too” drugs, though uptake may be slow if distinguishing factors cannot be established
55 More DMTs will become available for underserved MS patient populations
56 CONSENSUS FORECASTS
61 RECENT EVENTS AND ANALYST OPINION
61 Ontinua ER for Multiple Sclerosis (December 29, 2020)
61 Ublituximab for Multiple Sclerosis (December 10, 2020)
62 Analyst Opinion
63 Opicinumab for Multiple Sclerosis (October 21, 2020)
65 IMU-838 for Multiple Sclerosis (August 2, 2020)
67 SAR442168 for Multiple Sclerosis (April 23, 2020)
69 Qizenday for Multiple Sclerosis (March 10, 2020)
70 Masitinib for Multiple Sclerosis (February 20, 2020)
72 SAR442168 for Multiple Sclerosis (February 6, 2020)
73 Gocovri for Multiple Sclerosis (December 17, 2019)
76 KEY UPCOMING EVENTS
77 KEY OPINION LEADER INSIGHTS
77 Quotes regarding specific drug use
77 Quote regarding unmet needs
77 Quotes regarding pricing
79 UNMET NEEDS
79 More effective therapies for PPMS/SPMS
79 Development of neuroprotective/remyelinating therapies
80 BIBLIOGRAPHY
81 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
41 Figure 6: Probability of success in the multiple sclerosis pipeline
45 Figure 7: Clinical trials in multiple sclerosis
45 Figure 8: Top 10 drugs for clinical trials in multiple sclerosis
46 Figure 9: Top 10 companies for clinical trials in multiple sclerosis
46 Figure 10: Trial locations in multiple sclerosis
47 Figure 11: Multiple sclerosis trials status
48 Figure 12: Multiple sclerosis trials sponsors, by phase
50 Figure 13: Datamonitor Healthcare’s drug assessment summary for multiple sclerosis
53 Figure 14: Market dynamics in multiple sclerosis
54 Figure 15: Future trends in multiple sclerosis
63 Figure 16: Ublituximab for Multiple Sclerosis (December 10, 2020): Phase III – ULTIMATE I, Phase III – ULTIMATE II
65 Figure 17: Opicinumab for Multiple Sclerosis (October 21, 2020): Phase IIb – AFFINITY
67 Figure 18: IMU-838 for Multiple Sclerosis (August 2, 2020): Phase II – EMPhASIS
69 Figure 19: SAR442168 for Multiple Sclerosis (April 23, 2020): Phase IIb – Dose Finding
70 Figure 20: Qizenday for Multiple Sclerosis (March 10, 2020): Phase III – MS-SPI2
72 Figure 21: Masitinib for Multiple Sclerosis (February 20, 2020): Phase IIb/III – PPMS/SPMS
75 Figure 22: Gocovri for Multiple Sclerosis (December 17, 2019): Phase III – INROADS (Walking Impairment)
76 Figure 23: Key upcoming events in multiple sclerosis
LIST OF TABLES
10 Table 1: Clinical subtypes of multiple sclerosis
13 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 in the US
57 Table 7: Historical global sales, by drug ($m), 2016–20
59 Table 8: Forecasted global sales, by drug ($m), 2021–25
61 Table 9: Ontinua ER for Multiple Sclerosis (December 29, 2020)
62 Table 10: Ublituximab for Multiple Sclerosis (December 10, 2020)
64 Table 11: Opicinumab for Multiple Sclerosis (October 21, 2020)
66 Table 12: IMU-838 for Multiple Sclerosis (August 2, 2020)
68 Table 13: SAR442168 for Multiple Sclerosis (April 23, 2020)
69 Table 14: Qizenday for Multiple Sclerosis (March 10, 2020)
71 Table 15: Masitinib for Multiple Sclerosis (February 20, 2020)
73 Table 16: SAR442168 for Multiple Sclerosis (February 6, 2020)
74 Table 17: Gocovri for Multiple Sclerosis (December 17, 2019)
© Informa UK Ltd. This document is a licensed product and is not to be reproduced or redistributed
Do you have a subscription to Datamonitor Healthcare, Biomedtracker or Meddevicetracker? You may already have access to these reports, contact your account manager or email pharma@informabi.com for further help or assistance.
Disease Analysis: Meningococcal Vaccines 
Sign up to the